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High-Dose Hydrochlorothiazide Gets Hard-to-Treat Hypertensive Patients to Blood Pressure Goal

By Ed Susman

SAN FRANCISCO, CA -- May 18, 2005 -- Hypertensive patients who are labeled 'hard-to-treat' – such as blacks, Hispanics, diabetics, and the elderly – appear to be able to control their blood pressure on a fixed-dose combination of an angiotensin-receptor blocker and a diuretic, researchers reported here May 17^th at the 20^th Annual Scientific Meeting and Exposition of the American Society of Hypertension.

More than three-fourths of patients who were unable to control hypertension with monotherapy on a wide variety of anti-hypertensive agents achieved blood pressure goals when they took a high dose of 300 mg irbesartan paired with 25 mg of the diuretic hydrochlorothiazide (Avalide).

"We were able to reduce blood pressure to goal in the vast majority of traditionally hard-to-treat patients with a fixed-dose combination and without significant adverse events," said Elijah Saunders, MD, professor of medicine and head of the section of hypertension at the University of Maryland in Baltimore, Maryland, United States.

"The percentage of patients whose blood pressure was controlled in this study was much higher compared to other combination therapy trials," said Dr. Saunders, one of the principal investigators of the INCLUSIVE trial – so named because of its attempt to find patients from traditionally difficult to treat groups. "This was the first large-scale hypertension study to include such a broad range of patient groups."

"We found that this combination therapy reduced systolic blood pressure to a desirable level in 77% of the patients, and 83% of the patients in our study achieved an acceptable diastolic blood pressure. These results are significant," he said.

Dr. Saunders explained that, after 18 weeks of treatment, systolic blood pressure, the primary endpoint of the study, was decreased 21.5 mmHg from baseline, a reduction that reached statistical significance at the P < .001 level. Diastolic blood pressure was lowered an average of 10.4 mmHg from baseline, also significant at the P < .001 level.

After enrolling 1,005 patients in the study, subjects received a placebo during a four-week run-in period to make sure they met the blood pressure inclusion criteria of the study: non-diabetic patients had to have systolic blood pressure between 140 and 159 mmHg; diabetic participants required blood pressure of 130-159 mmHg at the start of the trial.

The participants were then given 12.5 mg hydrochlorothiazide for two weeks, and if they were not at goal, they received irbesartan/hydrochlorothiazide 150/12.5 mg for eight weeks, followed by irbesartan/hydrochlorothiazide 300/25 mg for another eight weeks if they were not at goal. More than half the patients reached goal with the 150/12.5 mg dose.

According to Dr. Saunders, the INCLUSIVE investigators were specifically seeking all comers to the trial and especially sought participants from minority communities. He said 52% of the participants were women; 46% were suffering from the metabolic syndrome; 30% had type 2 diabetes; 25% were over age 65; 23% were black; and 14% were Hispanic. Each group included at least 100 people.

Dr. Saunders said 73% of the elderly, 72% of blacks, 75% of Hispanic, 73% of those with the metabolic syndrome, 82% of women, and 73% of men reached their blood pressure goal. The researchers were pleased that 56% of diabetics reached their systolic blood pressure goal, which was below 130 mmHg. The non-diabetic patients' goal was below 140 mmHg.

Keith Ferdinand, MD, a clinical cardiologist and director of Heartbeats Life Center and professor of clinical pharmacology at Xavier University in New Orleans, Louisiana, United States served as moderator of the late breaker presentation at which the INCLUSIVE trial was presented. He said the study might indicate that doctors need to do more in offering patients additional medication to reach their blood pressure goals.

"Some of the difficult-to-treat hypertension is due to physicians," said Dr. Ferdinand. "Physicians do not titrate patients. Monotherapy is probably not the way to go with elderly patients, African Americans, diabetics, and probably Hispanics."

He said the study indicates that "clinical inertia" can be overcome with combination therapy.

The Bristol-Myers Squibb/Sanofi-Synthelabo Partnership, makers of Avalide, funded the study.


[Presentation title: The Efficacy and Safety of Irbesartan/HCTZ 150/12.5 mg and Irbesartan/HCTZ 399/25 mg in Patients With Hypertension Uncontrolled on Monotherapy.]

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