Table 2.
Safety endpoints
| Outcome | Pioglitazone, mean (95% CI) | Placebo, mean (95% CI) | Mean difference (95% CI) between periods | P-value |
|---|---|---|---|---|
| BIA (Ω), increase = decrease in total body water | 45.78 (39.19–52.36) | 44.17 (37.96–50.39) | 1.60 (0.24–2.96) | 0.024 |
| Episodes of congestive heart failure, echocardiography or visit to doctor for shortness of breath, n | 0 | 0 | – | – |
| Episodes of edema that were sustained or refractory to diuretics, n | 0 | 0 | – | – |
| Hypoglycemia <70 mg/dL ( patients and episodes), n | One patienta with three episodes | One patient with four episodes | – | – |
| Elevated ALT or AST >2 times the upper limit of normal (patients and episodes), n | One patient with one episode | 0 | – | – |
a
The same patient had episodes in both arms, occurring at nearly every visit with fasting. Glucometer at home confirmed >70 in non-fasting state. All episodes asymptomatic.