Efficacy and safety of rilmenidine in elderly patients--comparison with hydrochlorothiazide. The Belgian Multicentre Study Group.
The aim of this trial was to study the treatment of hypertension in the elderly, comparing a new oxazoline antihypertensive agent, rilmenidine, with the diuretic hydrochlorothiazide (HCZ). After 2 weeks on placebo, 88 elderly patients (mean age 75 years; 65 women), corresponding to strict inclusion criteria, were randomized to 8 weeks double-blind monotherapy with rilmenidine 1-2 mg/day (n = 46) or HCZ 25-50 mg/day (n = 42), with administration of potassium supplements as required. Particular emphasis was placed on the evaluation of safety: blood screens were repeated after 2, 4, and 8 weeks of treatment and symptoms were systematically evaluated every 2 weeks. The rilmenidine and HCZ groups were comparable at randomization, with baseline supine systolic/diastolic blood pressures of 167/101 mm Hg and 172/101 mm Hg, respectively. Both drugs induced a significant decrease in blood pressure: at 8 weeks, supine blood pressure had decreased to 154/89 mm Hg and to 155/87 mm Hg in the rilmenidine and HCZ groups, respectively (difference not significant between groups). Changes in heart rate did not differ significantly between groups (-3 bpm at 8 weeks). Drug-related symptoms were rare and the incidence was similar in both groups. Weight decreased significantly in the HCZ group by 1 kg (p < 0.001) and did not change in the rilmenidine group. After 8 weeks of monotherapy, expected variations in serum biochemistry were detected in the HCZ group, resulting in a significant difference in comparison with the rilmenidine group: serum potassium and chloride decreased significantly and uric acid levels increased significantly in the HCZ group.(ABSTRACT TRUNCATED AT 250 WORDS)
Pelemans
W
W
Belgium Multicenter Study Group, Leuven.
Verhaeghe
J
J
Creytens
G
G
Coupez
G
G
Van Dessel
A
A
Opsomer
M
M
Corcoran
C
C
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010080:Oxazoles / Q000627:therapeutic use*; D000077769:Rilmenidine
D000970:Antineoplastic Agents; D010080:Oxazoles; D006852:Hydrochlorothiazide; D000077769:Rilmenidine