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Table 6 Clinical adverse experiences occurring at an incidence rate ≥1% in any group

From: Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis

Adverse Experience

Sitagliptin 100 mg

n (%)

(N = 3415)

Non-Exposed

n (%)

(N = 2724)

Difference between Sitagliptin

and Non-Exposed,

% (95% CI)*

Vertigo

24 (0.7)

27 (1.0)

-0.3 (-0.8, 0.2)

Abdominal Pain

39 (1.1)

33 (1.2)

-0.1 (-0.6, 0.5)

Abdominal Pain Upper

59 (1.7)

33 (1.2)

0.5 (-0.1, 1.1)

Constipation

79 (2.3)

47 (1.7)

0.6 (-0.1, 1.3)

Diarrhea

170 (5.0)

144 (5.3)

-0.3 (-1.4, 0.8)

Dyspepsia

70 (2.0)

40 (1.5)

0.6 (-0.1, 1.2)

Gastritis

36 (1.1)

30 (1.1)

-0.0 (-0.6, 0.5)

Nausea

85 (2.5)

70 (2.6)

-0.1 (-0.9, 0.7)

Toothache

35 (1.0)

33 (1.2)

-0.2 (-0.8, 0.3)

Vomiting

51 (1.5)

34 (1.2)

0.2 (-0.4, 0.8)

Fatigue

56 (1.6)

53 (1.9)

-0.3 (-1.0, 0.4)

Peripheral Edema

62 (1.8)

54 (2.0)

-0.2 (-0.9, 0.5)

Bronchitis

135 (4.0)

83 (3.0)

0.9 (-0.0, 1.8)

Cellulitis

28 (0.8)

26 (1.0)

-0.1 (-0.6, 0.3)

Gastroenteritis

68 (2.0)

48 (1.8)

0.2 (-0.5, 0.9)

Gastroenteritis Viral

29 (0.8)

27 (1.0)

-0.1 (-0.7, 0.3)

Influenza

145 (4.2)

127 (4.7)

-0.4 (-1.5, 0.6)

Nasopharyngitis

244 (7.1)

162 (5.9)

1.2 (-0.1, 2.4)

Pharyngitis

52 (1.5)

35 (1.3)

0.2 (-0.4, 0.8)

Sinusitis

80 (2.3)

60 (2.2)

0.1 (-0.6, 0.9)

Upper Respiratory Tract Infection

265 (7.8)

228 (8.4)

-0.6 (-2.0, 0.8)

Urinary Tract Infection

134 (3.9)

100 (3.7)

0.3 (-0.7, 1.2)

Viral Infection

36 (1.1)

21 (0.8)

0.3 (-0.2, 0.8)

Blood Glucose Decreased

13 (0.4)

28 (1.0)

-0.6 (-1.1, -0.2)

Blood Glucose Increased

42 (1.2)

51 (1.9)

-0.6 (-1.3, -0.0)

Hyperglycemia

34 (1.0)

39 (1.4)

-0.4 (-1.0, 0.1)

Hypoglycemia†

117 (3.4)

296 (10.9)

-7.4 (-8.8, -6.1)

Arthralgia

113 (3.3)

92 (3.4)

-0.1 (-1.0, 0.8)

Back Pain

142 (4.2)

108 (4.0)

0.2 (-0.8, 1.2)

Muscle Spasms

38 (1.1)

35 (1.3)

-0.2 (-0.8, 0.4)

Musculoskeletal Pain

54 (1.6)

40 (1.5)

0.1 (-0.5, 0.7)

Myalgia

38 (1.1)

29 (1.1)

0.0 (-0.5, 0.6)

Neck Pain

23 (0.7)

26 (1.0)

-0.3 (-0.8, 0.2)

Osteoarthritis

58 (1.7)

24 (0.9)

0.8 (0.2, 1.4)

Pain in Extremity

84 (2.5)

53 (1.9)

0.5 (-0.2, 1.2)

Dizziness

86 (2.5)

63 (2.3)

0.2 (-0.6, 1.0)

Headache

169 (4.9)

129 (4.7)

0.2 (-0.9, 1.3)

Hypoesthesia

24 (0.7)

31 (1.1)

-0.4 (-1.0, 0.0)

Anxiety

32 (0.9)

27 (1.0)

-0.1 (-0.6, 0.4)

Depression

40 (1.2)

29 (1.1)

0.1 (-0.4, 0.6)

Insomnia

44 (1.3)

35 (1.3)

0.0 (-0.6, 0.6)

Cough

88 (2.6)

73 (2.7)

-0.1 (-0.9, 0.7)

Pharyngolaryngeal Pain

44 (1.3)

34 (1.2)

0.0 (-0.5, 0.6)

Rash

35 (1.0)

24 (0.9)

0.1 (-0.4, 0.6)

Hypertension

110 (3.2)

89 (3.3)

-0.0 (-1.0, 0.8)

  1. CI = confidence interval; *Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. "0.0" and "-0.0" represent rounding for values that are slightly greater and slightly less than zero, respectively.
  2. †Includes studies in which a sulfonylurea was an active comparator or a background agent.