EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study

Faruqui, A.A.

Journal of the Indian Medical Association 105(5): 272; 274; 276-277

2007


ISSN/ISBN: 0019-5847
PMID: 17915798
Document Number: 12152
The objective of EVOLVE [nebivolol (nevol)] evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73±14.16 mm Hg which dropped to 135.13±11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p<0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21±8.25 mm Hg that dropped to 83.69±6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p<0.001). The heart rate in this study showed a significant decrease from 86.13±9.35 at basal to 75.09±7.42 at the end of the study (p<0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n=22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by JNC VII. EVOLVE PMS study confirms the safety and efficacy of nebivolol hydrochloride in Indian population. With its novel mechanism of action, good efficacy and favourable tolerability profile, nebivolol hydrochloride is poised to claim a prominent position in the management of patients with essential hypertension.

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EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study