Abstract
Objective
To compare the antipyretic and analgesic effects of a single oral dose of diclofenac potassium 6.25, 12.5 or 25mg with paracetamol l000mg and placebo in patients with fever resulting from acute febrile sore throat.
Design and setting
This was a multicentre, double-blind, double-dummy, randomised, placebo-controlled, parallel group study conducted at 21 primary-care centres throughout France.
Patients
In total, 343 adult patients with acute febrile sore throat (fever ≥38.0°C) were randomised to the five treatment groups.
Interventions
Patients received one oral dose of medication. Fever, spontaneous throat pain and pain on swallowing were recorded over 6 hours. If acute symptoms persisted 2 hours after study drug administration, the patient was allowed to take rescue medication and discontinue the trial.
Results
The antipyretic effects of diclofenac potassium 6.25, 12.5 and 25mg and paracetamol l000mg were significantly greater than placebo. The antipyretic effects of diclofenac potassium 12.5 and 25mg were numerically greater than paracetamol l000mg, which was comparable to the effect of diclofenac potassium 6.25mg. The analgesic effects of the higher doses, diclofenac potassium 12.5 and 25mg, and of paracetamol l000mg were significantly better than placebo. Summary efficacy measures over the first 4 hours post-dose showed a dose-response relationship among the diclofenac doses, with statistically significant differences on some outcomes between the 25mg and the 6.25mg doses. On the global efficacy evaluation for relief of fever and throat pain, patients rated both diclofenac potassium 12.5 and 25mg significantly higher than paracetamol lOOOmg (p ≤ 0.01). In contrast, paracetamol l000mg and diclofenac 6.25mg were not rated significantly higher than placebo. Diclofenac potassium was well tolerated, with a safety profile comparable to that of placebo, and slightly favourable compared with that of paracetamol.
Conclusions
Diclofenac potassium administered as single doses of 12.5 and 25mg significantly reduced fever and throat pain in patients with acute febrile sore throat. The overall efficacy of these doses was rated significantly higher than that of paracetamol l000mg or placebo. A dose-response relationship was seen between placebo and the three diclofenac doses. On most outcomes, paracetamol l000mg was similar to or only slightly better than the diclofenac potassium 6.25mg dose. Diclofenac potassium 12.5mg is the lowest unit dose that could be recommended to provide reliable reduction of oral temperature and relief of throat pain.
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Notes
1The use of trade names is for product identification only and does not imply endorsement.
References
Keinänen-Kiukaanniemi S, Similä S, Käpylä H. Antipyretic therapy: evaluation of diclofenac sodium as an antipyretic agent. Clin Ther 1980; 2: 421–7
Polman HA, Huijbers WA, Augusteijn R. The use of diclofenac sodium (Voltaren®) suppositories as an antipyretic in children with fever due to acute infections: a double-blind, between-patient, placebo-controlled study. J Int Med Res 1981; 9: 343–8
Bettini R, Grossi E, Rapazzini P, et al. Diclofenac sodium versus acetylsalicylic acid: a randomized study in febrile patients. J Int Med Res 1986; 14: 95–100
Schachtel BP, Fillingim JM, Thoden WR, et al. Sore throat pain in the evaluation of mild analgesics. Clin Pharmacol Ther 1988; 44: 704–11
Weckx LL, Ruiz JE, Duperly J, et al. Efficacy of celecoxib in treating symptoms of viral pharyngitis: a double-blind, randomized study of celecoxib and diclofenac. J Intl Med Res 2002; 30(2): 185–94
Schachtel BP, Thoden WR. A placebo-controlled model for assaying systemic analgesics in children. Clin Pharmacol Ther 1993; 53: 593–601
Grebe W, Ionescu I, Gold MS, et al. A multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group comparison of diclofenac-K and ibuprofen for the treatment of adults with influenza-like symptoms. Clin Therap 2003; 25(2): 444–59
Autret E, Rebout-Marty J, Henry-Launois B, et al. Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever. Eur J Clin Pharmacol 1997; 51: 367–71
Acknowledgements
This study was supported by Novartis Consumer Health SA, Nyon, Switzerland.
The following investigators, listed by city, participated in this study: Dr Philippe Angeli, Villejuif; Dr Paul Amar, Levallois-Perret; Dr Sylvie Augy, Neuilly; Dr Philippe Benat, Paris; Dr Hector Boccara, Paris; Dr Lucien Boujenah, Paris; Dr Eric Chabaud, Ivry/Seine; Dr André Cohen, Saunt-Ouen; Dr Gerard Duclos, Villemonble; Dr Sylvaine Dumas, Villejuif; Dr Gerard Forcada, Vincennes; Dr Pascal Guérillot, Paris; Dr Jean-Marie Halmenschlager, Paris; Dr Marc Hindamian, Gentilly; Dr Jean-Michel Huet, Villeneuve-Le-Roi; Dr Michel Hoze, Vincennes; Dr Max Labyod, Arcueil; Dr Come Leclerc, Maison Alfort; Dr Georges Lupczinski, Paris; Dr Patrick Machin, Arcueil; Dr André Serero, Paris.
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Gehanno, P., Dreiser, R.L., Ionescu, E. et al. Lowest Effective Single Dose of Diclofenac for Antipyretic and Analgesic Effects in Acute Febrile Sore Throat. Clin. Drug Invest. 23, 263–271 (2003). https://doi.org/10.2165/00044011-200323040-00006
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DOI: https://doi.org/10.2165/00044011-200323040-00006