Long-term effectiveness of enalapril plus extended-release diltiazem in essential hypertension.

STUDY OBJECTIVE

To evaluate the efficacy and safety of a new combination product, enalapril-diltiazem ER, when administered over the long term.

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% men, 83% Caucasian, mean age 54.9 yrs) with essential hypertension (sitting diastolic blood pressure 95-115 mm Hg) enrolled, 167 completed the trial.

INTERVENTIONS

Patients received either the dosage of enalapril-diltiazem ER that they were given during the double-blind phase, or were prescribed enalapril 5 mg-diltiazem ER 120 mg once/day. The dosage was increased until blood pressure was controlled or to a maximum of 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 evidence of tolerance to the agents' antihypertensive effects. The most common drug-related adverse events were cough, headache, dizziness, and asthenia or fatigue.

CONCLUSION

The combination effectively managed essential hypertension when administered on a long-term basis and was generally well tolerated. It should improve both compliance and management of hypertension.