Electronic monitoring of compliance to lipid-lowering therapy in clinical practice

Nonadherence to treatment is a common problem in the clinical management of hypercholesterolemic patients. This study was carried out with the aim of monitoring the daily compliance to a g-month course of lipid-lowering therapy, using a microelectronic device, the Medication Event Monitoring System (MEMS(TM)), versus pill count. Forty men with primary hypercholesterolemia were prescribed fluvastatin 1 x 40 mg daily, provided in a MEMS(TM) package to record the date and time of each opening of the pillbox. Thirty-nine of 40 patients (98%) completed the study. Total cholesterol and LDL cholesterol levels decreased significantly (18% and 25%, p < 0.001) during the g-month therapy period. A high mean rate of compliance was achieved by MEMS(TM) using the following three indexes-compliance to total prescribed dose (88.8% +/- 13.5%), compliance to prescribed days (82.4% +/- 19.5%), and compliance to prescribed time of day (81.86% +/- 19.5%)-and by pill count (93.4% +/- 9.5%). In addition, the MEMS(TM) provided some patterns of nonadherence to medication, undetectable by pill count alone, such as a drug holiday in 38% of cases, a drug omission for more than 7 consecutive days in 9% of cases, and, conversely, use of more than the one prescribed daily dose in 47% of cases. A significant correlation between the rate of compliance and the decrease in LDL cholesterol was observed only when the compliance was assessed by MEMS(TM). The results indicate that MEMS(TM) is a useful tool for monitoring compliance in clinical practice and may possibly increase adherence to long-term lipid-lowering therapy. (C) 1999 the American College of Clinical Pharmacology.