The efficacy and safety of irbesartan in primary hypertension even if a dose is missed: Results from the NO PROBLEM Study.

OBJECTIVES: This study aimed to demonstrate that irbesartan is successful in reducing diastolic blood pressure (BP) even following a missed dose after 6-8-weeks' treatment as measured by 24-hour ambulatory BP monitoring (ABPM).

METHODS: Eighty-eight patients (64 females, mean age: 53.4 +/- 10.6 years) with primary hypertension were included in this national, single-center, single-arm, open-label, prospective clinical study. Irbesartan (150 or 300 mg/day) was administered for 8 weeks. All patients were asked to cease treatment for 1 day during weeks 6-8. Changes in diastolic and mean 24-hour BP on the day of cessation and diastolic BP values during visits were efficacy parameters. Adverse events were also recorded.

RESULTS: Systolic, diastolic, and mean BP values measured via ABPM before and on the day of a missed dose did not differ significantly. Irbesartan effectively controlled BP of the patients. BP normalization rates were 54% for 150 mg/day irbesartan only and 77% for both doses (150 or 300 mg/day) of irbesartan. None of the patients experienced serious adverse events throughout the study period.

CONCLUSIONS: Irbesartan is successful and safe in the control of BP levels even following a missed dose at the end of a 6-8-week treatment period.