SMOOTH
Background/Rationale: Hypertension, diabetes and obesity are cardiovascular risk factors that often cluster in a single patient, thereby increasing his/her overall cardiovascular risk.
Objective: To compare PritorPlus®/Kinzalkomb® (telmisartan+HCTZ) (80 mg/12.5 mg) to valsartan+HCTZ (160 mg/12.5 mg) in the treatment of obese hypertensive patients with type 2 diabetes.
Study Design: SMOOTH was a 10-week Prospective, randomised, open-label, blinded-endpoint (PROBE), multicentre trial in overweight/obese hypertensive patients with type 2 diabetes.
Study Endpoints:
- Primary endpoint: changes from baseline in SBP and DBP during the last 6 hours of the dosing interval using ambulatory blood pressure monitoring (ABPM).
- Secondary endpoint: changes from baseline in mean 24-hour, morning (0600 hours to noon), daytime (noon to 2200 hours), and night-time (2200 hours to 0600 hours) ambulatory SBP and DBP; changes in trough seated clinic BP; and response rates based on both 24-hour mean ambulatory SBP (24-hour mean SBP < 130 mm Hg and/or reduction ≥ 10 mm Hg) and DBP (24-hour mean DBP < 80 mm Hg and/or reduction ≥ 10 mm Hg).
Results:
- PritorPlus®/Kinzalkomb® provided superior blood pressure lowering (SBP and DBP) compared to valsartan+HCTZ in the last 6 hours of the dosing interval.
- PritorPlus®/Kinzalkomb® provides superior SBP and DBP reductions compared with valsartan/HCTZ through the entire 24-hour dosing interval in obese hypertensive patients with type 2 diabetes.
Sharma AM and the Smooth Study Group - Cardiovascular Diabetology 2007.
Conclusion:
In obese/overweight hypertensive patients with type 2 diabetes, PritorPlus®/Kinzalkomb® was significantly more effective than valsartan/HCTZ: - throughout the 24-hour dosing interval
- during the last 6 hours, the time when most cardiovascular events occur
