• 21 Sep 2020 4:58 PM | Anonymous

    By: Jamie Sullivan and Brooke Jacobson, PharmD Candidates 2021, UMKC School of Pharmacy

    Mentor: E. Claire Elson, PharmD, BCPPS; Children’s Mercy Kansas City


    Cystic fibrosis (CF) is an autosomal recessive genetic disorder caused by dysfunction in the cystic fibrosis transmembrane conductance regulator (CFTR) protein. As a result, abnormal, viscous secretions primarily affect the gastrointestinal and respiratory system in people with CF.1 These secretions cause a complex respiratory triad of increased inflammation, obstruction, and infection that may eventually lead to bronchiectasis, parenchymal destruction, and increased morbidity and mortality.1

    While there have been significant advances in therapies to treat the underlying cause of CF over the last decade, a major focus of treatment remains the prevention and treatment of acute and chronic infection in the airways.1 A mainstay of treating airway infections in CF is the utilization of antibiotic therapy. However, because CF individuals have altered airway pathophysiology and require increased treatment, individuals are at risk of resistant infections. A child with CF may develop chronic infections and become colonized with certain organisms such as Staphylococcus aureus and Haemophilus influenzae which eventually causes damage to the lungs.3 Consequently, this allows the introduction of more virulent pathogens such as Pseudomonas aeruginosa, Burkholderia species, Achromobacter, and Stenotrophomonas maltophila to infect the lungs of the individual. Because chronic infection with P. aeruginosa is associated with lung function decline and mortality in CF patients,3 utilization of antimicrobial stewardship in the early stages of CF is imperative for slowing the progression of disease.

    In every patient, it is important to practice proper antimicrobial stewardship. Most institutions use an institutional-specific antibiogram to guide antimicrobial empiric therapy. However, this can be difficult in special populations like CF as most institutions do not include CF cultures in their antibiogram. Not having access to a CF-specific antibiogram can lead to inappropriate and improper antibiotic selection and potentially increased rates of resistance. Therefore, Children’s Mercy Kansas City (CMKC) Cystic Fibrosis Center developed a CF-specific antibiogram to guide antimicrobial selection and monitor changes in susceptibility patterns over time.


    This was a single center, retrospective, observational study beginning in 2015 and extending to 2026. To conduct this study, approval was obtained from the Institutional Review Board. This report includes a five-year interim data analysis from 2015-2019. The primary objective was to develop a CF-specific antibiogram at CMKC in order to guide empiric antimicrobial selection and treatment. Secondary objectives included a comparison of the institutional antibiogram with the CF-specific antibiogram in order to characterize differences in susceptibilities and changes of susceptibility patterns over time. CF patient culture data collection started in 2015. All CF patient cultures, obtained by sputum or deep pharyngeal swab, obtained at CMKC were included in the CF antibiogram. Patients were identified via a microbiology report. The following data were collected: demographics, microorganism isolated, and susceptibility information. Susceptibility information was reported for methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa (PA), Achromobacter, Stenotrophomonas maltophila, and Burkholderia species. CMKC hospital-wide (HW) antibiogram and CF-specific antibiogram were compared. Descriptive statistics and Fisher’s exact test for categorical data were utilized for analysis.


    At CMKC, the CF-specific antibiogram has been reviewed and published from 2015-2019 in conjunction with the institutional antibiogram. The MSSA, MRSA and PA isolates collected from expectorated sputum or deep pharyngeal swab in the CF population were compared to the CMKC HW antibiogram.

    Over the five-year period there was a total of 6864 cultures with MSSA and 3202 cultures with MRSA isolated in both CF and HW antibiograms. Overall, MSSA and MRSA CF isolates were less susceptible compared to HW isolates for every antimicrobial tested. Clindamycin was significantly less susceptible in the CF population compared to the HW population for MSSA (71% vs. 79%, p=0.25) and MRSA (39% vs. 83%, p<0.001). MRSA was found at a higher rate in the HW isolates compared to the CF isolates (33% versus 27.5%). These results are summarized in the table below.

    PA was the most prevalent gram-negative isolate seen among CF cultures, with 480 isolates identified over the five-year period. The PA isolates were less susceptible in CF cultures than in the CMKC HW population for every antimicrobial tested. The difference was most significant for aminoglycoside antibiotics in the CF population compared to the HW population for amikacin (71% vs. 99%, p<0.0001), gentamicin (71% vs. 93%, p<0.0001), and tobramycin (87% vs. 97%, p=0.0165). These results are summarized in the table below.


    Overall, gram-positive and gram-negative microorganisms isolated from CF cultures were less susceptible when compared to the CMKC hospital-wide antibiogram. Furthermore, there did not appear to be significant changes in susceptibility patterns throughout this five-year interim analysis. At CMKC, the CF-specific antibiogram will continue to be reviewed and published each year with our institutional antibiogram. It will continuously be utilized to guide empiric antibiotic therapy selection for individuals with CF. The development of a CF-specific antibiogram has important clinical implications to guide empiric antimicrobial selection, and its development will allow for monitoring of resistance trends over time.


    1. Paranjape SM, and Mogayzel PJ. Cystic Fibrosis. Pediatrics in Review. 2014;35;194. DOI: 10.1542/pir.35-5-194.
    2. Bhagirath AY, Li Y, Somayajula D, et al. Cystic Fibrosis Lung Environment and Pseudomonas Aeruginosa Infection. BMJ Pulm Med. 2016; 16: 175. DOI: 10.1186/s12890-016-0339-5.
    3. Lyczak JB, Cannon CL, Pier GB. Lung Infections Associated with Cystic Fibrosis. Clin Microbiol Rev. 2002; 15(2): 194-222. DOI: 10.1128/CMR.15.2.194-222.2002.
  • 21 Sep 2020 4:35 PM | Anonymous

    By: Nirali Ragha and Yostena Khalil, PharmD Candidates 2022; St. Louis College of Pharmacy at University of Health Sciences and Pharmacy in St. Louis

    Mentor: Nausheen Hasan, PharmD, BCPPS; St. Louis Children’s Hospital

    Spinal muscular atrophy, more commonly known as SMA, is a genetic disease. This disease primarily effects muscles; muscles start to get smaller, or atrophy, because nerve cells located in the spinal cord are not stimulating them. This atrophy hinders the patient's ability to eat, walk, or breathe. SMA is characterized by four different categories ranging from type 1 to type 4. The earlier in the age that a baby is diagnosed with SMA, the greater the impact on their motor function. Genetic testing (tests for any

    variations in the SMN1 gene) and a muscle biopsy are both methods of diagnosing a pediatric patient with SMA; as of January 2019, SMA is now on the newborn screening for Missouri.1 The most severe type of SMA is type 1, which includes babies diagnosed at birth or in infancy.2 Pediatric patients with type 1 SMA have a life expectancy of fewer than 2 years.2 With the addition of new treatments, the survival rates in pediatric patients have improved tremendously, but at an extraordinary cost. Nusinersen (Spinraza) costs about $708,000 in the first year of treatment and about $354,000 in subsequent years due to it being a long-life therapy.3 Another treatment on the market is onasemnogene abeparvovec (Zolgensma), which retails at about $2.125 million dollars, but insurers have the ability to pay $425,000 a year for five years; however, coverage varies based on patient’s insurance.3

    Zolgensma has a targeted approach by selecting the genetic root cause of SMA. It replaces the Survival of Motor Neuron 1 (SMN1) gene that is nonfunctioning. The SMN1 gene constitutes the critical point in making SMN protein, which is essential to the survival of the motor neuron cell.4 If the motor neuron cell is dead, then it will cause the muscles to weaken so that breathing, eating, and moving would become extremely difficult. Zolgensma is made up of a working copy of a human SMN gene. This gene is placed inside a vector.5 The vector then takes the new working human SMN gene to the motor neurons cell body. The vector is made from a particular virus that is known as adeno-associated virus 9 (AAV9).5 This particular vector is not seen as a foreign pathogen, thus our immune system does not attack it. Once the human SMN gene reaches its destination in the motor neurons cell body, it prompts the motor neuron to start producing SMN protein. Since the motor neuron will not be able to produce a sufficient amount of SMN protein, the motor neurons that have not died off will be able to survive.

    Spinraza works by penetrating the central nervous system. In order to penetrate the central nervous system, children receive intrathecal injection through a lumbar puncture. Spinraza then uses the spinal fluid to move through the central nervous system. Children with SMA have a difficult time relaying messages from the brain to the motor cells. While taking Spinraza, the spine will act as a tunnel to relay motor messages from the brain to the body in a quicker motion. It contains an antisense oligonucleotide (ASO) which controls the mutations that are present in the affected chromosomes.6 The binding then targets RNA and regulates gene expression. This regulation then has the potential to enhance the functional SMN proteins.5

    During phase 3 of a trial for Spinraza, called ENDEAR, there were 121 patients (age ≤ 7 months) with early-onset of SMA who received their first-time dose of Spinraza. The primary endpoint of this trial was to see if Spinraza could decrease the need for permanent ventilation and meeting the criteria for motor milestone responders using HINE-2 compared to patients not receiving treatment at all. The study found that 61% of patients on Spinraza survived without the need for permanent ventilation, compared to patients who were not receiving treatment.7 In addition, 51% of treated patients compared to 0% of untreated patients achieved the motor milestone responder criteria, which are defined by an HINE-2 score at 9 months. Patients on Spinraza achieve full head control, supine to prone rolling, independent sitting, and standing.6 The study also found that over time patients who were treated with Spinraza continued to improve quality of life, compared to patients who were untreated and saw a decline in motor milestones.

    In the STR1VE clinical study for Zolgensma, 22 patients with SMA type 1 received a therapeutic dose of Zolgensma at an average mean age of 3.7 months.8 The results of this study showed that 91% of patients who received Zolgensma were alive and did not require any permanent breathing support at the age of 14 and 18 months. The result of patients who were able to sit without any assistance for at least 30 seconds at the age of 18 months was 59%.8 In addition, about 95% of patients achieved a CHOP INTEND score (a scoring system that measures motor function) of at least 40, which has a scale of 0-64 where higher scores indicate better motor function.8

    Spinal muscular atrophy is an extremely dangerous genetic disease, and patients who have it have a very low rate of survival. Patients may be placed permanently on ventilators, and their ability to eat and walk may be hindered, as well. Fortunately, Spinraza and Zolgensma can improve both the quality and life span for these patients, but at a great cost. The STRIVE and ENDEAR trials have shown that Zolgensma and Sprinraza are effective for the treatment of SMA. Unfortunately, both these drugs are high-priced, and insurance may not be readily available for everyone.


    1. Spring 2019 SMA newborn screening update - cure SMA. Curesma.org. https://www.curesma.org/spring-2019-sma-newborn-screening-update/. Published May 13, 2019. Accessed September 4, 2020.
    2. Diseases - SMA - top level | muscular dystrophy association. Mda.org. https://www.mda.org/disease/spinal-muscular-atrophy. Published December 2015. Accessed August 29, 2020.
    3. Cost comparison. Pharmacoeconomic Review Report: Nusinersen (Spinraza): (Biogen Canada Inc.): Indication: Treatment of patients with 5q SMA [Internet]. https://www.ncbi.nlm.nih.gov/books/NBK534119. Accessed August 29, 2020.
    4. Stein R. At $2.1 million, new gene therapy is the most expensive drug ever. NPR. https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever. Published May 2019. Accessed August 29, 2020.
    5. ZOLGENSMA® (onasemnogene abeparvovec-xioi). Zolgensma.com. https://www.zolgensma.com/how-zolgensma-works?gclid=Cj0KCQjw3s_4BRDPARIsAJsyoLNqlX22nDesFFWkmtE-UhRzhDnGBuAWDQzpMCuG-dgA8GTZial9JJkaAuhvEALw_wcB. Accessed August 29, 2020.
    6. FDA approves SPINRAZA. Accp1.org. https://www.accp1.org/accp1/5publications_and_news/fda_approves_spinraza.aspx. Accessed August 29, 2020.
    7. Early-onset SPINRAZA® (nusinersen) Efficacy | HCP. Spinraza-hcp.com. https://www.spinraza-hcp.com/en_us/home/why-spinraza/early-onset-efficacy.html. Accessed August 29, 2020.
    8. ZOLGENSMA® (onasemnogene abeparvovec-xioi). Zolgensma.com. https://www.zolgensma.com/clinical-studies. Accessed August 29, 2020.
  • 21 Sep 2020 4:08 PM | Anonymous

    By: Samira Zantout, PharmD Candidate 2021; UMKC School of Pharmacy

    Mentors: Jamie Rouch, PharmD, BCPPS and Jean Freudenthal, PharmD; Children’s Mercy Kansas City

    How many vaccines have you received in your lifetime? Following the Centers for Disease Control and Prevention (CDC) recommendations, the average person receives over 30 doses of vaccinations by the age of 18 and that is not counting the annual influenza vaccine.10 Completing and staying up to date on different vaccination series is an investment into building long-term immunity against vaccine-preventable diseases. However, it can be a lengthy time commitment, especially for patients that have to redo their entire vaccination schedules. This is the reality for patients that receive a hematopoietic stem cell transplant (HSCT). 2,4

    HSCT is a procedure in which hematopoietic stem cells are harvested from a donor (termed allogeneic) or from the patient (termed autologous) and then transfused intravenously into the patient. Ultimately, the newly transfused cells will travel and reach the bone marrow, where they can completely take over or enhance the functionality of the patient’s bone marrow to produce new blood cells.6 With almost 84,000 stem cell transplants completed worldwide every year, the number of living HSCT recipients is on the rise.8 A growing number of those living recipients are pediatric patients.

    The role of HSCT in the pediatric population has widely expanded over the past two decades to go beyond conventional, oncological indications like leukemias and lymphomas.4,5,6 In fact, one-third of pediatric patients undergo HSCT to treat a variety of non-oncological disorders, such as sickle cell anemia, metabolic disorders, and immune deficiencies like beta thalassemia.4,5,6 While the procedure aims to replace defective cell lines and ultimately improve the patient’s impaired immune system, it comes with numerous risks and complications the transplant team must address. For example, serious infections have been shown to account for 4- 20% of late deaths after receiving an HSCT and infections are the leading cause of posttransplant complications.6 Due to the complete dissolution of the recipient’s current immune system and the slow reconstitution process over 1 to 2 years to recover those immune defenses, the risk of developing an infection or contracting communicable diseases is the highest in those first 2 years after the transplant.4,5,6 This is especially true for vaccine-preventable diseases.

    HSCT-recipients lose their antibody titers to vaccine-preventable diseases like tetanus, polio, measles, mumps, rubella, and others within months to 10 years post-transplant if they are not revaccinated.2,3,7 Moreover, this gradual loss of immunity is affected and

    can be accelerated by several factors, including chemotherapy regimens, immunosuppressive regimens, the type of HSCT, and the source of the received stem cells, among other factors.2,3,7 Previous studies have noted that HSCT recipients have a nearly 50-fold increased incidence of invasive pneumococcal disease compared to the general population, with a case-fatality rate of 10-20%.5 Similarly, studies on influenza infections have noted significant morbidity and mortality rates as high as 15- 17% in HSCT-recipients.5 While this reality impacts HSCT-recipients of all ages, the pediatric population is particularly vulnerable.

    Pediatric HSCT recipients may not have completed many of their vaccination series prior to the transplant due to young age or disease-associated morbidity and, as a result, may not have built up any pre-transplant immunity.3,5,6 Combined with post-transplant immunosuppressive regimens that can further diminish vaccine-induced immunity, recent occurrence of vaccine-preventable disease outbreaks, a decline in vaccine coverage among the pediatric population, and the exposure risks that naturally accompany daycare or school entry, pediatric HSCT-recipients are at a significant risk of contracting vaccine-preventable diseases.3,5,6,7 Working proactively to minimize this risk is imperative for this population. The most effective, proactive measure health care providers can take to combat vaccine-preventable diseases is quite simple: revaccination. This is a paramount initiative where pharmacists can lead a phenomenal impact.

    While the concept of revaccinating all HSCT-recipients seems simple enough in theory, many HSCT recipients remain unvaccinated, are vaccinated late, or undergo an incomplete schedule of vaccinations after their transplant.1,4,6 The most common reasons for these gaps in care include poor documentation of vaccine administration, loss to follow-up with other providers, and conscious deferral by clinicians.1 HSCT recipients follow a unique vaccination schedule that pharmacists can familiarize themselves with and utilize to identify the optimal timing and the best candidate for each vaccination (see IDSA’s Clinical Practice Guideline for Vaccination of the Immunocompromised Host).9 As pharmacists, we are optimally placed in healthcare institutions and in community settings to identify these vulnerable patients and recommend appropriate vaccinations. We can be their vocal advocates to prevent deviating from the recommended vaccination schedule. Moreover, we can be the safety net to catch those missed vaccination opportunities so that they do not fall through the cracks.


    1. Ariza-Heredia, E.j., A.m. Gulbis, K.r. Stolar, P. Kebriaei, D.p. Shah, K.k. Mcconn, R.e. Champlin, and R.f. Chemaly. “Vaccination Guidelines after Hematopoietic Stem Cell Transplantation: Practitioners' Knowledge, Attitudes, and Gap between Guidelines and Clinical Practice.” Transplant Infectious Disease 16, no. 6 (2014): 878–86. https://doi.org/10.1111/tid.12312.
    2. Tsang, Vivian. “Vaccination Recommendations for the Hematology and Oncology and Post–Stem Cell Transplant Populations.” Journal of the Advanced Practitioner in Oncology 3, no. 2 (2012). https://doi.org/10.6004/jadpro.2012.3.2.2.
    3. Bunin, Nancy, Trudy Small, Paul Szabolcs, K. Scott Baker, Michael A. Pulsipher, and Troy Torgerson. “NCI, NHLBI/PBMTC First International Conference on Late Effects After Pediatric Hematopoietic Cell Transplantation: Persistent Immune Deficiency in Pediatric Transplant Survivors.” Biology of Blood and Marrow Transplantation 18, no. 1 (2012): 6–15. https://doi.org/10.1016/j.bbmt.2011.11.014.
    4. Chong, Pearlie P., and Robin K. Avery. “A Comprehensive Review of Immunization Practices in Solid Organ Transplant and Hematopoietic Stem Cell Transplant Recipients.” Clinical Therapeutics 39, no. 8 (2017): 1581–98. https://doi.org/10.1016/j.clinthera.2017.07.005.
    5. Dulek, Daniel E., Annabelle De St. Maurice, and Natasha B. Halasa. “Vaccines in Pediatric Transplant Recipients-Past, Present, and Future.” Pediatric Transplantation 22, no. 7 (2018). https://doi.org/10.1111/petr.13282.
    6. Jesudas, Rohith, Aimee Malesky, Roland Chu, Howard Fischer, and Deepak Kamat. “Reviewing the Follow-up Care of Pediatric Patients’ Status Post–Hematopoietic Stem Cell Transplantation for the Primary Care Pediatrician.” Clinical Pediatrics 52, no. 6 (2013): 487–95. https://doi.org/10.1177/0009922813483361.
    7. Ljungman, Per. “Viral Infections in Hematopoietic Stem Cell Transplant Recipients.” Allogeneic Stem Cell Transplantation, 2009, 505–32. https://doi.org/10.1007/978-1- 59745-478-0_29.
    8. Niederwieser, Dietger, Helen Baldomero, Yoshiko Atsuta, Mahmoud Aljurf, Adriana Seber, Hildegard T. Greinix, Mickey Koh, et al. “One and Half Million Hematopoietic Stem Cell Transplants (HSCT). Dissemination, Trends and Potential to Improve Activity By Telemedicine from the Worldwide Network for Blood and Marrow Transplantation (WBMT).” Blood 134, no. Supplement_1 (2019): 2035–35. https://doi.org/10.1182/blood-2019-125232.
    9. Rubin, Lorry G., Myron J. Levin, Per Ljungman, E. Graham Davies, Robin Avery, Marcie Tomblyn, Athos Bousvaros, et al. “2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host.” Clinical Infectious Diseases 58, no. 3 (2013). https://doi.org/10.1093/cid/cit684.
    10. “Birth-18 Years Immunization Schedule.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, February 3, 2020. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html.

  • 21 Sep 2020 4:04 PM | Anonymous

    By: Jackie A. Harris, PharmD, BCPS; Executive Director, MSHP Research & Education Foundation

    Dr. Joseph Walter, a PGY2 Ambulatory Care resident at CoxHealth this past residency year, was awarded the Best Resident Project during the Virtual KCHP/MSHP Spring Meeting for his project entitled “Impact of Pharmacist-led Education on Providers’ Prescribing Rates and Perceptions of Naloxone in High-Risk Opioid Patients”. With the number of naloxone prescriptions increasing by 106% from 2017 to 2018, one would expect to see that same correlation in our high-risk patient populations. Unfortunately, that is not the case with only one naloxone prescription for every 69 high-dose opioid prescription.

    This prospective, observational study was conducted to evaluate the impact of pharmacist-led education had on providers’ naloxone prescription rates. In addition, the study also assessed providers’ perceptions of naloxone in high-risk patients after pharmacist-led education. Provider perceptions of naloxone in high-risk patients was assessed before and after education utilizing a Likert scale. Providers across three primary care clinics were sent an online link to pharmacist-led education on how to identify high-risk opioid patients and how to order naloxone for those patients. The

    percentage of naloxone prescriptions for high-risk opioid patients were evaluated six months before education and six months after education to evaluate the effectiveness of the pharmacist-led education.

    High-risk patients were defined as being 18 years or older with chronic pain receiving > 50 morphine milligram equivalent (MME). Additionally those patients 65 years or older receiving < 50 MME/day with either kidney, liver, and/or respiratory disease, concurrent use of benzodiazepines, and a history of substance use disorder were also considered high-risk.

    The naloxone prescription rate in these three primary care clinics was 8% before pharmacist education and then 6% post education. Note this data was derived from 3 months. Provider perceptions of naloxone in high-risk opioid patients was assessed by the following survey questions:

    1. How likely are you to identify patients at high-risk for overdose on opioids for chronic pain?
    2. How likely are you to prescribe naloxone for high-risk patients on opioids for chronic pain?
    3. How likely are you to provide education to patients who may initially refuse a prescription for naloxone?
    4. How likely are you to incorporate a pharmacist into the patient care team for naloxone education?

    Based upon the survey results, pharmacist-led education did improve their ability to identify patients at a high-risk for overdose on opioids for chronic pain, increased the likelihood of physicians prescribing naloxone alongside opioids in patients with chronic pain that are high-risk, and increased the ability of the providers to provide education on naloxone.

    This study highlighted the need for pharmacist education on naloxone prescribing for high-risk opioid patients and showed the impact of that education. The pharmacists will continue to work alongside those physicians at the primary care clinics and make recommendations to prescribe naloxone in those high-risk opioid patients.

    If you have any questions about Dr. Walter’s project, please contact him at joseph_walter@my.uri.edu.

  • 31 Jul 2020 1:53 PM | Anonymous

    By: Elaine Ogden, PharmD, BCPS, BC-ADM

    Each year, the MSHP Treasurer has the responsibility to provide a financial report to its membership. The fiscal year is July 1 through June 30th which coincides with the policy development process and timetable. The report below describes MSHP past and project financial performance.

    Fiscal Year Ending June 30, 2020 (actual)

    The internal audit team will plan on conducting a review of the finances in Fall when we can meet inperson. This is generally completed in May during the board live meeting, but was postponed this year due to COVID. The internal audit will review all finances covering the entire fiscal year. The external audit was also postposed due to the pandemic, but the plan is to complete this during the next year.

    As of June 30, 2020, the MSHP balance sheet reported total assets at $175,986 with a net income of $6,896 for the fiscal year. For the fiscal year the organization collected over $20,000 in membership dues. The FIRST EVER VIRTUAL Spring Meeting had a net income of over $12,000.

    Fiscal Year Ending June 30, 2021 (projected)

    The board met virtually in July to finalize and approve the 2020-2021 budget which noted a surplus of $5,700. Most notable changes for 2020-2021 include addition of a 50 year celebration in the Fall, additional social media resources for public relation outreach campaigns, and small increase in operating fees for online transitions.

    It is exciting to see how MSHP continues to grow and expand. I feel blessed to have the opportunity to serve on the Executive Board and as the Treasurer of an organization that is committed to supporting its members and our profession.

  • 28 Jul 2020 3:54 PM | Anonymous

    By: Brenda Gleason, Interim Dean of Pharmacy 

    As we close out the 2019-20 academic year at St. Louis College of Pharmacy, we are reflecting on a year filled with extraordinary accomplishments and challenges.

    Over the past 12 months, we have seen our institution recognized nationally as the top college in the U.S. for return on investment at 15 and 20 years after enrollment, and we’ve watched as extensive growth in our research initiatives has continued, with the College earning honors as the top-ranked private college of pharmacy in the nation for National Institutes of Health grant funding.

    Amid this incredible recognition for the College, we, like other colleges and universities nationwide, also have been navigating unique challenges stemming from the Coronavirus 2019 (COVID-19) pandemic.

    In March, the College moved quickly to an online learning format to protect the health and safety of campus community. Over the past several months, I have been enormously proud of how well our students, faculty and staff have adapted and excelled during this challenging time, especially our 2020 graduates. With our traditional May Commencement postponed due to the pandemic, we look forward to recognizing the achievements of these talented and dedicated graduates this fall.

    As the College pivoted to online learning, faculty in the School of Pharmacy went above and beyond to transition their curriculum and develop new and innovative methods to educate student pharmacists, and I can’t thank them enough for their tireless efforts.

    In addition, as the Washington University Medical Campus established hospital surge plans this spring, several faculty members from the Department of Pharmacy Practice volunteered for surge teams that were on standby to provide medication expertise and lead critical medication management in the event that the COVID-19 pandemic reached crisis status in the St. Louis area. Those who volunteered their services included:

    • Anastasia Armbruster, Pharm.D., AACC, BCPS, BCCP, associate professor of pharmacy practice
    • Yvonne Burnett, Pharm.D., assistant professor of pharmacy practice, Infectious Diseases/Outpatient Antibiotic Team
    • Laura Challen, Pharm.D., MBA, BCPS, BCACP, associate professor of pharmacy practice
    • Patrick Finnegan, B.S. ’02, Pharm. D. ’03, BCPS, associate professor of pharmacy practice
    • Alexandria Garavaglia-Wilson, Pharm.D., BCPS (AQ ID), associate professor of pharmacy practice
    • Michelle Jeon, Pharm.D., BCACP, assistant professor of pharmacy practice
    • Paul Juang, Pharm.D., BCPS, BCCCP, FASHP, FCCM, professor of pharmacy practice
    • Scott Micek, Pharm.D., FCCP, BCPS, professor and director of the College’s Center for Health Outcomes and Education
    • Sara Richter, Pharm. D. ’12, BCPS, assistant professor of pharmacy practice
    Over the past several months, College faculty have also continued to provide dedicated service to their patients, both in-person and remotely, underscoring the important role that pharmacists play in providing access to health care for patients across the country.

    During the pandemic, we have also seen numerous students and alumni step up to serve their patients and communities. From our students, who continue to work in pharmacy internships at local hospitals and in community pharmacies across Missouri and Illinois, to our alumni, who have gone above and beyond to provide access to essential COVID-19 testing for the region’s most vulnerable populations, I continue to be amazed by the many efforts of those in our College community.

    While the COVID-19 pandemic has transformed much of our work since early spring, the 2019-20 academic year saw the successful implementation of our four health care-focused bachelor’s degrees as standalone programs:

    • Bachelor of Arts in Global Health
    • Bachelor of Arts in Medical Humanities with a choice of emphasis in Interdisciplinary Studies or Health Care Communication
    • Bachelor of Science in Biomedical Sciences
    • Bachelor of Science in Pharmaceutical Chemistry

    Tailored to the demands of the market and the needs of students, the programs are providing students with options and the ability to explore their passions within health care.

    As we look to 2021, the College aims to further expand its academic programs to include a Master of Science in Medicinal Chemistry and a aster of Science in Global Health. Faculty, staff and students also continue to work on a new strategic plan for the School of Pharmacy that will propel us forward over the next three years.

    We are also thrilled to note that this academic year has been highlighted by a wide range of recognition for members of the College community.

    Last fall, the following individuals were named Next-Generation Pharmacist awards finalists:
    • Bruce Canaday, Pharm.D., FASHP, FAPhA, former dean of the School of Pharmacy
    • Kevin Colgan, B.S. ’77, FASHP, vice president and chief pharmacy officer at University of Chicago Medical Center and former chairman of the College’s Board of Trustees
    • Curt Gielow, B.S. ’68, MHA, Hon. D.H.L., business consultant at Gielow Ventures, LLC
    • Lisa Umfleet, B.S. ’96, BCGP, owner of Parkland Health Mart Pharmacy

    Canaday and Gielow each took home awards, with Canaday being presented with the Lifetime Leadership award and Gielow receiving the Civic Leader Award.

    • Anastasia Armbruster, Pharm.D. ’09, AACC, BCPS, BCCP, associate professor of pharmacy practice at the College, was appointed to the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
    • Sara Fietsam, Pharm.D. ‘11, American Pharmacists Association (APhA) certified instructor for travel health, diabetes and immunizations, and immunization coordinator for Schnuck Markets, Inc., was recently awarded with an honorable mention as part of APhA’s annual Immunization Champion Awards.
    • Alicia Forinash, B.S. ’00, Pharm.D. ’01, FCCP, BCPS, BCACP, professor of pharmacy practice at the College, was recognized by the American College of Clinical Pharmacy with its 2019 Clinical Practice Award. In February, Forinash was also selected to serve on a working group for the Task Force on Research Specific to Pregnant Women and Lactating Women formed by the National Institutes of Health.
    • Nicole Gattas, Pharm.D., FAPhA, BCPS, director of experiential education and associate professor of pharmacy practice at the College, was the recent recipient of a 2019 Excellence in Teaching Award from Emerson.
    • Kendra Holmes, B.S. '99, Pharm.D. '00, CHCEM, senior vice president of Affinia Healthcare, was named to the St. Louis Business Journal's Most Influential Business Women class of 2019. MSHP Submission from Interim Dean of Pharmacy Brenda Gleason
    • Golden Peters, Pharm.D., BCPS, associate professor of pharmacy practice at the College was named 2019 Educator of the Year by the Illinois Pharmacists Association.
    • Last fall, John A. Pieper, Pharm.D., FCCP, FAPhA, president of the College, was awarded fellowship in the International Pharmaceutical Federation. This spring, Pieper was also selected as the 2020 recipient of the Willis G. Gregory Memorial Award from the University at Buffalo School of Pharmacy and Pharmaceutical Sciences.

    In addition, at the close of the 2019-20 academic year, we said farewell to Bruce Canaday, Pharm.D., FASHP, FAPhA, who officially retired as dean of the School of Pharmacy. Having joined the College in 2014, dean Canaday provided six years of dedicated service to the College and his retirement marks the conclusion of a storied career in academic pharmacy that has spanned more than four decades. While he will be greatly missed, we wish him the very best as he embarks on this new and exciting chapter of his life.

    While the last few months certainly presented great challenges, they have also provided the College with great opportunities to continue to showcase our many strengths, including our commitment to educating highly trained health care professionals, our dedication to creating a healthier society and our ability to innovate and adapt.

    Even during difficult times, there are incredible things underway at the College as we continue our work to prepare students for expert practice and leadership in pharmacy and health care education, interprofessional patient-centered care and collaborative research.

    As our College, and the nation, work to return to a “new normal,” we hope to welcome you back to campus soon!

  • 27 Jul 2020 5:02 PM | Anonymous

    By Russell Melchert, PhD; Dean, UMKC School of Pharmacy

    “Mulligan” is defined by the New American Oxford Dictionary as “an extra golf stroke allowed after a poor shot, not counted on the scorecard”. In my not so professional golf experience, I have requested and utilized numerous mulligans, and sadly, even those didn’t help my score that much. Had it not been for some really great accomplishments from UMKC students, staff, and faculty this past academic year (okay, and maybe the Chiefs winning the Superbowl as well), I would have to call on a mulligan for 2020. Despite the difficult year, the school continued to thrive and excel. Our students, staff, and faculty were up to the challenges associated with the pandemic including remote teaching and learning as necessary, and I am very proud of all of them and what they have done to keep things moving forward.

    APhA-ASP Number 1 Again! Dynasty!

    There is no better word to describe it. The UMKC chapter of the American Pharmacists Association-Academy of Student Pharmacists (APhA-ASP) once again received the Chapter of the Year award signifying it as the best in the country! It may seem like I just keep copying and pasting this news every year as our chapter was number 1 in 2012 and 2018, and the years between and after were no drop off in quality as each year the chapter has finished in the top 7 or top 4 in the country. The student success is no doubt a reflection of the hard work and mentorship provided by their outstanding faculty advisors: Drs. Angela Brownfield, Lisa Cillessen, Sarah Cox, , Kathryn Holt, Cameron Lindsey, and Heather Taylor. Many thanks to the students and advisors for all the positive recognition for our school.

    Other National Student Awards.

    Our students received many other national awards as well this past academic year. The National Community Pharmacists Association announced the top ten proposals submitted to their Good Neighbor Pharmacy NCPA Pruitt-Schutte Student Business Plan Competition. Congratulations to Jacob Deronde, Katie Pennell, and Taylor Mize and their faculty mentor Dr. Heather Lyons-Burney for having their business plan proposal chosen as a Top Ten proposal—again keeping UMKC in the top ten over the past few years! Other national award winners included: Keaton Thomas received the ACT/CPESN scholarship to attend the CPESN midyear meeting in North Carolina, and he was one of 5 students nationally to receive the scholarship; Kayla Shaw was selected for Independent Pharmacy Cooperative Scholarship, one of 8 in the nation; Amelia Gooch and Garret Matthews represented UMKC and finished in the Top 10 in the clinical skills competition at the annual American Society of Health Systems Pharmacists midyear clinical meeting; Amelia Godfrey was selected for the 2019 Paul Ambrose Scholars Program of the Association for Prevention Teaching and Research; and Kaitlyn Riggs selected as 1 of only 89 nation-wide who won the United States Public Health Service Excellence in Public Health Pharmacy Award in 2020.

    Student Success.

    Once again, we absolutely love all the national attention our students bring to UMKC through all of their many accomplishments and awards. However, some other milestones are likely more important to all of our students. That is, of the class that entered in our program in 2016, 91% graduated on time in 2020 and 97% will have graduated by 2021. While we do not yet have NAPLEX pass rates from them, we do know that for 2019 graduates—94% of whom graduated on time—85.1% passed the NAPLEX on first sitting and 96.6% passed by the end of 2019. Further, their MPJE pass rate was 90.5% compared to 82.2% national average. And again, while we do not have full placement data yet for our 2020 graduates, we do know that more than 82.4% of our 2020 graduates who applied for PGY1 residency training matched in Phase I (well above the 63% national match rate). Of them, 26 students will conduct their residency training at Missouri institutions including Kansas City’s Truman Medical Center, Saint’s Luke’s Hospital, Children’s Mercy Hospital, Research Medical Center, and North Kansas Hospital as well as University Hospital in Columbia and Cox Medical Center and Mercy Hospital in Springfield. Many also placed at other highly recognized national programs across the country including the Duke University, Johns Hopkins, Mayo Clinic, and the University of North Carolina-Chapel Hill. Going back to the Class of 2019, another 13 UMKC alumni successfully matched with second-year residency programs. Four more students were early commitments to PGY-2 programs and another placed in a second-year fellowship. Combined, the school’s second-year match rate of 92.8% far outpaced the national second-year match rate of 73.2%.

    Outstanding Faculty Accomplishments in 2019-2020.

    The many successes of our students no doubt reflect the outstanding guidance and instruction they receive from our outstanding faculty. In our Division of Pharmacology and Pharmaceutical Sciences, Dr. Simon Friedman received a new NIH R01 grant providing ~$1.6 M in total costs over the next 4 years to continue in his successful work developing continuously variable protein delivery using a photoactivated depots. His previous work resulted a patent for insulin delivery in this manner. Drs. Kelly Cochran and Erica Ottis served as coinvestigators on a new $4.2 million HRSA grant awarded to MU as an Innovative Model to Increase Primary Care Physicians for Rural and Underserved Missouri. Dr. Jerry Wyckoff was awarded a $50,000 grant from BioNexus KC to work on creating a set of highly curated potential therapeutic target genes for rare diseases. Dr. Mark Sawkin worked with our School of Medicine faculty creating the Dramatic STD/HIV Project, which received one of four honorable mentions with their application for the USPHS Excellence in Interprofessional Education Collaboration National Award. Dr. Heather Taylor received a grant from ACT Missouri for work on the DREAM (Drug Responsibility Education & Advocacy Movement) to deal with substance abuse prevention and treatment. Dr. Angela Brownfield was selected as a Missouri Pharmacy Association Faculty Member of the Year. Dr. Paul Gubbins was selected as the 2020 recipient of the American Association of Colleges of Pharmacy (AACP) Pharmacy Practice Section Distinguished Service Award, and Dr. Steve Stoner was slated to run for Speaker of the House of Delegates for AACP. Receiving promotion in faculty rank this year were Clinical Associate Professors Drs. Kylie Barnes and Amanda Stahnke and Professor Dr. Orisa Igwe. And, our student pharmacists recognized Drs. Karen Bame, Lisa Cillessen, Tom Johnston, Diane McClaskey, Valerie Ruehter, Diana Tamer and Karyn Turla as Teachers of the Year.

    Like previous years, there are many other accolades that our students, staff, and faculty achieved this year, far too many to list in this update. If you can make time to come by and see us, we’d be happy to tell you all about it. You are all welcome to visit the school anytime at our sites in Kansas City, Columbia, and/or Springfield. We also would greatly appreciate your assistance in helping us identify any students who might be interested in pursuing pharmacy careers. Just let us know, we love to talk to anyone about our great profession! Best wishes to everyone in MSHP!! 

  • 20 Jul 2020 1:59 PM | Anonymous
    By: Brianna Chambers, PharmD Candidate 2022; UMKC SSHP President - Columbia and Samuel Halleck, PharmD Candidate 2022; UMKC SSHP President – Kansas City

    UMKC’s SSHP chapter had a challenging but strong spring semester. In February, KCHP and KU School of Pharmacy invited us to join their Pharmacy Forecast Workshop. Students learned about emerging healthcare trends and future opportunities of pharmacy practice. Groups discussed and came up with possible solutions to current practice problems involving electronic health records, Big Data, and payment reform. We had 80 members of the UMKC SSHP chapter attend this wonderful collaborative event.

    This year in Springfield, SSHP members participated in various outreach initiatives including organizing an organ donor drive for students at Missouri State University and a legislative outreach campaign during COVID-19. Springfield’s Project Committee member Brandon Cole created materials explaining how to register for organ donation online. Springfield student members Zach Hitchcock and Amelia Godfrey organized a legislative calling campaign in partnership with APhA-ASP which included an informational session about the joint report released in March and ways students can contact their legislators. Next year, incoming Springfield Liaison Mariah Berg plans to focus on expanding community outreach by increasing member involvement with the Project Committee and finding new events/programs to teach the community about initiatives like Vial of Life.

    Columbia's SSHP membership saw tremendous growth in participation over the past school year. Our members were excited about the opportunities to learn and lead in health systems pharmacy. We had a record level of involvement from students at events including general meetings, Residency Roundtable, and Pharmacy Forecast. Residency Roundtable was a highlight for the Columbia campus this year. We had 17 students in attendance as well as 6 residency program directors and residents.

    We held our monthly general meetings throughout the semester with visiting speakers who shared their experiences working as health-system pharmacists. One noteworthy speaker we had was Gina Luchan, who was previously the 2018-2019 Executive Fellow in Association Leadership and Management. Luchan now serves as the Director of Academic Programs at ASHP. She presented on Practice Advancement Initiative (PAI) and empowered our students to play a role in improving patient outcomes in acute and ambulatory care settings. As pharmacy students, we want to help our current and future patients achieve optimal health outcomes by ensuring safe and effective medication use. One way we can do this is by learning about practice advancement opportunities during our time in pharmacy school. For many of the attendees, this was their first time hearing of PAI and enjoyed learning how they could make a difference.

    During the week of final exams, our SSHP chapter talked to our students about maintaining their well-being and resilience through the power of social media. SSHP used Facebook to reach out to pharmacy students to promote ASHP’s initiative to encourage pharmacy resiliency. Topics included positive thinking, setting goals, and creatively solving problems among others.

    The executive team is gearing up for our main events in the fall. Residency program directors should be on the lookout for their invitation to attend Residency Roundtable. The events will take place at each of the following UKMC campuses: Kansas City, Columbia, and Springfield. Our clinical skills competition and membership drive are planned for the fall as well. We acknowledge that conditions outside of our control may affect our ability to hold any or all of these events. We will notify all appropriate parties of any schedule changes.

    We understand that this has been a challenging year. We are thankful for your involvement with SSHP and hope you’re staying safe and healthy! All three campuses are excited to jump into the new school year in August and see our chapter grow, serve, and learn.

  • 20 Jul 2020 1:23 PM | Anonymous

    St. Louis College of Pharmacy

    By: Lauren Busch, STLCOP SSHP President and Maram Hamdan, STLCOP SSHP President-Elect; PharmD Candidates 2022

    The St. Louis College of Pharmacy SSHP had a successful 2019-2020 school year despite the challenges presented by COVID-19 in the spring semester. The STLCOP SSHP held several residency preparation events including: the Introduction to Residency and CV 101 seminars led by faculty member Dr. Jack Burke; the Resident Roundtable with residents from all over the St. Louis area; and the Residency-Focused Mentorship Program events which continued to be expanded. The Residency-Focused Mentorship Program, which is a mentorship program between pre-professional students and students early in the pharmacy program (P1’s) and students later in the program (P2’s and P3’s), received the SSHP Outstanding Professional Development Project Award and was presented at the 2019 Midyear Clinical Meeting Student Society Showcase.

    STLCOP SSHP worked with other student organizations on volunteering events including BooFest with JDRF and the other student organizations on campus, the Washington University Health Fair with STLCOP APhA-ASP, National Kidney Foundation kidney screenings with SNPhA, and tie blanket making events for local cancer patients hosted by SSHP. On Halloween, STLCOP SSHP held a Poison Control Lunch and Learn led by the SSM Health Director of Poison Control, Dr. Julie Weber, and students learned about the possibility of a rotation at the Missouri Poison Control Center and a career in this field.

    The STLCOP SSHP held Practice Advancement Initiative (PAI) Week the week of February 24th and held several events during this week, including an APPE Student Panel during which P4 students explained how activities they completed during their rotations relate to the PAI pillars. Students were able to ask the P4s questions about rotations, applying for residencies, and tips for the future.

    The Innovation and Development Committee introduced a new seminar, Combating Burnout in Healthcare Professionals Seminar, led by guest speaker Vicki Good, who shared her research on burnout and taught students about the prevalence of burnout for pharmacists and other healthcare professionals.

    Although several events, including the Residency Director’s Roundtable, were cancelled due to COVID-19, STLCOP SSHP was able to hold a virtual CV review session for students with the help of STLCOP faculty and local StLSHP members. STLCOP SSHP is eager to host events for students once again in the fall.

  • 20 Jul 2020 12:11 PM | Anonymous

    By: Jack Pluenneke, PharmD Candidate 2021 and Andrew Smith, Pharm.D., FCCP, BCCP, BCPS; UMKC School of Pharmacy


    There has been a large amount of observational evidence supporting low-density lipoprotein cholesterol (LDL-C) as a causal risk factor for the development of atherosclerotic cardiovascular disease (ASCVD).1 With the emergence of genetic and clinical trials showing linear relationships between exposure to cholesterol, in particular LDL-C, and ASCVD risks, reducing LDL-C levels has become a standard in the prevention of cardiovascular disease.2,3,4 Lifestyle modification continues to be one of the most important and effective interventions in the management of high LDL-C levels.5 Unfortunately, many patients require additional LDL-C lowering despite lifestyle modification and must turn to pharmacological management. HMG CoA reductase inhibitors (statins) are the most established and cost effective first line medication for the treatment of elevated LDL-C levels.6 Statins are generally well tolerated, but their use can be limited by their adverse reactions. Statin- associated muscle symptoms are the most frequent adverse reaction leading to nonadherence or discontinuation.7 Other pharmacological therapies have been developed to help patients who are unable to tolerate statin therapy, such as ezetimibe and PSCK9 inhibitors. Although these agents are also generally well tolerated, they do have disadvantages. Ezetimibe only has modest LDL-C lowering effects and PSCK9 inhibitors are limited by their current costs and route of use.4 Due to these limitations, many patients fail to achieve goal LDL-C levels and continue to be at risk for ASCVD events.8

    In February 2020, the U.S Food and Drug Administration (FDA) approved a first in its class medication for patients with heterozygous familial hypercholesterolemia or established ASCVD who require additional lowering of LDL-C.9 Bempedoic acid, sold under the brand name Nexletol™, reduces LDL-C by inhibiting adenosine triphosphate-citrate lyase (ACL).10 ACL acts upstream of HMG-CoA reductase (statins site of action) and catalyzes the production of acetyl coenzyme A. Acetyl coenzyme A is the precursor of the mevalonate pathway of cholesterol synthesis.10 Similar to statins, bempedoic acid leads to upregulation of LDL receptors and increased uptake of LDL particles, thereby reducing LDL-C levels.10 Bempedoic acid is converted to its active form by a hepatic synthetase that is not expressed in skeletal muscle, resulting in fewer effects on the musculoskeletal system.10 Due to the potential decreased muscle adverse effects of bempedoic acid, this medication may be useful in patients who require additional LDL-C lowering, despite being on maximum tolerated statin therapy, or those with statin intolerance. This remainder of this article will evaluate the phase 3 trials resulting in bempedoic acid’s approval, analyze the safety and efficacy of this drug, and provide important information on its clinical use.

    Cholesterol Lowering via Bempedoic acid, an ACL-inhibiting Regimen (CLEAR) Trials

    The CLEAR Harmony trial was a double-blind, placebo-controlled, randomized control trial (RCT) that primarily evaluated the safety of bempedoic acid 180mg daily in patients with heterozygous familial hypercholesterolemia, atherosclerotic cardiovascular disease, or both.11 To be included in the study, patients had to have an LDL-C ≥70 mg/dL and be on maximally tolerated statin therapy. Safety parameters between bempedoic acid vs placebo were determined by incidence of adverse events and changes in safety lab values. The incidence of severe adverse events did not differ between the two groups (14.5% vs. 14.0%; P=0.80). However, the incidence of adverse events leading to a discontinuation of bempedoic acid was different (10.9% vs. 7.1%; P<0.005). In addition, the incidence of gout was higher in the bempedoic acid group versus placebo (1.2% vs. 0.3%; P<0.03). Efficacy of bempedoic acid versus placebo was evaluated as a secondary outcome measure. A difference of -18.1% LDL-C lowering was seen in the patients treated with bempedoic acid compared to placebo at week 12 (95% confidence interval [CI] -20.0% to -16.1%; P<0.001). The CLEAR Harmony trial suggests that bempedoic acid added to maximally tolerated statin therapy is generally well tolerated and led to lower overall LDL cholesterol levels.

    The CLEAR Serenity trial was a double-blind, placebo controlled, RCT that analyzed the efficacy and safety of bempedoic acid 180mg daily in patients with hypercholesterolemia and a history of intolerance to at least 2 statins.12 Patients were eligible if their LDL-C levels were ≥130 mg/dL, for primary prevention, and ≥100 mg/dL for those requiring secondary prevention. The primary outcome measure was the mean percent change in LDL-C from baseline at week 12. A difference of -21.4% reduction in LDL-C levels was seen at week 12 in patients treated with bempedoic acid when compared to placebo (95% CI -25.1 to -17.7%; P<0.001). The overall incidence of adverse reactions was similar between the groups with, with the most common treatment-emergent adverse event being muscle related. Of the muscle related adverse effects, myalgia occurred in 4.7% in patients on bempedoic acid and 7.2% of patients in the placebo group. Patients on bempedoic acid did report more adverse reactions resulting in discontinuation (18.4% vs. 11.7%), there was no mention of statistically significance between the groups. The CLEAR Serenity trial suggests that bempedoic acid is an effective option for lipid lowering and is generally well tolerated in in patients who cannot tolerate statin therapy.

    The CLEAR Tranquility trial was a double-blind, placebo-controlled, RCT that investigated the efficacy and safety of bempedoic acid 180mg daily in statin-intolerant patients taking ezetimibe.13 This study enrolled patients with a history of statin intolerance and an LDL-C ≥100 mg/dL while on ezetimibe. The primary outcome measure was the percent change in LDL-C at week 12 compared to baseline. A 28.5% reduction was seen in patients taking ezetimibe with the addition of bempedoic acid as compared to the addition of placebo at week 12 (bempedoic acid -23.5% vs. +5.0% placebo; P<0.001).13 In regards of safety, rates of treatment-emergent adverse events, muscle- related adverse events, discontinuation were similar between groups. The CLEAR Tranquility trial suggests that bempedoic acid, when combined with ezetimibe, is safe and effective for patients who require additional LDL-C lowering and are intolerant to statins.

    Lastly, the CLEAR Wisdom trial was a double-blind, placebo-controlled, RCT that analyzed the efficacy and safety of bempedoic acid vs placebo in patients at high risk for cardiovascular disease when added to maximally tolerated lipid-lowering therapy.14 The trial included patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both and a LDL-C ≥70 mg/dL while taking a maximally tolerated statin or other lipid-lowering therapy. The primary outcome measure was the percent change in LDL-C at week 12 as compared to baseline. A placebo-corrected difference of -17.4% was seen at week 12 in patients treated with bempedoic acid in addition to their maximally tolerated LDL-C lowering therapy regimen when compared to placebo (95% CI -19.5 to -10.0%; P<0.001). Adverse events between the bempedoic acid group and placebo group were similar. The most common included urinary tract infections (5.0% vs. 1.9%) and hyperuricemia (4.2% and 1.9%), respectively. The CLEAR Wisdom trial suggests that in patients at high risk for cardiovascular disease receiving maximally tolerated statins requiring additional LDL-C lowering, bempedoic acid was safe and effective in further lowering of LDL-C levels.

    Clinical Utility of Bempedoic Acid

    Bempedoic acid is currently available as a 180mg oral tablet (with or without ezetimibe) and dosed once daily with or without food.15,16 No dosage adjustments are required for patients with mild to moderate hepatic impairment as indicated by Child-Pugh Class A or B, or who have an estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2.16 Patients with severe hepatic impairment, indicated by Child-Pugh Class C, or those with an eGFR of <30 ml/min/1.73 m2 have not been studied. Currently, there are no identified contraindications according to the manufacturer.15 Warnings and/or precautions include hyperuricemia and tendon rupture.16 According to the manufacturer, increase in uric acid levels usually occur within the first 2 weeks of treatment initiation and persisted throughout treatment.15 It is recommended that health care providers monitor patients for signs and symptoms of hyperuricemia and gout, as well as monitor serum uric acid concentrations when clinically indicated.16 Tendon rupture has been reported within weeks to months of initiation. Health care providers should consider alternate therapy in patients with previous tendon disorders or tendon ruptures, or in patients at high risk for tendon rupture.16 Based on the mechanism of action of bempedoic acid, in utero exposure may cause fetal harm and should be discontinued if pregnancy occurs.16 According to the drug manufacturer, Esperion, bempedoic acid will cost $10 a day, or for patients who qualify, $10 for a 3 month supply.17


    Based on the results of the CLEAR trials, bempedoic acid is effective for patients that require additional LDL-C lowering, or who have a history of statin intolerance. There is a risk that patients may develop an adverse reaction requiring discontinuation, so they should be monitored closely. The approval of bempedoic acid, a non-statin agent, will provide healthcare providers with more flexibility in the treatment of hypercholesterolemia and ASCVD. An important limitation to note is that long term safety, durability, and clinical effect of bempedoic acid has not been established. Further research is needed to establish the effect of bempedoic acid on clinical outcomes such as the rates of nonfatal myocardial infarction, stroke and cardiovascular death.


    1. Gidding SS, Allen NB. Cholesterol and Atherosclerotic Cardiovascular Disease: A Lifelong Problem. JAHA 2019; 8:11
    2. Musunuru K, Kathiresan S. Surprises From Genetic Analyses of Lipid Risk Factors for Atherosclerosis. Circulation Research. 2016;118:579–585
    3. Ference BA, Ginsberg HN, Ray KK, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. European Heart Journal 2019; 38:2459-2472
    4. Grundy SM, Stone NJ, Bailey AL, et al. 2018 Guideline on the Management of Blood Cholesterol. Circulation. 2019;139:e1082–e1143
    5. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk. Circulation. 2014;129:S76–S99
    6. Fulcher J, Mihaylova B, O’Connell R, et al on behalf of the Cholesterol Treatment Trialists’ Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Lancet 2019;393:407-15.
    7. Zhang H, Plutzky J, Turchin A. Discontinuation of Statins in Routine Care Settings. Annals of Internal Medicine. 2013
    8. Fox KM, Tai MH, Kostev K, et al. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018; 107(5): 380-388
    9. Center for Drug Evaluation and Research. “Drug Trials Snapshots: NEXLETOL.” U.S. Food and Drug Administration, FDA, 2 Mar. 2020
    10. Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): An Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016; 18(61)
    11. Ray KK, Bays HE, Catapano AL, et al. (2019) Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. NEJM 380(11);1022-1032
    12. Laufs U, Banach M, Mancini G, et al. Efficacy and Safety of Bempedoic Acid in Patients with Hypercholesterolemia and Statin Intolerance. JAHA 2019 8:7
    13. Ballantyne CM, Banach M, Manacini GJ, et al. Efficacy and Safety of Bempedoic Acid Added to Ezetimibe in Statin-Intolerant Patients with Hypercholesteremia: A Randomized, Placebo-Controlled Study. Atherosclerosis 2018 277;195-203.
    14. Goldberg AC, Leiter L.A., Stroes ESG, et al. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease. JAMA 2019; 322;18
    15. NEXLETOL [package insert]. Ann Arbor, MI: Esperion Therapeutics, Inc; 2020.
    16. Nexletol. In: Lexi-Drugs Online [Internet Database]. Hudson, OH: Lexi-Comp, Inc. Updated 2020 April 14.
    17. NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe): Access and Co-Pay Card. (n.d.). nexletolhcp.com. Updated 2020 June

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