SynthesisBMC cardiovascular disorders2014

The risk of heart failure associated with the use of noninsulin blood glucose-lowering drugs: systematic review and meta-analysis of published observational studies.

Cristina Varas-Lorenzo, Andrea V Margulis, Manel Pladevall, Nuria Riera-Guardia, Brian Calingaert, Lorna Hazell, Silvana Romio, Susana Perez-Gutthann

Open access · goldFull text readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BMC cardiovascular disorders, 2014. The graph read 7 numbers from its abstract, feeding 7 cells of the map: it favours the comparator in 3. Cited by 25 papers, 3 of them syntheses that pooled it.

7numbers the graph read from it
3cells of the map it votes in
25citing papers in PubMed, 3 pooled it
6.4field-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.

← favours the treatmentfavours the comparator →
241 · no effect
Cardiovascular eventsfavours the comparator · against placebo · t2d, heart_failurefeeds 3 cells of the map
RR 2.231.41 to 3.53
For example, because at Maccabi Healthcare Services rosiglitazone could be prescribed only if there was an inadequate control of blood glucose with sulfonylurea, metformin, or both, the heart failure effect estimate for rosiglitazone versus metformin monotherapy in the study by Loebstein et al. [40] (relative risk, 2.23; 95% CI, 1.41-3.53) might be overestimated.

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

Cardiovascular eventscomparator not stated · t2d, heart_failurefeeds 2 cells of the map
RR 1.221.02 to 1.46
Only 2 studies were restricted to new users, yielding a summary relative risk of 1.22 (95% CI, 1.02-1.46) (Table 3 and Additional file 1: Figure S3e) [38, 41].Table 3 Risk of heart failure in sulfonylurea users compared with metformin users, overall and subgroup analyses Relative risk (95% confidence interval)Subgroup analysesStudy Author, YearOverallCohort studiesMonotherapy a Incident heart failureNew usersNew or prevalent users Individual Studies Koro [39]0.96 (0.78, 1.19)-0.96 (0.78, 1.19)0.96 (0.78, 1.19)-0.96 (0.78, 1.19)McAlister [41]1.16 (0.96, 1.41)1.16 (0.96, 1.41)1.16 (0.96, 1.41)1.16 (0.96, 1.41)1.16 (0.96, 1.41)-Horsdal [35]1.23 (0.78, 1.96)1.23 (0.78, 1.96)1.23 (0.78, 1.96)--1.23 (0.78, 1.96)Tzoulaki [42]1.21 (1.13, 1.30)1.21 (1.13, 1.30)1.21 (1.13, 1.30)1.21 (1.13, 1.30)-1.21 (1.13, 1.30)Karter [38]1.43 (1.01, 2.04)1.43 (1.01, 2.04)-1.43 (1.01, 2.04)1.43 (1.01, 2.04)- Meta-Analysis Fixed-effects, RR1.19 (1.12, 1.26)1.21 (1.14, 1.29)1.18 (1.11, 1.26)1.19 (1.12, 1.26)1.22 (1.03, 1.44)1.18 (1.11, 1.27)Random effects, RR1.17 (1.06, 1.29)1.21 (1.14, 1.29)1.15 (1.04, 1.28)1.16 (1.03, 1.31)1.22 (1.02, 1.46)1.13 (0.95, 1.33)Heterogeneity statisticsτ2 = 0.00τ2 = 0.00τ2 = 0.00
Cardiovascular eventscomparator not stated · t2d, heart_failurefeeds one cell of the map
HR 1.381.20 to 1.60
Monotherapy sulfonylurea users exposed to high doses (defined as higher than the median daily dose for each individual medication) were more likely to develop heart failure than those using lower doses (hazard ratio, 1.38; 95% CI, 1.20-1.60) [41].
Cardiovascular eventscomparator not stated · t2d, heart_failurefeeds 2 cells of the map
RR 1.220.86 to 1.74
The only study evaluating the risk of heart failure in rosiglitazone users compared with sulfonylureas users reported a relative risk of 1.22 (95% CI, 0.86-1.74) [36].
Cardiovascular eventscomparator not stated · t2d, heart_failurefeeds 2 cells of the map
RR 1.140.86 to 1.50
Two of these studies evaluated the risk of heart failure in pioglitazone users compared with metformin users, yielding a summary relative risk of 1.14 (95% CI, 0.86-1.50); we included these studies in the overall forest plot for completeness [36, 42].
Glycemic controlcomparator not stated · t2d, heart_failurefeeds 3 cells of the map
lowering -1.36-1.59 to -1.17
Based on 3 studies, the summary relative risk for rosiglitazone, as monotherapy or in combination with other blood glucose-lowering agents, versus metformin was 1.36 (95% CI, 1.17-1.59) [36, 40, 42] (Figure 2).
Adverse events & safetycomparator not stated · t2d, heart_failurefeeds one cell of the map
RR 1.211.03 to 1.42
In that study, stratified results suggested that, among patients without a prior history of heart failure, new users of rosiglitazone had a greater risk of heart failure hospitalization than new users of pioglitazone (relative risk, 1.21; 95% CI, 1.03-1.42), and patients with prior heart failure did not experience increased risk (relative risk, 1.04; 95% CI, 0.89-1.22).Table 2 Risk of heart failure in Rosiglitazone users compared with Pioglitazone users, overall and subgroup analyses Relative risk (95% Confidence interval)Subgroup analysesStudy (Author, Year)All usersNew usersNew users, Aged ≥ 65 years Individual Studies Chou [33]0.82 (0.62-1.09)--Graham [34]1.25 (1.16-1.34)1.25 (1.16-1.34)1.25 (1.16-1.34)Juurlink [37]1.30 (1.16-1.46)1.30 (1.16-1.46)1.30 (1.16-1.46)Wertz [43]1.12 (0.94-1.33)1.12 (0.94-1.33)-Winkelmayer [44]1.13 (1.01-1.26)1.13 (1.01-1.26)1.13 (1.01-1.26) Meta-Analysis Fixed effects, RR1.20 (1.15-1.27)1.22 (1.16-1.28)1.23 (1.17-1.30)Random effects, RR1.16 (1.05-1.28)1.21 (1.14-1.30)1.23 (1.14-1.32)Heterogeneity statisticsτ2 = 0.01τ2 = 0.00τ2 = 0.00 χ 2 = 11.81 (df = 4) χ 2 = 4.35 (df = 3) χ 2 = 3.33 (df = 2) I 2 = 66% I 2 = 31% I 2 = 40%Df = degrees of freedom; RR =

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.

Metformin×cardiovascular events

ContradictsOpen on the map →What to test next →

5 readable studies in this cell: 4 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.50contested · 4 families support, 2 contradict · against placebo
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.

Sulfonylureas & glinides×cardiovascular events

ContradictsOpen on the map →What to test next →

3 readable studies in this cell: 2 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.96replicated · 2 families support, 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

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

Thiazolidinediones×cardiovascular events

ContradictsOpen on the map →What to test next →

2 readable studies in this cell: 0 favour the treatment, 2 find no difference, 0 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
1 · no effect
HR 1.080.89 to 1.31

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

Metformin×glycemic control

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

40 readable studies in this cell: 41 favour the treatment, 13 find no difference, 7 favour the comparator.

Belief with this paper
0.84replicated · 32 families support, 6 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 -0.89-1.08 to -0.69
NCT008598981,093 enrolled · 2009
Δ -0.53-0.74 to -0.32
Δ -0.85-43.8 to 26.7
NCT00643851994 enrolled · 2008
Δ -0.86-1.11 to -0.62
NCT01708902876 enrolled · 2012
Δ -1.00-1.23 to -0.78
NCT00676338820 enrolled · 2008
Δ -0.05-0.26 to 0.17
NCT01126580807 enrolled · 2010
Δ -0.22-0.36 to -0.08
NCT01023581784 enrolled · 2009
Δ -0.67-0.96 to -0.37
NCT01076088744 enrolled · 2010
Δ -0.84-1.15 to -0.52
NCT00386100688 enrolled · 2006
Δ -0.49-0.67 to -0.30

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

Other glucose-lowering×glycemic control

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

8 readable studies in this cell: 5 favour the treatment, 0 find no difference, 3 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017093055,570 enrolled · 2012
Δ 0.190.02 to 0.36
NCT050350821,018 enrolled · 2021
Δ -0.24-0.44 to -0.04
placebo-subtracted decrease -0.44

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

Thiazolidinediones×glycemic control

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

16 readable studies in this cell: 9 favour the treatment, 4 find no difference, 3 favour the comparator.

Belief with this paper
0.83established · 5 families support, 1 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT00676338820 enrolled · 2008
Δ 0.10-0.15 to 0.35
NCT00839527685 enrolled · 2009
Δ 0.250.10 to 0.40
NCT00727857600 enrolled · 2007
Δ 0.840.50 to 1.18
NCT01076075427 enrolled · 2010
Δ -0.68-0.87 to -0.50
NCT00770653305 enrolled · 2007
Δ 0.16-0.02 to 0.33
NCT0158944577 enrolled · 2008
Δ -0.74-7.90 to 8.00
NCT0031865623 enrolled · 2005
Δ 5.02-0.32 to 10.4

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

Thiazolidinediones×adverse events & safety

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

6 readable studies in this cell: 3 favour the treatment, 2 find no difference, 1 favour the comparator.

Belief with this paper
0.00contested · 0 families support, 2 contradict · against placebo
Without itNot a counted family in this claim, so removing it changes nothing.
← favours the comparatorfavours the treatment →
0 · no effect
NCT00839527685 enrolled · 2009
Δ 0.250.10 to 0.40
NCT00727857600 enrolled · 2007
Δ 0.840.50 to 1.18
NCT00770653305 enrolled · 2007
Δ 28.1-95.6 to 152
NCT0158944577 enrolled · 2008
Δ -0.64-4.40 to 2.40

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

25 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Comparative safety of sulfonylureas among U.S. nursing home residents.Journal of the American Geriatrics Society · 2023
    Article
  9. Observational
  10. Evaluation of pancreatic regeneration activity ofJournal of traditional and complementary medicine · 2021
    Article
  11. Evaluation of Antidiabetic Activity of the Leaf Latex ofEvidence-based complementary and alternative medicine : eCAM · 2020
    Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Cardiovascular effects of anti-diabetes drugs.Expert opinion on drug safety · 2016
    Review
  18. Review
  19. Review
  20. Article
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

8 authors at 3 institutions in 4 countries.

Cristina Varas-LorenzoRTI Health Solutions, Trav, Gracia 56 Atico 1 08006, Barcelona, Spain. cvaras@rti.org.
Andrea V Margulis
Manel Pladevall
Nuria Riera-Guardia
Brian Calingaert
Lorna Hazell
Silvana Romio
Susana Perez-Gutthann
Drug Safety Research Unit · GBErasmus MC · NLRTI Health Solutions · US

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.

backgroundPatients with type 2 diabetes mellitus (T2DM) are at high risk of heart failure. A summary of the effects of blood glucose-lowering drugs other than glitazones on the risk of heart failure in routine clinical practice is lacking. The objective of this study was to conduct a systematic review and meta-analysis of observational studies on the risk of heart failure when using blood glucose-lowering drugs.

methodsWe systematically identified and reviewed cohort and case-control studies in which the main exposure of interest was noninsulin blood glucose-lowering medications in patients with T2DM. We searched Medline, Embase, and the Cochrane Library to identify publications meeting prespecified eligibility criteria. The quality of included studies was assessed with the Newcastle-Ottawa Scale and the RTI item bank. Results were combined using fixed and random-effects models when at least 3 independent data points were available for a drug-drug comparison.

resultsThe summary relative risk of heart failure in rosiglitazone users versus pioglitazone users (95% CI) was 1.16 (1.05-1.28) (5 cohort studies). Heterogeneity was present (I2 = 66%). For new users (n = 4) the summary relative risk was 1.21 (1.14-1.30) and the heterogeneity was reduced (I2 = 31%);. The summary relative risk for rosiglitazone versus metformin was 1.36 (95% CI, 1.17-1.59) (n = 3). The summary relative risk (95% CI) of heart failure in sulfonylureas users versus metformin users was 1.17 (95% CI, 1.06-1.29) (5 cohort studies; I2 = 24%) and 1.22 (1.02-1.46) when restricted to new users (2 studies).Information on other comparisons was very scarce. Information on dose and duration of treatment effects was lacking for most comparisons. Few studies accounted for disease severity; therefore, confounding by indication might be present in the majority of the within-study comparisons of this meta-analysis.

conclusionsUse of glitazones and sulfonylureas was associated with an increased risk of heart failure compared with metformin use. However, indication bias cannot be ruled out. Ongoing large multidatabase studies will help to evaluate the risk of heart failure in treated patients with diabetes, including those using newer blood glucose-lowering therapies.

Indexed as

BiasBiomarkersBlood GlucoseChi-Square DistributionDiabetes Mellitus, Type 2Heart FailureHumansHypoglycemic AgentsMetforminOdds RatioRisk AssessmentRisk FactorsSulfonylurea CompoundsThiazolidinedionesBiomarkersBlood GlucoseHypoglycemic AgentsMetforminSulfonylurea CompoundsThiazolidinediones

Identifiers

PMID25260374
PMCPMC4246471
OpenAlexW2131809420

What Socratic holds

Textfull text, public
LicenceCC BY
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.