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Clinical adverse experiences occurring at an incidence rate ≥1% in any group |
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| Adverse Experience |
Sitagliptin 100 mg n (%) (N = 3415) |
Non-Exposed n (%) (N = 2724) |
Difference between Sitagliptin and Non-Exposed, % (95% CI)* |
|
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| Vertigo |
24 (0.7) |
27 (1.0) |
-0.3 (-0.8, 0.2) |
|
|
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| Abdominal Pain |
39 (1.1) |
33 (1.2) |
-0.1 (-0.6, 0.5) |
|
|
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| Abdominal Pain Upper |
59 (1.7) |
33 (1.2) |
0.5 (-0.1, 1.1) |
|
|
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| Constipation |
79 (2.3) |
47 (1.7) |
0.6 (-0.1, 1.3) |
|
|
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| Diarrhea |
170 (5.0) |
144 (5.3) |
-0.3 (-1.4, 0.8) |
|
|
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| Dyspepsia |
70 (2.0) |
40 (1.5) |
0.6 (-0.1, 1.2) |
|
|
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| Gastritis |
36 (1.1) |
30 (1.1) |
-0.0 (-0.6, 0.5) |
|
|
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| Nausea |
85 (2.5) |
70 (2.6) |
-0.1 (-0.9, 0.7) |
|
|
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| Toothache |
35 (1.0) |
33 (1.2) |
-0.2 (-0.8, 0.3) |
|
|
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| Vomiting |
51 (1.5) |
34 (1.2) |
0.2 (-0.4, 0.8) |
|
|
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| Fatigue |
56 (1.6) |
53 (1.9) |
-0.3 (-1.0, 0.4) |
|
|
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| Peripheral Edema |
62 (1.8) |
54 (2.0) |
-0.2 (-0.9, 0.5) |
|
|
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| Bronchitis |
135 (4.0) |
83 (3.0) |
0.9 (-0.0, 1.8) |
|
|
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| Cellulitis |
28 (0.8) |
26 (1.0) |
-0.1 (-0.6, 0.3) |
|
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| Gastroenteritis |
68 (2.0) |
48 (1.8) |
0.2 (-0.5, 0.9) |
|
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| Gastroenteritis Viral |
29 (0.8) |
27 (1.0) |
-0.1 (-0.7, 0.3) |
|
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| Influenza |
145 (4.2) |
127 (4.7) |
-0.4 (-1.5, 0.6) |
|
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| Nasopharyngitis |
244 (7.1) |
162 (5.9) |
1.2 (-0.1, 2.4) |
|
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| Pharyngitis |
52 (1.5) |
35 (1.3) |
0.2 (-0.4, 0.8) |
|
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| Sinusitis |
80 (2.3) |
60 (2.2) |
0.1 (-0.6, 0.9) |
|
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| Upper Respiratory Tract Infection |
265 (7.8) |
228 (8.4) |
-0.6 (-2.0, 0.8) |
|
|
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| Urinary Tract Infection |
134 (3.9) |
100 (3.7) |
0.3 (-0.7, 1.2) |
|
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| Viral Infection |
36 (1.1) |
21 (0.8) |
0.3 (-0.2, 0.8) |
|
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| Blood Glucose Decreased |
13 (0.4) |
28 (1.0) |
-0.6 (-1.1, -0.2) |
|
|
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| Blood Glucose Increased |
42 (1.2) |
51 (1.9) |
-0.6 (-1.3, -0.0) |
|
|
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| Hyperglycemia |
34 (1.0) |
39 (1.4) |
-0.4 (-1.0, 0.1) |
|
|
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| Hypoglycemia† |
117 (3.4) |
296 (10.9) |
-7.4 (-8.8, -6.1) |
|
|
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| Arthralgia |
113 (3.3) |
92 (3.4) |
-0.1 (-1.0, 0.8) |
|
|
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| Back Pain |
142 (4.2) |
108 (4.0) |
0.2 (-0.8, 1.2) |
|
|
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| Muscle Spasms |
38 (1.1) |
35 (1.3) |
-0.2 (-0.8, 0.4) |
|
|
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| Musculoskeletal Pain |
54 (1.6) |
40 (1.5) |
0.1 (-0.5, 0.7) |
|
|
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| Myalgia |
38 (1.1) |
29 (1.1) |
0.0 (-0.5, 0.6) |
|
|
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| Neck Pain |
23 (0.7) |
26 (1.0) |
-0.3 (-0.8, 0.2) |
|
|
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| Osteoarthritis |
58 (1.7) |
24 (0.9) |
0.8 (0.2, 1.4) |
|
|
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| Pain in Extremity |
84 (2.5) |
53 (1.9) |
0.5 (-0.2, 1.2) |
|
|
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| Dizziness |
86 (2.5) |
63 (2.3) |
0.2 (-0.6, 1.0) |
|
|
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| Headache |
169 (4.9) |
129 (4.7) |
0.2 (-0.9, 1.3) |
|
|
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| Hypoesthesia |
24 (0.7) |
31 (1.1) |
-0.4 (-1.0, 0.0) |
|
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| Anxiety |
32 (0.9) |
27 (1.0) |
-0.1 (-0.6, 0.4) |
|
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| Depression |
40 (1.2) |
29 (1.1) |
0.1 (-0.4, 0.6) |
|
|
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| Insomnia |
44 (1.3) |
35 (1.3) |
0.0 (-0.6, 0.6) |
|
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| Cough |
88 (2.6) |
73 (2.7) |
-0.1 (-0.9, 0.7) |
|
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| Pharyngolaryngeal Pain |
44 (1.3) |
34 (1.2) |
0.0 (-0.5, 0.6) |
|
|
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| Rash |
35 (1.0) |
24 (0.9) |
0.1 (-0.4, 0.6) |
|
|
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| Hypertension |
110 (3.2) |
89 (3.3) |
-0.0 (-1.0, 0.8) |
|
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. †Includes studies in which a sulfonylurea was an active comparator or a background agent. | |||
Williams-Herman et al. BMC Endocrine Disorders 2008 8:14 doi:10.1186/1472-6823-8-14 |
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