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
- V Channaraya1,
- R K Marya2,
- M Somasundaram3,
- Debashish Mitra4,
- K D Tibrewala5 on the behalf of BRIGHT investigators
- 1KIMS Hospital, Bengaluru, India
- 2Delhi, India
- 3Department of Cardiology, Madras Medical College, Chennai, India
- 4Department of Cardiology, RNT Institute of Cardiac Sciences, Kolkata, India
- 5Ahmedabad, India
- Correspondence to Dr V Channaraya;
- Received 30 November 2011
- Accepted 30 March 2012
- Published 14 May 2012
Objectives This study was aimed to evaluate the efficacy and tolerability of bisoprolol, in Indian patients diagnosed with stage I essential hypertension as first-line drug.
Design This was an open-label, phase IV, multicentric prospective study.
Settings 239 outpatient centres across India.
Participants After 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 measures The 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.
Results Of 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.
Conclusion Bisoprolol is an effective and safe option to control BP. Thus, it can be used as one of the first-line antihypertensive in Indian patients.
BRIGHT investigators are listed in the supplementary file.
To cite: Channaraya V, Marya RK, Somasundaram M, et al. 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. BMJ Open 2012;2:e000683. doi:10.1136/bmjopen-2011-000683
Contributors VCR: substantial contribution to conception and design, drafting the article and final approval. RKM: substantial contribution to data analysis and interpretation, article revision as well as correction and final approval. MS: substantial contribution to conception and design, acquisition of data as well as data analysis, drafting article and final approval. DM: substantial contribution to conception and design, drafting the article and final approval. KDT: substantial contribution to data analysis and interpretation, article revision as well as correction and final approval.
Funding The study was funded by Merck Serono Ltd, Mumbai, India. The sponsor played no role in the study design, data collection and management, analysis and interpretation of the data. Also, sponsor did not play any role in report writing as well as submission to the journal.
Competing interests None.
Patient consent Obtained.
Ethics approval Ethics approval was provided by Unique Independent Ethics Committee and Institutional Ethics Committee wherever applicable.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data available.
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