Electronic Monitoring of Compliance to Lipid‐Lowering Therapy in Clinical Practice

Abstract
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 6-month course of lipid-lowering therapy, using a microelectronic device, the Medication Event Monitoring System (MEMS), versus pill count. Forty men with primary hypercholesterolemia were prescribed fluvastatin 1 × 40 mg daily, provided in a MEMSpackage 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 6-month therapy period. A high mean rate of compliance was achieved by MEMSusing 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 MEMSprovided 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™. The results indicate that MEMSis a useful tool for monitoring compliance in clinical practice and may possibly increase adherence to long-term lipid-lowering therapy.