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[Antihypertensive effectiveness of enalapril and hydrochlorothiazide as a combination drug]

Author(s): Pirich C, Banyai M

Affiliation(s): Wilhelm Auerswald Atheroskleroseforschungsgruppe (ASF), Wien.

Publication date & source: 1993, Wien Med Wochenschr., 143(11):290-3.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

1062 patients with moderate to severe hypertension were enrolled in an open-label multicenter trial investigating the antihypertensive efficacy and safety of the preconstituted formulation enalapril (20 mg) and hydrochlorothiazide (12.5 mg) over a treatment period of 12 weeks. According to the inclusion criteria of the study protocol 489 patients had to be excluded from statistical evaluation of efficacy. Results were calculated from 573 patients (339 females, 234 males, mean age 59.1 +/- 12.3 years) of whom 89% (n = 510) received the standard dosage of 1 tablet daily. They revealed a significant reduction (p < 0.001) of both diastolic and systolic blood pressure (BP) from a mean of 108.2 +/- 7.8 mm Hg (182.2 +/- 17.6 mm Hg) before treatment to a mean of 88.4 +/- 6.7 mm Hg (152.6 +/- 10.8 respectively) after 12 weeks of treatment. 81% responded to therapy defined as a lowering of diastolic BP < 90 mm Hg. Heart frequency dropped significantly (from a mean of 77.8 +/- 10.6 to a mean of 71.7 +/- 8.0, p < 0.01), too. Adverse effects leading to discontinuation were seen in 2.8% (n = 30) of all participating patients. Cough and gastrointestinal discomfort were the most frequent side effects. None of the safety parameters i.e. serum potassium and creatinine changed during the period of investigation. In conclusion, the preconstituted formulation enalapril (20 mg) and hydrochlorothiazide (12.5 mg) was shown to be an effective and well tolerated treatment not only for patients with newly diagnosed moderate to severe hypertension, but also for nonresponders to previous antihypertensive therapy.

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