CLINICAL EFFICACY AND SAFETY OF TREATMENT WITH BISOPROLOL AND HYDROCHLOROTHIAZIDE: A SYSTEMATIC REVIEW AND META-ANALYSIS

Objective: To assess the blood pressure (BP) lowering effect and the safety profile of treatment with bisoprolol and hydrochlorothiazide in patients affected by hypertension. Design and method: The study was designed in according to guidelines of the 2020 preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement. A systematic literature search was conducted in multiple electronic databases to identify the randomized controlled clinical studies investigating the effect of combined treatment with bisoprolol and hydrochlorothiazide on BP. Effect sizes for changes in SBP and DBP were expressed as mean differences (MDs) and 95% confidence intervals (95%CIs). For safety analysis, odds ratios (OR) and 95% CI intervals were calculated using the Mantel-Haenszel method. Results: Data were pooled from 5 clinical studies. Meta-analysis of available data showed that treatment with Bisoprolol / Hydrochlorothiazide significantly reduced SBP [MD: -8.35 mmHg, 95%CI (-11.44, -5.25) mmHg, P <0.001, compared to control; MD: -9.88 mmHg, 95%CI (-12.62, -7.14) mmHg, P <0.001, compared to placebo] and DBP [MD: -7.62 mmHg, 95%CI (-11.20, -4.04) mmHg, P <0.001, compared to control; MD: -8.79 mmHg, 95%CI (-11.92, -5.67) mmHg, P <0.001, compared to placebo]. Moreover, BP response rate and BP control rate after treatment with Bisoprolol / Hydrochlorothiazide were significantly greater compared to control [Response rate: OR: 4.86 mmHg, 95%CI (2.52, 9.37), P <0.001; Control rate: OR: 1.67 mmHg, 95%CI (1.11, 2.51), P = 0.014]. Finally, treatment with Bisoprolol / Hydrochlorothiazide was associated with a reduced risk of any AE and peripheral edema compared to control. Conclusions: Our results show that treatment with Bisoprolol/Hydrochlorothiazide has favorable effects on BP and an good safety profile.