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Clinical adverse experiences for which the 95% confidence intervals around the difference in incidence rate exclude 0 |
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| Adverse Experience |
Sitagliptin 100 mg n (%) (N = 3415) |
Non-Exposed n (%) (N = 2724) |
Difference in Sitagliptin and Non-Exposed, % (95% CI)* |
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| Sitagliptin > Non-exposed |
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| Atrial fibrillation† |
18 (0.5) |
5 (0.2) |
0.3 (0.0, 0.7) |
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| Asthenia |
19 (0.6) |
6 (0.2) |
0.3 (0.0, 0.7) |
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| Chest discomfort |
9 (0.3) |
1 (0.0) |
0.2 (0.0, 0.5) |
|
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| Tooth abscess‡ |
27 (0.8) |
10 (0.4) |
0.4 (0.0, 0.8) |
|
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| Osteoarthritis |
58 (1.7) |
24 (0.9) |
0.8 (0.2, 1.4) |
|
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| Acne |
7 (0.2) |
0 (0) |
0.2 (0.0, 0.4) |
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| Dermatitis Contact |
24 (0.7) |
7 (0.3) |
0.4 (0.1, 0.8) |
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| Non-exposed > Sitagliptin |
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| Bradycardia |
0 (0) |
4 (0.1) |
-0.1 (-0.4, -0.0) |
|
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| Goiter |
1 (0.0) |
6 (0.2) |
-0.2 (-0.5, -0.0) |
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| Change in bowel habit |
0 (0) |
4 (0.1) |
-0.1 (-0.4, -0.0) |
|
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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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| Weight increased |
12 (0.4) |
20 (0.7) |
-0.4 (-0.8, -0.0) |
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| Hypoglycemia |
117 (3.4) |
296 (10.9) |
-7.4 (-8.8, -6.1) |
|
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| Sinus headache |
3 (0.1) |
12 (0.4) |
-0.4 (-0.7, -0.1) |
|
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| Prostatitis |
3 (0.1) |
9 (0.3) |
-0.2 (-0.5, -0.0) |
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| Balanitis |
0 (0) |
4 (0.1) |
-0.1 (-0.4, -0.0) |
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| Hyperkeratosis |
0 (0) |
8 (0.3) |
-0.3 (-0.6, -0.1) |
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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. †When atrial fibrillation and atrial flutter were combined, the incidence rates were 0.5% and 0.3% for the sitagliptin and non-exposed groups, respectively (between-group difference [95% CI] = 0.3 [-0.1, 0.6]). ‡When tooth abscess and tooth infection were combined, the incidence rates were 1.3% and 0.9% for the sitagliptin and non-exposed groups, respectively (between-group difference [95% CI] = 0.4 [-0.1, 1.0]). | |||
Williams-Herman et al. BMC Endocrine Disorders 2008 8:14 doi:10.1186/1472-6823-8-14 |
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