Table 3.
Incidence of AEs, SAEs and hypoglycaemic events in treatment groups (safety population).
| Patient | Vildagliptin 50 mg bid (N = 188) n (%) | Voglibose 0.2 mg tid (N = 192) n (%) |
|---|---|---|
| All AEs* | 115 (61.2) | 137 (71.4) |
| Specific AEs (occurring in >4% of any group) | ||
| Nasopharyngitis | 34 (18.1) | 32 (16.7) |
| Constipation | 13 (6.9) | 13 (6.8) |
| Flatulence | 6 (3.2) | 23 (12.0) |
| Abdominal distension | 4 (2.1) | 14 (7.3) |
| Diarrhoea | 3 (1.6) | 11 (5.7) |
| Alanine aminotransferase increased | 3 (1.6) | 11 (5.7) |
| Suspected drug-related AE† | 47 (25.0) | 78 (40.6) |
| Hypoglycaemia | 0 (0.0) | 1 (0.5) |
| SAEs | 0 (0.0) | 4 (2.1) |
| Discontinuations as a result of AE | 4 (2.1) | 4 (2.1) |
| Any GI event (detail below) | 35 (18.6)‡ | 63 (32.8) |
| Constipation | 13 (6.9) | 13 (6.8) |
| Flatulence | 6 (3.2) | 23 (12.0) |
| Dyspepsia | 5 (2.7) | 0 (0.0) |
| Abdominal distension | 4 (2.1) | 14 (7.3) |
| Abdominal pain upper | 3 (1.6) | 3 (1.6) |
| Diarrhoea | 3 (1.6) | 11 (5.7) |
| Stomach discomfort | 2 (1.1) | 1 (0.5) |
| Deaths | 0 (0.0) | 0 (0.0) |
AE, adverse event; GI, gastro intestinal; SAE, serious adverse events.
*
A subject with multiple occurrences of an adverse event was counted only once in the adverse event category. When a subject exhibited multiple occurrences of an adverse event in categories of different severity, the subject was counted in the category of worst severity.
†
Adverse events occurring in 4% of each group.
‡
p-Value 0.002.