[Effect of nilvadipine on nifedipine-induced edema of the lower leg. Results of a double-blind randomized comparative study].
OBJECTIVE
Evaluation of the effects of nilvadipine on nifedipine-induced lower-leg edema.


METHODS
multicenter, randomized, double-blind study.


METHODS
61 outpatients suffering from essential hypertension with diastolic blood pressure adjusted to < or = 95 mmHg by nifedipine, and simultaneous lower-leg edema.


METHODS
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).


METHODS
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.
Vollmuth
M
M
Schmitt
W
W
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004487:Edema / Q000139:chemically induced* / Q000188:drug therapy; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives*
D000959:Antihypertensive Agents; C035100:nilvadipine; D009543:Nifedipine
Einfluss von Nilvadipin auf Nifedipin-induzierte Unterschenkelödeme. Ergebnisse einer doppelblinden randomisierten Vergleichsstudie.