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Table 3 Signal strength for DPP-4is at the PT level in FAERS

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

 

PTs

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

Diarrhoea

42

4.17 (3.04,5.71)*

245

2.15 (1.88,2.46)*

23

1.85 (1.22,2.81)*

20

3.84 (2.44,6.04)*

329

2.44 (2.16,2.75)*

 

Nausea

40

3.70 (2.68,5.11)*

327

2.82 (2.50,3.18)*

35

2.69 (1.91,3.79)*

14

2.47 (1.44,4.22)*

413

3.00 (2.69,3.34)*

 

Vomiting

15

2.02 (1.21,3.38)*

160

1.97 (1.67,2.32)*

12

1.36 (0.77,2.40)

14

3.77 (2.20,6.46)*

200

2.04 (1.75,2.37)*

 

Dyspepsia

10

5.54 (2.94,10.44)*

50

2.55 (1.89,3.44)*

7

3.24 (1.53,6.87)*

1

1.05 (0.15,7.49)

68

2.95 (2.27,3.85)*

Pancreas

Acute pancreatitis

26

11.80 (7.89,17.65)*

119

5.50 (4.46,6.78)*

8

2.87 (1.42,5.80)*

6

5.01 (2.22,11.29)*

159

6.66 (5.50,8.07)*

Malignancies

Pancreatic carcinoma

1

0.92 (0.13,6.58)

122

22.04 (16.77,28.97)*

4

3.18 (1.18,8.57)*

1

1.81 (0.25,12.97)

127

19.44 (14.76,25.60)*

Infection

Nasopharyngitis

8

5.97 (2.94,12.12)*

34

2.30 (1.61,3.30)*

4

2.48 (0.92,6.66)

1

1.42 (0.20,10.12)

47

2.70 (1.97,3.71)*

 

Pneumonia

6

1.47 (0.65,3.29)

85

1.90 (1.52,2.39)*

11

2.30 (1.26,4.19)*

10

4.92 (2.62,9.27)*

112

2.09 (1.71,2.56)*

 

Upper respiratory tract infection

6

8.52 (3.75,19.36)*

71

15.71 (11.32,21.80)*

1

1.15 (0.16,8.25)

0

–

78

15.30 (11.01,21.24)*

 

Urinary tract infection

5

1.79 (0.74,4.33)

62

2.04 (1.57,2.66)*

7

2.13 (1.01,4.51)*

6

4.27 (1.90,9.61)*

79

2.16 (1.70,2.75)*

Musculoskeletal

Arthralgia

13

3.46 (1.99,6.02)*

145

3.87 (3.22,4.64)*

10

2.23 (1.19,4.18)*

7

3.63 (1.71,7.71)*

173

3.88 (3.27,4.60)*

 

Pain in extremity

10

1.96 (1.05,3.68)*

113

2.04 (1.67,2.48)*

10

1.66 (0.89,3.11)

6

2.31 (1.03,5.20)*

138

2.05 (1.72,2.46)*

 

Myalgia

9

3.00 (1.55,5.82)*

133

4.64 (3.82,5.64)*

15

4.30 (2.56,7.21)*

3

1.93 (0.62,6.04)

159

4.71 (3.93,5.66)*

 

Fracture

0

–

9

1.22 (0.62,2.41)

0

–

1

3.04 (0.42,21.80)

10

1.10 (0.58,2.09)

Cardiac

Cardiac failure

5

1.00 (0.42,2.43)

43

0.74 (0.54,1.00)

9

1.54 (0.80,2.99)

5

1.99 (0.82,4.82)

61

0.86 (0.66,1.11)

 

Cardiac failure congestive

5

0.06 (0.02,0.14)

53

0.05 (0.04,0.06)

6

0.06 (0.03,0.13)

1

0.02 (0,0.16)

65

0.05 (0.04,0.06)

 

Myocardial infarction

3

0.02 (0.01,0.06)

122

0.06 (0.05,0.08)

14

0.08 (0.04,0.13)

10

0.13 (0.07,0.24)

149

0.06 (0.05,0.07)

Hypersensitivity and skin

Angioedema

20

27.80 (17.30,44.65)*

50

7.06 (5.06,9.86)*

5

5.21 (2.13,12.72)*

0

–

75

10.90 (8.01,14.83)*

 

Oedema peripheral

19

3.95 (2.49,6.26)*

124

2.36 (1.95,2.85)*

1

0.17 (0.02,1.20)

13

5.32 (3.05,9.30)*

156

2.47 (2.08,2.94)*

 

Pruritus

13

3.94 (2.26,6.86)*

138

4.26 (3.53,5.14)*

17

4.40 (2.70,7.16)*

4

2.33 (0.87,6.26)

171

4.52 (3.79,5.38)*

 

Rash

38

9.76 (6.99,13.64)*

240

6.63 (5.70,7.72)*

10

2.01 (1.07,3.76)*

6

2.80 (1.24,6.29)*

294

7.17 (6.21,8.28)*

 

Rash generalised

3

4.43 (1.41,13.96)*

42

7.27 (5.04,10.47)*

7

9.08 (4.23,19.49)*

0

–

52

8.09 (5.71,11.44)*

 

Urticaria

21

12.47 (7.97,19.51)*

74

4.20 (3.25,5.43)*

10

4.78 (2.54,6.90)*

0

–

104

5.31 (4.22,6.67)*

 

Pemphigoid

3

8.37 (2.63,26.64)*

9

2.25 (1.12,4.53)*

20

63.72 (37.92,107.09)*

16

112.37 (63.87,197.70)*

47

23.33 (14.44,37.68)*

General disorders

Asthenia

8

1.36 (0.67,2.73)

111

1.71 (1.40,2.08)*

26

3.87 (2.61,5.75)*

4

1.33 (0.49,3.56)

148

1.89 (1.59,2.25)*

 

Dizziness

15

1.75 (1.05,2.93)*

224

2.48 (2.15,2.86)*

25

2.51 (1.68,3.75)*

5

1.13 (0.47,2.74)

269

2.46 (2.16,2.81)*

 

Fatigue

14

1.92 (1.13,3.27)*

141

1.74 (1.46,2.08)*

15

1.74 (1.04,2.91)*

5

1.33 (0.55,3.22)

175

1.78 (1.52,2.09)*

 

Headache

19

2.87 (1.81,4.54)*

286

4.51 (3.95,5.15)*

22

2.82 (1.84,4.32)*

2

0.57 (0.14,2.30)

329

4.33 (3.82,4.91)*

 

Malaise

14

2.26 (1.33,3.86)*

130

1.91 (1.59,2.29)*

13

1.77 (1.02,3.07)*

23

7.73 (5.04,11.84)*

180

2.22 (1.90,2.61)*

 

Pain

18

2.18 (1.36,3.49)*

122

1.29 (1.07,1.55)*

13

1.32 (0.76,2.28)

1

0.23 (0.03,1.64)

154

1.33 (1.13,1.57)*

  1. FAERS FDA Adverse Event Reporting System
  2. Dpp-4is Dipeptidyl peptidase-4 inhibitors
  3. N The number of adverse events reports
  4. ROR The reporting odds ratio
  5. CI The confidence interval
  6. PTs Preferred Terms
  7. *: signal detected, see “Methods” for the criteria of detection
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