A randomised trial to compare the efficacy and safety of Felodipine (Plendil) and Nifedipine (Adalat) retard in patients with mild-to-moderate hypertension.

The efficacy and tolerability of Felodipine extended-release was compared with Nifedipine retard in the management of patients with mild-to-moderate hypertension. A total of one hundred and thirty three patients were screened out of which one hundred and twenty-one patients were enrolled in a 9-week multicentre open, randomised rising-dose trial to receive either Felodipine 5-10 mg once daily or Nifedipine 10-20 mg twice daily. Blood pressure was measured at the end of the dosing interval that is 24 hours and 12 hours after Felodipine and Nifedipine respectively. Both drugs, Felodipine and Nifedipine were found to lower blood pressure significantly compared with baseline. After three weeks of treatment, seated blood pressure was reduced by 20/14 mmHg (systolic/diastolic) and by 24/16 mmHg after 6 weeks in the felodipine group. Corresponding values in the Nifedipine group were 16/09 mmHg and 24/13mmHg. Pulse rate was not significantly affected by either drugs. The percentage of patients who had satisfactory control after 3 weeks treatment was 57.6% for Felodipine and 33.3% for Nifedipine (significant). After dose titration (where necessary), at the end of the study the response rates were 76.3% (n=45) and 79.6% (n=43) for Felodipine and Nifedipine respectively (non significant). Both drugs were metabolically inert and did not derange the haematologic and biochemical profile of patients. They produced no significant weight changes. The pattern of side effects were similar in both groups but tended to be more severe with Nifedipine necessitating withdrawal of two patients in this group. In conclusion, Felodipine ER 5mg - 10mg once daily, and Nifedipine Retard, 20mg twice daily were equally effective medications for mild-to-moderate hypertension but Felodipine was better tolerated.