https://orcid.org/0000-0002-2520-5673
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ABSTRACT
Introduction
Statins are highly used in cardiovascular prevention. Statin intolerance is the most significant cause of decreased adherence, translating into a higher cardiovascular risk. This systematic review aims to estimate the incidence of muscle adverse events in patients with a history of statin intolerance receiving placebo.
Methods
Database search was performed in CENTRAL, MEDLINE, and EMBASE until March 2023. This systematic review included blinded randomized control trials enrolling patients with a history of statin intolerance who received a placebo. A random-effects meta-analysis was performed. Results were presented in percentages, with 95% confidence intervals (95% CI).
Results
Overall, eight studies with 8095 patients with a history of statin intolerance receiving placebo were included. The muscle adverse events incidence rate was 21.34% (95% CI 13.26–30.63%, 8 studies), and discontinuation due to adverse muscle events was 6.12% (95% CI 1.22–13.70%, 3 studies). The incidence was higher in subcutaneous placebo/sham (41.67%, 1 study) compared to oral placebo studies (22.95%, 6 studies).
Conclusion
In patients previously labeled as statin-intolerant, about a fifth of the patients exhibited muscle symptoms when receiving a placebo. This highlights the importance of ruling out non-statin-related symptoms to further optimize statin therapy for cardiovascular risk improvement.
Declaration of interests
D Caldeira has participated in educational meetings and/or attended conferences or symposia with Bristol-Myers Squibb, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Merck Serono, Ferrer, Pfizer, Novartis, and Roche.
J Ruivo is an employee of Daiichi Sankyo Portugal (Head of Cardiovascular Medical Affairs).
FJ Pinto has previously received consultant and speaker fees from Astra Zeneca, Bayer, BMS, Boehringer Ingelheim, and Daiichi Sankyo.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.
Author contributions statement
Rita Louro had substantial work regarding the execution, acquisition of data, analysis and interpretation. Rita Louro has drafted and critically reviewed the article, has agreed on the journal to which the article will be submitted, and with the final version submitted.
Ryan Gouveia e Melo had substantial work regarding the analysis, interpretation, critically reviewed the article, has agreed on the journal to which the article will be submitted, and with the final version submitted.
Jorge Ruivo had substantial work regarding the analysis, interpretation, critically reviewed the article, has agreed on the journal to which the article will be submitted, and with the final version submitted.
Ana G. Almeida had substantial work regarding the analysis, interpretation, critically reviewed the article, has agreed on the journal to which the article will be submitted, and with the final version submitted.
Fausto J. Pinto had substantial work regarding the analysis, interpretation, critically reviewed the article, has agreed on the journal to which the article will be submitted, and with the final version submitted.
Daniel Caldeira had substantial work regarding the conception, study design, execution, acquisition of data, analysis, interpretation and critically reviewed the article. Daniel Caldeira has agreed on the journal to which the article will be submitted, and with the final version submitted. Daniel Caldeira is the guarantor.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14779072.2023.2274502