Evidence map›Paper›PMID 20532476›Full record

Trial reportDiabetologia2010

Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials.

P D Home, S E Kahn, N P Jones, D Noronha, H Beck-Nielsen, G Viberti, ADOPT Study Group, RECORD Steering Committee

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetologia, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01195259. Cited by 85 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 26 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT01195259 completed

A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.

Ran2009Enrolled1Registered outcomes1Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsallocation of treatment with metformin or rosiglitazone
Open the trial in the graph
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 26 syntheses or guidelines pooled it, 177 citations in OpenAlex.

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  3. The effect of metformin on gastric cancer in patients with type 2 diabetes: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020 · on this map
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  4. Metformin and colorectal cancer: a systematic review, meta-analysis and meta-regression.International journal of colorectal disease · 2020 · on this map
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  5. Metformin monotherapy for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2020 · on this map
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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 4 countries.

P D HomeICM - Diabetes, The Medical School, Newcastle University, Newcastle upon Tyne, UK. philip.home@newcastle.ac.uk
S E Kahn
N P Jones
D Noronha
H Beck-Nielsen
G Viberti
ADOPT Study Group
RECORD Steering Committee
GlaxoSmithKline (India) · INGlaxoSmithKline (United Kingdom) · GBKing's College London · GBNewcastle University · GBOdense University Hospital · DKVA Puget Sound Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisObservational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes. We extracted data for malignancies from the ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) randomised controlled clinical trials, in which the efficacy and/or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone.

methodsNeoplasm occurrences were collected as adverse events in these studies. We reviewed and re-analysed the individual participant data in both studies for serious adverse events, malignancies reported as adverse events and related neoplasms of special interest.

resultsIn ADOPT, 50 participants (3.4%) on metformin and 55 (3.8%) on each of rosiglitazone and glibenclamide (known as glyburide in the USA and Canada) developed serious adverse event malignancies (excluding non-melanoma skin cancers). This corresponds to 1.03, 1.12 and 1.31 per 100 person-years, giving hazard ratios for metformin of 0.92 (95% CI 0.63-1.35) vs rosiglitazone and 0.78 (0.53-1.14) vs glibenclamide. In RECORD, on a background of sulfonylurea, 69 (6.1%) participants developed malignant neoplasms in the metformin group, compared with 56 (5.1%) in the rosiglitazone group (HR 1.22 [0.86-1.74]). On a background of metformin, 74 (6.7%) participants in the sulfonylurea group developed malignant neoplasms, compared with 57 (5.1%) in the rosiglitazone group (HR 1.33 [0.94-1.88]). CONCLUSIONS/

interpretationThe malignancy rates in these two randomised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone. However, they do not refute the possibility of a difference compared with sulfonylureas.

Indexed as

Diabetes Mellitus, Type 2HumansHypoglycemic AgentsMetforminNeoplasmsRosiglitazoneSulfonylurea CompoundsThiazolidinedionesThiazolidinesTreatment OutcomeHypoglycemic AgentsMetforminRosiglitazoneSulfonylurea CompoundsThiazolidinedionesThiazolidinesthiazoline-2-thione

Identifiers

PMID20532476
PMCPMC2910882
OpenAlexW2126978426

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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.