04 Oct Diabetes Progression With Initiation of Statins
MedicalResearch.com Interview with:
Ishak Mansi, MD
Staff Internist, VA North Texas Health System.
Professor in Department of Medicine &
Department of Data & Population Science,
University of Texas Southwestern, Dallas, TX
MedicalResearch.com: What is the background for this study?
Response: Several scientific societies guidelines recommend Statins prescription to patients with diabetes aged 40 to 75 with LDL-cholesterol ≥70 mg/dL to prevent cardiovascular diseases from occurring. Statins have been shown to lower the risk of cardiovascular diseases. However, prior research has shown statins to be associated with increased insulin resistance. But doctors do not routinely measure “insulin resistance” for their patients, rather, it is done on research and academic circles only but not in everyday life. Increased insulin resistance may result in less controlled diabetes and/or escalation of anti-diabetes medications.
MedicalResearch.com: What are the main findings?
Response: In this study, we examined this issue: we examined real life data of more than 700,000 patients with diabetes from the Veterans Administration (VA) Healthcare system. We compared the risk of diabetes progression (by assessing new insulin initiations, changes in the number of glucose lowering medication classes, and new persistent hyperglycemia or acute glycemic complications) following statin initiation vs nonusers of statins. Our primary analysis focused on 83,022 pairs of statin users and nonusers, who were matched on 93 characteristics to ensure comparability using a well-known technique called propensity score matching. Diabetes progression outcome occurred in 55.9% of statin users vs 48.0% of nonusers (Odds ratio [OR]: 1.37; p<0.001-that is statin users had 37% higher odds than nonusers). Each individual component of the diabetes progression outcome (new insulin initiations, changes in the number of glucose lowering medication classes, and new persistent hyperglycemia or acute glycemic complications) was significantly higher among statin users. We performed several additional analyses to ensure consistency of our results and results were consistent, which increase our confidence in our findings. Patients on high intensity statins and who were otherwise healthy had the highest risk of diabetes progression.
MedicalResearch.com: What should readers take away from your report?
Response: Three important precautions in reading our study:
1) No patient should stop taking their statins based on our study;
2) Association does not prove causation; and
3) No single study should dictate treatment policy but all pieces of evidence together.
But this study is very important because it translated findings reported on academic studies of increased insulin resistance associated with statin use in research papers into everyday language of patients care, that is patients on statins may need to escalate their anti-diabetes therapy. Hence, it may alert clinicians that they may need to pay close attention and expect to adjust anti-diabetes medications when they initiate statins. Adjusting anti-diabetes medications is a common practice in management of diabetes.
Of course, we have to differentiate between using statins for primary prevention of cardiovascular diseases (that is in patients who never had any cardiovascular disease previously) and those using statins for secondary prevention (those who have pre-existing cardiovascular disease). In the latter group, statins are one of the most important lines of treatment and their benefits are tremendous.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: This study should be a start to more research examining the balance of benefits/harms of statins in patients with diabetes. We know well about the benefits but the harms are much less investigated (despite that statins have been in use for > 30 years!). Observational data and registries can be an excellent method to examine this topic. Specifically, what is the population characteristics that may benefit less from use of statins for primary prevention or get more harm. This type of studies should be prioritized since diabetes is very common in the USA and the world; hence, answering these questions impact hundreds of millions of patients and cannot be postponed.
MedicalResearch.com: Is there anything else you would like to add?
Response: There should be dedicated funding for such research about unintended adverse effects of commonly used medications. Whereas investigating beneficial effects of drugs get funded by manufactures (and we are grateful for them for doing that), there is no dedicated funding mechanism for a study like our study. I can see many researchers deterred from performing necessary research due to difficulty in obtaining funding.
There is no potential conflict of interest for any of the authors in relation to this study
Mansi IA, Chansard M, Lingvay I, Zhang S, Halm EA, Alvarez CA. Association of Statin Therapy Initiation With Diabetes Progression: A Retrospective Matched-Cohort Study. JAMA Intern Med. Published online October 04, 2021. doi:10.1001/jamainternmed.2021.5714
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