ANTIHYPERTENSIVE EFFECTS OF TWO FIXED-DOSE COMBINATIONS OF LOSARTAN AND HYDROCHLOROTHIAZIDE VERSUS HYDROCHLOROTHIAZIDE MONOTHERAPY IN SUBJECTS WITH AMBULATORY SYSTOLIC HYPERTENSION

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ANTIHYPERTENSIVE EFFECTS OF TWO FIXED-DOSE COMBINATIONS OF LOSARTAN AND HYDROCHLOROTHIAZIDE VERSUS HYDROCHLOROTHIAZIDE MONOTHERAPY IN SUBJECTS WITH AMBULATORY SYSTOLIC HYPERTENSION

L Poirier, Y Lacourcière

Quebec, Quebec

OBJECTIVE: To assess the BP-lowering effects of two fixed-dose combinations of losartan/hydrochlorothiazide (L/HCTZ) compared with hydrochlorothiazide (HCTZ) monotherapy.

METHODS: Patients with clinic systolic BP 160-220 mmHg and mean daytime systolic BP ³ 135 mm Hg were randomized to receive L 50 mg (n=60) or HCTZ 12.5 mg (n=60) for 6 weeks. They were then force-titrated to L 50/HCTZ 12.5 mg or sham-titrated to HCTZ 12.5 mg for 6 weeks, and to L100/ HCTZ 25 mg and HCTZ 25 mg for the final 6 weeks of the study. Clinic and 24-hour ambulatory BP were measured at baseline and after each 6-week treatment period.

RESULTS: After 6 weeks, L 50 mg and HCTZ 12.5 mg induced significant and similar decreases in clinic and 24-hour ambulatory BP. At weeks 12 and 18, the combinations of L 50/HCTZ 12.5 mg and L 100/HCTZ 25 mg provided significant respective additional decreases in ambulatory systolic and diastolic BP suggesting a clear dose-response relationship. In contrast, the L 100/HCTZ 25 mg combination did not provide additional decreases vs L 50/HCTZ 12.5 mg in clinic BP. For the HCTZ-treated group, ambulatory and clinic BP decrements were statistically significant with the use of HCTZ 12.5 mg and HCTZ 25 mg. However, increasing the dosage of HCTZ 12.5 mg to 25 mg induced marginal and non-significant additional BP decrements. Between-treatment group comparisons demonstrated that both combinations of L/HCTZ provided significantly greater BP decreases than monotherapies with HCTZ during each period of the 24-hour interval and in clinic BP.

CONCLUSION: The results of this study demonstrated the efficacy of a combination therapy with L and HCTZ in decreasing ambulatory BPs with a clear dose response relationship in patients with systolic hypertension. These results provided further evidence for the use of ABPM when assessing the efficacy of antihypertensive agents given alone or in combination.

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