National Healthcare Quality and Disparities Report
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- (-) Adverse Drug Events (ADE) (13)
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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 13 of 13 Research Studies DisplayedHorton DB, Xie F, Chen L
Oral glucocorticoids and incident treatment of diabetes mellitus, hypertension, and venous thromboembolism in children.
The purpose of this study was to quantify rates of incident treatment for diabetes mellitus, hypertension, and venous thromboembolism (VTE) associated with oral glucocorticoid exposure in children aged 1-18 years. Participants were identified using US Medicaid claims data and included more than 930,000 children diagnosed with autoimmune diseases or a nonimmune comparator condition. Findings showed strong dose-dependent relationships between current glucocorticoid exposure and all outcomes, suggesting strong relative risks, but low absolute risks, of newly-treated VTE, diabetes, and especially hypertension in children taking high-dose oral glucocorticoids.
AHRQ-funded; HS021110.
Citation: Horton DB, Xie F, Chen L .
Oral glucocorticoids and incident treatment of diabetes mellitus, hypertension, and venous thromboembolism in children.
Am J Epidemiol 2021 Feb 1;190(3):403-12. doi: 10.1093/aje/kwaa197..
Keywords: Children/Adolescents, Diabetes, Chronic Conditions, Blood Clots, Medication: Safety, Medication, Adverse Drug Events (ADE), Adverse Events, Risk, Patient Safety, Blood Pressure
Hickson RP, Cole AL, Dusetzina SB
Implications of removing rosiglitazone's black box warning and restricted access program on the uptake of thiazolidinediones and dipeptidyl peptidase-4 inhibitors among patients with type 2 diabetes.
The purpose of this study was to describe trends over time in the initiation of rosiglitazone and pioglitazone-both in the thiazolidinedione (TZD) class-and medications from the dipeptidyl peptidase-4 (DPP-4) inhibitor class before and after the FDA removed a black box warning and restricted access program for rosiglitazone regarding an increased risk of myocardial infarction.
AHRQ-funded; HS000032.
Citation: Hickson RP, Cole AL, Dusetzina SB .
Implications of removing rosiglitazone's black box warning and restricted access program on the uptake of thiazolidinediones and dipeptidyl peptidase-4 inhibitors among patients with type 2 diabetes.
J Manag Care Spec Pharm 2019 Jan;25(1):72-79. doi: 10.18553/jmcp.2019.25.1.072..
Keywords: Adverse Drug Events (ADE), Adverse Events, Cardiovascular Conditions, Diabetes, Medication, Heart Disease and Health, Patient Safety
Leonard CE, Han X, Brensinger CM
Comparative risk of serious hypoglycemia with oral antidiabetic monotherapy: a retrospective cohort study.
The purpose of this study was to examine and compare risks of serious hypoglycemia among antidiabetic monotherapy-treated adults receiving metformin, a sulfonylurea, a meglitinide, or a thiazolidinedione. The investigators found that sulfonylureas were associated with the highest rates of serious hypoglycemia. Among all study drugs, the highest rate was seen with glyburide. Pioglitazone was associated with a lower adjusted hazard for serious hypoglycemia vs metformin, while rosiglitazone and nateglinide had hazards similar to that of metformin.
AHRQ-funded; HS023898.
Citation: Leonard CE, Han X, Brensinger CM .
Comparative risk of serious hypoglycemia with oral antidiabetic monotherapy: a retrospective cohort study.
Pharmacoepidemiol Drug Saf 2018 Jan;27(1):9-18. doi: 10.1002/pds.4337..
Keywords: Risk, Adverse Drug Events (ADE), Adverse Events, Diabetes, Medication
Zhou M, Wang SV, Leonard CE
Sentinel modular program for propensity score-matched cohort analyses: application to glyburide, glipizide, and serious hypoglycemia.
Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. This cohort assessment was conducted to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce, in an expedited fashion, the known association between glyburide (vs. glipizide) and serious hypoglycemia. The study’s findings were consistent with the literature, and demonstrated the ability of the tool to reproduce this known association in an expedited.
AHRQ-funded; HS022193.
Citation: Zhou M, Wang SV, Leonard CE .
Sentinel modular program for propensity score-matched cohort analyses: application to glyburide, glipizide, and serious hypoglycemia.
Epidemiology 2017 Nov;28(6):838-46. doi: 10.1097/ede.0000000000000709..
Keywords: Adverse Drug Events (ADE), Diabetes, Medication: Safety, Medication, Patient Safety
Leonard CE, Hennessy S, Han X
Pro- and antiarrhythmic actions of sulfonylureas: Mechanistic and clinical evidence.
In this review, the authors explore the influence of sulfonylureas on the risk of serious arrhythmias, with specific foci on ischemic preconditioning, cardiac excitability, and serious hypoglycemia as putative mechanisms. They argue that elucidating the relationship between individual sulfonylureas and serious arrhythmias is critical, especially as the diabetes epidemic intensifies and sudden cardiac arrest (SCA) incidence increases in persons with diabetes.
AHRQ-funded; HS023898.
Citation: Leonard CE, Hennessy S, Han X .
Pro- and antiarrhythmic actions of sulfonylureas: Mechanistic and clinical evidence.
Trends Endocrinol Metab 2017 Aug;28(8):561-86. doi: 10.1016/j.tem.2017.04.003.
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Keywords: Adverse Drug Events (ADE), Cardiovascular Conditions, Diabetes, Medication, Mortality
Salber GJ, Wang YB, Lynch JT
Metformin use in practice: compliance with guidelines for patients with diabetes and preserved renal function.
This article reports on an examination of a population of patients with diabetes with preserved renal function to evaluate provider compliance with guidelines on metformin use and to identify factors that contributed when practice diverged from recommendations. It found that although providers generally follow current recommendations for the use of metformin, deviations from guidelines in practice are common.
AHRQ-funded; HS019474.
Citation: Salber GJ, Wang YB, Lynch JT .
Metformin use in practice: compliance with guidelines for patients with diabetes and preserved renal function.
Clin Diabetes 2017 Jul;35(3):154-61. doi: 10.2337/cd15-0045.
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Keywords: Medication, Guidelines, Diabetes, Adverse Drug Events (ADE)
Schroeder EB, Xu S, Goodrich GK
Predicting the 6-month risk of severe hypoglycemia among adults with diabetes: development and external validation of a prediction model.
Researchers developed and validated two prediction models for predicting the 6-month risk of hypoglycemia. The 16-variable model had slightly better performance than the 6-variable model, but in some practice settings, use of the simpler model may be preferred.
AHRQ-funded; HS019859; HS022963.
Citation: Schroeder EB, Xu S, Goodrich GK .
Predicting the 6-month risk of severe hypoglycemia among adults with diabetes: development and external validation of a prediction model.
J Diabetes Complications 2017 Jul;31(7):1158-63. doi: 10.1016/j.jdiacomp.2017.04.004.
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Keywords: Adverse Drug Events (ADE), Diabetes, Medication, Risk
Gabriel MH, Powers C, Encinosa W
AHRQ Author: Encinosa W
E-prescribing and adverse drug events: an observational study of the Medicare part D population with diabetes.
The researchers examined the impact of e-prescribing on emergency visits or hospitalizations for diabetes-related adverse drug events (ADEs) including hypoglycemia. They concluded that at the e-prescribing threshold of 75 percent and above, there were significant reductions in ADE risk.
AHRQ-authored.
Citation: Gabriel MH, Powers C, Encinosa W .
E-prescribing and adverse drug events: an observational study of the Medicare part D population with diabetes.
Med Care 2017 May;55(5):456-62. doi: 10.1097/mlr.0000000000000684.
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Keywords: Adverse Drug Events (ADE), Electronic Prescribing (E-Prescribing), Diabetes, Medicare, Medication
Lipska KJ, Flory JH, Hennessy S
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Although healthcare professionals rarely submit citizen petitions, they can exert a powerful impact on the labeling requirements for drugs. Metformin is one such example. The authors filed 2 petitions to the FDA, asking the FDA to change the label and to relax the renal contraindications. In 2016, the FDA issued a safety communication that partially granted our requests by requiring the manufacturers of metformin to change the labeling of metformin in several ways.
AHRQ-funded; HS023898.
Citation: Lipska KJ, Flory JH, Hennessy S .
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Circulation 2016 Nov 1;134(18):1405-08. doi: 10.1161/circulationaha.116.023041.
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Keywords: Medication, Medication: Safety, Adverse Drug Events (ADE), Kidney Disease and Health, Diabetes
McCoy RG, Lipska KJ, Yao X
Intensive treatment and severe hypoglycemia among adults with type 2 diabetes.
The objectives of this study were to estimate the prevalence of intensive treatment and the association between intensive treatment, clinical complexity, and incidence of severe hypoglycemia among adults with type 2 diabetes who are not using insulin. The researchers found that over 20% of patients with type 2 diabetes received intensive treatment that might have been unnecessary and that among patients with high clinical complexity, intensive treatment nearly doubled the risk of severe hypoglycemia.
AHRQ-funded; HS018339.
Citation: McCoy RG, Lipska KJ, Yao X .
Intensive treatment and severe hypoglycemia among adults with type 2 diabetes.
JAMA Intern Med 2016 Jul;176(7):969-78. doi: 10.1001/jamainternmed.2016.2275.
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Keywords: Adverse Drug Events (ADE), Diabetes, Medication, Patient-Centered Healthcare, Risk
Mansi I, Frei CR, Wang CP
Statins and new-onset diabetes mellitus and diabetic complications: a retrospective cohort study of US healthy adults.
The authors studied the long-term relationship between statin use and new-onset diabetes among Tricare beneficiaries. They found that diabetes, diabetic complications, and overweight/obesity were more commonly diagnosed among statin-users than similar nonusers in a healthy cohort of adults, demonstrating that short-term clinical trials might not fully describe the risk/benefit of long-term statin use for primary prevention.
AHRQ-funded; HS022418.
Citation: Mansi I, Frei CR, Wang CP .
Statins and new-onset diabetes mellitus and diabetic complications: a retrospective cohort study of US healthy adults.
J Gen Intern Med 2015 Nov;30(11):1599-610. doi: 10.1007/s11606-015-3335-1.
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Keywords: Adverse Drug Events (ADE), Diabetes, Medication, Obesity
Tsai HT, Keating NL, Van Den Eeden SK
Risk of diabetes among patients receiving primary androgen deprivation therapy for clinically localized prostate cancer.
The researchers sought to determine if primary androgen deprivation therapy increases the risk of diabetes and to determine the susceptibility factors. They found that primary androgen deprivation therapy may increase diabetes risk by 60% and recommended using caution when managing localized prostate cancer. They further recommended routine screening and lifestyle interventions to reduce the risk of diabetes in men receiving androgen deprivation therapy.
AHRQ-funded; HS022915.
Citation: Tsai HT, Keating NL, Van Den Eeden SK .
Risk of diabetes among patients receiving primary androgen deprivation therapy for clinically localized prostate cancer.
J Urol 2015 Jun;193(6):1956-62. doi: 10.1016/j.juro.2014.12.027.
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Keywords: Adverse Drug Events (ADE), Diabetes, Medication, Cancer: Prostate Cancer, Risk
Camelo Castillo W, Boggess K, Sturmer T
Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes.
The purpose of this study was to estimate the risks of adverse pregnancy outcomes among women receiving glyburide compared with insulin for the treatment of gestational diabetes mellitus (GDM) in a US population-based cohort. It found an association between glyburide (compared with insulin) and elevated risk of NICU admission, neonatal hypoglycemia, respiratory distress, birth injury, and large for gestational age in women with GDM.
AHRQ-funded; HS017950.
Citation: Camelo Castillo W, Boggess K, Sturmer T .
Association of adverse pregnancy outcomes with glyburide vs insulin in women with gestational diabetes.
JAMA Pediatr 2015 May;169(5):452-8. doi: 10.1001/jamapediatrics.2015.74..
Keywords: Adverse Drug Events (ADE), Adverse Events, Comparative Effectiveness, Diabetes, Labor and Delivery, Maternal Care, Medication, Newborns/Infants, Outcomes, Pregnancy, Women