Safety and efficacy study of Hyzaar(R) in patients with hypertension: a community-based study

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Abstract

BACKGROUND
This study was designed to evaluate efficacy and safety of losartan/hydrochlorothiazide combined tablet (Hyzaar(R)) under usual practice condition.
METHODS
In HIGH (Hyzaar(R) In Group of Hypertensive patients) study, patients diagnosed as hypertension were on losartan (50 mg)/hydrochlorothiazide (12.5 mg) combined tablet (Hyzaar(R)) once daily for more than 8 weeks. Blood pressure was measured at least twice; prior to administering Hyzaar(R) and 8 weeks after. Blood pressure at week 4 was also measured when possible. Adverse experience was investigated throughout and 14 days following the treatment.
RESULTS
A total of 2428 patients (male : female=4:6, mean age; 57.5+/-11.3) were assessed. On week 8 of treatment, systolic blood pressure and diastolic blood pressure measured were 135.3+/-14.7 mmHg, 84.4+/-9.3 mmHg, respectively. These denote 23.1 mmHg, 12.4 mmHg decrease from the baseline levels, respectively. After 8 weeks of treatment, blood pressure in 79% of patients either reached the goal (SBP<140 mmHg and DBP<90 mmHg) or was under control (reduction of diastolic blood pressure > or = 10 mmHg). Gender, presence of diabetes mellitus, body mass index and co-medication of other antihypertensive agents did not affect the degree of blood pressure reduction by Hyzaar(R) treatment. Decrease of diastolic blood pressure in younger age groups under 40 and 41-49 years-old were significantly greater compared to that of elderly patients over 70 years-old (p<0.05, p<0.01, respectively). Greater decrease of blood pressure (p<0.001) was seen in patients with higher baseline blood pressure. Clinical adverse experience was seen in 26 patients (1.1%) and any specific adverse experience did not exceed 1%.
CONCLUSION
Treatment of losartan (50 mg)/hydrochlorothiazide (12.5 mg) is highly effective in lowering blood pressure with few adverse experience in hypertension patients.Hyzaar(R), Losartan, Angiotensin II receptor antagonist, Hypertension patients.