Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

Sever, Peter; Dahlöf, Björn; Poulter, Neil; Wedel, Hans; Beevers, Gareth; Caulfield, Mark; Collins, Rory; Kjeldsen, Sverre E.; Kristinsson, A; McInnes, Gordon T.; Mehlsen, Jesper; Nieminen, Markku S.; O’Brien, Eoin; Östergren, Jan

doi:10.1016/s0140-6736(03)12948-0

Cited by 3,205 publications

(986 citation statements)

References 25 publications

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“…The safety findings from these pooled short‐term studies were supported by the analysis of long‐term trials that enrolled a wide range of patients, including those with diabetes,18, 28 stable CHD,20 hypertension,22 recent myocardial infarction,21 or stroke 23. After adjusting for differences in baseline characteristics, no significant differences in the rates of AEs or SAEs were observed between pooled treatment groups; however, there was a higher rate of treatment‐related AE/SAE discontinuations with high‐dose atorvastatin (80‐mg).…”

Section: Discussionmentioning

confidence: 81%

“…As in the overall trial populations,18, 20, 21, 22, 23, 28 treatment and comparator groups for Asian patients in the individual long‐term trials were generally well‐matched (Table S1). There were notable exceptions in some baseline variables such as: age ≥65 years and current smokers in ASCOT‐LLA; smoking status and triglyceride levels in ASPEN; age ≥65 years and smoking status in CARDS; age, smoking status, and SBP in IDEAL; age, age ≥65 years, male gender, smoking status, and triglyceride levels in SPARCL; and age ≥65 years in TNT (Table S1).…”

Section: Resultsmentioning

confidence: 88%

“…With one exception,22 these trials are part of a pooled repository database; however, available data from the remaining trial were included in this analysis. A programmatic search for patient race or ethnicity captured on case report forms (CRFs) revealed 58 trials that had enrolled ≥1 patient self‐identified as Asian, Oriental, South Asian, Indian, or Pacific Islander.…”

Section: Methodsmentioning

confidence: 99%

“…1) so that the several large trials did not confound results from the smaller trials. Six long‐term trials18, 20, 21, 22, 23, 28 (see footnote to Table 1 for trial details) investigating the effect of atorvastatin on CV outcomes were analyzed both individually and pooled according to treatment group; the median study duration was 3.1–4.9 years. The remaining 52 short‐term studies (≤2 years) were pooled according to treatment group; the median study duration was 4–72 weeks.…”

Section: Methodsmentioning

confidence: 99%

“…Long‐term CV outcomes trials with atorvastatin,17, 18, 19, 20, 21, 22, 23 as well as other statins,24, 25 have demonstrated the safety of this class in a range of populations. However, compared with the wealth of evidence from Western populations, the availability of statin safety data from Asian populations is limited, which may be a contributing factor in the underutilization of statins for the treatment of dyslipidemia in this ethnic group.…”

Section: Introductionmentioning

confidence: 99%

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Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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SummaryIntroductionData on statin safety in Asian patients are limited compared with evidence from Western populations.AimThis study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.MethodsData from 52 short‐term trials (median exposure 4–72 weeks) and six long‐term cardiovascular outcomes trials (median exposure 3.1–4.9 years) conducted across the atorvastatin 10–80‐mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.ResultsA total of 77 952 patients were identified (49 974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short‐term trials, the incidence of all‐causality adverse events (AEs) and serious AEs (SAEs) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment‐related AEs/SAEs were infrequent (2.0% across all doses). These observations were confirmed in the long‐term trials. Treatment‐related SAEs were rare (n = 4) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin‐treated Asian patients, and the incidence of myalgia was 1.8% in the short‐term studies and 6.7% in the long‐term trials. Elevations (>3× the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal AEs occurred in <2%.ConclusionThe incidence of AEs/SAEs with atorvastatin 10–40‐mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80‐mg is required owing to the limited number of Asian patients (n = 281; 11.2%) who received this dose.

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Section: Discussionmentioning

confidence: 81%

Section: Resultsmentioning

confidence: 88%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety of atorvastatin in Asian patients within clinical trials

Chan

Kong

Bao

et al. 2016

Cardiovascular Therapeutics

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Ethnic and Sex Differences in the Prevalence, Treatment, and Control of Dyslipidemia Among Hypertensive Adults in the GENOA Study

O’Meara¹,

Kardia²,

Armon³

et al. 2004

Arch Intern Med

167

107

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Statin Use and Survival Outcomes in Elderly Patients With Heart Failure

Ray¹,

Gong²,

Sykora³

et al. 2005

Arch Intern Med

103

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Statin use is associated with a lower risk of death among seniors newly diagnosed as having congestive heart failure. While statin use has been previously shown to be efficacious in patients with coronary heart disease and stroke, we could not control for all prognostic risk factors in the present study, including left ventricular ejection fraction and serum lipid levels. Better evidence can direct clinicians about which patients with heart failure might benefit from these drugs.

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Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

Cited by 3,205 publications

References 25 publications

Safety of atorvastatin in Asian patients within clinical trials

Safety of atorvastatin in Asian patients within clinical trials

Ethnic and Sex Differences in the Prevalence, Treatment, and Control of Dyslipidemia Among Hypertensive Adults in the GENOA Study

Statin Use and Survival Outcomes in Elderly Patients With Heart Failure

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