Effect of fenofibrate on progression of coronary-artery disease in type 2 diabetes: the Diabetes Atherosclerosis Intervention Study, a randomised study

Background— The Diabetes Atherosclerosis Intervention Study showed that treatment with fenofibrate decreases progression of coronary atherosclerosis in subjects with type 2 diabetes. We determined whether on-treatment plasma lipid concentrations and LDL particle size contribute to the favorable effect of fenofibrate on the progression of coronary artery disease (CAD). Methods and Results— A total of 418 subjects with type 2 diabetes were randomly assigned to 200 mg micronized fenofibrate daily or placebo. The mean follow-up time was 39.6 months. LDL peak particle diameter (LDL size) was determined by polyacrylamide gradient gel electrophoresis from 405 subjects at baseline and at the end of the study. Progression of CAD was measured with quantitative coronary angiography. LDL size increased significantly more in the fenofibrate group than in the placebo group (0.98±1.04 versus 0.32±0.92 nm, P<0.001). In the combined group, small LDL size was significantly associated with progression of CAD measured as the...

Relationships Between Low-Density Lipoprotein Particle Size, Plasma Lipoproteins, and Progression of Coronary Artery Disease The Diabetes Atherosclerosis Intervention Study (DAIS)

OBJECTIVE: To establish a surveillance network for cardiovascular diseases (CVD) risk factors in industrial settings and estimate the risk factor burden using standardized tools. METHODS: We conducted a baseline cross-sectional survey (as part of a CVD surveillance programme) of industrial populations from 10 companies across India, situated in close proximity to medical colleges that served as study centres. The study subjects were employees (selected by age and sex stratified random sampling) and their family members. Information on behavioural, clinical and biochemical determinants was obtained through standardized methods (questionnaires, clinical measurements and biochemical analysis). Data collation and analyses were done at the national coordinating centre. FINDINGS: We report the prevalence of CVD risk factors among individuals aged 20-69 years (n = 19 973 for the questionnaire survey, n = 10 442 for biochemical investigations); mean age was 40 years. The overall prevalence of most risk factors was high, with 50.9% of men and 51.9% of women being overweight, central obesity was observed among 30.9% of men and 32.8% of women, and 40.2% of men and 14.9% of women reported current tobacco use. Self-reported prevalence of diabetes (5.3%) and hypertension (10.9%) was lower than when measured clinically and biochemically (10.1% and 27.7%, respectively). There was marked heterogeneity in the prevalence of risk factors among the study centres. CONCLUSION: There is a high burden of CVD risk factors among industrial populations across India. The surveillance system can be used as a model for replication in India as well as other developing countries.

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Methods for establishing a surveillance system for cardiovascular diseases in Indian industrial populations

https://www.ajkd.org/article/S0272-6386(04)01467-2/pdf

Fenofibrate reduces progression to microalbuminuria over 3 years in a placebo-controlled study in type 2 diabetes: results from the Diabetes Atherosclerosis Intervention Study (DAIS).

Less than 25% of eligible patients attend cardiac rehabilitation programs (CRP), with geographical proximity being a predominant barrier. Therefore, we undertook a pilot study to assess the feasibility and safety of using the Internet as a medium for delivery of an interactive “virtual” CRP (vCRP) to patients at a distance. Fifteen patients on the waiting list for a local hospital-based CRP were randomized to either an Internet-based vCRP or observational control. The vCRP consisted of on-line intake forms, one-on-one chat sessions with a nurse, dietitian, and exercise specialist, downloadable exercise heart rate monitoring, education and data monitoring of blood pressure, weight, and glucose. Participants were assessed for exercise capacity, risk factors, and lifestyle behaviors at baseline and at 12 weeks. Those in the vCRP logged onto the Internet-based CRP an average of 4.2 times per week. There were no adverse events in the vCRP participants. The vCRP group significantly improved their HDL-C...

Cathy McGuinness

Papers

Laboratory standardization of a large international clinical trial: the DAIS experience