标题：Clinical audit for the adherence to safety monitoring for pioglitazone use in patients with type 2 diabetes in the Al-Wazarat primary care center, Saudi Arabia
摘要：Aim: Despite the safety warnings issued for pioglitazone, its utilization continued in several countries. However, an individualized patient risk–benefit assessment has been advised before the use of pioglitazone. The objectives of the current study are to assess the adherence to pioglitazone safety monitoring and determine the reasons for pioglitazone discontinuation. Methods: Retrospective cohort study of patients with type 2 diabetes was carried out for patients who have been started on oral pioglitazone at the Al-Wazarat primary care center between January 2011 until the end of 2014. Adverse events and pioglitazone discontinuation were monitored during patient visits scheduled in 12-month period following the start of pioglitazone. The Chronic Disease Unit at the Al-Wazarat primary care center designed a monitoring data sheet. The safety-monitoring sheet included patients’ demographics (age and gender), history of bladder cancer, current bladder cancer, and current bladder diseases. The patient’s weight, edema status, liver function test (LFT), electrocardiogram (ECG), bone mass density (BMD), and hematuria were recorded at pioglitazone initiation and weeks 12, 24, and 48. Results: A total of 183 patients (78 males and 105 females) were included in the cohort. The side effect that was associated with highest monitoring adherence (two or more times during the study) was weight gain (94.5%), followed by LFTs (47.5%), edema (31.1%), bone mineral density (18.0%), and ECG (16.4%). Approximately 47.4% had one or more adverse events, with the most common side effect being weight gain (35.1%), followed by osteoporosis (10.5%), edema (8.8%), hypoglycemia (7.0%), elevated liver enzymes (3.5%), and osteopenia (3.5%). Approximately 63.9% discontinued pioglitazone, with the common reasons being shifting to insulin therapy (28.2%), weight gain (25.6%), loss to follow-up (15.4%), hypoglycemia (10.2%), and osteoporosis (8.4%). This reports an appropriate initiation of pioglitazone but suboptimal adherence to pioglitazone safety monitoring in a primary care setting.
