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Benefits of and Risks Associated With Statin Therapy for Primary Prevention in Older Adults
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
There is little consensus on using statins for primary prevention of cardiovascular diseases (CVDs) and all-cause mortality in adults aged 75 years or older due to the underrepresentation of this population in randomized controlled trials.
OBJECTIVE
To investigate the benefits and risks of using statins for primary prevention in old (aged 75 to 84 years) and very old (aged ≥85 years) adults.
DESIGN
Sequential target trial emulation comparing matched cohorts initiating versus not initiating statin therapy.
SETTING
Territory-wide public electronic medical records in Hong Kong.
PARTICIPANTS
Persons aged 75 years or older who met indications for statin initiation from January 2008 to December 2015 were included. Participants with preexisting diagnosed CVDs at baseline, such as coronary heart disease (CHD), were excluded from the analysis. Among 69 981 eligible persons aged 75 to 84 years and 14 555 persons aged 85 years or older, 41 884 and 9457 had history of CHD equivalents (for example, diabetes) in the respective age groups.
INTERVENTION
Initiation of statin therapy.
MEASUREMENTS
Incidence of major CVDs (stroke, myocardial infarction, or heart failure), all-cause mortality, and major adverse events (myopathies and liver dysfunction).
RESULTS
Of 42 680 matched person-trials aged 75 to 84 years and 5390 matched person-trials aged 85 years or older (average follow-up, 5.3 years), 9676 and 1600 of them developed CVDs in each age group, respectively. Risk reduction for overall CVD incidence was found for initiating statin therapy in adults aged 75 to 84 years (5-year standardized risk reduction, 1.20% [95% CI, 0.57% to 1.82%] in the intention-to-treat [ITT] analysis; 5.00% [CI, 1.11% to 8.89%] in the per protocol [PP] analysis) and in those aged 85 years or older (ITT: 4.44% [CI, 1.40% to 7.48%]; PP: 12.50% [CI, 4.33% to 20.66%]). No significantly increased risks for myopathies and liver dysfunction were found in both age groups.
LIMITATION
Unmeasured confounders, such as lifestyle factors of diet and physical activity, may exist.
CONCLUSION
Reduction for CVDs after statin therapy were seen in patients aged 75 years or older without increasing risks for severe adverse effects. Of note, the benefits and safety of statin therapy were consistently found in adults aged 85 years or older.
PRIMARY FUNDING SOURCE
Health Bureau, the Government of Hong Kong Special Administrative Region, China, and National Natural Science Foundation of China.
Additional Info
Disclosure statements are available on the authors' profiles:
Benefits and Risks Associated With Statin Therapy for Primary Prevention in Old and Very Old Adults : Real-World Evidence From a Target Trial Emulation Study
Ann. Intern. Med 2024 May 28;[EPub Ahead of Print], W Xu, AL Lee, CLK Lam, G Danaei, EYF WanFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
The benefits of and risks associated with initiation of a statin for the primary prevention of atherosclerotic cardiovascular disease in older patients (age, ≥80 years) are not known. The best evidence for a treatment recommendation comes from double-blind randomized controlled trials. For statins, the numerous placebo-controlled, randomized, double-blind cardiovascular disease outcomes trials were not conducted in individuals aged over 80 years. The meta-analysis of individual participant data in these trials, involving patients who were randomized at age 75 years and followed for about 5 years, showed a statistically significant 21% relative risk reduction (RR, 0.79; 95% CI, 0.77–0.81) in major vascular events per 1.00 mmol/L (38.7 mg/dL) reduction in LDL-C level and a 24% relative risk reduction in major coronary events (RR, 0.76; 95% CI, 0.73–0.79) per 1.00 mmol/L reduction in LDL-C level over a median treatment period of 4.9 years.1 However, the benefit was less evident in patients over the age of 75 years who did not have cardiovascular disease.
This published paper describes an observational retrospective trial emulation study, designed to evaluate the benefits of and risks associated with statin therapy for primary prevention in old (age, 75–84 years) and very old (age, ≥85 years) adults. Data from public electronic medical records in Hong Kong were analyzed. Patients with no history of statin use or atherosclerotic cardiovascular disease over the age of 60 years and with indications for statin therapy based on risk factors and LDL-C level were identified and placed into three age groups: ages 60 to 74 years, 75 to 84 years, and 85 years or older. Each group was categorized into individuals who initiated a statin and those who did not initiate statin therapy. In an effort to balance the baseline characteristics in each group, and mimic randomization, propensity scores were calculated and individuals in the statin initiation group and the noninitiation group were matched. The incidences of stroke, myocardial infarction, heart failure, all-cause mortality, myopathies, and liver abnormalities were calculated. An intention-to-treat analysis involving 42,680 individuals in the 75 to 84–year group and 5390 in the 85-year and older group found a reduction in the relative risk of overall cardiovascular disease, myocardial infarction, and total mortality in initiators of statin treatment compared with noninitiators. No evidence of myopathy or liver dysfunction, as defined by the investigators, were seen.
These results suggest that initiation of statin therapy may have a clinical benefit without major safety risks in individuals over the age of 75 years, including those who are 85 years or older. However, interpretation and generalization of the results are limited by the potential biases owing to a lack of randomization.2 The authors acknowledge that unmeasured confounders — such as lifestyle, diet, and physical activity — may exist; thus, the current evidence is still insufficient to recommend statins for primary prevention in individuals aged 85 years or older. As with all decisions about prescribing a treatment, individualized benefits and risks must be examined and discussed with the patient.
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