Abstract
BackgroundThe Study of Micardis (telmisartan) in Overweight/Obese patients with Type 2 diabetes and Hypertension (SMOOTH) compared hydrochlorothiazide (HCTZ) plus telmisartan or valsartan fixed-dose combination therapies on early morning blood pressure (BP), using ambulatory BP monitoring (ABPM).MethodsSMOOTH was a prospective, randomized, open-label, blinded-endpoint, multicentre trial. After a 2- to 4-week, single-blind, placebo run-in period, patients received once-daily telmisartan 80 mg or valsartan 160 mg for 4 weeks, with add-on HCTZ 12.5 mg for 6 weeks (T/HCTZ or V/HCTZ, respectively). At baseline and week 10, ambulatory blood pressure (ABP) was measured every 20 min and hourly means were calculated. The primary endpoint was change from baseline in mean ambulatory systolic and diastolic blood pressure (SBP; DBP) during the last 6 hours of the 24-hour dosing interval.ResultsIn total, 840 patients were randomized. At week 10, T/HCTZ provided significantly greater reductions versus V/HCTZ in the last 6 hours mean ABP (differences in favour of T/HCTZ: SBP 3.9 mm Hg, p < 0.0001; DBP 2.0 mm Hg, p = 0.0007). T/HCTZ also produced significantly greater reductions than V/HCTZ in 24-hour mean ABP (differences in favour of T/HCTZ: SBP 3.0 mm Hg, p = 0.0002; DBP 1.6 mm Hg, p = 0.0006) and during the morning, daytime and night-time periods (p < 0.003). Both treatments were well tolerated.ConclusionIn high-risk, overweight/obese patients with hypertension and type 2 diabetes, T/HCTZ provides significantly greater BP lowering versus V/HCTZ throughout the 24-hour dosing interval, particularly during the hazardous early morning hours.
Highlights
The Study of Micardis in Overweight/Obese patients with Type 2 diabetes and Hypertension (SMOOTH) compared hydrochlorothiazide (HCTZ) plus telmisartan or valsartan fixed-dose combination therapies on early morning blood pressure (BP), using ambulatory BP monitoring (ABPM)
Patients were required to have 24-hour mean ambulatory systolic and diastolic blood pressure (SBP) ≥ 130 mm Hg and/or diastolic BP (DBP) ≥ 85 mm Hg, type 2 diabetes that had remained stable and controlled for ≥ 3 months, defined as glycolated haemoglobin (HbA1C) ≤ 10% and a body mass index (BMI) ≥ 27 kg/m2 in non-Asians and ≥ 24 kg/m2 in Asians
These findings show that the PROBE study design is an attractive and validated alternative to the DBPC design, in hypertension trials using ABPM
Summary
The Study of Micardis (telmisartan) in Overweight/Obese patients with Type 2 diabetes and Hypertension (SMOOTH) compared hydrochlorothiazide (HCTZ) plus telmisartan or valsartan fixed-dose combination therapies on early morning blood pressure (BP), using ambulatory BP monitoring (ABPM). Insufficient suppression of the renin-angiotensin-aldosterone system (RAAS) has been implicated in the development of obesity-related high arterial pressure, and is linked with insulin resistance and type 2 diabetes [1,2]. Cardiovascular Diabetology 2007, 6:28 http://www.cardiab.com/content/6/1/28 hypertensive treatment of patients with type 2 diabetes, features of metabolic syndrome and obesity, as this population is poorly controlled. Adequate BP control is overlooked during the morning hours. During this time there is typically a surge in BP, which is associated with a high incidence of cerebro- and cardiovascular events [4]. The early morning hours are an important therapeutic target for antihypertensive treatment [5]
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