Robert Madder, MD, geriatrics and internal medicine, Tri-State Medical Group, Inc., Beaver, Pennsylvania, United States, and co-workers studied the efficacy and safety of irbesartan/HCTZ fixed-dose combination therapy in patients 65 years of age or older who were enrolled in the Irbesartan/hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial.

The INCLUSIVE trial found that irbesartan/HCTZ fixed-dose combination therapy is safe in more than 75% of participants whose systolic blood pressure was previously uncontrolled on at least 4 weeks of antihypertensive monotherapy.

Treatment was sequential -- placebo for 4 to 5 weeks; HCTZ 12.5 mg for 2 weeks; irbesartan/HCTZ 150/12.5 mg for 8 weeks; and irbesartan/HCTZ 300/25 mg for 8 weeks.

In his presentation on May 21^st, Dr. Madder presented results of a subanalysis, which found that the mean change in blood pressure levels from baseline at week 18 in the 184 elderly patients in the intent-to-treat population was a decrease of 23.0 mm Hg (P <.001) in systolic and a decrease of 10.9 mm Hg (P <.001) in diastolic levels, respectively.

Blood pressure reductions were similar regardless of age and sex, Dr. Madder said.

Most participants achieved their systolic blood pressure and dual systolic blood pressure/diastolic blood pressure goals by week 18.

Systolic blood pressure and systolic blood pressure/diastolic blood pressure control rates at week 18 were similar irrespective of age and sex. Diastolic blood pressure goal attainment rates at week 18 were higher in participants aged 65 years or older than in those under 65 (96 % vs 78% for the 2 groups, respectively, P =.001)

Irbesartan/HCTZ fixed-dose combination therapy was generally safe and well tolerated in elderly participants with previously uncontrolled hypertension. The frequency of adverse events throughout the treatment phases was similar in participants who were 65 years of age or older and those who were younger than 65 years.

Overall, the results demonstrate that the efficacy and safety of irbesartan/HCTZ combination therapy in elderly patients was similar to that which has been observed in the general population, Dr. Madder said.


[Presentation title: Efficacy and Safety of the Fixed Combination of Irbesartan/HCTZ in Patients Aged >/=65 Years With Uncontrolled SBP on Monotherapy in the INCLUSIVE Trial. Abstract P-375]

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