Exploring rates of PCSK9 inhibitor persistence and reasons for treatment non-persistence in an integrated specialty pharmacy model

D, Donald; Reynolds, Victoria W.; Hall, Nicole; DeClercq, Josh; Choi, Leena

doi:10.1016/j.jacl.2022.03.004

Cited by 7 publications

(2 citation statements)

References 16 publications

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“…Additionally, a new study by Donald and colleagues found an incidence rate of 32% to 36% for muscle-related PCSK9i AEs. 27 Collectively, the data from clinical trials and our study indicate that patients with prior intolerances to statin and/or ezetimibe appear to have a higher likelihood of developing a muscle-related PCSK9i intolerance. In our study, 23 of 24 patients who developed a muscle-related PCSK9i AE had a prior history of statin and/or ezetimibe intolerances.…”

Section: Discussionmentioning

confidence: 54%

Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population

Cencetti¹

2023

Federal Practitioner

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Background: Statins and PCSK9 inhibitors (PCSK9i) are used to lower low-density lipoprotein cholesterol and reduce cardiovascular events, yet some patients are unable to tolerate statin therapy due to muscle-related adverse events (AEs). The effect of PCSK9i on muscle-related AEs is not well studied, and available data show inconsistent incidence rates. Methods: The primary study outcome was to determine the percentage of patients who developed muscle-related PCSK9i AEs. A secondary outcome was to analyze data based on 4 subgroups: tolerated a full PCSK9i dose; tolerated alternative PCSK9i following initial intolerance; required a PCSK9i dose reduction, or discontinued PCSK9i. In addition, the percentage of statin-and/or ezetimibe-intolerant patients in these 4 groups was determined. Another secondary outcome was the management strategies taken for patients who were on a reduced (monthly) dose of PCSK9i who did not reach their low-density lipoprotein cholesterol goal. Statin intolerance was defined as intolerable skeletal muscle AEs on at least 3 different statins. We conducted a singlecenter, retrospective review of patients prescribed a PCSK9i between December 1, 2017, and September 1, 2021, at a patient aligned care team clinic at the Wilkes-Barre Veterans Affairs Medical Center.Results: The study included 137 veterans. Twenty-four patients (17.5%) developed a muscle-related AE while on a PCSK9i. In predefined subgroups studied, statin intolerance ranged from 68.1% to 100%, ezetimibe intolerance ranged from 41.6% to 83.3%, and both statin and ezetimibe intolerance ranged from 36.3% to 83.3%. Conclusions: In this study, muscle-related PCSK9i AEs occurred at a similar incidence rate to that reported in previous clinical trials and exceeded the incidence rate reported in the prescribing information for alirocumab and evolocumab. It also appears that patients who have a prior muscle-related intolerance to a statin and/or ezetimibe have a higher likelihood of developing a muscle-related AE to a PCSK9i.

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Section: Discussionmentioning

confidence: 54%

Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population

Cencetti¹

2023

Federal Practitioner

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“…However, there is currently no standard definition of persistence. Different definitions to the one used in the present study have been reported in the literature, e.g., filled prescriptions [ 21 ], non-violation of certain gap windows [ 19 , 22 ], or self-reported surveys [ 20 , 23 ]. Additionally different periods of observation have been published [ 19 – 23 ].…”

Section: Discussionmentioning

confidence: 99%

Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study

Lehrke,

Vogt,

Schettler

et al. 2024

Adv Ther

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Introduction Low-density lipoprotein cholesterol (LDL-C) is among the most important modifiable risk factors for cardiovascular disease. In very high-risk patients, the European Society of Cardiology/European Atherosclerosis Society guidelines recommend attaining LDL-C < 55 mg/dL. In the German cohort of the observational HEYMANS study, we aimed to describe the clinical characteristics and LDL-C control among patients initiating evolocumab. Methods Data was collected between 09/2016 and 05/2021 for ≤ 6 months before (retrospectively) and ≤ 30 months after evolocumab initiation (prospectively). Patient characteristics, lipid-lowering therapy (LLT), lipid values, evolocumab use, and safety were collected. Results Of 380 enrolled patients, 93% received evolocumab in secondary prevention and 69% had a history of statin intolerance. At study baseline, 49% did not receive any statins and LDL-C was very high (145 mg/dL). Use of evolocumab decreased LDL-C by a median of 53% within 3 months and remained stable thereafter, despite mainly unchanged background LLT. Overall, 59% attained an LDL-C level < 55 mg/dL (69% with, 49% without LLT). Persistence to evolocumab was 90.6% in months 1–12 and 93.5% in months 13–30. Adverse drug reactions were reported in 8% of patients. Conclusion Data from the German HEYMANS cohort corroborate previous reports on evolocumab effectiveness and safety in clinical practice. Evolocumab initiation was associated with a rapid and sustained LDL-C reduction. Persistence with evolocumab was high. Our finding that patients receiving an evolocumab/LLT combination are more likely to attain the LDL-C goal than those receiving evolocumab alone corroborates previous data showing the importance of using highly intensive therapy. Graphical abstract available for this article. Trial Registration ClinicalTrials.gov Identifier NCT02770131 (registration date 27 April 2016). Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02757-x.

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Treatment intensification with bempedoic acid to achieve LDL-C goal in patients with ASCVD: A simulation model using a real-world patient cohort in the US

Migliaccio-Walle,

Elsea,

Gupta

et al. 2024

Atherosclerosis Plus

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Exploring rates of PCSK9 inhibitor persistence and reasons for treatment non-persistence in an integrated specialty pharmacy model

Cited by 7 publications

References 16 publications

Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population

Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran Population

Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The HEYMANS Study

Treatment intensification with bempedoic acid to achieve LDL-C goal in patients with ASCVD: A simulation model using a real-world patient cohort in the US

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