Combined Enalapril and Felodipine Extended Release (ER) for Systemic Hypertension
Section snippets
Patient Selection and Study Design
Seven hundred seven patients (457 men [65%], 548 white [78%]), mean age 53.5 years, with essential hypertension and sitting diastolic BP in the range of 95 to 115 mm Hg were enrolled in a multicenter, placebo-controlled, double-blind, parallel, randomized 3 × 4 factorial design study after giving informed consent. Patients with evidence of significant renal (calculated creatinine clearance <60 ml/min) or hepatic dysfunction, recent myocardial infarction, or congestive heart failure were
Results
The baseline characteristics of the 707 patients who took part in the study are given in Table 2. The 12 treatment groups were similar with respect to age, gender, race, duration of hypertension, and baseline BP. Of the 707 patients, data were available on 705 for efficacy analysis (2 patients without treatment records were excluded).
The estimated (additive model) trough sitting systolic and diastolic BP reductions at week 8 are presented in Fig. 1Fig. 2. All doses of enalapril and felodipine
Discussion
In this study, the combination of enalapril and felodipine ER effectively lowered BP and was generally well tolerated with an excellent safety profile when used in the treatment of hypertension. Moreover, both efficacy and tolerability were enhanced when these drugs were used in combination compared to their monotherapies. At each combination dose, both drugs contributed significantly to lowering BP. The trough to peak ratios were consistent with 1dose/day in that BP reduction 24 hours after
Acknowledgements
We gratefully acknowledge the assistance of Clara Hwang, MS, for conducting the statistical analyses of the study.
This study was supported in part by Astra Merck, Inc., Wayne, Pennsylvania.
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A list of participating investigators appears in the Appendix.