Efficacy of Celecoxib in Treating Symptoms of Viral Pharyngitis: A Double-Blind, Randomized Study of Celecoxib versus Diclofenac

Abstract

This study compared the efficacy and safety of the cyclooxygenase-2 specific inhibitor celecoxib with the conventional non-steroidal anti-inflammatory drug diclofenac in the symptomatic treatment of viral pharyngitis. Adult patients from 27 study centers in Latin America were treated with oral doses of celecoxib 200 mg once daily or 200 mg twice daily, or diclofenac 75 mg twice daily for 5 days in a double-blind, randomized study. The primary efficacy assessment was 'Throat Pain on Swallowing' on day 3. In addition, secondary quality-of-life assessments were performed on days 3 and 5. All adverse events and treatment-emergent signs and symptoms were recorded. Data from 313 patients were evaluable for efficacy (105 celecoxib 200 mg once daily, 107 celecoxib 200 mg twice daily, 101 diclofenac 75 mg twice daily). The upper 95% confidence limits for the visual analog scale of 'Throat Pain on Swallowing' on day 3 for celecoxib 200 mg once daily relative to diclofenac 75 mg twice daily, and celecoxib 200 mg twice daily relative to diclofenac 75 mg twice daily were 9.26 and 7.83, respectively. All secondary efficacy and quality-of-life measures were clinically similar for the three treatment groups, and no statistically significant differences were detected. The incidences of treatment-emergent adverse events and withdrawals due to adverse events were similar for all groups, but numerically higher among patients taking diclofenac than celecoxib. More patients in the diclofenac group reported gastrointestinal complaints (7.3%) compared with those in the celecoxib groups (4.3% in the celecoxib 200 mg once-daily group and 3.4% in the celecoxib 200 mg twice-daily group). In conclusion, 5 days of treatment with celecoxib 200 mg once daily is as effective as diclofenac 75 mg twice daily in the symptomatic treatment of viral pharyngitis. Celecoxib 200 mg once daily is also as effective as celecoxib 200 mg twice daily in this condition.

Utility and Sensitivity of the Sore Throat Pain Model: Results of a Randomized Controlled Trial on the COX‐2 Selective Inhibitor Valdecoxib

“…At 12 and 24 hours after dosing, patients provided a global evaluation of the study medication on a 4‐point scale (1 = poor , 4 = excellent ) and rated their satisfaction with treatment on a 7‐point scale (1 = very satisfied , 7 = very dissatisfied ) 22 . All patients randomized to treatment were included in the efficacy and safety analyses.…”

“…Fundamental principles of clinical trial methodology are followed in the model, such as confirmation of the pain‐causing condition, elimination of confounding clinical features, a relatively severe pain intensity (PI) at baseline, homogeneity of the pretreatment status of patients, and disease‐specific rating scales 5 – 9 . Similar to the post—oral surgery 10 and periodontal 11 pain models, the sore throat pain model has been used to distinguish the analgesic efficacy between active treatments and placebo, between different analgesic agents, and between doses of analgesic agents in adult patients 4 – 6 , 12 – 22 . The sore throat pain model has also been adapted to distinguish between active treatments and placebo in children 16 – 18 .…”

An Instrument for Rating Quality of Life Related to Sore Throat in Patients Suffering from Acute Pharyngitis or Tonsillitis

“…Pain was always taken into account (15, 7), and sometimes difficulties with swallowing (16), but quality of sleep and breathing were mostly missed. The items from Physical domain of STQoL cover both pain and difficulties with swallowing, sleep and breathing, giving wider picture how sore throat affects physical functioning of a patient.…”

Nonsteroidal anti-inflammatory drugs: cyclooxygenase 2 inhibitors

“…Pediatras, otorrinolaringologistas, reumatologistas, ginecologistas e ortopedistas são os maiores prescritores desses medicamentos. As indicações habituais dos AINH são apresentadas na Tabela 2 [11][12][13][14][15][16][17] .…”