Efficacy and safety of losartan-amplodipine combination--an Indian postmarketing surveillance experience.

ABSTRACT

The present study was conducted among 719 patients enrolled by 109 doctors to evaluate the efficacy and tolerability of the combination of losartan potassium and amlodipine besylate in Indian patients with mild to moderate hypertension. Out of them 11 patients were dropped out. Of these 708 patients 643 patients received once daily dosage of the combination whereas 10 patients received 1/2 daily, 13 patients received 1 1/2 daily and 42 patients received 1 twice daily dosage of the combination. The mean SBP in the study was 172.89 +/- 19.18 mm Hg baseline. After the 10-day treatment, the mean SBP had significant reduction ie, 13.1% from basal and at the end of day 20 of the treatment, the reduction was 19.13% from the baseline which was significant. Similarly mean DBP was 105.42 +/- 10.85 mm Hg at baseline. After treatment, the mean DBP had significant reduction. After 10- day treatment, there was 12.7% reduction from the baseline and at the end of the treatment ie, after day 20, the reduction was 17.70% from basal, which was significant. Global evaluation of efficacy was done by the physicians; 93.8% of the cases had excellent to good response and 4.9% patients had fair response. Details of any adverse event reported or noted during the treatment with the combination were recorded in the appropriate section of the case record form, whether considered treatment related or not, as reported by the patients. The severity of an adverse event was graded on a 3-point scale as mild, moderate and severe. The most common side-effects reported were oedema of feet (5.08%), ankle oedema (1.98%). Remaining adverse events included some cardiovascular events such as palpitations, gastro-intestinal events such as constipation, miscellaneous events, muscular pain, weakness, generalised swelling, etc. CNS events included giddiness, headache, insomnia, etc.