To assess the efficacy and safety of bisoprolol/6.25-mg hydrochlorothiazide
(HCTZ), amlodipine, and enalapril in black and nonblack patients, data fro
m two comparative studies were pooled and subgroup analyses performed. Both
studies had similar designs and included all three active treatments. The
second study also included a placebo group. Subjects (n=541) with a sitting
diastolic blood pressure of 95-114 mmHg were titrated to achieve a diastol
ic blood pressure less than or equal to 90 mmHg. The studies included 114 b
lacks and 427 nonblocks.
Results of an intention-to-treat analysis of mean change from baseline afte
r 12 weeks of treatment showed the following: 1) blood pressure was signifi
cantly towered by all three active drugs compared with baseline or placebo;
2) in blacks, bisoprolol/6.25-mg HCTZ resulted in significantly greater re
ductions of systolic and diastolic blood pressure than enalapril or placebo
, but was not significantly different from amlodipine; 3) in nonblacks, bis
oprolol/6.25-mg HCTZ resulted in significantly greater reduction of diastol
ic blood pressure than amlodipine, enalapril, or placebo. The placebo-corre
cted change in blood pressure was greater for blacks than whites on the bis
oprolol/6.25-mg HCTZ combination, but this was not statistically significan
t. Bisoprolol/6.25-mg HCTZ controlled diastolic blood pressure to less than
or equal to 90 mmHg in significantly more patients than enalapril or place
bo in blacks and nonblocks. The difference in control rates was not signifi
cant versus amlodipine. The incidence of drug-related adverse events was si
milar between treatments; however, bisoprolol/6.25-mg HCTZ had a lower disc
ontinuation rate due to lack of blood pressure control or adverse experienc
es in both blacks and nonblacks.