gms | German Medical Science

OBJECTIVE: Newer data from hypertension outcome trials highlight the necessity of a quick and effective reduction of blood pressure; Olmesartan has demonstrated that a profound reduction of blood pressure can be expected within the first 14 treatment days which should be verified by this study.

DESIGN: The OLMEBEST study, a multinational, multicentre, partly randomised, double blind study inves-tigated the efficacy of a stepped care approach to treatment with Olmesartan 20 mg in the first step. After 14 days Placebo run-in patients received open label 20 mg Olmesartan for 8 weeks. Responders, defined as pa-tients, in whom a reduction of diastolic blood pressure (DBP) of > 10 mmHg after 8 weeks of treatment could be achieved or whose DBP was <90 mmHg, normalisers were defined as patients whose DBP was <90 mmHg after 8 weeks. Normalisers were treated for another 4 weeks open label with 20 mg Olmesartan.

RESULTS: A total of 1463 patients (758 male/705 female; Ø 55.7 years; Ø BMI 29 kg/m2) in 346 study sites entered the study. After 8 weeks treatment with Olmesartan, mean sitting BP decreased from 156.3/97.8 mmHg to 140.4/86.5 mmHg in the total population, after 12 weeks the blood pressure reached 134.8/82.0 mmHg for the normalisers. Mean reduction from baseline after 8 weeks treatment in sitting DBP was 11.5 mmHg (normalis-ers: 14.3 mmHg; non-normalisers: 4.6 mmHg) and SBP was 17.4 mmHg (normalisers: 19.9 mmHg; non-normalisers: 10.5 mmHg). In normalisers continuing open-label Olmesartan treatment, mean reduction from baseline at 12 weeks in sitting DBP was 14.8 mmHg and in sitting SBP was 20.9 mmHg. The majority of blood pressure reduction was achieved within the first 14 days (SBP/DBP total population 70.2%/68%; nor-malisers 66.8%/63.2%). The normalisation rate after 8 weeks treatment with 20 mg Olmesartan was 68% and response rate was impressive: 75% (week 8) respectively. Olmesartan once daily was well tolerated. 48.7% of the patients had at least one adverse event, 1341 adverse events occurred during the study overall, of which 83.6% were not related (58.5% unrelated and 25.1% unlikely).

CONCLUSIONS: Olmesartan once daily confirmed the early onset of the antihypertensive efficacy of Olme-sartan, with the majority of the BP-lowering effect having occurred within the first 2 weeks of treatment. It showed a profound efficacy in reducing elevated blood pressure with a normalisation rate of 68% after 8 weeks of treatment. The rapid onset of efficacy may partly explain the excellent responder rates, observed in this study