Abstract 14146: The Risk of New-Onset Diabetes Associated With Pravastatin and Relationship Between Pravastatin and Diet Adherence
Background and aims: In February 2010, a meta-analysis of 13 statin trials with more than 90,000 individuals, including the MEGA Study, reported that statin treatment significantly increased the risk of new-onset diabetes (NODM) by 9%. In the present analysis, we aim to clarify the factors that contributed to NODM in the MEGA Study.
Material and methods: The MEGA Study evaluated the effect of low-dose pravastatin (10-20 mg/day, approved dose in Japan) on primary prevention of cardiovascular disease in 7,832 Japanese patients with mild to moderate hypercholesterolemia without cardiovascular disease. Patients were randomized to diet alone (n=3,966) or diet + pravastatin (n=3,866) and followed for an average 5 years. The patients in both groups were counseled to follow the National Cholesterol Education Program (NCEP) Step 1 diet. Adherence to the NCEP diet was evaluated every 6 months by the attending physician. To determine the factors that contributed to NODM, the multivariable Cox proportional hazards model was used. The diet adherence scores were determined using the physician grading (Good=1.0, Almost good=0.75, Slightly poor=0.25, Poor=0) averaged throughout the follow-up.
Results: The hazard ratios for NODM for each covariate are: men against women, 1.91 (p<0.001); age ≥ 60 against <60 years old, 1.08 (p=0.48); BMI ≥25 against <25 kg/m2, 1.98 (p<0.001); HDL-C ≥1.0 against <1.0 mmol/L, 0.87 (p=0.42); triglycerides ≥1.7 against <1.7 mmol/L, 1.72 (p<0.001); adherence score ≥0.75 and <0.75 in diet plus pravastatin group against diet group, 0.78 (p=0.13) and 1.27 (p=0.05), respectively. The average adherence scores during follow-up were 0.72 in diet group, and 0.63 and 0.89 in diet plus pravastatin group with good adherence and poor adherence, respectively.
Conclusions: Male sex, high BMI, and triglycerides are the significant risk factors that contribute to the development of NODM, independent of statin use. Poor diet adherence during statin treatment significantly increases the incidence of new-onset diabetes. These results suggest that poor diet adherence is of key importance of new-onset diabetes when patients are treated with a statin.
- © 2010 by American Heart Association, Inc.