Pharmacists' Role in ASCVD Management: Integrating Inclisiran into Patient Care

Pharmacists play a crucial role in preventing and managing treatment for patients with atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular (CV) conditions, which require continuous monitoring of medications, cholesterol levels, blood pressure, lipid profiles, or other metabolic panels. Inclisiran (Leqvio; Novartis) is a small interfering RNA (siRNA) therapy to lower LDL-C that is administered twice yearly through a subcutaneous injection, which may help overcome the challenges of treatment adherence in patients with ASCVD receiving cholesterol-related therapies.¹

Without the need for daily use of medications, patients may better overcome barriers to optimal treatment responses, such as missing doses. The twice-yearly injection of inclisiran may alter how pharmacists’ approach management of ASCVD treatments for their patients and continued monitoring of metabolic panels.

Pharmacists have the potential to play various roles in the administration, treatment management, and monitoring of patients with ASCVD receiving inclisiran. Image Credit: © Prins Productions - stock.adobe.com

ASCVD affects millions of individuals around the globe and accounts for nearly 85% of all CV deaths. It refers to various conditions including coronary heart disease, cerebrovascular disease, peripheral artery disease, and aortic atherosclerotic disease. ASCVD is caused by the buildup of plaque in the inner lining of the arterial walls, which is mainly composed of LDL-C that accumulates over time. This cumulative exposure to LDL-C increases the risk of heart attack and stroke.^1,2

Treatments to reduce LDL-C levels are the standard of care for preventing and treating ASCVD, such as statins. Due to the persistent, chronic nature of ASCVD, continued monitoring of lipid levels and management of treatments is essential for optimizing patient outcomes. However, providers may struggle to meet these care needs with the high volumes of patients they treat across various health conditions. The availability of pharmacists opens avenues of care for patients who need education, resources, treatment, and continued monitoring to ensure success of CV treatments. The twice-yearly inclisiran injection may have treatment adherence benefits without the eliminated need for a daily dose; however, it becomes crucial for pharmacists to ensure these patients continue to monitor their cholesterol levels and maintain regular follow-up appointments to assess the effectiveness of the treatment and manage any potential side effects.

Pharmacists have the potential to play various roles in the administration, treatment management, and monitoring of patients with ASCVD receiving inclisiran; although, regulations do vary by state. Some states may not allow pharmacists to administer certain medications which can be dependent on eligibility and licensing, as well as scope of practice. Despite potential administration limitations, pharmacists are still integral to effective monitoring of treatment and guidance for patients. Additionally, inclisiran can be administered in clinic or hospital opening opportunities fir pharmacists to facilitate proper transition of care between hospital, clinic, and community medical centers.^3,4

In a Pharmacy Times Peer Exchange, Kelsey E. Norman, PharmD, BCCP, BCACP, BCPS, clinical pharmacy specialist in the Cardiovascular Center at Boston Medical Center, emphasized the crucial role of pharmacists to support patients transitioning from inpatient to outpatient care, which is often when disruptions in treatment adherence and improper management of medications can occur.⁵

“Some of that comes from provider education and working through a clinical decision pathway, timing, and putting as much emphasis on our GDMT and heart failure patients to make it more protocolized,” she said. “Utilizing a pharmacist in the clinic is an excellent opportunity to get more patients on these medications, because they are very well trained in how to use these medications and can take over from there.”⁵

In the phase 3 V-MONO study (NCT05763875) evaluating patients with low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD), inclisiran demonstrated statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus placebo and ezetimibe [Zetia; Merck and Shering-Plough Pharmaceuticals]. V-MONO is a 6-month randomized, double-blind, placebo- and active-comparator controlled phase 3 study to evaluate the efficacy of inclisiran as monotherapy in patients at low or moderate risk of developing ASCVD. It is part of the larger clinical trial VictORION (NCT05739383) investigating inclisiran across diverse patient populations through clinical trials, implementation research, real-world evidence, and primary and secondary prevention trials.^1,6,7

V-MONO assessed 350 patients aged 18 to 75 years old who were randomizedin a 2:1:1 ratio to receive inclisiran (n=174), ezetimibe (n=89) or placebo (n=87). The primary end point was the percent change in LDL-C from baseline to day 150 with inclisiran. The initial phase 3 results, which demonstrated clinically significant reductions in LDL-C, add to the growing body of evidence for inclisiran as a treatment for ASCVD.⁶

Pharmacists play a significant role in the treatment of patients with ASCVD and the potential of inclisiran opens avenues for twice yearly subcutaneous administration of the treatment leading to the potential for improvement in treatment adherence. As healthcare professionals deeply involved in patient care, pharmacists can help bridge the gap between patients and physicians, ensuring that treatments are not only administered correctly but also monitored effectively.

REFERENCES

1. Novartis twice-yearly* leqvio® demonstrated clinically meaningful, statistically significant ldl-c lowering as a monotherapy in patients at low or moderate ascvd risk. Novartis. August 28, 2024. Accessed September 3, 2024. https://www.novartis.com/news/media-releases/novartis-twice-yearly-leqvio-demonstrated-clinically-meaningful-statistically-significant-ldl-c-lowering-monotherapy-patients-low-or-moderate-ascvd-risk

2. Atherosclerotic cardiovascular disease (ascvd). American Heart Association. Accessed September 3, 2024. https://www.heart.org/en/professional/quality-improvement/ascvd

3. Prescribing authority for pharmacists: rules and regulations by state. GoodRX Health. July 22, 2022. Accessed September 4, 2024. https://www.goodrx.com/hcp-articles/pharmacists/prescriber-authority-for-pharmacists

4. Inclisiran injection. Cleveland Clinic. Accessed September 4, 2024. https://my.clevelandclinic.org/health/drugs/23670-inclisiran-injection

5. The role of pharmacists in treating very high-risk ascvd. Pharmacy Times. May 21, 2024. Accessed September 3, 2024. https://www.pharmacytimes.com/view/the-role-of-pharmacists-in-treating-very-high-risk-ascvd

6. Efficacy and safety of inclisiran as monotherapy in patients with primary hypercholesterolemia not receiving lipid-lowering therapy. (v-mono). ClinicalTrials.gov Identifier: NCT05763875. Updated July 11, 2024. Accessed September 3, 2024. https://clinicaltrials.gov/study/NCT05763875

7. A study of inclisiran to prevent cardiovascular events in high-risk primary prevention patients. ClinicalTrials.gov Identifier: NCT05739383. Updated August 6, 2024. Accessed September 3, 2024. https://clinicaltrials.gov/study/NCT05739383