Rate of FDA-Defined Arthropathy 6 Weeks and 1 Year After Treatment With Ciprofloxacin or a Comparator
| . | Ciprofloxacin (n = 335) . | Comparator (n = 349) . |
|---|---|---|
| Arthropathy rate at 6-week follow-up,an (%) | 31 (9.3) | 21 (6.0%) |
| 95% CI, % | (–0.8 to 7.2) | |
| Cumulative arthropathy rate at 1-year follow-up,an (%) | 46 (13.7) | 33 (9.5%) |
| 95% CI, % | (–0.6 to 9.1) | |
| Selected musculoskeletal adverse eventsb in patients with arthropathy at 1-year follow-up | Ciprofloxacin n = 46 patientsc | Comparator n = 33 patientsc |
| Arthralgia | 35 (76) | 20 (61) |
| Abnormal joint and/or gait examination | 11 (24) | 8 (24) |
| Accidental injury | 6 (13) | 1 (3) |
| Leg pain | 5 (11) | 1 (3) |
| Back pain | 4 (9) | 0 |
| Arthrosis | 4 (9) | 1 (3) |
| Bone pain | 3 (7) | 0 |
| Joint disorder | 2 (4) | 0 |
| Pain | 2 (4) | 2 (6) |
| Myalgia | 1 (2) | 4 (12) |
| Arm pain | 0 | 2 (6) |
| Movement disorder | 1 (2) | 1 (3) |
| . | Ciprofloxacin (n = 335) . | Comparator (n = 349) . |
|---|---|---|
| Arthropathy rate at 6-week follow-up,an (%) | 31 (9.3) | 21 (6.0%) |
| 95% CI, % | (–0.8 to 7.2) | |
| Cumulative arthropathy rate at 1-year follow-up,an (%) | 46 (13.7) | 33 (9.5%) |
| 95% CI, % | (–0.6 to 9.1) | |
| Selected musculoskeletal adverse eventsb in patients with arthropathy at 1-year follow-up | Ciprofloxacin n = 46 patientsc | Comparator n = 33 patientsc |
| Arthralgia | 35 (76) | 20 (61) |
| Abnormal joint and/or gait examination | 11 (24) | 8 (24) |
| Accidental injury | 6 (13) | 1 (3) |
| Leg pain | 5 (11) | 1 (3) |
| Back pain | 4 (9) | 0 |
| Arthrosis | 4 (9) | 1 (3) |
| Bone pain | 3 (7) | 0 |
| Joint disorder | 2 (4) | 0 |
| Pain | 2 (4) | 2 (6) |
| Myalgia | 1 (2) | 4 (12) |
| Arm pain | 0 | 2 (6) |
| Movement disorder | 1 (2) | 1 (3) |
Data are from ref 8. CI, confidence interval.
The study was designed to show that the arthropathy rate for the ciprofloxacin group did not exceed that of the comparator group by more than +6.0%. At both evaluations, the 95% CI indicated that it could not be concluded that ciprofloxacin had findings comparable to the comparator.
Events occurring in 2 or more patients.
A patient with arthropathy may have had more than 1 event.