First‐Line Therapy Option with Low‐Dose Bisoprolol Fumarate and Low‐Dose Hydrochlorothiazide in Patients with Stage I and Stage II Systemic Hypertension

Abstract

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).(ABSTRACT TRUNCATED AT 250 WORDS)

Low-dose Fixed Combination of Bisoprolol/Hydrochlorothiazide as First Line for Hypertension: A Review of the Rationale and Clinical Evidence

“…The low-dose combination was shown to provide safety advantages over by less hypokalemia (< 1% with combination vs. 6.5% with HCTZ). 16 Similar results are obtained from a randomized, double-blind, placebo-controlled, multifactorial trial aimed to assess the safety and effectiveness of different dosages and combinations in 512 patients with mild-to-moderate essential hypertension randomized to once-daily treatment with bisoprolol, HCTZ, and all possible combinations. Diastolic and systolic BP was monitored during this 12-week trial.…”

β-Blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial

“…A previous pediatric study of a β-blocker/diuretic combination, propranolol and chlorthalidone, showed significant reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared with placebo over a 30-month period [6]. In adults, the specific B/HT combination product has been shown to have a significant antihypertensive effect, with a side effect profile comparable to that seen with placebo [7,8]. Since no data were available for B/HT in hypertensive children, the Ziac Pediatric Hypertension Study was conducted to determine the safety and efficacy of B/HT in hypertensive children compared with placebo.…”

Implication of the Fixed Combinations in the Hypertension Treatment

“…В плацебо-контролируемом исследовании с уча-стием 547 пациентов в группе бисопролола 5 мг/гид-рохлортизида 6,25 мг было отмечено значительно более выраженное снижение диастолического АД, чем в группах бисопролола 5 мг или гидрохлортиази-да 25 мг, при этом эффект не зависел от расы, пола, воз-раста пациентов и курения [28]. Данными исследова-ний с использованием суточного мониторирования под-твержден 24-часовой эффект комбинации [28,29].…”

“…Данными исследова-ний с использованием суточного мониторирования под-твержден 24-часовой эффект комбинации [28,29].…”