Table 5.
Adverse events reported in prospective studies of lobeglitazone
| Variable | Monotherapy (24 weeks) [41] |
Monotherapy-extension (52 weeks)a [42] |
Add-on to metformin (24 weeks) [43] |
|||
|---|---|---|---|---|---|---|
| Lobeglitazone (n=112) | Placebo (n=58) | Maintenance group (n=64) | Switch group (n=29) | Lobeglitazone (n=128) | Pioglitazone (n=125) | |
| Any AE | 55 (49.1) | 30 (51.7) | 41 (64.1) | 18 (62.1) | 66 (51.6) | 64 (51.2) |
| Drug-related AE | 10 (8.9) | 3 (5.2) | 8 (12.5) | 2 (6.9) | 8 (6.3) | 6 (4.8) |
| Serious AE | 4 (3.6) | 0 | 3 (4.7) | 0 | 7 (5.5) | 6 (4.8) |
| Frequent AE | ||||||
| Hyperglycemia | 3 (2.7) | 4 (6.9) | 3 (4.7) | 0 | <3%b | <3%b |
| Nasopharyngitis | 6 (5.4) | 0 | 3 (4.7) | 0 | 6 (4.7) | 10 (8.0) |
| URTI | 2 (1.7) | 3 (5.2) | 8 (12.5) | 1 (3.5) | 2 (1.6) | 4 (3.2) |
| Peripheral edema | 4 (3.6) | 0 | 2 (3.1) | 0 (0) | 5 (3.9) | 2 (1.6) |
| Headache | 3 (2.7) | 2 (3.5) | 3 (4.7) | 1 (3.5) | <3%b | <3%b |
| Hematuria | 3 (2.7) | 3 (5.2) | 3 (4.7) | 2 (6.9) | 0 | 0 |
| AE of special interest | ||||||
| Hypoglycemia | 0 | 0 | 0 | 0 | 1 (0.8) | 3 (2.4) |
| Heart failure | 0 | 0 | 0 | 0 | <3%b | <3%b |
| Ischemic heart disease | 0 | 0 | 0 | 0 | <3%b | <3%b |
| Neoplasm | 1c (0.9) | 0 | 1c (1.6) | 0 | 0 | 1d (0.8) |
Values are presented as number (%).
AE, adverse event; URTI, upper respiratory tract infection.
a
Maintenance group received lobeglitazone for weeks 0–52. Switch group received placebo for weeks 0–24 and lobeglitazone for weeks 25–52,
b
Exact number of cases not presented in the published article,
c
Lung cancer, not considered to be related to lobeglitazone by investigators,
d
Colon cancer, not considered to be related to pioglitazone by investigators.