Table 2.
Summary of adverse events over 24 weeks (treated set)
| Patients (%) | Linagliptin/metformin (n = 62) | Linagliptin (n = 63) |
|---|---|---|
| Any adverse event | 71.0 | 63.5 |
| Drug‐related adverse event | 9.7 | 4.8 |
| Serious adverse event | 1.6 | 1.6 |
| Death | 0.0 | 0.0 |
| Requiring hospitalization | 1.6 | 1.6 |
| Adverse event leading to discontinuation | 0.0 | 1.6 |
| Adverse events of special interest† | ||
| Hepatic adverse events | 3.2 | 4.8 |
| Hypersensitivity reactions | 1.6 | 3.2 |
| Gastrointestinal disorders‡ | 12.9 | 12.7 |
| Adverse events with an incidence >5.0% in either group§ | ||
| Dyslipidemia | 17.7 | 30.2 |
| Urinary tract infection | 9.7 | 12.7 |
| Headache | 6.5 | 4.8 |
| Hypoglycemia¶ | 6.5 | 4.8 |
| Back pain | 6.5 | 3.2 |
| Hypertension | 6.5 | 0.0 |
| Upper respiratory tract infection | 4.8 | 7.9 |
| Hyperglycemia | 3.2 | 12.7 |
†Pancreatitis, renal adverse event, hepatic adverse event, hypersensitivity reaction or severe cutaneous reaction. ‡System organ class from the Medical Dictionary for Regulatory Activities, version 16.0 (MedDRA). §Preferred terms from MedDRA. ¶Includes asymptomatic hypoglycemia, which was not reported as an adverse event; the incidence of symptomatic hypoglycemia alone was 1.6% with linagliptin/metformin and 4.8% with linagliptin.