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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.