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Safety After Fifty Evaluation - SAFE
Description:
Safety and tolerability of metoprolol and hydrochorothiazide in elderly.
Hypothesis:
To determine the short-term efficacy and tolerability of once-daily therapy with metoprolol alone or in combination with hydrochlorothiazide in the treatment of mild hypertension in patients 50 to 75 years of age.
Study Design
Patients Screened: 24,816
Patients Enrolled: 21,692
Mean Follow Up: 8 weeks
Mean Patient Age: 60
Female: 55.5
Patient Populations:
50 to 75 years of age
Newly diagnosed hypertension: diastolic BP between 90 and 104 mmHg and systolic BP ≤ 200 mmHg
Previously treated hypertension if therapy withdrawn before study entry
Exclusions:
Angina requiring beta blocker therapy
Heart rate < 55 bpm
Heart block greater than first degree
Congestive heart failure
Bronchospastic disease
Cardiac pacemakers
Intolerance to beta blockers or sulfonamide therapy
Primary Endpoints:
Blood pressure
Secondary Endpoints:
Safety and tolerability
Drug/Procedures Used:
Metoprolol 100 mg qd; hydrochlorothiazide 25 mg qd added if necessary after 4 weeks.
Principal Findings:
Patients had a mean duration of 4.8 years of hypertension; 40.3% were newly diagnosed and 59.7% were previously treated.
At 4 weeks, mean systolic and diastolic blood pressures decreased from 162/95 to 148/87 mmHg (p < 0.001)
At 8 weeks, the mean blood pressure was 143/84 mmHg.
At the termination of the study, 50% of patients continued metoprolol monotherapy and 27% continued combined therapy with hydrochlorothiazide.
Forty patients died during the study; 25 of these deaths were due to cardiovascular or cerebrovascular causes.
Interpretation:
Metoprolol, alone or in combination with hydrochlorothiazide, reduced blood pressure in elderly patients. Although declines in blood pressure have traditionally been the regulatory basis for approval for most antihypertensive agents, long-term clinical outcomes remain highly important.
References:
1. Am Heart J 1988;116:301-4. Study design
2. J Am Geriatr Soc 1992;40:354-58. Final results
Keywords: Diuretics, Hydrochlorothiazide, Metoprolol, Hypertension, Systole
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