Objective: Evaluation of the effects of nilvadipine on nifedipine-induced lower-leg edema.
Study design: multicenter, randomized, double-blind study.
Patients: 61 outpatients suffering from essential hypertension with diastolic blood pressure adjusted to < or = 95 mmHg by nifedipine, and simultaneous lower-leg edema.
Medication: First phase: wash-out--placebo b.i.d.; Second phase: slow-release nifedipine 20 mg b.i.d.; Third phase: slow-release nifedipine 20 mg b.i.d. or nilvadipine 8 mg (mornings) and placebo (evenings).
Parameters: Lower leg volume, blood pressure, heart rate, weight, laboratory investigations, undesired effects, assessment of effectiveness and tolerability by the physician, subjective patient assessment.
Results: Patients treated with nilvadipine immediately following nifedipine therapy showed a significant decrease in lower-leg volume as compared with those continuing to receive nifedipine. In about half of the patients receiving nilvadipine, nifedipine-induced lower-leg edema disappeared completely. No differences were seen between the two substances in terms of effectiveness or tolerability.