Table 3.
Incidence of adverse drug reactions of special interest and adverse events related to cardiovascular disorders and malignant tumours
| < 65 years (n = 4596) | ≥ 65 to < 75 years (n = 3371) | ≥ 75 years (n = 2729) | |
|---|---|---|---|
| All ADRs | 154 (3.35%) | 149 (4.42%) | 109 (3.99%) |
| Serious ADRs | 30 (0.65%) | 41 (1.22%) | 46 (1.69%) |
| ADRs/AEs of special interest | |||
| Hypoglycaemia-related events | |||
| All ADRs | 11 (0.24%) | 19 (0.56%) | 8 (0.29%) |
| Per 100 patient-years | 0.10 | 0.23 | 0.13 |
| IRR (95% CI) | 1 | 2.27 (1.08–4.77) | 1.25 (0.50–3.10) |
| Serious | 2 (0.04%) | 3 (0.09%) | 3 (0.11%) |
| Skin and subcutaneous disorder-related events | |||
| All ADRs | 15 (0.33%) | 15 (0.44%) | 14 (0.51%) |
| Per 100 patient-years | 0.14 | 0.18 | 0.22 |
| IRR (95% CI) | 1 | 1.31 (0.64–2.69) | 1.60 (0.77–3.32) |
| Serious | 1 (0.02%) | 1 (0.03%) | 4 (0.15%) |
| Pemphigoid | 1 (0.02%) | 0 | 4 (0.15%) |
| Gastrointestinal disorder-related events | |||
| All ADRs | 25 (0.54%) | 32 (0.95%) | 16 (0.59%) |
| Per 100 patient-years | 0.23 | 0.39 | 0.25 |
| IRR (95% CI) | 1 | 1.68 (1.00–2.84) | 1.10 (0.59–2.06) |
| Serious | 3 (0.07%) | 4 (0.12%) | 5 (0.18%) |
| Pancreatitis | 0 | 1 (0.03%) | 0 |
| Intestinal obstruction (ileus) | 0 | 2 (0.06%) | 2 (0.07%) |
| Hepatic impairment-related events | |||
| All ADRs | 25 (0.54%) | 13 (0.39%) | 9 (0.33%) |
| Per 100 patient-years | 0.23 | 0.16 | 0.14 |
| IRR (95% CI) | 1 | 0.68 (0.35–1.33) | 0.62 (0.29–1.32) |
| Serious | 3 (0.07%) | 0 (0%) | 1 (0.04%) |
| Renal impairment-related events | |||
| All ADRs | 16 (0.35%) | 13 (0.39%) | 5 (0.18%) |
| Per 100 patient-years | 0.15 | 0.16 | 0.08 |
| IRR (95% CI) | 1 | 1.07 (0.51–2.22) | 0.54 (0.20–1.46) |
| Serious | 4 (0.09%) | 1 (0.03%) | 2 (0.07%) |
| Cardiovascular events | |||
| All AEs | 14 (0.30%) | 29 (0.86%) | 42 (1.54%) |
| Per 100 patient-years | 0.13 | 0.35 | 0.66 |
| IRR (95% CI) | 1 | 2.73 (1.44–5.17) | 5.16 (2.82–9.45) |
| All ADRs | 4 (0.09%) | 7 (0.21%) | 7 (0.26%) |
| Per 100 patient-years | 0.04 | 0.08 | 0.11 |
| IRR (95% CI) | 1 | 2.30 (0.67–7.86) | 3.00 (0.88–10.26) |
| Serious AEs | 11 (0.24%) | 25 (0.74%) | 40 (1.47%) |
| Serious ADRs | 1 (0.02%) | 6 (0.18%) | 7 (0.26%) |
| Malignant tumours* | |||
| All AEs | 22 (0.48%) | 48 (1.42%) | 41 (1.50%) |
| Per 100 patient-years | 0.20 | 0.58 | 0.65 |
| IRR (95% CI) | 1 | 2.88 (1.74–4.77) | 3.21 (1.91–5.39) |
| All ADRs | 8 (0.17%) | 9 (0.27%) | 10 (0.37%) |
| Per 100 patient-years | 0.07 | 0.11 | 0.16 |
| IRR (95% CI) | 1 | 1.48 (0.57–3.83) | 2.15 (0.85–5.44) |
| Pancreatic carcinoma, AE | 1 (0.02%) | 6 (0.18%) | 8 (0.29%) |
| Pancreatic carcinoma, ADR | 1 (0.02%) | 3 (0.09%) | 1 (0.04%) |
| Dizziness | |||
| All ADRs | 2 (0.04%) | 5 (0.15%) | 4 (0.15%) |
| Serious | 0 | 0 | 0 |
ADRs were defined as AEs for which a causal relationship with teneligliptin could not be excluded (i.e. causal or unknown)
Values are n (%) of patients, incidence rate per 100 patient-years, or incidence rate ratio (95% CI) versus the < 65-year-old subgroup
ADR adverse drug reaction, IRR incidence rate ratio, CI confidence interval, AE adverse event
*All tumours were classified as serious