What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=530). Intervention: Aspirin vs. Placebo. Primary outcome: 1-year compliance rate (percentage of days with one opening per day).

July 1, 1999

Compliance with aspirin or placebo in the hypertension optimal treatment (HOT) study

Key Result

One-year compliance with 75 mg daily aspirin added to anti-hypertensive therapy was high and similar to placebo (78.3% vs 78.5%).

Study Design

Type

RCT (n=530)

Blinding

Double-blind

Multicenter

Yes

PICO

Population

Hypertension (n=530)

Intervention / Comparator

Aspirin vs Placebo (75 mg daily)

Primary Outcome

1-year compliance rate (percentage of days with one opening per day)

Main Result

Absolute Event Rate: 78.3% vs 78.5%

Abstract

OBJECTIVE: The Hypertension Optimal Treatment (HOT) study is a large, prospective trial aimed at defining the level of diastolic blood pressure required during anti-hypertensive therapy in order to achieve maximal protection against cardiovascular complications. A further aim is to assess the effects on morbidity and mortality of a 75 mg daily dose of aspirin compared with placebo. SUBJECTS AND METHODS: Compliance with double-blind administration of aspirin or placebo added to anti-hypertensive treatment was evaluated for 1 year in a subset (n = 530) of the study population (n = 18 790) by placing the medication in a container closed with an electronic cap that records precisely the time of each opening. RESULTS: The 1-year compliance rate (percentage of days with one opening per day) could be assessed in 501 patients. It averaged 78.3 +/- 25% in aspirin-treated patients (n = 236, mean +/- SD), compared with 78.5 +/- 25% in patients having received placebo (n = 265), and was not influenced by age, sex or country (Germany, Italy, Switzerland, UK). The compliance rate was also similar irrespective of whether the patients had reached their target blood pressure, but was significantly better during the first than the second 6-month monitoring period (84.1 +/- 22% versus 72.3 +/- 32%, n = 501). CONCLUSIONS: The high rate of compliance with aspirin or placebo observed in the HOT study suggests that the patients were highly motivated and may account for the unusually good blood pressure control achieved in this trial during long-term anti-hypertensive treatment.

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