Marie C. Bradley, PhD, MPharm, MScPH Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, Maryland

Diabetes: Risk of Hypoglycemia With Long Acting Insulin in Older Patients

MedicalResearch.com Interview with:

Marie C. Bradley, PhD, MPharm, MScPH Office of Surveillance and Epidemiology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, Maryland

Dr. Bradley

Marie C. Bradley, PhD, MPharm, MScPH
Office of Surveillance and Epidemiology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, Maryland

MedicalResearch.com: What is the background for this study?

Response: Long-acting insulin analogs, insulin glargine (glargine) and insulin detemir (detemir) are increasingly used in the management of type 2 diabetes mellitus (T2DM). In recent years the price of long-acting insulin analogs has increased substantially2 Higher costs for these insulin analogs may limit patient access.1 Clinical trials showed the risk of severe hypoglycemia did not differ between long-acting insulin analogs and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus (T2DM). An observational study examining severe hypoglycemia in T2DM patients found similar results. However, these previous studies did not focus on patients aged ≥65 years, who are at an increased risk for hypoglycemia, or did not include patients with concomitant prandial insulin use. Therefore, to investigate this further we used Medicare data to assess the risk of severe hypoglycemia among older T2DM patients who initiated a long acting analog ( glargine or detemir) compared to NPH in real-world settings.

MedicalResearch.com: What are the main findings?

Response: The findings showed a reduced risk of severe hypoglycemia in older T2DM patients who initiated long-acting insulin analogs compared to NPH in Medicare. However, no difference in risk was seen in initiators of either insulin who concurrently used prandial insulin. We also noted that the protective association of long-acting insulin analogs varied by age and was stronger at ages 69 to 87 than at other ages.

MedicalResearch.com: What should readers take away from your report?

Response: The findings suggest that when making decisions about initiating insulin use in older patients with diabetes consideration should be given to the potential risk of hypoglycemia. Particular care is needed when considering insulin therapy in older adults who may be at greatest risk for hypoglycemia.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Future research should focus on examining changes in hemoglobin A1c level among older adults who initiate long acting analogs compared to NPH to investigate any difference between the two insulins on glycemic control in real world settings.

Disclosures: These responses reflect the views of the author and should not be construed to represent FDA’s views or policies.

Citation:

Bradley MC, Chillarige Y, Lee H, et al. Severe Hypoglycemia Risk With Long-Acting Insulin Analogs vs Neutral Protamine Hagedorn Insulin. JAMA Intern Med. Published online March 01, 2021. doi:10.1001/jamainternmed.2020.9176

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Mar 7, 2021 @ 5:56 pm

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