Five of the PROTECTION^® clinical studies evaluated the blood pressure (BP) control of telmisartan during the last 6 hours of the 24-hour dosing interval in at-risk patient populations. Patients were considered at-risk if they were elderly, had isolated systolic hypertension (ISH), or were overweight/obese with hypertension and type 2 diabetes.

The early morning hours usually coincide with a sharp rise in blood pressure and a correspondingly high incidence of cerebro- and cardiovascular events such as sudden death, myocardial infarction, and stroke. Therefore, 24-hour blood pressure control that includes the risky early hours is crucial.

Even when blood pressure as assessed in the office setting meets established target values, many patients who appear to be adequately treated remain at increased risk for cardiovascular events and end-stage renal disease. It is therefore necessary to follow patients? 24-hour blood pressure using ambulatory blood pressure monitoring (ABPM) when determining the efficacy of antihypertensive drugs.

Cross-sectional and longitudinal studies have supported the hypothesis that adverse outcomes are directly related to the inability to maintain 24-hour average BP within the normal range.

Few studies have analysed the efficacy of BP control with specific reference to the early morning hours when BP changes are most dramatic and the incidence of CV events is highest.

All five early-morning BP PROTECTION^® studies shared primary and secondary endpoints. The primary endpoints were changes from baseline for either systolic blood pressure (SBP), diastolic blood pressure (DBP), or both during the last 6 hours of the 24-hour dosing interval using ABPM. Secondary endpoints were changes in BP over 24 hours, and in the early morning, daytime and night-time periods, as well as ambulatory BP response rates.

The five clinical studies from the PROTECTION^® programme that assessed the protective effects of telmisartan on early-morning BP control are as follows:

• PRISMA I and PRISMA II compared telmisartan and ramipril in patients with mild to moderate hypertension


• ARBS FDC compared telmisartan in fixed dose combination with hydrochlorothiazide (HCTZ) with losartan/HCTZ in patients with mild to moderate hypertension


• ATHOS compared the efficacy and safety of telmisartan/HCTZ with the calcium channel blocker amlodipine/HCTZ in elderly patients with isolated systolic hypertension


• SMOOTH compared the efficacy of telmisartan/HCTZ to valsartan/HCTZ in obese/overweight hypertensive patients with type 2 diabetes