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Original Investigation
May 22, 2017

Effect of Statin Treatment vs Usual Care on Primary Cardiovascular Prevention Among Older AdultsThe ALLHAT-LLT Randomized Clinical Trial

Author Affiliations
  • 1Division of Geriatric Medicine and Palliative Care, Department of Medicine, New York University School of Medicine, New York
  • 2Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston Salem, North Carolina
  • 3Coordinating Center for Clinical Trials, University of Texas School of Public Health, Houston
JAMA Intern Med. Published online May 22, 2017. doi:10.1001/jamainternmed.2017.1442
Key Points

Question  Are statins beneficial when used for primary cardiovascular prevention in older adults?

Findings  In this post hoc secondary analysis of older adults in the randomized clinical trial Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial–Lipid-Lowering Trial (ALLHAT-LLT), there were no significant differences in all-cause mortality or cardiovascular outcomes between pravastatin sodium and usual care for primary prevention for adults 65 years and older.

Meaning  No benefit was found when a statin was given for primary prevention to older adults. Treatment recommendations should be individualized for this population.

Abstract

Importance  While statin therapy for primary cardiovascular prevention has been associated with reductions in cardiovascular morbidity, the effect on all-cause mortality has been variable. There is little evidence to guide the use of statins for primary prevention in adults 75 years and older.

Objectives  To examine statin treatment among adults aged 65 to 74 years and 75 years and older when used for primary prevention in the Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).

Design, Setting, and Participants  Post hoc secondary data analyses were conducted of participants 65 years and older without evidence of atherosclerotic cardiovascular disease; 2867 ambulatory adults with hypertension and without baseline atherosclerotic cardiovascular disease were included. The ALLHAT-LLT was conducted from February 1994 to March 2002 at 513 clinical sites.

Interventions  Pravastatin sodium (40 mg/d) vs usual care (UC).

Main Outcomes and Measures  The primary outcome in the ALLHAT-LLT was all-cause mortality. Secondary outcomes included cause-specific mortality and nonfatal myocardial infarction or fatal coronary heart disease combined (coronary heart disease events).

Results  There were 1467 participants (mean [SD] age, 71.3 [5.2] years) in the pravastatin group (48.0% [n = 704] female) and 1400 participants (mean [SD] age, 71.2 [5.2] years) in the UC group (50.8% [n = 711] female). The baseline mean (SD) low-density lipoprotein cholesterol levels were 147.7 (19.8) mg/dL in the pravastatin group and 147.6 (19.4) mg/dL in the UC group; by year 6, the mean (SD) low-density lipoprotein cholesterol levels were 109.1 (35.4) mg/dL in the pravastatin group and 128.8 (27.5) mg/dL in the UC group. At year 6, of the participants assigned to pravastatin, 42 of 253 (16.6%) were not taking any statin; 71.0% in the UC group were not taking any statin. The hazard ratios for all-cause mortality in the pravastatin group vs the UC group were 1.18 (95% CI, 0.97-1.42; P = .09) for all adults 65 years and older, 1.08 (95% CI, 0.85-1.37; P = .55) for adults aged 65 to 74 years, and 1.34 (95% CI, 0.98-1.84; P = .07) for adults 75 years and older. Coronary heart disease event rates were not significantly different among the groups. In multivariable regression, the results remained nonsignificant, and there was no significant interaction between treatment group and age.

Conclusions and Relevance  No benefit was found when pravastatin was given for primary prevention to older adults with moderate hyperlipidemia and hypertension, and a nonsignificant direction toward increased all-cause mortality with pravastatin was observed among adults 75 years and older.

Trial Registration  clinicaltrials.gov Identifier: NCT00000542

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