Efficacy and tolerability of a β-1 selective β blocker, bisoprolol, as a first-line antihypertensive in Indian patients diagnosed with essential hypertension (BRIGHT): an open-label, multicentric observational study

Abstract

ObjectivesThis study was aimed to evaluate the efficacy and tolerability of bisoprolol, in Indian patients diagnosed with stage I essential hypertension as first-line drug.DesignThis was an open-label, phase IV, multicentric prospective study.Settings239 outpatient centres across India.ParticipantsAfter ethical approval, patients who were willing to sign informed consent, who are newly diagnosed with JNC VII stage I essential hypertension (systolic blood pressure 140–159 mm Hg or diastolic blood pressure 90–99 mm Hg) and who are prescribed bisoprolol were enrolled in the study. Patients with significant organ disease or complications, women of childbearing age refusing reliable contraceptive method, patients with known contraindications (like symptomatic bradycardia, significant atrioventricular blockade, sick sinus syndrome) and patients with known hypersensitivity reactions to bisoprolol and unwilling patients were excluded.Primary and secondary outcomes measuresThe primary outcome measure was percentage of patients achieving blood pressure (BP) ≤140/90 mm Hg at the end of 12 weeks, while multiple secondary outcome measures were assessed.ResultsOf 2418 patients screened, 2161 patients were recruited (66.64% men, mean age 51.7±9.8 years, smokers 19.19%) and 2131 (96.44%) patients achieved BP control. There was significant reduction in systolic blood pressure (−25.29; SD: 13.22 mm Hg), diastolic blood pressure (−14.14; SD: 7.67 mm Hg) and heart rate (−12/min; SD: 6.15) compared with baseline (all p values <0.05). The median dose of bisoprolol and average period required for the response were 5 mg/day and 33 days, respectively. Bisoprolol was found to be well tolerated in the patients up to 10 mg/day. A total of 1.9% patients showed adverse events, which were mild to moderate in severity without any severe adverse event. None required treatment withdrawal.ConclusionBisoprolol is an effective and safe option to control BP. Thus, it can be used as one of the first-line antihypertensive in Indian patients.

Management of Hypertension With a Fixed‐Dose (Single‐Pill) Combination of Bisoprolol and Amlodipine

“…A recent open‐label, multicenter phase 4 study in Indian patients reinforced these findings; significant reductions in SBP, DBP, and heart rate were observed in the majority of patients (96.4%) following 12 weeks of bisoprolol monotherapy. This study also supported the good tolerability of bisoprolol, with mild AEs reported in only 1.9% of patients, no serious AEs reported, and no withdrawals at the request of either the patient or physician …”

“…This study also supported the good tolerability of bisoprolol, with mild AEs reported in only 1.9% of patients, no serious AEs reported, and no withdrawals at the request of either the patient or physician. 41 Amlodipine is a dihydropyridine-type CCB that selectively blocks L-type voltage-gated calcium channels in cardiac muscle and vascular smooth muscle. 16 By blocking L-type voltage-gated calcium channels, amlodipine reduces calcium influx and prevents calciumdependent myocyte contraction and vasoconstriction, resulting in an overall decrease in BP.…”