Single drug antihypertensive therapy with rilmenidine

OBJECTIVE: To study the therapeutic interest of dose adaptation from 1 mg to 2 mg daily when treating essential hypertension with rilmenidine in monotherapy, in terms of normalisation of blood pressure, of clinical tolerance and of laboratory parameters. METHODS: In a non-comparative multicentre study conducted in France in patients with essential hypertension, rilmenidine was started at 1 mg daily. When the target blood pressure was not achieved (supine diastolic blood pressure (DBP) less than or equal to 90 mm Hg) after 6 weeks, the dose was adapted to 2 mg daily. For persistent non-responders, a second antihypertensive was added from 3 months and a third from 6 months as necessary. Total follow up was for 12 months. RESULTS: Eighteen thousand two hundred and thirty five (18 235) patients of either sex, average age 61.2 years and 90 mm Hg< supine DBP <115 mm Hg were included. Sixteen thousand four hundred and ninety six (16 496) patients were followed for 12 months, with complete data being available for 15 963 of them., 13 565 (84.9 %) were treated with rilmenidine in monotherapy, 9 626 (60.3%) at 1 mg daily, and 3 939 (24.6 %) at 2 mg daily. For patients who were treated with rilmenidine 1 mg daily throughout the study mean reduction of blood pressure between DO and M12 was -27.5/-18.9 mm Hg. Mean reduction was -30.0/-20.3 mm Hg for those who completed the study on 2 mg per day. 82.8 % of the analysed population were normalised with rilmenidine in monotherapy, 59.1 % with 1 mg daily. Dose adaptation to 2 mg normalised an additional 23.7 % of patients. Rilmenidine monotherapy was associated with good clinical and laboratory acceptability. CONCLUSION: The step-wise adaptation of rilmenidine dose in the treatment of essential hypertension is justified by the superior normalisation rate achieved by increasing the dose from 1 mg to 2 mg daily This adaptation neither increases side effects not changes laboratory parameters. These data support dose adaptation of rilmenidine monotherapy before association with another antihypertensive. However, neither blood pressure level nor associated risk factors predict the type of patients who will be normalised by 1 mg daily or those who require 2 mg. The practice of always starting rilmenidine at 1 mg daily in essential hypertension is therefore supported.