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Compliance with aspirin or placebo in the Hypertension Optimal Treatment (HOT) study
B Waeber1, G Leonetti, R Kolloch
1Division of Clinical Physiopathology and Medical Teaching, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Insights
High compliance with aspirin or placebo in the HOT study indicates patient motivation, contributing to excellent blood pressure control during anti-hypertensive therapy.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- The Hypertension Optimal Treatment (HOT) study investigated optimal diastolic blood pressure targets for cardiovascular protection.
- A secondary objective was to evaluate the impact of low-dose aspirin on morbidity and mortality.
Purpose of the Study:
- To determine the required diastolic blood pressure levels for maximal cardiovascular protection.
- To assess the effects of daily 75 mg aspirin versus placebo on cardiovascular outcomes.
Main Methods:
- A subset of 530 participants from the 18,790-patient HOT study had medication compliance monitored electronically for 1 year.
- Compliance was measured by the electronic cap openings of aspirin or placebo containers.
Main Results:
- One-year compliance rates averaged 78.3% for aspirin and 78.5% for placebo, unaffected by demographics or target blood pressure achievement.
- Compliance was significantly higher in the first six months (84.1%) compared to the second six months (72.3%).
Conclusions:
- High compliance rates in the HOT study suggest strong patient motivation.
- This high compliance may explain the effective blood pressure control observed during long-term anti-hypertensive treatment.
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.