Abstract
Objective: To compare the efficacy of OM/HCTZ 40/25 mg versus 20/25 mg, as assessed by ambulatory blood pressure monitoring (ABPM), in elderly and hypertension severity subgroups in patients whose BP was inadequately controlled by OM 40 mg. Design and Methods: This was a subgroup analysis of a 16-week study in patients aged >/=18 years. The study consisted of 2 periods, each 8 weeks long. Eligible patients received 8 weeks' open-label OM 40 mg (Weeks 0–8). At Week 8 (baseline), patients with inadequate BP control (mean trough seated BP 140–180/90–115mmHg, mean 24-h diastolic BP [DBP] >/=80mmHg and >/=30% of daytime DBP readings >85mmHg) were randomised to a further 8 weeks' double-blind treatment with OM/HCTZ 40/25 or 20/25 mg (Weeks 8–16). Changes in ABPM from Week 8 to Week 16 were evaluated in patients aged >/=65 years (N=184) and in patients with moderate (160–179/100–109mmHg; N=679) or severe (>/=180/110mmHg; N=263) hypertension using a Spacelabs90207 device. Analyses were performed on the FAS OC. Results: In elderly patients OM/HCTZ 40/25 mg provided greater reductions in mean 24-h, daytime and night-time systolic BP (SBP) compared with 20/25 mg (15.4, 15.8 and 14.1mmHg vs 13.7, 14.0 and 13.5mmHg, respectively; Figure), while ambulatory DBP reductions were similar for both treatments. In patients with moderate hypertension, OM/HCTZ 40/25 mg provided greater mean 24-h (Figure), daytime and night-time ABP reductions than OM/HCTZ 20/25 mg (14.6/9.4 vs 11.4/7.4, 15.0/9.6 vs 11.7/7.4, and 13.4/8.5 vs 10.1/6.8mmHg, respectively). In patients with severe hypertension, ABP reductions were more pronounced with OM/HCTZ 40/25 mg than 20/25 mg for 24-h (Figure), daytime and night-time SBP (14.5 vs 13.8, 14.7 vs 14.2 and 13.4 vs 12.4mmHg, respectively), and for 24-h and night-time DBP (8.8 vs 8.4 and 8.8 vs 7.6mmHg, respectively). Conclusions: Elderly patients and individuals with more severe hypertension are harder to treat. OM/HCTZ 40/25 mg provides further incremental reductions in ABP compared with OM/HCTZ 20/25 mg in these subgroups, which may be of clinical relevance.
Published Version
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