What question did this study set out to answer?

To assess therapeutic equivalence, clinical safety, and subjective quality of life across four antihypertensive drug classes in patients with mild-to-moderate untreated hypertension.

January 1, 1995Journal of Hypertension

A randomized comparison of the effect of four antihypertensive monotherapies on the subjective quality of life in previously untreated asymptomatic patients: field trial in general practice

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Why the study?

Do different antihypertensive monotherapies (diuretics, beta-blocker, calcium antagonist, ACE inhibitor) have equivalent efficacy, safety, and quality of life impacts in patients with untreated mild-to-moderate hypertension?

Population

653 patients aged ≥ 18 years with previously untreated asymptomatic mild-to-moderate hypertension

Comparison

Antihypertensive monotherapy with either a… vs Active comparators

Design

RCT, randomly allocated

Follow-up

1 year

Authors

JBJean‐Pierre BoisselIn Silico Toxicology (Switzerland)JCJean-Paul ColletBritish Columbia Children's Hospital LLL. LionLille’s Cardiology Hospital

Discussion

Member takes

Implication

Any first-line monotherapy is reasonable for mild-to-moderate hypertension; confirms equivalent efficacy, safety, and quality-of-life impact across the four classes.

Key Points

To assess therapeutic equivalence, clinical safety, and subjective quality of life across four antihypertensive drug classes in patients with mild-to-moderate untreated hypertension.
Randomized trial allocating 653 untreated hypertensive patients aged ≥ 18 years in general practice to one of four monotherapies with a 1-year follow-up.
Interventions comprised a diuretic combination (altizide and spironolactone), a beta-blocker (bisoprolol), a calcium antagonist (verapamil), or an ACE inhibitor (enalapril).
Composite success required 12-month visit attendance, ≥9 supine DBP measurements, and median supine DBP < 90 mmHg with a reduction of ≥10 mmHg, testing an equivalence margin of ±10%.
Treatment success rates were 43.9% for diuretics, 42.0% for bisoprolol, 32.5% for verapamil, and 43.9% for enalapril, failing to demonstrate equivalence under the prespecified ±10% margin.
Reductions in systolic and diastolic blood pressure showed no statistically significant differences between any of the four treatment groups.
Verapamil recipients reported improved satisfaction on specific quality-of-life items at 1 month, with safety questionnaire differences noted at 1 month for verapamil and bisoprolol, though all differences resolved by 9 months.

Structured PICO

Population

653 patients aged ≥ 18 years with previously untreated asymptomatic mild-to-moderate hypertension

Intervention

Antihypertensive monotherapy with either a combination of two diuretics (altizide and spironolactone), a beta-blocker (bisoprolol), a calcium antagonist (verapamil), or an ACE inhibitor (enalapril)

Comparator

Active comparators (the four treatment groups were compared against each other)

Outcome

Composite outcome of success at 1 year: attendance at the 12-month visit, at least nine supine DBP measurements during the study, median supine DBP < 90 mmHg, and a reduction of at least 10 mmHg compared with baselinecomposite

Four common antihypertensive monotherapies showed comparable efficacy in blood pressure lowering and similar long-term impacts on safety and quality of life in newly diagnosed mild-to-moderate hypertension.

Cite This Study

Boissel et al. (1995) studied this question.

synapsesocial.com/papers/6a711d1126a7f98052dd88eb https://doi.org/10.1097/00004872-199509000-00018

Topics

Hypertension management

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Implication

Any first-line monotherapy is reasonable for mild-to-moderate hypertension; confirms equivalent efficacy, safety, and quality-of-life impact across the four classes.