my personal edition > hypertension > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Telmisartan 40 or 80 mg/Hydrochlorothiazide 12.5 mg Fixed-Dose Combinations Can Thwart Early Morning Blood Pressure Surge: Presented at ESH

By Jill Stein

PARIS, FRANCE -- June 15, 2004 -- Telmisartan 40 mg plus hydrochlorothiazide 12.5 mg (T40/H12.5) and telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) provide significantly better diastolic and systolic blood pressure reductions during the risky early morning hours when a blood pressure spike may trigger cardiovascular events than does a fixed-dose combination of losartan 50 mg plus hydrochlorothiazide 12.5 mg (L50/H12.5), new data suggest.

These findings were presented on June 15th at the 14th European Meeting on Hypertension.

Joel M. Neutel, MD, with the Orange County Heart Institute in Tustin, California, United States, reported the results of a prospective, randomised, open-label, parallel-group study using ambulatory blood pressure monitoring (ABPM) in patients with mild to moderate hypertension. The study design allowed for a head-to-head comparison of 2 doses of telmisartan with losartan, with a blinded end point to decrease bias. Dr Neutel is an associate professor of medicine at the University of California Medical Center in Irvine, California.

"Hypertension is a major risk factor for cardiovascular morbidity and mortality," Dr. Neutel said. "The critical surges in morning blood pressure that have been well documented are believed to be a factor in precipitating cardiovascular events, including myocardial infarction and stroke. In hypertensive patients, it is therefore important to maintain the efficacy of antihypertensive therapy over the full 24-hour dosing interval."

Following a 2- to 4-week single-blind, placebo run-in period, 805 patients with diastolic blood pressure >/= 95 mm Hg and </=109 mm Hg (24-hour mean diastolic blood pressure >/= 85 mm Hg) were randomly assigned to 1 of 3 treatment regimens in a 2:1:2 ratio; T40/H12.5, T80/H12.5, or L50/H12.5. Patients underwent 24-hour ABPM at baseline and at the end of the trial. In-clinic blood pressure was also assessed at each visit by cuff sphygmomanometry.

The primary end point was the change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure as measured by ABPM at the end of a 6-week treatment phase.

The 3 treatment groups were comparable with respect to baseline demographic and clinical characteristics.

An overall significant (P =.0004) treatment effect on the primary endpoint among the 3 active treatments was noted, Dr. Neutel said. Both telmisartan fixed-dose combinations showed a significant difference versus the losartan fixed-dose combination.

Adjusted mean reductions in the last 6-hour ABPM diastolic pressures were -12.1 mmHg for T40/H12.5 (P =.0031) and -13.0 mm Hg for T80/H12.5 (P =.0003) versus -10.2 mm Hg for L50/H12.5.

T40/H12.5 was superior to L50/H12.5 on almost all secondary end points over the entire 24-hour dosing interval for both systolic and diastolic blood pressure, including the last 6-hour mean systolic blood pressure and the morning mean systolic and diastolic blood pressure. T80/H12.5 was highly superior to L50/H12.5 on all secondary end points.

Trough cuff blood pressure decreases were greater for both telmisartan groups (P </=.01) compared with the losartan group.

The study drugs were well tolerated. Drug-related adverse events and discontinuation rates were low and similar across all treatment groups.

Overall, the results suggest that T40 or 80/H12.5 may be more effective at attenuating the morning blood pressure hike, and, in turn, the risk of cardiovascular events, Dr. Neutel said.

These findings align with the results of the MICARDIS Community Access Trial II (MICCAT II), which were reported recently at the 19th Annual Meeting of the American Society of Hypertension (ASH) meeting by William B. White, MD, professor in the department of medicine and chief of hypertension and clinical pharmacology at the University of Connecticut School of Medicine in Farmington, Connecticut, United States. The study found that once-daily telmisartan provided highly consistent blood pressure control, especially in patients who were untreated or inadequately treated. The results also demonstrated the feasibility of ABPM in the community practice setting, a venue that is often overlooked in clinical trials of antihypertensive agents.

Both studies were sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., in Ridgefield, Connecticut, United States.


[Presentation title: Stroke Outcome in Hypertensive CAD Patients Treated With Verapamil, SR-(VE) and Atenolol based strategies; the International Verapamil SR-Trandolapril Study (INVEST). Abstract 336]

E-Mail this DGDispatch to a colleague

To print, use this version