Compliance to multiple interventions in a high risk population

PURPOSE: Assess compliance with study medications and examine reasons for n oncompliance. Individuals with peripheral arterial disease present the clin ician with a unique combination of symptoms and therapeutic needs; the trea tment of this population has not been adequately studied. METHODS: The Arterial Disease Multiple Intervention Trial was a randomized double-blind placebo-controlled trial that randomized 468 participants to a combination of antioxidants, niacin and warfarin or matching placebos. Men and women (mean age 65 yrs) with peripheral arterial disease and low densi ty lipoprotein (LDL) < 190 mg/dl were enrolled and followed for one year. C ompliance to the study medications was measured by pill count for each medi cation. An overall measure of compliance was determined by combining pill c ounts from all study visits. RESULTS: Mean overall pill counts ranged from 88 to 94% in the right treatm ent groups. No statistically significant differences were found in mean pil l counts over time or between active and placebo groups. History of coronar y artery disease and number of follow-up visits were associated with higher overall pill counts while low compliance during screening was associated w ith lower counts during follow up. Participants with an overall mean pill c ount < 800% had more adverse events compared to those with a higher count. Side effects were reported as the reason for missing pills significantly mo re often in the active versus placebo niacin group. CONCLUSIONS: Individuals with peripheral arterial disease were able to comp ly with the complex drug regimen. The ability of this drug combination to r educe cardiovascular events-and improve quality of life warrants study. (C) 1999 Elsevier Science Inc. All rights reserved.