Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience

Fenofibrate has been noted to cause an elevation in serum creatinine in some individuals. Participants in the Action to Control Cardiovascular Risk in Diabetes Lipid Study were studied to better characterise who is at risk of an increase in creatinine level and to determine whether those with creatinine elevation have a differential risk of adverse renal or cardiovascular outcomes

Reversibility of Fenofibrate Therapy-Induced Renal Function Impairment in ACCORD Type 2 Diabetic Participants

OBJECTIVETo assess the reversibility of the elevation of serum creatinine levels in patients with diabetes after 5 years of continuous on-trial fenofibrate therapy.RESEARCH DESIGN AND METHODSAn on-drug/off-drug ancillary study to the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial to investigate posttrial changes in serum creatinine and cystatin C. Eligible participants were recruited into a prospective, nested, three-group study based on retrospective on-trial serum creatinine levels: fenofibrate case subjects (n = 321, ≥20% increase after 3 months of therapy); fenofibrate control subjects (n = 175, ≤2% increase); and placebo control subjects (n = 565). Serum creatinine and cystatin C were measured at trial end and 6–8 weeks after discontinuation of trial therapy.RESULTSAt trial end, case subjects had the highest adjusted serum creatinine (± SE) mg/dL (1.11 ± 0.02) and the lowest adjusted estimated glomerular filtration rate (eGFR) (± SE) mL/min/1.73 m2 (68.4 ± 1.0) versus control subjects (1.01 ± 0.02; 74.8 ± 1.3) and placebo subjects (0.98 ± 0.01; 77.8 ± 0.7). After 51 days off-drug, serum creatinine in case subjects was still higher (0.97 ± 0.02) and eGFR still lower (77.8 ± 1.0) than control subjects (0.90 ± 0.02; 81.8 ± 1.3) but not different from placebo subjects (0.99 ± 0.01; 76.6 ± 0.7). Changes in serum cystatin C recapitulated the serum creatinine changes.CONCLUSIONSParticipants with significant initial on-trial increases in serum creatinine (≥20%) returned to the same level of renal function as participants receiving placebo while participants who had ≤2% increase in serum creatinine had net preservation of renal function compared with the same unselected placebo reference group. The fenofibrate-associated on-trial increases in serum creatinine were reversible, and the reversal was complete after 51 days off-drug. The similarity of the cystatin C results suggests that the mechanism of this change is not specific for serum creatinine

Factors influencing the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty training:A systematic review protocol

Background In 2013, there was a shortage of approximately 7.2 million health workers worldwide, which is larger among family physicians than among specialists. eLearning could provide a potential solution to some of these global workforce challenges. However, there is little evidence on factors facilitating or hindering implementation, adoption, use, scalability and sustainability of eLearning. This review aims to synthesise results from qualitative and mixed methods studies to provide insight on factors influencing implementation of eLearning for family medicine specialty education and training. Additionally, this review aims to identify the actions needed to increase effectiveness of eLearning and identify the strategies required to improve eLearning implementation, adoption, use, sustainability and scalability for family medicine speciality education and training. Methods A systematic search will be conducted across a range of databases for qualitative studies focusing on experiences, barriers, facilitators, and other factors related to the implementation, adoption, use, sustainability and scalability of eLearning for family medicine specialty education and training. Studies will be synthesised by using the framework analysis approach. Discussion This study will contribute to the evaluation of eLearning implementation, adoption, use, sustainability and scalability for family medicine specialty training and education and the development of eLearning guidelines for postgraduate medical education