Trial reportDiabetologia2011

Prognostic implications of glucose-lowering treatment in patients with acute myocardial infarction and diabetes: experiences from an extended follow-up of the Diabetes Mellitus Insulin-Glucose Infusion in Acute Myocardial Infarction (DIGAMI) 2 Study.

L G Mellbin, K Malmberg, A Norhammar, H Wedel, L Rydén, DIGAMI 2 Investigators

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2011. The graph read 4 numbers from its abstract, feeding 3 cells of the map, but none could be read as for or against, so it casts no vote. It also reports 3 associations that do not count as treatment evidence, such as HR 0.65 (0.47 to 0.90) for all-cause mortality. Cited by 43 papers, 4 of them syntheses that pooled it.

4numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
4.5field-weighted citation impact, top 4% 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.

Read, but not usablea number the graph found but could not read as for or against

All-cause mortalityan association or prognostic statement, not a treatment comparison · ascvd, t2dfeeds one cell of the map
HR 0.650.47 to 0.90p = 0.01
Metformin was associated with a lower mortality rate (HR 0.65, 95% CI 0.47-0.90; p = 0.01) and a lower risk of death from malignancies (HR 0.25, 95% CI 0.08-0.83; p = 0.02).
Adverse events & safetyan association or prognostic statement, not a treatment comparison · ascvd, t2dfeeds one cell of the map
HR 0.250.08 to 0.83p = 0.02
Metformin was associated with a lower mortality rate (HR 0.65, 95% CI 0.47-0.90; p = 0.01) and a lower risk of death from malignancies (HR 0.25, 95% CI 0.08-0.83; p = 0.02).
Cardiovascular eventsan association or prognostic statement, not a treatment comparison · ascvd, t2dfeeds one cell of the map
OR 1.300.93 to 1.81p = 0.13
Insulin treatment was associated with non-fatal cardiovascular events (OR 1.89 95% CI 1.35-2.63; p = 0.0002), but not with mortality (OR 1.30, 95% CI 0.93-1.81; p = 0.13).
Cardiovascular eventsan association or prognostic statement, not a treatment comparison · ascvd, t2dfeeds one cell of the map
OR 1.891.35 to 2.63p = 0.0002
Insulin treatment was associated with non-fatal cardiovascular events (OR 1.89 95% CI 1.35-2.63; p = 0.0002), but not with mortality (OR 1.30, 95% CI 0.93-1.81; p = 0.13).

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Insulin×cardiovascular events

No readable resultOpen on the map →What to test next →

1 readable study in this cell: 0 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.25no deciding trial · 0 families support, 0 contradict · head-to-head
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Metformin×all-cause mortality

No readable resultOpen on the map →What to test next →

1 readable study in this cell: 0 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.50one trial · 1 family supports, 0 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect
NCT000387272,779 enrolled · 1996
HR 0.990.79 to 1.25

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

Metformin×adverse events & safety

No readable resultOpen on the map →What to test next →

22 readable studies in this cell: 9 favour the treatment, 8 find no difference, 5 favour the comparator.

Belief with this paper
0.27contested · 4 families support, 11 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017190031,413 enrolled · 2012
Adjusted mean -0.72-0.95 to -0.48
NCT018093271,186 enrolled · 2013
Δ -0.40-0.59 to -0.21
NCT022730501,136 enrolled · 2014
Δ -8.90-13.3 to -4.50
NCT01126580807 enrolled · 2010
Δ -0.22-0.36 to -0.08
NCT01023581784 enrolled · 2009
Δ -0.67-0.96 to -0.37
NCT00386100688 enrolled · 2006
Δ 1.47-14.8 to 20.8
NCT01217073685 enrolled · 2010
Δ 1.00-9.80 to 13.1
NCT01890122647 enrolled · 2013
Δ -0.68-0.89 to -0.47
NCT00727857600 enrolled · 2007
Δ 0.860.51 to 1.22
NCT01958671461 enrolled · 2013
Δ -2.60-13.1 to 8.10
NCT00328172302 enrolled · 2006
Δ -0.85-1.10 to -0.59
NCT01485614200 enrolled · 2012
Δ 2.40-10.0 to 14.9

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
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  6. Two-year follow-up of 4 months metformin treatment vs. placebo in ST-elevation myocardial infarction: data from the GIPS-III RCT.Clinical research in cardiology : official journal of the German Cardiac Society · 2017
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  14. Review
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  18. Observational
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6 · The record

Corrections and comments

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

7 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

L G MellbinCardiology Unit, Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden. linda.mellbin@karolinska.se
K Malmberg
A Norhammar
H Wedel
L Rydén
DIGAMI 2 Investigators
Karolinska Institutet · SEKarolinska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aims/hypothesisThis post hoc analysis from the Diabetes Mellitus Insulin-Glucose Infusion in Acute Myocardial Infarction (DIGAMI) 2 trial reports on extended long-term outcome in relation to glucose-lowering agents in patients with myocardial infarction and type 2 diabetes.

methodsPatients were randomised as follows: group 1, insulin-based treatment; group 2, insulin during hospitalisation followed by conventional glucose control; and group 3, conventional treatment. Treatment according to the above protocol lasted 2.1 years. Using the total DIGAMI 2 cohort as an epidemiological database, this study presents mortality rates in the randomised groups, and mortality and morbidity rates by glucose-lowering treatment during an extended period of follow-up (median 4.1 and max 8.1 years).

resultsFollow-up data were available in 1,145 of the 1,253 patients. The mortality rate was 31% (72% cardiovascular) without significant differences between treatment groups. The total number of fatal malignancies was 37, with a trend towards a higher risk in group 1. The HR for death from malignant disease, compared with group 2, was 1.77 (95% CI 0.87-3.61; p = 0.11) and 3.60 (95% CI 1.24-10.50; p = 0.02) compared with group 3. Insulin treatment was associated with non-fatal cardiovascular events (OR 1.89 95% CI 1.35-2.63; p = 0.0002), but not with mortality (OR 1.30, 95% CI 0.93-1.81; p = 0.13). Metformin was associated with a lower mortality rate (HR 0.65, 95% CI 0.47-0.90; p = 0.01) and a lower risk of death from malignancies (HR 0.25, 95% CI 0.08-0.83; p = 0.02). CONCLUSIONS/

interpretationPatients with type 2 diabetes and myocardial infarction have a poor prognosis. Glucose-lowering drugs appear to be of prognostic importance. Insulin may be associated with an increased risk of non-fatal cardiac events, while metformin seems to be protective against risk of death.

Indexed as

AgedCardiovascular DiseasesComorbidityDiabetes Mellitus, Type 2FemaleFollow-Up StudiesHumansHypoglycemic AgentsInsulinLongitudinal StudiesMaleMetforminMiddle AgedMyocardial InfarctionNeoplasmsPrognosisHypoglycemic AgentsInsulinMetformin

Identifiers

PMID21359582
OpenAlexW2033900534

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

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 Socratic graph.