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Table 3 Temporal association between severe hypoglycemia and subsequent risk of experiencing hHF in DEVOTE and LEADER

From: Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14

Time window (days after each severe hypoglycemic event)DEVOTE (SMQ definition)LEADER (SMQ definition)LEADER (EAC confirmed)
DegludecGlargine U100Main analysisSensitivity analysisaLiraglutidePlaceboMain analysisSensitivity analysisaLiraglutidePlaceboMain analysisSensitivity analysisa
NENEHRbp-valueHRbp-valueNENEHRbp-valueHRbp-valueNENEHRbp-valueHRbp-value
0–end trial17310238182.20.00021.70.01191068136173.0< 0.00012.3< 0.00011085141173.2< 0.00012.40.0001
0–71731238211.1< 0.00019.8< 0.00011061136332.7< 0.000123.1< 0.000110801412N/AN/A
8–end trial17310238181.60.03581.30.25071068136172.3<0.00011.70.01091085141173.3< 0.00012.4< 0.0001
  1. Total number of patients experiencing severe hypoglycaemia: DEVOTE, degludec n = 187, glargine U100 n = 252 [38]; LEADER, liraglutide n = 114, placebo n = 153 [46]
  2. For events occurring on the same day as a hypoglycemic event, 0.5 days were added to the day of the event
  3. CV cardiovascular, E number of events, EAC Event Adjudication Committee; eGFR estimated glomerular filtration rate, glargine U100 insulin glargine 100 units/mL, hHF hospitalization for heart failure, HR hazard ratio, N number of patients, N/A analysis did not converge, SMQ standardized Medical Dictionary for Regulatory Activities Query
  4. aAdjusted for sex, region, age, eGFR, smoking status, diabetes duration, CV risk, and whether or not the patients were insulin naïve
  5. bhHF with prior severe hypoglycemia in window versus hHF without severe hypoglycemia in window