Efficacy and Tolerability of 5 mg of Cilazapril plus 12.5 mg of Hydrochlorothiazide in Mild-to-Moderate Hypertension: Results of 24-Hour Ambulatory Blood Pressure Monitoring

SUMMARYThe efficacy and tolerability of a fixed combination of 5 mg of cilazapril and 12.5 mg of hydrochlorothiazide against hypertension was evaluated in 36 patients (26 men and 10 women) between 33–68 years old. Twenty-two had newly diagnosed hypertension and 14 had previously treated hypertension. Twenty-four-hour noninvasive ambulatory blood pressure monitoring (ABPM) was performed after a 2-week washout period. Measurements were taken at 20-min intervals during the day (from 8 a.m. to 10 p.m.) and at 30-min intervals during the night (from 10 p.m. to 8 a.m.). Patients with a mean diastolic daytime pressure of ≥ 90 < 115 mg Hg were then given 5 mg of cilazapril plus 12.5 mg of hydrochlorothiazide once daily between 6 a.m. and 8 a.m. for 6 weeks. After this period, a second 24-h ABPM was performed. Office blood pressure measurements were taken at weeks −2, 0, 2, and 6. Routine laboratory blood samples were taken at weeks 0 and 6. Single blood pressure readings did not change significantly during the washout period (between weeks - 2 and 0). The ABPM 24-h mean systolic pressure changed between weeks 0–6 from 143 ± 13 to 126 ± 11 mm Hg (p < 0.0001), and the mean diastolic pressure from 100 ± 9 to 90 ± 9 mm Hg (p < 0.0001). Twenty-eight patients (80) responded to treatment (response criteriamean diastolic daytime pressure at week 6 < 90 mm Hg and/or a difference between weeks 0–6 3 ≥ 5 mm Hg). A reduction in blood pressure was observed throughout the 24-h period in the systolic as well as the diastolic values. Treatment was well tolerated; no significant changes in glucose, potassium, and creatinine values were recorded and no adverse event necessitated premature discontinuation of treatment. Data gained from 24-h ambulatory monitoring thus confirm the efficacy and safety of a combination of 5 mg of cilazapril and 12.5 mg of hydrochlorothiazide.