Key result
Bisoprolol 5 mg/HCTZ 6.25 mg produced significantly greater mean reductions in sitting systolic and diastolic blood pressure (-15.8/-12.6 mm Hg) than either monotherapy.
Why the study?
Does low-dose bisoprolol fumarate and low-dose hydrochlorothiazide improve blood pressure reduction in patients with stage I and stage II systemic hypertension compared to monotherapy?
RCT
Double-blind
parallel-group
Yes
Does low-dose bisoprolol fumarate and low-dose hydrochlorothiazide improve blood pressure reduction in patients with stage I and stage II systemic hypertension compared to monotherapy?
Absolute Event Rate: 73% vs 61%
Low-dose combination therapy with bisoprolol 5 mg and hydrochlorothiazide 6.25 mg provides superior blood pressure reduction and a better safety profile compared to higher-dose monotherapy in mild to moderate hypertension.
Supports low-dose bisoprolol/HCTZ over monotherapy for greater BP reduction in stage I-II hypertension; extends evidence for combination regimens as initial therapy.
This 30‐center, randomized, double‐blind, placebo‐controlled, parallel‐group study was designed to (1) establish that 6.25 mg of hydrochlorothiazide (HCTZ) given once daily with 5 mg of bisoprolol fumarate can contribute to antihypertensive effectiveness in patients with stage I and stage II (mild to moderate) systemic hypertension; and (2) assess whether this formulation was more effective or possessed a safety advantage over standard monotherapy with bisoprolol or 25 mg of HCTZ. Results showed that HCTZ 6.25 mg contributed significantly to the antihypertensive effectiveness of bisoprolol 5 mg. Bisoprolol 5 mg/HCTZ 6.25 mg (B5/H6.25) produced significantly greater mean reductions from baseline in sitting systolic and diastolic blood pressure (−15.8 mm Hg/−12.6 mm Hg) than bisoprolol 5 mg alone (−10.0 mm Hg/−10.5 mm Hg) and HCTZ 25 mg alone (−10.2 mm Hg/−8.5 mm Hg). A 73% response rate was achieved with the low‐dose formulation compared with 61% for the bisoprolol 5 mg (B5) group and 47% for the HCTZ 25 mg (H25) group. B5/H6.25 was found to be significantly more effective than B5 or H25 in all subgroups of patients, regardless of gender, race, age, or smoking history. Antihypertensive effects were maintained during the 24‐hour dosing interval. The incremental effectiveness of B5/H6.25 was not accompanied by an increase in the frequency or severity of adverse experiences; the incidence of adverse experiences in the B5/H6.25 group was comparable to that in the placebo group. B5/H6.25 was shown to provide safety advantages over H25, as shown by less hypokalemia (<1% with B5/H6.25 versus 6.5% with H25). Treatment effects on triglycerides were similar to placebo, although small decreases in high‐density lipoprotein (HDL) cholesterol were observed in the bisoprolol‐treated groups. The benefits of low‐dose bisoprolol 5 mg/HCTZ 6.25 mg provide a rational basis for the use of this medication in the first‐line treatment of patients with stage I and stage II systemic hypertension.
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Frishman et al. (1995) conducted an RCT in stage I and stage II systemic hypertension. Bisoprolol fumarate and hydrochlorothiazide vs. bisoprolol 5 mg alone, HCTZ 25 mg alone, and placebo was evaluated on response rate. Bisoprolol 5 mg/HCTZ 6.25 mg produced significantly greater mean reductions in sitting systolic and diastolic blood pressure (-15.8/-12.6 mm Hg) than either monotherapy.
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