Table 4 |
|||
|
Most common adverse events and events of interest in evaluating COX-inhibitors |
|||
|
Placebo |
Etoricoxib 90 mg |
Naproxen 1000 mg |
|
|
(N = 357) |
(N = 353) |
(N = 181) |
|
|
|
|||
|
n (%) |
n (%) |
n (%) |
|
|
Most Common Adverse Events† |
|||
|
Headache |
20 (5.6) |
24 (6.8) |
6 (3.3) |
|
Hypertension |
5 (1.4) |
12 (3.4) |
5 (2.8) |
|
Upper Respiratory Infection |
11 (3.1) |
8 (2.3) |
8 (4.4) |
|
Urinary Tract Infection |
16 (4.5) |
15 (4.2) |
8 (4.4) |
|
Events of Interest in Evaluating COX Inhibitors |
|||
|
Gastrointestinal (GI) Adverse Events |
|||
|
GI Nuisance Symptoms‡ |
36 (10.1) |
38 (10.8) |
21 (11.6) |
|
Discontinuations |
2 (0.6) |
2 (0.6) |
2 (1.1) |
|
Renovascular Adverse Events |
|||
|
Lower Extremity Edema (LEE) |
3 (0.8) |
3 (0.8) |
2 (1.1) |
|
Discontinuations due to LEE |
0 (0.0) |
0 (0.0) |
0 (0.0) |
|
Congestive Heart Failure |
0 (0.0) |
0 (0.0) |
0 (0.0) |
|
Hypertension |
5 (1.4) |
12 (3.4) |
5 (2.8) |
|
Discontinuations due to hypertension |
0 (0.0) |
0 (0.0) |
1 (0.6) |
|
|
|||
|
† Incidence ≥ 3% in any treatment group. ‡ Includes abdominal pain, acid reflux, dyspepsia, epigastric discomfort, heartburn, nausea, and vomiting. |
|||
|
Collantes et al. BMC Family Practice 2002 3:10 doi:10.1186/1471-2296-3-10 |
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