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Table 2 The top 20 most frequently reproted SMQs of DPP-4is

From: Adverse event profiles of dipeptidyl peptidase-4 inhibitors: data mining of the public version of the FDA adverse event reporting system

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)*

  1. Dpp-4is Dipeptidyl peptidase-4 inhibitors
  2. N The number of adverse events reports
  3. ROR The reporting odds ratio
  4. CI The confidence interval
  5. SMQs Standardized MedDRA queries
  6. *: signal detected, see “Methods” for the criteria of detection
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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