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Patients Who Fail Anti-Hypertensive Monotherapy Respond to Fixed-Dose Combination of Irbesartan/Hydrochlorothiazide

By Ed Susman

SAN FRANCISCO, CA -- May 19, 2005 -- A substantial percentage of hypertensive patients who had failed previous monotherapy were able to successfully reach their blood pressure goals by taking a fixed-dose combination of irbesartan/hydrochlorothiazide (Avalide). The findings were reported here May 16^th at the 20^th Annual Scientific Meeting and Exposition of the American Society of Hypertension.

"The response to irbesartan/hydrochlorthiazide combination therapy was not greatly influenced by the class of antihypertensive agent that the patient had been treated with previously," said Michael Weber, MD, professor of medicine at the State University of New York Downstate Medical Center in Brooklyn, New York, United States.

The INCLUSIVE trial enrolled patients who were failing to reach blood pressure goals on monotherapy with ACE inhibitors, angiotensin-receptor blockers, calcium channel blockers, diuretics, and beta blockers. After 18 weeks of treatment with the combination of irbesartan/hydrochlorothiazide, 77% of the patients were able to attain their blood pressure goals.

The investigators analyzed the type of medication the patients were taking prior to entering the study to determine whether the prior treatment had any effect on the combination therapy. They found that:

--Of the 247 patients who had taken ACE inhibitors, 72% reached their blood pressure goal, with an average decrease in systolic blood pressure of 20.1 mmHg.
--Of the 150 patients who had taken angiotensin receptor blockers, 83% reached their blood pressure goal, with an average decrease in systolic blood pressure of 22.9 mmHg.
--Of the 148 patients who had taken calcium channel blockers, 76% reached their blood pressure goal, with an average decrease in systolic blood pressure of 21.3 mmHg.
--Of the 100 patients who had taken diuretics, 77% reached their blood pressure goal, with an average decrease in systolic blood pressure of 21.0 mmHg.
--Of the 77 patients who had taken beta blockers, 84% reached their blood pressure goal, with an average decrease in systolic blood pressure of 24.2 mmHg.

The ability to reach the systolic blood pressure goal was the primary endpoint in the INCLUSIVE study, so named because it enrolled large numbers of patients in various ethnic and racial categories and also included a high percentage of persons over age 65. More than half the subjects in the trial were women.

Dr. Weber also reported that similar reductions in diastolic blood pressure were seen in patients taking monotherapy drugs across the spectrum of antihypertensive regimens. At least 80% of each group reached their diastolic blood pressure goals.


[Presentation title: Efficacy and Safety of Fixed Combinations of Irbesartan/HCTZ in Patients with Uncontrolled SBP on Monotherapy, According to Previous Antihypertensive Drug Class, in the INCLUSIVE Trial.]

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