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See detailEfficacy and tolerability of olmesartan medoxomil in patients with mild to moderate essential hypertension - The OLMEBEST Study
Barrios, Vivencio; Boccanelli, Allesandro; Ewald, Silke et al

in Clinical Drug Investigation (2007), 27(8), 545-558

Background and objective: Achieving target BP is important to control the increased cardiovascular risk associated with uncontrolled hypertension. However, failure to respond to therapy is common with all ... [more ▼]

Background and objective: Achieving target BP is important to control the increased cardiovascular risk associated with uncontrolled hypertension. However, failure to respond to therapy is common with all classes of antihypertensive agents. Angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]) possess many of the positive features of angiotensin-converting enzyme inhibitors, with fewer adverse effects. However, many patients fail to respond adequately to low-dose monotherapy. This study examined whether olmesartan medoxomil dose titration and olmesartan medoxomil/hydrochlorothiazide combination therapy were therapeutically equivalent in patients with mild to moderate essential hypertension who had shown an inadequate response to low-dose olmesartan medoxomil monotherapy. Methods: This was a prospective, parallel group, partially randomised, doubleblind study set in 463 centres in nine European countries. 2306 male and female adult patients aged 18–75 years with mild to moderate essential hypertension (sitting diastolic BP [DBP] ≥90mm Hg and <110mm Hg) were enrolled. All enrolled patients received open-label olmesartan medoxomil 20mg once daily for 8 weeks. At the end of this period, patients whose BP had not normalised (sitting DBP ≥90mm Hg) were randomised to receive olmesartan medoxomil monotherapy (40mg once daily, n = 302) or olmesartan medoxomil (20mg once daily)/ hydrochlorothiazide (12.5mg once daily) combination therapy (n = 325) for 4 weeks. The main outcome measure was change in mean sitting DBP during randomised treatment. Results: After 8 weeks of open-label treatment with olmesartan medoxomil 20 mg/day, 76% of patients showed a DBP response (sitting DBP <90mm Hg or reduction of ≥10mm Hg). During the randomised phase of the study, both treatments were associated with further improvements in sitting SBP/DBP: a reduction of 5.3/5.1mm Hg with olmesartan medoxomil 40 mg/day, and a reduction of 10.8/7.9mm Hg with olmesartan medoxomil/hydrochlorothiazide combination therapy. Final mean BPs of 145.3/90.9mm Hg (olmesartan medoxomil 40 mg/day) and 140.7/88.7mm Hg (olmesartan medoxomil 20mg + hydrochlorothiazide) were achieved, compared with a mean BP of 160.8/100.5mm Hg at baseline. The two treatments were not therapeutically equivalent. Sitting DBP showed a response and was normalised (<90mm Hg) in 62% and 47% of olmesartan medoxomil monotherapy patients, respectively. In the combination therapy group, these endpoints were achieved by 71% (response) and 59% (normalisation) of patients. Treatment with olmesartan medoxomil 40 mg/day was associated with a lower frequency of adverse events than olmesartan medoxomil/ hydrochlorothiazide combination therapy (21.5% vs 28.3%, respectively). Conclusion: For patients who did not achieve adequate BP control after initial treatment with olmesartan medoxomil 20 mg/day, olmesartan medoxomil dose titration (to 40 mg/day) or addition of hydrochlorothiazide (12.5 mg/day) elicited a sitting DBP response in the majority of patients who had failed to respond to low-dose monotherapy, and normalisation of sitting DBP in approximately 50% of patients. Both these strategies represent effective and well tolerated treatment options in patients who show an inadequate response to low-dose monotherapy with olmesartan medoxomil. [less ▲]

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See detailBlood pressure reduction with olmesartan in mild-to-moderate essential hypertension: a planned interim analsis of an open label sub-study in German patients
Barrios, Vivencio; Böhm, Michael; Boccanelli, Alessandro et al

in Current Medical Research & Opinion (2006), 22(7), 1375-1380

Objective : To present the baseline characteristics and open-label treatment phase results for German patients in OLMEBEST, a European, multinational, partially randomized, partially double-blind study in ... [more ▼]

Objective : To present the baseline characteristics and open-label treatment phase results for German patients in OLMEBEST, a European, multinational, partially randomized, partially double-blind study in patients with mild-to-moderate essential hypertension. Research design an methods: after a 2-week placebo run-in, patients received olmesartan 20 mg for 8 weeks. Controlled patients (mean sitting diastolic blood pressure [sDBP] < 90 mmHg) continued on olmesartan 20 mg/day for a further 4 weeks. Non-controlled patients (sDBP > 90 mmHg) were randomized to olmesartan 40 mg/day or olmesartan 20 mg/day plus 12.5 mg hydrochlorothiazide for 4 weeks. Of 823 patients included, 558 continued olmesartan 20 mg treatment and 228 patients were randomized to olmesartan 40 mg/day or combination therapy. Efficacy variables included the change from baseline in mean sitting DBP and systolic blood pressure [sDBP] at Week 8 (and Week 12 for controlled patients), and the proportion of controlled patients and responders (mean sDBP < 90 mmHg or improvement of > 10 mmHg from baseline at Week 8). Results: After 8 Weeks of olmesartan medoxomil 20 mg, mean reduction from baseline in sDBP was 11.8 mmHg and in sSBP was 17.1 mmHg. In controlled patients continuing open-label olmesartan medoxomil 20 mg, mean reduction from baseline at 12 weeks in sDBP was 14.9 mmHg and in sSBP was 20.1 mmHg. At Week 8, the response rate was 76% and the control rate was 30.9% of patients experienced and adverse event, and the majority of these events were judged by the investigators to be mild. Conclusion:l Olmesartan medoxomil monotherapy at the recommended dosage of 20 mg once daily is effective and well tolerated in patients with mild-to-moderate hypertension. [less ▲]

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