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Compliance with medication in the Helsinki Heart Study
H Mäenpää1, V Manninen, O P Heinonen
1First Department of Medicine, University of Helsinki, Finland.
European Journal of Clinical Pharmacology
|January 1, 1992
Summary
Medication compliance in the Helsinki Heart Study was assessed using capsule counting, urine analysis, and a digoxin marker. Compliance slightly declined over time, with slightly better adherence in the placebo group.
Area of Science:
- Clinical Research
- Pharmacology
- Public Health
Background:
- Medication compliance is critical for clinical trial validity.
- The Helsinki Heart Study evaluated gemfibrozil's efficacy in dyslipidaemic men.
Purpose of the Study:
- To assess medication compliance in the Helsinki Heart Study.
- To compare three methods for estimating compliance: capsule counting, urine gemfibrozil analysis, and a digoxin marker.
Main Methods:
- Employed capsule counting at 3-month intervals.
- Utilized urine gemfibrozil analysis every 6 months.
- Introduced a novel digoxin marker in years 3 and 5.
Main Results:
- Capsule counting: 36-39% took >90% of medication; 5% took ≤50%.
- Urine analysis: 30% of gemfibrozil subjects had >90% positive results; 28% had ≤50% positive.
- Digoxin marker: 42-50% of completers had good results; 12-14% had poor results.
- Compliance showed a slight decline over the study period, confirmed by all methods.
Conclusions:
- Multiple methods provide estimates of medication compliance.
- Compliance slightly decreased during the Helsinki Heart Study.
- Slightly better compliance was observed in the placebo group based on two methods.