TABLE 4

Adverse events by treatment assignment

EventPlaceboMetforminTroglitazoneILS
n582587585589
CHF0 (0.0)1 (0.2)0 (0.0)1 (0.2)
MI2 (0.3)0 (0.0)0 (0.0)2 (0.3)
Anemia7 (1.2)5 (0.9)7 (1.2)4 (0.7)
Edema31 (5.3)8 (1.4)27 (4.6)26 (4.4)
LFT ≥321 (3.6)18 (3.1)25 (4.3)NA
LFT ≥101 (0.2)0 (0.0)7 (1.2)NA
  • Data are n (%) of individuals in each randomization group experiencing at least one adverse event of the type specified. Liver function tests were not measured on the same schedule in the ILS group. CHF, congestive heart failure; MI, myocardial infarction; LFT ≥3, liver function test (either alanine aminotransferase or aspartate aminotransferase) ≥3 times the upper limit of normal; LFT ≥10, liver function test (either alanine aminotransferase or aspartate aminotransferase) ≥10 times the upper limit of normal; NA, not applicable.