Table 2.
The top 20 most frequently reproted SMQs of DPP-4is
| SMQs | Saxagliptin | Sitagliptin | Linagliptin | Vildagliptin | DPP-4is | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| N | ROR(95% CI) | N | ROR(95% CI) | N | ROR(95% CI) | N | ROR(95% CI) | N | ROR(95% CI) | ||
| Gastrointestinal nonspecific inflammation and dysfunctional conditions | 114 | 4.27 (3.48,5.23)* | 948 | 3.23 (3.00,3.48)* | 86 | 2.53 (2.02,3.17)* | 37 | 2.50 (1.78,3.52)* | 1180 | 3.39 (3.17,3.63)* | |
| Hypersensitivity | 113 | 8.04 (6.55,9.87)* | 732 | 4.91 (4.51,5.35)* | 68 | 3.68 (2.86,4.73)* | 22 | 2.66 (1.73,4.10)* | 932 | 5.47 (5.05,5.91)* | |
| Acute pancreatitis | 79 | 11.27 (8.87,14.33)* | 738 | 14.99 (13.54,16.58)* | 42 | 4.62 (3.37,6.33)* | 7 | 1.69 (0.80,3.58) | 862 | 16.32 (14.76,18.04)* | |
| Haemodynamic oedema, effusions and fluid overload | 40 | 2.26 (1.64,3.11)* | 329 | 1.64 (1.46,1.84)* | 23 | 1.06 (0.70,1.61) | 21 | 2.32 (1.49,3.61)* | 411 | 1.68 (1.52,1.87)* | |
| Malignancies | 21 | 1.97 (1.27,3.05)* | 346 | 3.22 (2.86,3.62)* | 34 | 2.76 (1.95,3.90)* | 9 | 1.64 (0.85,3.19) | 405 | 3.12 (2.79,3.48)* | |
| Noninfectious diarrhoea | 44 | 4.28 (3.15,5.83)* | 250 | 2.15 (1.88,2.46)* | 28 | 2.22 (1.52,3.25)* | 20 | 3.75 (2.38,5.91)* | 341 | 2.48 (2.20,2.79)* | |
| Angioedema | 52 | 10.82 (8.10,14.46)* | 254 | 5.21 (4.52,6.01)* | 30 | 4.96 (3.43,7.19)* | 3 | 1.09 (0.35,3.40) | 337 | 6.20 (5.44,7.07)* | |
| Embolic and thrombotic events | 10 | 0.05 (0.03,0.09) | 180 | 0.07 (0.06,0.09) | 30 | 0.13 (0.09,0.19) | 19 | 0.20 (0.12,0.31) | 239 | 0.08 (0.07,0.09) | |
| Hepatic disorders | 15 | 3.53 (2.11,5.92)* | 148 | 3.40 (2.85,4.07)* | 8 | 1.56 (0.78,3.15) | 10 | 4.63 (2.46,8.72)* | 179 | 3.45 (2.92,4.08)* | |
| Cardiac failure | 11 | 0.11 (0.06,0.21) | 122 | 0.10 (0.09,0.12) | 23 | 0.20 (0.13,0.31) | 12 | 0.25 (0.14,0.44) | 167 | 0.11 (0.10,0.13) | |
| Hypertension | 15 | 1.21 (0.73,2.02) | 118 | 0.81 (0.68,0.98) | 6 | 0.40 (0.18,0.90) | 27 | 4.57 (3.08,6.78)* | 166 | 0.94 (0.80,1.10) | |
| Chronic kidney disease | 7 | 0.67 (0.32,1.41) | 137 | 1.16 (0.98,1.39) | 12 | 0.98 (0.55,1.74) | 7 | 1.33 (0.63,2.82) | 162 | 1.12 (0.95,1.31) | |
| Arthritis | 6 | 1.93 (0.86,4.34) | 79 | 2.39 (1.88,3.03)* | 10 | 2.76 (1.47,5.17)* | 3 | 1.89 (0.60,5.90) | 97 | 2.43 (1.96,3.03)* | |
| Gastrointestinal perforation, ulceration, haemorrhage or obstruction | 6 | 1.60 (0.71,3.59) | 66 | 1.58 (1.23,2.04)* | 11 | 2.52 (1.38,4.58)* | 7 | 3.72 (1.75,7.89)* | 90 | 1.79 (1.44,2.24)* | |
| Dyslipidaemia | 8 | 1.38 (0.68,2.78) | 70 | 1.05 (0.82,1.34) | 2 | 0.29 (0.07,1.15) | 3 | 1.01 (0.32,3.15) | 82 | 1.00 (0.79,1.25) | |
| Severe cutaneous adverse reactions | 6 | 4.84 (2.14,10.91)* | 62 | 5.34 (4.01,7.13)* | 8 | 5.51 (2.72,11.19)* | 4 | 6.30 (2.33,17.01)* | 80 | 6.12 (4.69,8.00)* | |
| Depression and suicide/self-injury | 9 | 1.74 (0.90,3.37) | 60 | 1.00 (0.77,1.30) | 6 | 0.97 (0.44,2.18) | 5 | 1.89 (0.78,4.59) | 80 | 1.09 (0.87,1.37) | |
| Retinal disorders | 4 | 1.29 (0.48,3.45) | 34 | 0.95 (0.67,1.34) | 7 | 1.92 (0.91,4.07) | 3 | 1.90 (0.61,5.93) | 46 | 1.05 (0.78,1.42) | |
| Taste and smell disorders | 0 | – | 37 | 2.82 (1.99,4.00)* | 2 | 1.34 (0.33,5.40) | 4 | 6.32 (2.34,17.08)* | 43 | 2.70 (1.94,3.76)* | |
| Anaphylactic reaction | 11 | 7.23 (3.94,13.26)* | 25 | 1.40 (0.93,2.11) | 3 | 1.61 (0.51,5.02) | 3 | 3.74 (1.20,11.73)* | 39 | 2.01 (1.45,2.78)* | |
Dpp-4is Dipeptidyl peptidase-4 inhibitors
N The number of adverse events reports
ROR The reporting odds ratio
CI The confidence interval
SMQs Standardized MedDRA queries
*: signal detected, see “Methods” for the criteria of detection