[Pharmaco-epidemiologic evaluation of rilmenidine in 18,235 hypertensive patients].

OBJECTIVES

Assess the effects of rilmenidine in routine clinical practice.

METHODS

18,235 patients with high blood pressure--mean age 61.2 years, arterial systolic pressure in supine position (SSP) over arterial diastolic pressure in supine position (SDP) at day 0: 174.58 +/- 0.12/101.51 +/- 0.06 mmHg--were followed by 2,072 general physicians. Treatment was initiated with a daily dose of 1 mg rilmenidine which was adapted as needed at different times in the study. At inclusion, diastolic pressure was between 90 and 115 mmHg in 84.5% of the patients; 1,126 patients had severe hypertension (SDP > or = 115 mmHg); 16,496 of these patients (81.5%) were followed for one year.

RESULTS

Mean fall in blood pressure between day 0 and month 12 was -28.7/-19.3 mmHg in the overall study population and -27.4/-18.9 mmHg in patients treated with 1 mg/day. Mean fall in blood pressure was comparable in the 8 risk populations identified. The percentage of patients who achieved normalized blood pressure status was 96.2% (SDP < or = 90 mmHg); 59.1% with a 1 mg daily dose, 23.7% with 2 mg/day, 11.6% with two-drug treatment and 1.8% with three-drug treatment. Acceptability, taking into account all possible imputabilities (more than 35,000 coprescriptions) and associated diseases, the incidence of undesirable side effects never exceeded 5.6% of the overall study population (5.2% in single-drug treatment, 8.3% in two- or three-drug treatment) and only 3.6% of the patients withdrew from the study due to an undesirable effect whether imputable to the treatment or not. There was little change in heart rate (mean--3 beats per minute between day 0 and month 12); variations observed depended on the rate at study onset. Laboratory tests (blood glucose, cholesterol, triglycerides, potassium, creatinine, uric acid) were not changed in any of the population groups.

CONCLUSIONS

This pharmaco-epidemiologic study showed that the benefit/acceptability ratio for rilmenidine is quite satisfactory and confirms the contribution of rilmenidine as first line treatment for hypertension.