SMOOTH (Study of Micardis in Overweight/Obese patients with Type-2 diabetes and Hypertension)

18 Mar, 14

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SMOOTH

Title

Telmisartan/hydrochlorothiazide more effective than valsartan/hydrochlorothiazide in overweight/obese patients with hypertension and type 2 diabetes.

To compare the effects of telmisartan/hydrochlorothiazide (T/HCTZ) versus valsartan/hydrochlorothiazide (V/HCTZ) on early morning blood pressure (BP) in obese hypertensive patients with type 2 diabetes.

Study Design

Prospective, randomized, open-label, blinded-endpoint, multicentre trial

Study Patients

Obese patients with type 2 diabetes and mild-to-moderate hypertension (N = 840)

Study Groups

Telmisartan 80 mg (n = 428) vs valsartan 160 mg (n = 412) for first 4 weeks, following which hydrochlorothiazide 12.5 mg was added in all patients for further 6 weeks

Study Duration

10 weeks

Primary End-point

Change from baseline in mean ambulatory systolic blood pressure (SBP) and diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval

Results

T/HCTZ provided significantly greater reduction in BP in the last 6 hours of 24-hour dosing interval as compared to V/HCTZ

T/HCTZ produced significantly greater reductions in 24-hour mean BP than V/HCTZ during the 24-hour dosing interval
During the morning, daytime and night-time periods, patients receiving T/HCTZ had significantly greater reductions in mean ambulatory SBP & DBP vs those taking V/HCTZ
Ambulatory as well as clinic DBP and SBP response rates were higher in patients taking T/HCTZ vs V/HCTZ

Safety

Both the treatments of T/HCTZ and V/HCTZ were well-tolerated and the overall incidence of adverse events was low.

Conclusion

In high-risk, overweight/obese patients with hypertension and type 2 diabetes, telmisartan/hydrochlorothiazide provides significantly greater BP lowering vs valsartan/hydrochlorothiazide throughout the 24-hour dosing interval, particularly during the hazardous early morning hours
The additional efficacy afforded by telmisartan/hydrochlorothiazide over valsartan/hydrochlorothiazide may confer a clinical advantage

Cardiovascular Diabetology 2007;6:28

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