Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone

Graham, David J.; Ouellet‐Hellstrom, Rita; MaCurdy, Thomas; Ali, Faridah; Sholley, Christopher; Worrall, Chris; Kelman, Jeffrey A.

doi:10.1001/jama.2010.920

Cited by 458 publications

(327 citation statements)

References 35 publications

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“…This trend followed the widely-publicized 2007 U.S. Food and Drug Administration Boxed Warning that cautioned against cardiovascular adverse events including myocardial infarction with the thiazolidinedione rosiglitazone, plus concerns about increased heart failure risk with both rosiglitazone and pioglitazone. [18][19][20][21][22] Similar shifts in prescribing for other classes of medications have been observed when the FDA issued boxed warnings that were widely disseminated among physicians. 23 .…”

Section: Discussionmentioning

confidence: 62%

National Trends in Treatment Initiation for Nursing Home Residents With Diabetes Mellitus, 2008 to 2010

Zullo

Dore

Daiello

et al. 2016

Journal of the American Medical Directors Association

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Objective-Diabetes mellitus is common in the nursing home (NH) population, yet little is known is known about prescribing of glucose-lowering medications in the NH setting. We describe trends in initiation of glucose-lowering medications in a national cohort of NH residents.Design and Setting-Retrospective cohort study using Part A and D claims for a random 20% of Medicare enrollees linked to NH Minimum Data Set (MDS) and Online Survey, Certification, And Reporting (OSCAR) databases in 7,158 U.S. NHs.Correspondence, Andrew R. Zullo, PharmD, ScM, Department of Health Services, Policy, and Practice, Brown University School of Public Health, 121 South Main Street, Box G-S121-2, Providence, RI 02912, Phone: 401-863-3172, andrew_zullo@brown.edu. Alternate Correspondence, Robert J. Smith, MD, Department of Health Services, Policy, and Practice, Brown University School of Public Health, 121 South Main Street, Box G-S121-6, Providence, RI 02912, Phone: 401-444-3420, robert_j_smith@brown.edu. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Measurements-Medicare Part D drug dispensings of glucose-lowering treatments; resident and facility characteristics preceding medication initiation. HHS Public AccessResults-We observed decreasing sulfonylurea initiation from 25.4% of initiations in 2008 to 11.7% in 2010, an average decrease of 1% per quarter (95% CLs: −1.5, −0.5). Thiazolidinedione initiation decreased from 4.7% to 1.9%, an average decrease of 0.3% per quarter (95% CLs: −0.4, −0.2), and meglitinide initiation from 1.5% to 0.3%. No appreciable linear trends were observed for metformin (range 12-18.8%) and dipeptidyl peptidase-4 (DPP-4) inhibitors (range 0.9-2.7%). In contrast, insulin use increased from 51.7% to 68.3% during the same time period, driven by a marked increase in initiation of rapid-acting insulin (11% to 29.4%; average increase of 1.4% per quarter, 95% CLs: 0.9, 1.9) and a modest increase in short-acting insulin (22.6% to 30.3%; an average increase of 0.6% per quarter, 95% CLs: −0.1, 1.3).Conclusions-Between 2008 and 2010 there were substantial decreases in the use of oral glucose-lowering agents and corresponding increases in the use of insulin among long-term residents of U.S. nursing homes.

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Section: Discussionmentioning

confidence: 62%

National Trends in Treatment Initiation for Nursing Home Residents With Diabetes Mellitus, 2008 to 2010

Zullo

Dore

Daiello

et al. 2016

Journal of the American Medical Directors Association

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“…59 Pharmacological manipulations of the molecular receptors involved in the pathways of hepatic fibrosis are promising areas of investigation, but studies to date have demonstrated discrepancies between animal and human experiences 127,130,134 and serious toxicities in some instances. 138,139 These early experiences have indicated a need for safer interventions with more precise targeting, greater understanding of the alternative fibrotic pathways that may circumvent site-specific interventions and more insight into the disease specificity of each treatment. The extracellular matrix is another therapeutic target, especially at early stages of formation before extensive cross-linkage of collagen fibrils.…”

Section: -111mentioning

confidence: 99%

Review article: the prevention and reversal of hepatic fibrosis in autoimmune hepatitis

Czaja

2014

Aliment Pharmacol Ther

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SummaryBackgroundImmunosuppressive treatment of autoimmune hepatitis can prevent or reverse hepatic fibrosis, but these anti‐fibrotic effects are inconsistent secondary gains.AimTo describe the anti‐fibrotic effects of current therapies for autoimmune hepatitis, discuss the pathogenic mechanisms of hepatic fibrosis that might be targeted by anti‐fibrotic interventions, indicate the non‐invasive diagnostic tests of hepatic fibrosis that must be validated in autoimmune hepatitis and to suggest promising treatment opportunities.MethodsStudies cited in PubMed from 1972 to 2013 for autoimmune hepatitis, hepatic fibrosis, cirrhosis, anti‐fibrotic therapy and non‐invasive tests of hepatic fibrosis were selected.ResultsHepatic fibrosis improves in 53–57% of corticosteroid‐treated patients with autoimmune hepatitis; progressive fibrosis slows or is prevented in 79%; and cirrhosis may be reversed. Progressive hepatic fibrosis is associated with liver inflammation, and the inability to fully suppress inflammatory activity within 12 months is associated with progression to cirrhosis (54%) and death or need for liver transplantation (15%). Liver tissue examination remains the gold standard for assessing hepatic fibrosis, but laboratory and radiological tests may be useful non‐invasive methods to measure the fibrotic response. Severe liver inflammation can confound radiological assessments, and the preferred non‐invasive test in autoimmune hepatitis is uncertain. Individualised treatment adjustments and adjunctive anti‐fibrotic therapies are poised for study in this disease.ConclusionsThe prevention and reversal of hepatic fibrosis are achievable objectives in autoimmune hepatitis. Strategies that evaluate individualised therapies adjusted to the rapidity and completeness of the inflammatory response, and the use of adjunctive anti‐fibrotic interventions, must be evaluated.

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“…A recent observational, retrospective, inception cohort of 227,571 Medicare patients who were treated with rosiglitazone or pioglitazone for a 12-month period and followed for up to 3 years after initiation of therapy showed rosiglitazone was associated with a higher risk of cardiovascular complications and all-cause mortality in patients 65 years or older compared with pioglitazone. 176 Rosiglitazone is currently restricted by the FDA to patients already benefiting from rosiglitazone or patients who cannot be controlled with other medications and are unwilling to use pioglitazone (http://www. fda.gov/Drugs/DrugSafety/ucm255005.htm; accession date: September 21, 2011).…”

Section: Emerging Therapeutic Agents For Diabetic Nephropathy Thiazolmentioning

confidence: 99%

Therapeutic Modalities in Diabetic Nephropathy: Standard and Emerging Approaches

et al. 2011

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Diabetes mellitus is the leading cause of end stage renal disease and is responsible for more than 40% of all cases in the United States. Current therapy directed at delaying the progression of diabetic nephropathy includes intensive glycemic and optimal blood pressure control, proteinuria/albuminuria reduction, interruption of the renin-angiotensin-aldosterone system through the use of angiotensin converting enzyme inhibitors and angiotensin type-1 receptor blockers, along with dietary modification and cholesterol lowering agents. However, the renal protection provided by these therapeutic modalities is incomplete. More effective approaches are urgently needed. This review highlights the available standard therapeutic approaches to manage progressive diabetic nephropathy, including markers for early diagnosis of diabetic nephropathy. Furthermore, we will discuss emerging strategies such as PPAR-gamma agonists, Endothelin blockers, vitamin D activation and inflammation modulation. Finally, we will summarize the recommendations of these interventions for the primary care practitioner.

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Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone

Abstract: Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older.

Cited by 458 publications

References 35 publications

National Trends in Treatment Initiation for Nursing Home Residents With Diabetes Mellitus, 2008 to 2010

National Trends in Treatment Initiation for Nursing Home Residents With Diabetes Mellitus, 2008 to 2010

Review article: the prevention and reversal of hepatic fibrosis in autoimmune hepatitis

Therapeutic Modalities in Diabetic Nephropathy: Standard and Emerging Approaches

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