Evaluation by ambulatory blood pressure measurement of the antihypertensive effect of the fixed combination therapy valsartan 80 mg and hydrochlorothiazide 12,5 mg

Objective: The aim of the study was to evaluate by ambulatory blood pressur e measurement (ABPM) the 24 hours antihypertensive efficacy of the fixed co mbination therapy, valsartan 80 mg+hydrochlorothiazide 12.5 mg (V+H), once daily, after 6 weeks of treatment, in patients with mild to moderate hypert ension. Study design: It was a French, multicenter, double blind, randomized trial in parallel groups comparing V+H and placebo. After an initial two weeks pl acebo period, patients were assigned to receive either V+H or placebo for s ix weeks. Were eligible those with clinical arterial blood pressure, measur ed by sphygmomanometer, between 160/95 and 209/114 mmHg after monotherapy. A 26 hours ABPM, with Spacelabs 90207, was done at JO and J42 (one measurem ent every 15 minutes, in day time and at night). Responders were defined as a fall in day diastolic blood pressure greater than or equal to5 mmHg and/ or day diastolic blood pressure <90 mmHg with ABPM. Results: 123 of the 138 randomized patients had two interpretative measurem ents. Their average age was 59+10 years. 57% (78) of them were males and th eir average ABPM before treatment was 143+/-15/88+/-11 mmHg. With V+H, the reduction of the systolic and the diastolic blood pressure measured by ABPM , was significally more important than with placebo (SBP: - 15.4 +/- 10.9 m mHg versus -0.6 +/- 7.7 mmHg, p<0.001; DBP: -9.1 +/- 7 mmHg versus -0.4 +/- 5.4 mmHg, p<0.001). Pulse pressure (PP) was also significally reduced with the combination therapy V+H, but it was not modified with placebo (-6.3+5. 5 mmHg versus -0.2+4.1 mmHg, p<0.001). ABPM responder rate was 73% with V+H versus 24% with placebo (p<0.001). Trough/peak ratio was 80.3% for systoli c blood pressure and 57.3% for diastolic blood pressure. The combination VH was as well tolerated as placebo. Conclusion: The fixed combination V+H used for treatment of hypertension, a fter failure of monotherapy, is very effective in reducing pulse pressure, systolic and diastolic blood pressure, over 24 hours, homogeneously, and is as well tolerated as placebo.