Table 4A.
Adverse events in older and younger patients with type 2 diabetes mellitus from five pooled studies of saxagliptin vs placebo as monotherapy and as add-on therapy18–21,24
| Age ≥ 65 years
|
Age < 65 years
|
|||||
|---|---|---|---|---|---|---|
| SAXA 2.5 mg n = 149 | SAXA 5 mg n = 142 | PBO n = 137 | SAXA 2.5 mg n = 733 | SAXA 5 mg n = 740 | PBO n = 662 | |
| Summary of AEs (including hypoglycemia), n (%) | ||||||
| ≥1 AE | 107 (71.8) | 101 (71.1) | 111 (81.0) | 528 (72.0) | 536 (72.4) | 453 (68.4) |
| ≥1 treatment-related AE | 25 (16.8) | 30 (21.1) | 27 (19.7) | 130 (17.7) | 135 (18.2) | 107 (16.2) |
| ≥1 SAE | 8 (5.4) | 4 (2.8) | 7 (5.1) | 23 (3.1) | 26 (3.5) | 20 (3.0) |
| ≥1 treatment-related SAE | 0 | 0 | 0 | 2 (0.3) | 1 (0.1) | 1 (0.2) |
| Discontinuations due to AEs | 4 (2.7) | 6 (4.2) | 3 (2.2) | 15 (2.0) | 23 (3.1) | 11 (1.7) |
| Discontinuations due to SAEs | 0 | 1 (0.7) | 1 (0.7) | 5 (0.7) | 1 (0.1) | 4 (0.6) |
| Deaths | 1 (0.7) | 0 | 0 | 1 (0.1) | 0 | 2 (0.3) |
| AEsa (excluding hypoglycemia) occurring in ≥5% of patients in any treatment group, n (%) | ||||||
| Urinary tract infection | 8 (5.4) | 8 (5.6) | 8 (5.8) | 37 (5.0) | 52 (7.0) | 41 (6.2) |
| Nasopharyngitis | 7 (4.7) | 7 (4.9) | 10 (7.3) | 43 (5.9) | 42 (5.7) | 44 (6.6) |
| Upper respiratory tract infection | 7 (4.7) | 6 (4.2) | 10 (7.3) | 55 (7.5) | 62 (8.4) | 51 (7.7) |
| Influenza | 5 (3.4) | 4 (2.8) | 11 (8.0) | 29 (4.0) | 26 (3.5) | 24 (3.6) |
| Bronchitis | 5 (3.4) | 2 (1.4) | 7 (5.1) | 19 (2.6) | 17 (2.3) | 7 (1.1) |
| Back pain | 2 (1.3) | 11 (7.7) | 6 (4.4) | 31 (4.2) | 27 (3.6) | 35 (5.3) |
| Arthralgia | 9 (6.0) | 6 (4.2) | 5 (3.6) | 25 (3.4) | 26 (3.5) | 19 (2.9) |
| Pain in extremity | 3 (2.0) | 3 (2.1) | 7 (5.1) | 26 (3.5) | 24 (3.2) | 26 (3.9) |
| Diarrhea | 9 (6.0) | 6 (4.2) | 10 (7.3) | 44 (6.0) | 30 (4.1) | 39 (5.9) |
| Headache | 9 (6.0) | 5 (3.5) | 9 (6.6) | 48 (6.5) | 52 (7.0) | 38 (5.7) |
| Dizziness | 5 (3.4) | 4 (2.8) | 10 (7.3) | 11 (1.5) | 17 (2.3) | 19 (2.9) |
| Hypertension | 6 (4.0) | 10 (7.0) | 4 (2.9) | 31 (4.2) | 25 (3.4) | 24 (3.6) |
| Cough | 5 (3.4) | 3 (2.1) | 11 (8.0) | 30 (4.1) | 21 (2.8) | 25 (3.8) |
| Hypoglycemia, n (%) | ||||||
| Reportedb | 14 (9.4) | 9 (6.3) | 11 (8.0) | 53 (7.2) | 60 (8.1) | 43 (6.5) |
| Confirmedc | 1 (0.7) | 0 | 1 (0.7) | 6 (0.8) | 4 (0.5) | 2 (0.3) |
| Hypoglycemia excluding study of saxagliptin add-on to glyburide, n (%) | n = 106 | n = 100 | n = 85 | n = 528 | n = 529 | n = 447 |
| Reportedb | 8 (7.5) | 4 (4.0) | 5 (5.9) | 23 (4.4) | 26 (4.9) | 17 (3.8) |
| Confirmedc | 0 | 0 | 0 | 2 (0.4) | 0 | 1 (0.2) |
Notes:
a
Presented by preferred term in order of system order class, in the subgroup ≥ 65 years of age;
b
signs or symptoms of hypoglycemia, with or without documented blood glucose levels;
c
finger stick glucose ≤ 50 mg/dL, with associated symptoms.
Abbreviations: AEs, adverse events; PBO, placebo; SAEs, serious AEs; SAXA, saxagliptin.