Current hypertension guidelines recommend using two antihypertensive agents when blood pressure (BP) control is not achieved with one single agent. Objective: This study was designed to assess the antihypertensive benefit of the olmesartan medoxomil 40mg/hydrochlorothiazide (HCTZ) 12.5mg combination versus olmesartan medoxomil 40 mg monotherapy in patients with moderate to severe hypertension. Methods: This was a randomized, double-blind, parallel-group, up-titration, multicentre, multinational, phase III study. Following a 2-week single-blind placebo run-in phase, 846 hypertensive patients with mean seated systolic BP (SeSBP) of 160200mmHg and mean seated diastolic BP (SeDBP) of 100120mmHg were randomized (1 : 2 ratio) to receive double-blind treatment with olmesartan medoxomil 40 mg or olmesartan medoxomil 40mg/HCTZ 12.5 mg for 8 weeks (phase A). At week 8, patients not reaching BP goal (<140/90 mmHg; <130/80mmHg in patients with diabetes mellitus) were up-titrated from olmesartan medoxomil 40mg to olmesartan medoxomil 40mg/HCTZ 12.5mg or from olmesartan medoxomil 40 mg/HCTZ 12.5mg to olmesartan medoxomil 40 mg/HCTZ 25mg for an additional 8 weeks (phase B). Patients on goal continued their initial treatment. The primary efficacy parameter was the change in mean SeDBP during phase A. Results: Olmesartan medoxomil 40 mg/HCTZ 12.5mg reduced mean SeDBP significantly more (-18.9mmHg) than olmesartan medoxomil 40mg (-15.8mmHg) after 8 weeks of double-blind treatment (difference: -3.1mmHg, p < 0.0001). Olmesartan medoxomil 40mg/HCTZ 12.5mg also reduced mean SeSBP significantly more than olmesartan medoxomil 40mg (-5.4 mmHg, p < 0.0001). As a result, BP goal rates at week 8 were significantly higher with olmesartan medoxomil 40mg/HCTZ 12.5 mg than with olmesartan medoxomil 40mg (58.5% vs 44.3%; odds ratio 1.88; 95% CI 1.32, 2.54). During phase B, mean BP reductions were greater in patients up-titrated from olmesartan medoxomil 40 mg to olmesartan medoxomil 40 mg/HCTZ 12.5mg than in those continuing on olmesartan medoxomil 40 mg (SeDBP: 9.3mmHg vs 0.5 mmHg; SeSBP: 12.4mmHg vs 0.5 mmHg). Similarly, mean BP reductions were greater in patients up-titrated from olmesartan medoxomil 40 mg/HCTZ 12.5mg to olmesartan medoxomil 40 mg/HCTZ 25mg than in those continuing on olmesartan medoxomil 40 mg/HCTZ 12.5mg (SeDBP: 8.0mmHg vs 0.3 mmHg; SeSBP: 12.1mmHg vs 0.4 mmHg). In patients not on goal at week 8, addition of HCTZ 12.5mg to olmesartan medoxomil 40 mg or up-titration from olmesartan medoxomil 40mg/HCTZ 12.5mg to olmesartan medoxomil 40 mg/HCTZ 25 mg brought additional patients to goal at week 16 (38.8% vs 36.9%). All treatments were well tolerated. Conclusion: The olmesartan medoxomil 40mg/HCTZ 12.5mg combination is superior to olmesartan medoxomil 40mg monotherapy in reducing SeDBP and SeSBP and increasing BP goal rates after 8 weeks. Patients not on goal at week 8 with olmesartan medoxomil 40mg or olmesartan medoxomil 40mg/HCTZ 12.5mg benefited from adding HCTZ 12.5mg or up-titrating to olmesartan medoxomil 40 mg/HCTZ 25 mg, respectively, confirming that uptitration is a clinically meaningful way to improve BP control.
|Autori:||Fogari R; Taddei S; Holm-Bentzen M; Baszak J; Melani L; Schumacher K|
|Titolo:||Efficacy and Safety of Olmesartan Medoxomil 40 mg/Hydrochlorothiazide 12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Moderate to Severe Hypertension|
|Anno del prodotto:||2010|
|Digital Object Identifier (DOI):||10.2165/11536710-000000000-00000|
|Appare nelle tipologie:||1.1 Articolo in rivista|