TABLE 3.
Summary of adverse events through 52 weeks in the <70 and ≥70 year subgroups
| Age group | <70 years | ≥70 years | |||||
|---|---|---|---|---|---|---|---|
| Variable, n (%) |
DU 1.5 mg (N = 543) |
DU 3.0 mg (N = 562) |
DU 4.5 mg (N = 561) |
DU 1.5 mg (N = 69) |
DU 3.0 mg (N = 54) |
DU 4.5 mg (N = 53) |
Interaction P value |
| Composite incidence of nausea, vomiting and diarrhoea | 107 (19.7) | 142 (25.3) | 157 (28.0) | 21 (30.4) | 12 (22.2) | 14 (26.4) | .171 |
| Nausea | 69 (12.7) | 91 (16.2) | 98 (17.5) | 18 (26.1) | 8 (14.8) | 8 (15.1) | .054 |
| Vomiting | 34 (6.3) | 49 (8.7) | 52 (9.3) | 5 (7.2) | 7 (13.0) | 10 (18.9) | .580 |
| Diarrhoea | 41 (7.6) | 69 (12.3) | 69 (12.3) | 6 (8.7) | 5 (9.3) | 2 (3.8) | .277 |
| Dyspepsia | 15 (2.8) | 26 (4.6) | 17 (3.0) | 2 (2.9) | 5 (9.3) | 0 (0) | .375 |
| Nasopharyngitis | 24 (4.4) | 27(4.8) | 36 (6.4) | 4 (5.8) | 5 (9.3) | 2 (3.8) | .402 |
| TEAEs related to supraventricular arrythmias, conduction disorders and adjudicated CV events | 29 (5.3) | 28 (5.0) | 28 (5.0) | 5 (7.2) | 6 (11.1) | 5 (9.4) | .730 |
| Overall discontinuation of study drug | 64 (11.8) | 84 (14.9) | 85 (15.2) | 15 (21.7) | 9 (16.7) | 9 (17.0) | .382 |
| Discontinuation of study drug because of an AE | 27 (5.0) | 36 (6.4) | 46 (8.2) | 10 (14.5) | 7 (13.0) | 6 (11.3) | .421 |
| Nausea | 5 (0.9) | 6 (1.1) | 9 (1.6) | 3 (4.3) | 2 (3.7) | 0 (0) | .379 |
| Diarrhoea | 1 (0.2) | 5 (0.9) | 6 (1.1) | 0 (0) | 1 (1.9) | 0 (0) | .762 |
| Vomiting | 0 (0) | 2 (0.4) | 8 (1.4) | 0 (0) | 3 (5.6) | 0 (0) | .166 |
| Overall serious adverse events | 44 (8.1) | 40 (7.1) | 32 (5.7) | 7 (10.1) | 2 (3.7) | 6 (11.3) | .282 |
| Hypoglycaemia incidences | |||||||
| Total a | 34 (6.3) | 28 (5.0) | 32 (5.7) | 9 (13.0) | 5 (9.3) | 5 (9.4) | .917 |
| Documented symptomatic (≤70 mg/dL) | 18 (3.3) | 14 (2.5) | 18 (3.2) | 1 (1.5) | 1 (1.9) | 1 (1.9) | .878 |
Note: Data presented as n (%).
Abbreviations: AE, adverse event; CV, cardiovascular; DU, dulaglutide; n, sample size; N, population size; TEAEs, treatment‐emergent adverse events.
a
Total hypoglycaemic incidences = any episode with plasma glucose level below the defined threshold (≤70 mg/dL), regardless of symptoms, an episode of symptomatic hypoglycaemia where plasma glucose level was not measured and all severe hypoglycaemia episodes.