Expanding Horizons for the Management of Obstructive Hypertrophic Cardiomyopathy:
Pharmacist Considerations (Archive)
This educational activity is sponsored by Postgraduate Healthcare Education, LLC (PHE) and supported by an educational grant from Bristol Myers Squibb.
Douglas Jennings, Pharm.D., FACC, FAHA, FCCP, FHFSA
Associate Professor of Pharmacy
Clinical Pharmacist, Heart Transplant and LVAD Team
Long Island University Department of Pharmacy Practice
New York-Presbyterian Hospital Columbia University Irving Medical Center
New York, NY
Dr. Jennings has disclosed that he has received consulting fees from Abiomed and fees for Non-CE services from Abiomed, AstraZeneca, La Jolla Pharmaceutical Company, Merck & Co., and Novartis.
The clinical reviewer, Tracy Macaulay, PharmD, has disclosed that she has no actual or potential conflicts of interest related to this program.
Susanne Batesko, RN, BSN, Robin Soboti, RPh, and Susan R. Grady, MSN, RN as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
All relevant financial relationships have been mitigated.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 1.0 hour (0.1 ceu)
Type of Activity: Application
Fee Information: There is no fee. This is a free continuing education activity.
Estimated time to complete activity: 60 minutes
November 18, 2022
November 18, 2023
Update:January 17, 2023
Desai MY, et al. Dose-Blinded Myosin Inhibition in Patients with Obstructive HCM Referred for Septal Reduction Therapy: Outcomes Through 32-Weeks. Originally published 6 Nov 2022https://doi.org/10.1161/CIRCULATIONAHA.122.062534Circulation. 2022;0.
Background:Septal reduction therapy (SRT) in patients with intractable symptoms from obstructive hypertrophic cardiomyopathy (oHCM) is associated with variable morbidity and mortality. The VALOR-HCM trial examined the effect of mavacamten on the need for SRT through Week 32 in oHCM.
Methods:A double-blind randomized placebo-controlled multicenter trial at 19 US sites included oHCM patients on maximal tolerated medical therapy referred for SRT, with left ventricular outflow tract (LVOT) gradient ≥50 mmHg at rest or provocation (enrollment 7/202010/2021). The group initially randomized to mavacamten continued the drug for 32 weeks and the placebo group crossed over to dose-blinded mavacamten from Week 16 to 32. Dose titrations were based on investigator-blinded echocardiographic assessment of LVOT gradient and LV ejection fraction. The principal endpoint was proportion of patients proceeding with SRT or remaining guideline eligible at 32 weeks in both treatment groups.
Results:From the 112 randomized oHCM patients, 108 (mean age 60.3 years, 50% men and 94% in New York Heart Association [NYHA] class III/IV) qualified for Week 32 evaluation (56 in original mavacamten and 52 in placebo crossover group). After 32 weeks, 6/56 (10.7%) patients in original mavacamten and 7/52 (13.5%) in placebo crossover group met SRT guideline criteria or elected to undergo SRT. After 32 weeks, a sustained reduction in resting LVOT gradient (-33.0 mmHg 95% confidence interval [CI] -41.1 to -24.9) and Valsalva LVOT gradient (-43.0 mmHg, 95% CI -52.1 to -33.9) was observed in the original mavacamten group. A similar reduction in resting (-33.7 mmHg, 95% CI -42.2 to -25.2) and Valsalva gradients (-52.9 mmHg, 95% CI -63.2 to -42.6) was quantified in the crossover group after 16 weeks of mavacamten. After 32 weeks, ≥1 NYHA class improvement was observed in 48/53 (90.6%) of original mavacamten and 35/50 (70%) after 16 weeks in the crossover group.
Conclusions:In severely symptomatic oHCM patients, 32 weeks of mavacamten treatment showed sustained reduction in the proportion proceeding to SRT or remaining guideline eligible, with similar effects observed in patients crossed over from placebo after 16 weeks.
Trial Registration: URL: Clinicaltrials.gov Unique Identifier: NCT04349072
HOW TO OBTAIN CREDIT
During the period November 18, 2022 to November 18, 2023, participants must 1) read the learning objectives and faculty disclosures; 2) view the educational activity; and 3) complete the posttest and evaluation form directly after the activity within a maximum of 60 days of participating in the activity. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on the Grade Exam button at the bottom of the page. Your posttest will automatically be graded. If you successfully complete the posttest (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the posttest. You will have 2 opportunities to pass the posttest. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.
The goal of these activities is to provide pharmacists with advanced and up-to-date knowledge of the obstructive hypertrophic cardiomyopathy (OHCM) treatment landscape to ensure appropriate access to patient-specific treatments, understanding of therapeutic management and any adverse effects, and enhancing pharmaceutical care, thus leading to improved therapeutic outcomes and quality of life.
Upon completion of this activity, the participant should be able to:
- Explain the pathology, pathophysiology, and epidemiology of hypertrophic cardiomyopathy (HCM) and its subtypes
- Describe the limitations of the current standard of care therapies for obstructive HCM (OHCM)
- Discuss the novel agent, mavacamten, for OHCM and its potential to improve treatment outcomes
- Develop effective approaches to educate patients on the safe and optimal use of the novel agent for OHCM
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Disclosure of Unlabeled Use and Disclaimer
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC, or Bristol Myers Squibb. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients' conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer's product information) and comparison with recommendations of other authorities.
The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this activity have not been evaluated by the FDA.