Evidence map›Paper›PMID 20584880›Full record

ArticleJAMA2010

Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone.

David J Graham, Rita Ouellet-Hellstrom, Thomas E MaCurdy, Farzana Ali, Christopher Sholley, Christopher Worrall, Jeffrey A Kelman

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in JAMA, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02491333 (The Effect of Acupuncture on Insulin Sensitivity of Women With Polycystic Ovary Syndrome and Insulin Resistance), which is not on this map. Cited by 216 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 13 pooled it
46.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02491333 phase3completedstarted 2015, after this paper: background citation

The Effect of Acupuncture on Insulin Sensitivity of Women With Polycystic Ovary Syndrome and Insulin Resistance: a Randomized Controlled Trial

Ran2015Enrolled342Registered outcomes12Posted comparisons0ConditionsInsulin Resistance, Polycystic Ovary SyndromeArmsMetformin, placebo metformin, sham acupuncture, true acupuncture
PMID 21950959PMID 18364705PMID 12243370PMID 11602624PMID 9165656PMID 21121941PMID 21672000PMID 21281021PMID 20590731PMID 20543992PMID 20471009PMID 19542239other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

216 citing papers in PubMed, 13 syntheses or guidelines pooled it, 508 citations in OpenAlex.

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156 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

David J GrahamOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Room 4314, Silver Spring, MD 20993-0002, USA. david.graham1@fda.hhs.gov
Rita Ouellet-Hellstrom
Thomas E MaCurdy
Farzana Ali
Christopher Sholley
Christopher Worrall
Jeffrey A Kelman
Center for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextStudies have suggested that the use of rosiglitazone may be associated with an increased risk of serious cardiovascular events compared with other treatments for type 2 diabetes.

objectiveTo determine if the risk of serious cardiovascular harm is increased by rosiglitazone compared with pioglitazone, the other thiazolidinedione marketed in the United States. DESIGN, SETTING, AND PATIENTS: Nationwide, observational, retrospective, inception cohort of 227,571 Medicare beneficiaries aged 65 years or older (mean age, 74.4 years) who initiated treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006-June 2009 and who underwent follow-up for up to 3 years after thiazolidinedione initiation.

main outcome measuresIndividual end points of acute myocardial infarction (AMI), stroke, heart failure, and all-cause mortality (death), and composite end point of AMI, stroke, heart failure, or death, assessed using incidence rates by thiazolidinedione, attributable risk, number needed to harm, Kaplan-Meier plots of time to event, and Cox proportional hazard ratios for time to event, adjusted for potential confounding factors, with pioglitazone as reference.

resultsA total of 8667 end points were observed during the study period. The adjusted hazard ratio for rosiglitazone compared with pioglitazone was 1.06 (95% confidence interval [CI], 0.96-1.18) for AMI; 1.27 (95% CI, 1.12-1.45) for stroke; 1.25 (95% CI, 1.16-1.34) for heart failure; 1.14 (95% CI, 1.05-1.24) for death; and 1.18 (95% CI, 1.12-1.23) for the composite of AMI, stroke, heart failure, or death. The attributable risk for this composite end point was 1.68 (95% CI, 1.27-2.08) excess events per 100 person-years of treatment with rosiglitazone compared with pioglitazone. The corresponding number needed to harm was 60 (95% CI, 48-79) treated for 1 year.

conclusionCompared 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.

Indexed as

AgedAged, 80 and overCohort StudiesDiabetes Mellitus, Type 2FemaleHeart FailureHumansHypoglycemic AgentsIncidenceMaleMedicare Part DMyocardial InfarctionPioglitazoneRetrospective StudiesRiskRosiglitazoneHypoglycemic AgentsPioglitazoneRosiglitazoneThiazolidinediones

Identifiers

PMID20584880
OpenAlexW1998418707

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.