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Table 3 GRADE evidence profile of glucagon-like peptide-1 receptor agonists and risk of heart failure in type 2 diabetes

From: Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies

Quality assessment Summary of findings Quality of evidence
       Study event rates Relative risk (95 % CI) Anticipated absolute effects (5-year time frame)  
No of participants (studies)
Follow-up time
Risk of bias Inconsistency Indirectness Imprecision Publication bias With control With GLP-1 agonists Risk with control Risk difference with GLP-1 agonists (95 % CI)  
Heart failure
 11758
 (20)
 16-164 weeks
Serious limitation due to risk of biasa No serious limitations No serious limitations Serious limitation,
confidence interval includes important benefit and harm
Undetected 19/4317 (0.44 %) 17/7441 (0.23 %) OR 0.62
(0.31 to 1.22)
50 per 1000b 19 fewer per 1000 (34 fewer to 11 more)  ΟΟ
Low due to risk of bias and imprecision
Hospitalization for heart failure
 6068
 (1)
 2.1 years
No serious limitations No serious limitations No serious limitations Serious limitation,
confidence interval includes important benefit and harm
Undetected 127/3034
4.2 %
122/3034
4 %
HR 0.96
(0.75 to 1.23)
100 per 1000c 4 fewer per 1000 (25 fewer to 23 more) Ο
Moderate due to imprecision
  1. GLP-1 glucagon-like peptide-1
  2. aSeveral trials probably had risk of bias on random sequence generation, allocation concealment and blinding (Additional file 2), and the follow up (median of 52 weeks) was not long enough for heart failure to occur in patients with low risk of cardiovascular disease
  3. bBaseline risk estimate for heart failure in a 5-year time frame comes from the control arm of the cohort study we identified to best represent our target population (Kannan 2015 [17]), with 528 events of heart failure in 13,185 participants (4.0 %) at four year follow up across control and intervention arm
  4. cBaseline risk estimate for hospitalization for heart failure in 5-year time frame comes from the control arm of the only included ELIXA trial [16] we identified to best represent our target population with 127 events in 3034 participants (42 per 1000) over a 2.1 year follow up period, in the absence of observational studies providing more credible baseline risk estimates