Table 2

Risk of side effects over 5 years with thiazolidinediones and sulfonylureas in ADOPT and RECORD combined by sex- and obesity-defined subgroup

Side effectPatients (n)Events (n)Absolute 5-year risk (%)Hazard ratio (95% CI) P value
TZDSUTZDSUTZDSU(TZD vs. SU)
Nonobese males
 Edema (moderate/severe)607620134313.57 (1.16–10.94)0.03
 Fracture (all)6136232618741.59 (0.87–2.89)0.16
 Hypoglycemia (moderate/severe)61362314903160.15 (0.09–0.27)<0.001
Obese males
 Edema (moderate/severe)7407193716732.45 (1.34–4.47)<0.01
 Fracture (all)7637433028651.02 (0.61–1.71)0.94
 Hypoglycemia (moderate/severe)76374313702110.17 (0.09–0.31)<0.001
Nonobese females
 Edema (moderate/severe)340293135522.10 (0.75–5.89)0.16
 Fracture (all)3453013181433.15 (1.45–6.87)<0.01
 Hypoglycemia (moderate/severe)34530110444170.17 (0.09–0.35)<0.001
Obese females
 Edema (moderate/severe)74974660251052.16 (1.35–3.45)<0.01
 Fracture (all)78677377331462.14 (1.42–3.23)<0.001
 Hypoglycemia (moderate/severe)78677318833130.19 (0.11–0.31)<0.001
  • SU, sulfonylureas; TZD, thiazolidinediones.