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A Journal on Otorhinolaryngology, Head and Neck Surgery,
Plastic Reconstructive Surgery, Otoneurosurgery
Indexed/Abstracted in: EMBASE, Scopus
Otorinolaringologia 1999 June;49(2):97-102
Efficacy and tolerability of nimesulide beta cyclodextrin (nimesulide betadex) in comparison with morniflumate in acute otitis. Preliminary results
Balli R., Passali D.* per conto di tutti i centri partecipanti
Istituto di Clinica ORL Policlinico Del Pozzo - Modena
* Università degli Studi - Siena Istituto di Discipline Otorinolaringoiatriche
Background. The analgesic and anti-inflammatory activities of nimesulide beta cyclodextrin have been assessed in patients affected with inflammatory conditions of the car.
Methods. Two hundred and forty-four outpatients of both sexes (aged 14-68 years) with acute or chronic relapsing otitis externa or otitis media were enrolled in this multicentre, randomised, double-blind, between-patient trial designed to evaluate the analgesic and anti-inflammatory efficacy and tolerability of nimesulide beta cyclodextrin in comparison with morniflumate. The patients should present at least moderate otalgia (defined as >50 mm on a visual analogue scale of 100 mm). One hundred and twenty patients were treated with nimesulide beta cyclodextrin (one 400 mg sachet every 12 hours) and 124 with morniflumate (one 700 mg sachet every 12 hours) until the remission of clinical symptoms for a maximum of ten days.
The intensity of otalgia was evaluated at baseline, and then 15, 30, 45, 60, 90, 120 and 180 minutes after the first drug administration; on the subsequent days, it was evaluated two hours after the evening administration. In addition, the following variables were evaluated at baseline and upon treatment discontinuation: edema and hyperemia of the external auditory canal; hyperemia of the tympanic membrane and exudation in the tympanic cavity (by means of otoscopy); hypoacusia, acouophonia, otorrhea, vertigo and body temperature. At the end of the trial, both the investigators and the patients were asked to give their personal judgements concerning the efficacy and tolerability of the assigned treatments.
Results. Both treatments led to a significant reduction (p<0.01) in pain 15 minutes after the first administration; however, the time for a 50% reduction in pain from baseline was 110 minutes in the patients receiving nimesulide beta cyclodextrin and 160 minutes in those receiving morniflumate. Furthermore, 55% of the patients in the nimesulide beta cyclodextrin group experienced a reduction in pain from baseline of ≥50% within three hours of the first administration, as compared with only 47% in the morniflumate group. During the subsequent days of treatment, the analgesic activity and clinical efficacy of the two drugs were similar.
The tolerability of nimesulide beta cyclodextrin was significantly better (p<0.05) than that of morniflumate: only one adverse effect (gastralgia) was observed in the first group and ten in the second (gastralgia, nausea, vomiting and diarrhea).
The final judgements of the investigators concerning the efficacy and tolerability of the trial treatments were in favour of nimesulide beta cyclodextrin (p<0.05).
Conclusions. Anti-inflammatory activities of nimesulide beta cyclodextrin and morniflumate are similar, but analgesic activity of nimesulide beta cyclodextrin has a more rapid onset, in comparison with morniflumate.