TY - JOUR
T1 - Adoption of New Glucose-Lowering Medications in the U.S. - The Case of SGLT2 Inhibitors
T2 - Nationwide Cohort Study
AU - McCoy, Rozalina G.
AU - Dykhoff, Hayley J.
AU - Sangaralingham, Lindsey
AU - Ross, Joseph S.
AU - Karaca-Mandic, Pinar
AU - Montori, Victor M.
AU - Shah, Nilay D.
N1 - Funding Information:
This effort was funded by the National Institute of Health National Institute of Diabetes and Digestive and Kidney Diseases grant K23DK114497 (R.G.M.), AHRQ’s Comparative Health System Performance Initiative grant 1U19HS024075 (N.D.S.), and AHRQ’s grant R01HS025164 (P.K.-M.). R.G.M. also receives support from the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. In the past 36 months, N.D.S. has received research support through Mayo Clinic from the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (R01HS025164; R01HS025402; R03HS025517); the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) (R56HL130496; R01HL131535); the National Science Foundation; and the Patient-Centered Outcomes Research Institute (PCORI) to develop a Clinical Data Research Network (LHSNet). In the past 36 months, J.S.R. has received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from Medtronic, Inc. and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585), from the FDA to establish Yale-Mayo Clinic CERSI program (U01FD005938), from the Blue Cross Blue Shield Association to better understand medical technology evaluation, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung, and Blood Institute of the NIH (R01HS025164), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale. P.K.-M. serves as the Principal Investigator to several grants on prescription drug studies (NIA/P01AG005842; NIH/R56 HL130496 and Agency for Healthcare Research and Quality/R01 HS025164; American Cancer Society 131611-RSGI-17-154-01-CPHPS). In the past 36 months, she reports receiving consulting fees unrelated to this work from Tactile Medical and Precision Health Economics.
PY - 2019/12
Y1 - 2019/12
N2 - Background: High-quality diabetes care is evidence-based, timely, and equitable. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are the most recently approved class of glucose-lowering medications with additional cardio- and renal-protective benefits and low risk of hypoglycemia. Cardiovascular and kidney disease are among the most common chronic diabetes complications, whereas hypoglycemia is the most prevalent adverse effect of glucose-lowering therapy. We examine the sociodemographic and clinical factors associated with early SGLT2i initiation and appropriateness of use based on contemporaneous scientific evidence. Materials and Methods: Retrospective analysis of medical and pharmacy claims data from OptumLabs® Data Warehouse for commercially insured and Medicare Advantage adult beneficiaries with diabetes types 1 and 2, who filled any glucose-lowering medication between January 1, 2013 and December 31, 2016. Demographic (age, sex, race, income), clinical (comorbidities), and insurance-related factors affecting first prescription for a SGLT2i were examined using multivariable logistic regression. Results: Among 1,054,727 adults with pharmacologically treated diabetes, 7.2% (n = 75,500) initiated a SGLT2i. Patients with prior myocardial infarction (MI) (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.91-0.96), heart failure (HF) (OR: 0.93, 95% CI: 0.91-0.94), kidney disease (OR: 0.80, 95% CI: 0.78-0.81), and severe hypoglycemia (OR: 0.96, 95% CI: 0.94-0.98) were all less likely to start a SGLT2i; P < 0.001 for all. SGLT2i were also less likely to be started by patients ≥75 years (OR: 0.57, 95% CI: 0.55-0.59, vs. 18-44 years), Black patients (OR: 0.93, 95% CI: 0.91-0.95, vs. White), and those with Medicare Advantage insurance (OR: 0.63, 95% CI: 0.62-0.64, vs. commercial). Conclusions: Younger, healthier, non-Black patients with commercial health insurance were most likely to start taking SGLT2i. Patients with MI, HF, kidney disease, and prior hypoglycemia were less likely to use SGLT2i, despite evidence supporting their preferential use in these patients. Efforts to address this treatment-risk paradox may help improve health outcomes among patients with type 2 diabetes.
AB - Background: High-quality diabetes care is evidence-based, timely, and equitable. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are the most recently approved class of glucose-lowering medications with additional cardio- and renal-protective benefits and low risk of hypoglycemia. Cardiovascular and kidney disease are among the most common chronic diabetes complications, whereas hypoglycemia is the most prevalent adverse effect of glucose-lowering therapy. We examine the sociodemographic and clinical factors associated with early SGLT2i initiation and appropriateness of use based on contemporaneous scientific evidence. Materials and Methods: Retrospective analysis of medical and pharmacy claims data from OptumLabs® Data Warehouse for commercially insured and Medicare Advantage adult beneficiaries with diabetes types 1 and 2, who filled any glucose-lowering medication between January 1, 2013 and December 31, 2016. Demographic (age, sex, race, income), clinical (comorbidities), and insurance-related factors affecting first prescription for a SGLT2i were examined using multivariable logistic regression. Results: Among 1,054,727 adults with pharmacologically treated diabetes, 7.2% (n = 75,500) initiated a SGLT2i. Patients with prior myocardial infarction (MI) (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.91-0.96), heart failure (HF) (OR: 0.93, 95% CI: 0.91-0.94), kidney disease (OR: 0.80, 95% CI: 0.78-0.81), and severe hypoglycemia (OR: 0.96, 95% CI: 0.94-0.98) were all less likely to start a SGLT2i; P < 0.001 for all. SGLT2i were also less likely to be started by patients ≥75 years (OR: 0.57, 95% CI: 0.55-0.59, vs. 18-44 years), Black patients (OR: 0.93, 95% CI: 0.91-0.95, vs. White), and those with Medicare Advantage insurance (OR: 0.63, 95% CI: 0.62-0.64, vs. commercial). Conclusions: Younger, healthier, non-Black patients with commercial health insurance were most likely to start taking SGLT2i. Patients with MI, HF, kidney disease, and prior hypoglycemia were less likely to use SGLT2i, despite evidence supporting their preferential use in these patients. Efforts to address this treatment-risk paradox may help improve health outcomes among patients with type 2 diabetes.
KW - Administrative claims data
KW - Diabetes mellitus
KW - Evidence-based medicine
KW - Health services research
KW - Pharmacoepidemiology
KW - SGLT2 inhibitor
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U2 - 10.1089/dia.2019.0213
DO - 10.1089/dia.2019.0213
M3 - Article
C2 - 31418588
AN - SCOPUS:85075911078
VL - 21
SP - 702
EP - 712
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
SN - 1520-9156
IS - 12
ER -