Coronary heart disease in moderately hypercholesterolemic, hypertensive black and non-black patients randomized to pravastatin versus usual care: the antihypertensive and lipid lowering to prevent heart attack trial (ALLHAT-LLT).
BACKGROUND
In previous analyses in ALLHAT, blacks had a significantly lower risk of coronary heart disease (CHD) in the pravastatin group compared to the usual care group, whereas non-blacks had no benefit from pravastatin. No previous statin trial has reported results separately in blacks.


OBJECTIVE
The study aimed to determine if apparent racial differences in CHD in ALLHAT are explained by differences in baseline characteristics, adherence during the trial, or achieved blood pressure and lipid lowering.


METHODS
This was a prespecified subgroup analysis of a randomized controlled trial. Hypertensive, moderately hypercholesterolemic participants were assigned to open-label pravastatin (40 mg/d) or usual care. The outcome was a composite of nonfatal myocardial infarction and fatal CHD. We performed intention-to-treat survival analyses using Cox proportional hazards models, adjusting for baseline covariates (age, sex, aspirin use, history of CHD and diabetes, and baseline hypertension treatment) and time-varying levels of blood pressure and total cholesterol.


RESULTS
After adjustment for baseline characteristics, there remained a significant interaction between race and treatment group (P = .02). In stratified models, blacks in the pravastatin group had a 29% lower risk of CHD (hazard ratio [HR] 0.71, 95% CI 0.57-0.90, P = .005) compared to those in the usual care group, whereas non-blacks had no benefit (HR 1.00, 95% CI 0.85-1.19, P = .95). With further adjustment for achieved blood pressure and total cholesterol, the HR in blacks was 0.65 (95% CI 0.45-0.96, P = .03) and in non-blacks was 1.07 (95% CI 0.81-1.41, P = .65).


CONCLUSIONS
Our results suggest that pravastatin is effective in preventing CHD in blacks.
Margolis
Karen L
KL
HealthPartners Research Foundation, Minneapolis, MN 55440-1524, USA. karen.l.margolis@healthpartners.com
Dunn
Kay
K
Simpson
Lara M
LM
Ford
Charles E
CE
Williamson
Jeff D
JD
Gordon
David J
DJ
Einhorn
Paula T
PT
Probstfield
Jeffrey L
JL
D001741:Black or African American; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003327:Coronary Disease / Q000150:complications* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000150:complications* / Q000188:drug therapy; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use*; D012720:Severity of Illness Index
D000959:Antihypertensive Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D017035:Pravastatin