Statin intolerance and new lipid-lowering treatments

Mesi, Oltion; Lin, Charlie; Ahmed, Haitham M.; Cho, Leslie S.

doi:10.3949/ccjm.88a.20165

Cited by 4 publications

(4 citation statements)

References 42 publications

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“…These occurred at a higher rate than reported in the prescribing information (< 5%) and were similar to the incidence rates reported in the GAUSS-2, GAUSS-3, and ODYSSEY-ALTERNATIVE clinical trials (12.0%-32.5%), which is what we hypothesized. 18,19,[22][23][24][25] It is important to note that the incidence rates of muscle-related AEs reported in the prescribing information for alirocumab and evolocumab were based on trials that did not include statin-and/ or ezetimibe-intolerant patients; whereas many patients in our study and patients in the clinical trials were statin and/or ezetimibe intolerant.…”

Section: Discussionmentioning

confidence: 94%

“…20,21 However, currently available safety data from 3 small, randomized clinical trials specifically in statin-intolerant patients taking a PCSK9i suggest that muscle-related AEs occur at a rate of 12.2% to 32.5% and discontinuation rates varied from 0% to 15.9%. [22][23][24][25] As the incidence rates of musclerelated AEs in the prescribing information and clinical trials varied widely, this study will provide quantitative data on the percentage of patients that developed muscle-related PCSK9i AEs in a veteran population to help shed light on a topic that is not well studied.…”

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confidence: 99%

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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: 94%

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confidence: 99%

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

Cencetti¹

2023

Federal Practitioner

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“…Thus, the use of non-statin LLAs such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and bile acid sequestrants becomes necessary to further lower the LDL-C, especially among patients with a high risk of ASCVD [ 6 ]. Besides the non-attainment of LDL-C targets, statin intolerance (SI) also often necessitates the initiation of non-statin LLAs [ 7 ]. Recently, bempedoic acid (BA), a new non-statin LLA, that inhibits the enzyme adenosine triphosphate (ATP)-citrate lyase (ACL), has been approved as an adjuvant to maximally tolerated statin therapy to lower LDL-C in patients with ASCVD and heterozygous familial hypercholesterolemia (HeFH) [ 8 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Bempedoic Acid for Lipid Management in the Indian Population: An Expert Opinion

Hiremath¹,

Mohan²,

Hazra³

et al. 2023

Cureus

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Lipid-lowering is a central theme in the management of patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH), with statins being currently used as the first-line lipid-lowering agent (LLAs). Bempedoic acid (BA) has been recently approved for lipid management in ASCVD/HeFH patients. This expert opinion paper brings out the essential concept to assess the current place of BA in the Indian population. Here we highlight that the majority of the patients with clinical ASCVD may not be receiving the optimal dose of statin, thereby failing to achieve their lipid targets. The addition of BA to statin results in a significant reduction in low-density lipoprotein cholesterol (LDL-C) along with substantial reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and high-sensitivity C-reactive protein (hsCRP) levels. For patients who do not achieve LDL-C targets, BA can be an effective add-on alternative to choose among non-statin LLAs. BA is a good choice for statin-intolerant cases, especially in combination with ezetimibe. Given the lack of effect of worsening hyperglycemia or any increase in the occurrence of new-onset diabetes, BA can be used without hesitation in patients with diabetes. The small risk of hyperuricemia could be mitigated with appropriate patient selection and monitoring of serum uric acid levels in patients at high risk of hyperuricemia. We believe BA is an excellent non-statin therapy that is efficacious, well-tolerated, and cost-effective for lipid management in ASCVD, HeFH, and statin-intolerant patients in India.

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“…To accurately diagnose statin intolerance, healthcare professionals must distinguish statin-associated from non-statin-associated muscle symptoms because many muscle symptoms can be unrelated to statin therapy [ 17 ]. Muscle symptoms are commonly reported by middle-aged or older patients who are not on statin treatment [ 18 ], and exacerbations of such symptoms can be due to increased intensity, prolonged duration, or new forms of physical activity, particularly if from a sedentary state.…”

Section: Introductionmentioning

confidence: 99%

A mobile health application for patients eligible for statin therapy: app development and qualitative feedback on design and usability

Cao

Mathur

et al. 2023

BMC Med Inform Decis Mak

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Background Cardiovascular disease is the leading cause of death in the United States (US). Despite the well-recognized efficacy of statins, statin discontinuation rates remain high. Statin intolerance is a major cause of statin discontinuation. To accurately diagnose statin intolerance, healthcare professionals must distinguish between statin-associated and non-statin-associated muscle symptoms, because many muscle symptoms can be unrelated to statin therapy. Patients’ feedback on muscle-related symptoms would help providers make decisions about statin treatment. Given the potential benefits and feasibility of existing apps for cardiovascular disease (CVD) management and the unmet need for an app specifically addressing statin intolerance management, the objectives of the study were 1) to describe the developmental process of a novel app designed for patients who are eligible for statin therapy to lower the risk of CVD; 2) to explore healthcare providers’ feedback of the app; and 3) to explore patients’ app usage experience. Methods The app was developed by an interdisciplinary team. Healthcare provider participants and patient participants were recruited in the study. Providers were interviewed to provide their feedback about the app based on screenshots of the app. Patients were interviewed after a 30 days of app usage. Results The basic features of the app included symptom logging, vitals tracking, patient education, and push notifications. Overall, both parties provided positive feedback about the app. Areas to be improved mentioned by both parties included: the pain question asked in symptom tracking and the patient education section. Both parties agreed that it was essential to add the trend report of the logged symptoms. Conclusions The results indicated that providers were willing to use patient-reported data for disease management and perceived that the app had the potential to facilitate doctor-patient communication. Results also indicated that user engagement is the key to the success of app efficacy. To promote app engagement, app features should be tailored to individual patient’s needs and goals. In the future, after it is upgraded, we plan to test the app usability and feasibility among a more diverse sample.

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Statin intolerance and new lipid-lowering treatments

Cited by 4 publications

References 42 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

Bempedoic Acid for Lipid Management in the Indian Population: An Expert Opinion

A mobile health application for patients eligible for statin therapy: app development and qualitative feedback on design and usability

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