Efficacy & tolerability of bisoprolol in comparison to metoprolol in Indian patients with stage-1 hypertension: multicentre, parallel group, open labelled, randomised noninferiority clinical study

Abstract Introduction Bisoprolol & Metoprolol are selective β1 adrenergic blockers used in treatment of several diseases, including hypertension (HTN). Unlike Metoprolol, the β1-receptor selectivity of Bisoprolol does not change with increasing dose and Bisoprolol also has a longer half-life. The objective was to compare the efficacy & tolerability of Bisoprolol with Metoprolol in Indian patients with Stage-1 HTN. Method Multicentre, parallel group, open labelled, randomised noninferiority trial was conducted at 6 cardiology centres in India (2010 – 2011). The study was approved by the institutional ethics committee at each centre and was performed in accordance with the good clinical practice guidelines and ICH-GCP. Out 218 adult patients screened, 200 patients between the age group of 18 to 65 years, with systolic blood pressure (SBP) 140–159 mm Hg or diastolic blood pressure (DBP) 90–99 mm Hg were randomly assigned to receive either Bisoprolol 5 mg once daily or Metoprolol-SR 50 mg once daily. Primary outcome measure was the responder rate (% of patients achieving BP