LONG-TERM EFFECTIVENESS OF ENALAPRIL PLUS EXTENDED-RELEASE DILTIAZEM IN ESSENTIAL-HYPERTENSION

Study Objective. To evaluate the efficacy and safety of a new combinat ion product, enalapril-diltiazem ER, when administered over the long t erm. Design. Open-label, titration to response, with treatment lasting 46 weeks after a 6-week, double-blind phase. Setting. Medical clinics in the private and academic sectors. Patients. Of 265 patients (68% m en, 83% Caucasian, mean age 54.9 yrs) with essential hypertension (sit ting diastolic blood pressure 95-115 mm Hg) enrolled, 167 completed th e trial. Interventions. Patients received either the dosage of enalapr il-diltiazem ER that they were given during the double-blind phase, or were prescribed enalapril 5 mg-diltiazem ER 120 mg once/day. The dosa ge was increased until blood pressure was controlled or to a maximum o f enalapril 10-diltiazem ER 360 mg/day. Measurements and Main Results. Combination therapy decreased sitting blood pressures by -11.1/-10.6 mm Hg. Overall, 58% of the patients achieved a sitting diastolic blood pressure of 90 mm Hg or below at the end of the study. There was no e vidence of tolerance to the agents' antihypertensive effects. The most common drug-related adverse events were cough, headache, dizziness, a nd asthenia or fatigue. Conclusion. The combination effectively manage d essential hypertension when administered on a long-term basis and wa s generally well tolerated. It should improve both compliance and mana gement of hypertension.