[Rilmenidine, a new antihypertensive agent in the first line treatment of essential arterial hypertension. Multicenter double-blind study versus atenolol].

1991 
: After 4 weeks on placebo, 90 hypertensive patients (37 men, 53 women, mean age 55 years) with systolic (SBP) and diastolic (DBP) blood pressures of 162/99 and 165/100 mmHg respectively received double-blind treatment with either rilmenidine 1 mg/day or atenolol 50 mg/day. This treatment was given alone for 8 weeks, with possible DBP greater than or equal to 90 mmHg, hydrochlorothiazide 25 mg/day was added between the 9th and 12th weeks of treatment. At week 13 all treatments were replaced by placebo. Both groups were similar at randomisation, and both treatments were similarly effective: after 8 weeks of monotherapy with rilmenidine or atenolol, the SBP/DBP had decreased by -18/-13 mmHg and by -21/-15 mmHg respectively, and the proportion of patients with normalised blood pressure (SBP/DBP less than or equal to 160/90 mmHg) was 66 percent and 65 percent. Effectiveness was maintained at 12 weeks, when less than 20 percent of the patients had taken hydrochlorothiazide. Both drugs were well tolerated clinically and electrocardiographically. There was a significantly greater decrease in heart rate on atenolol than on rilmenidine. Eleven patients (5 on rilmenidine, 6 on atenolol) dropped out of the trial, 2 and 3 patients in the respective groups on account of side-effects. Laboratory tests showed that the HDL-cholesterol level significantly decreased on atenolol and remained stable on rilmenidine (P less than 0.01), whereas the LDL-cholesterol level was stable on atenolol and decreased on rilmenidine (P less than 0.05). No rebound in blood pressure was observed on discontinuation of both treatments. This study shows that rilmenidine administered as first-line treatment is as effective as atenolol in lowering blood pressure, and it confirms that this drug is clinically and biochemically well tolerated.
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