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Table 4 The signal value per preferred term of GERD-like symptoms of GLP-1-RAs and DPP-4-Is

From: Signals of gastroesophageal reflux disease caused by incretin-based drugs: a disproportionality analysis using the Japanese adverse drug event report database

AE

GLP-1-RAs (n1+ = 429)

DPP-4-Is (n1+ = 3276)

 

n11

n + 1

ROR (95%CI)

IC (95%CI)

n11

n + 1

ROR (95%CI)

IC (95%CI)

Vomiting

23

344

6.73* (4.36–10.39)

2.32* (1.69–2.94)

12

344

0.39 (0.22–0.70)

−1.21 (−2.03 – −0.39)

Nausea

17

310

5.37* (3.26–8.85)

2.02* (1.31–2.73)

9

310

0.32 (0.17–0.63)

−1.44 (− 2.37 – − 0.52)

Impaired gastric emptying

1

3

44.93* (4.07–496.40)

0.94 (− 1.57–3.44)

0

3

Oesophageal ulcer

1

18

5.28(0.70–39.79)

0.72 (− 1.42–2.87)

0

18

Gastrooesophageal reflux disease

1

24

3.90 (0.53–28.98)

0.65 (− 1.48–2.77)

6

18

3.63* (1.44–9.15)

1.17 (− 0.06–2.41)

Dysphagia

1

28

3.33 (0.45–24.53)

0.60 (−1.52–2.71)

5

28

2.37 (0.90–6.23)

0.80 (−0.49–2.10)

Abdominal distension

1

33

2.81 (0.38–20.58)

0.54 (− 1.56–2.64)

1

33

0.34 (0.05–2.49)

−0.95 (−3.05–1.15)

Erosive oesophagitis

0

25

1

25

0.45 (0.06–3.35)

− 0.67 (− 2.79–1.44)

Dyspepsia

0

45

1

45

0.25 (0.03–1.79)

−1.29(− 3.37–0.80)

  1. AE adverse event, GERD gastroesophageal reflux disease, GLP-1-RAs glucagon-like peptide-1 receptor agonists, DDP-4-Is dipeptidyl peptidase-4 inhibitors, n11 the number of target drug induced GERD-like symptoms, n1+ the number of target drug induced all adverse events, n + 1 the number of all drug induced target adverse events, ROR reporting odds ratio, IC information component
  2. * signal detection