Patients with diabetes who used statins experienced less control of their diabetes than patients who did not take statins, suggests a new retrospective study published in JAMA Internal Medicine. Individuals who had diabetes and were prescribed statins had a higher chance of insulin treatment initiation, were more likely to develop significant hyperglycemia and experience acute glycemic complications, and were more likely to be prescribed extra glucose-lowering medications, according to the study results. The overall increase in diabetes progression was 37% more compared to patients not taking statins. “Given this increase, I was not surprised by the increased number of patients needing glucose-lowering medications or insulin,” said Kristi Kelley, PharmD, BCPS, BCACP, a clinical professor at Auburn University Harrison School of Pharmacy in Alabama. “I was surprised by the results of the secondary analysis showing that the odds of progression of diabetes was greatest with the high intensity statins.” The study authors note that the “findings of the secondary analyses should be interpreted as exploratory.” Statins are among the most-prescribed medications and are known to be associated with greater insulin resistance and higher blood glucose levels. FDA added a warning to all statins in 2012 that states that increases in A1C and fasting blood glucose have been noted in patients receiving statin therapy. In their 2019 scientific statement, the American Heart Association (AHA) also acknowledged adverse events related to statins. “This is something that is going to continue to be investigated and will be discussed among health care providers,” said Kelley. In the JAMA Internal Medicine study, Mansi and colleagues analyzed 12 years (2003–2015) of data on patients covered through the VA health system. The study included roughly 83,000 propensity-scored matched pairs of statin users and nonusers. Since data originated within the VA health system, the overwhelming majority of participants were white men around 60 years old, which could limit the external validity of the results, according to Kelley. The medical record data included inpatient and outpatient diagnoses and procedure codes, pharmacy and medication usage, vital signs records, and laboratory data. For those who filled a statin prescription during the study period, roughly 63% of the prescriptions were for simvastatin; 12% for atorvastatin; 11% for rosuvastatin; and 10% for pravastatin. Lead author Ishak Mansi, MD, said patients should not stop taking their statin, but rather discuss it with their health care provider. While no single study should change practice, he said this research may alert clinicians to keep a close eye on the blood glucose of patients who initiate statins. “The biggest implication for this study is that further research is urgently needed to define the diabetes subpopulation that would benefit most from statin use and the subpopulation that may suffer most harm,” said Mansi, who is a staff internist at the VA North Texas Health System. Jingchuan Guo, MD, PhD, an assistant professor in the Department of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy, said she would like to see further research on this topic, specifically concerning the potential effect variation across individual drugs within the therapeutic class of statins, the individualized effect of stains on diabetes progression in real-world populations and subgroups, the risk-benefit of using (or not using) statins for long-term cardiovascular health outcomes among patients with diabetes, and whether the increased risk of diabetes progression is linked with statin use or with lower LDL cholesterol. Kelley said it will be important for pharmacists and other health care providers to be prepared to have discussions with patients about the risk-benefit of statins. “The decision to initiate a statin or continue a statin will need to be an individualized patient-centered decision,” she said. The study authors noted that “the higher risk of diabetes progression associated with statin use may seem less consequential, at least in the short and intermediate term, than the cardiovascular benefits of statin use, especially when used for secondary prevention. However, diabetes progression has long-term effects on quality of life and treatment burden, which warrant consideration when discussing the overall risk-benefit profile, especially when used for primary prevention.” With over 34 million Americans currently living with diabetes, Guo said these types of studies have major public health relevance. Mansi noted that with statins in clinical use for more than 30 years, he would have expected such research to be done much sooner.
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Jul 1, 2024
Ramya Ramadurai + 1
Open Access