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Titration-Extension Study Shows Losartan-Based Treatment Significantly Reduced Blood Pressure in Real-Life Practice Settings

MONTREAL, CANADA -- October 24, 2005 -- In a population of patients seen in family physician settings, the TITRATION-EXTENSION study demonstrated that the approach of using Cozaar(R) (losartan potassium), Hyzaar(R) (losartan potassium/ hydrochlorothiazide), and Hyzaar(R)DS (losartan potassium/hydrochlorothiazide) significantly reduced systolic and diastolic blood pressure -- in absolute mean numbers, by about 21 mm Hg and 11 mm Hg respectively. Results of this new study were presented for the first time at the opening of the Canadian Cardiovascular Congress taking place in Montreal between October 22 and October 26.

"In this study, the titration approach using Cozaar(R), Hyzaar(R) and Hyzaar(R)DS demonstrated that patients were able to lower their blood pressure significantly," said Dr. Howard Rudner, study investigator, family physician and assistant professor in the Faculty of Medicine at the University of Toronto. "Since there was a high incidence of obesity and diabetes in the patient population for this study, results suggest that this titration approach is effective for the management of hypertension in a real-life setting."

TITRATION-EXTENSION study highlights
This 14-week prospective, open label study was designed to evaluate the efficacy and tolerability of a treatment regimen based on losartan 50 mg, losartan 50 mg/ hydrochlorothiazide 12.5 mg and losartan 100 mg/hydrochlorothiazide 25 mg. The study was conducted in 234 family physician clinics across Canada with 1,172 patients diagnosed with grade I or II hypertension and who had either untreated hypertension or had experienced failure or intolerance to their current antihypertensive treatment.

The patient characteristics were as follows:
Age (in years): 58% 50 to 69, 24% 30 to 49, 17% 70 to 89, 1% under 30
Overweight: 47.9%
Dyslipidemia: 35.7%
Past smokers: 28.1%
Current smokers: 17.4%
Diabetes: 13.4%
Cardiac disorders: 7%
Gastrointestinal disorders: 5.1%
Arthritic conditions: 4.5%
Hypothyroidism: 4.1%
Poor peripheral circulation: 2.3%
Osteoporosis: 1.7%
Post-menopausal: 1.7%

After only 6 weeks of treatment, both systolic and diastolic pressures were significantly decreased. After 14 weeks, systolic blood pressure decreased 21 mm Hg from a mean of 153 mm Hg at baseline to 132 mm Hg, and diastolic blood pressure decreased 11.2 mm Hg from 91.4 mm Hg to 80.2 mm Hg.

The patient distribution per treatment regimen was as follows:
467 patients were on losartan 50 mg
392 patients were titrated to losartan 50 mg/hydrochlorothiazide 12.5 mg
231 patients were titrated further to losartan100 mg/hydrochlorothiazide 25 mg
15 patients discontinued their treatment.

Sixty-seven percent of patients on losartan 50 mg had their blood pressure under control, whereas 54.6% of patients on losartan 50 mg/hydrochlorothiazide 12.5 mg and 45.5% of patients on losartan 100 mg/hydrochlorothiazide 25 mg had their blood pressure controlled.

"In general, only 16% of Canadians with hypertension have controlled blood pressure. The results of this Canadian study are therefore very encouraging and show that it is possible to improve the control of blood pressure," said Dr. Yves Lacourcière, Director of the Hypertension Clinic and Research Unit on Hypertension at the Centre Hospitalier de l'Université Laval.

Hypertension in Canada
An estimated five million Canadians over the age of 18 have high blood pressure and nearly 43% do not know they have it. High blood pressure is a major risk factor for cardiovascular disease, which is responsible for 34% of all deaths in Canada - the higher the blood pressure, the greater the risk of stroke, heart attacks, heart failure and kidney disease.


SOURCE: Merck Frosst

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