Igrexa-nimesulide

Clin Drug Investig. 2003;23(10):651-60.

Nimesulide versus Ibuprofen for Postoperative Tonsillectomy Pain : A Double-Blind, Randomised, Active Comparator-Controlled Clinical Trial.

Aho M, Kokki H, Nikanne E.

Department of Ear, Nose and Throat Surgery, North-Carelian Central Hospital, Joensuu, Finland.

BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs are effective analgesics but their use during tonsillectomy is controversial because of the risk of postoperative bleeding. The aim of this study was to compare the analgesic efficacy and safety of nimesulide, a preferential cyclo-oxygenase type-2 inhibitor, with ibuprofen in the treatment of pain after tonsillectomy. STUDY DESIGN: A prospective, double-blind, randomised clinical trial. PATIENTS AND METHODS: A total of 80 consenting generally healthy patients, aged 14-58 years, undergoing tonsillectomy were randomly assigned to receive either nimesulide 100mg or ibuprofen 800mg orally 60 minutes before surgery. Subsequent doses of the same study medication were administered at 12-hour intervals for the first 7 days, and thereafter when needed. During the first 24 postoperative hours in hospital oxycodone was used for rescue analgesia, and after discharge patients were allowed to use a paracetamol-codeine combination for breakthrough pain. Recovery was recorded up to 3 weeks after surgery. RESULTS: The need for rescue analgesia during the first 24 hours was similar in the two study groups; 0-7 doses (mean +/- SD 3.3 +/- 1.7 doses) in the nimesulide group and 0-11 doses (3.3 +/- 2.4 doses) in the ibuprofen group. After discharge significant differences were found between the two study groups in favour of the nimesulide-treated patients. Cessation of significant pain while swallowing occurred after 3-19 (10.9 +/- 3.8) days in the nimesulide group versus 7-20 (12.9 +/- 3.3) days in the ibuprofen group (p = 0.041), and return to normal daily activities occurred after 3-21 (10.3 +/- 4.9) days in the nimesulide group versus after 3-19 (12.7 +/- 4.2) days in the ibuprofen group (p = 0.048). At 3 weeks, six of 33 patients in the nimesulide group versus 15 of 37 patients in the ibuprofen group had pain during swallowing (p = 0.049). One patient (3%) in the nimesulide group and five patients (12%) [p = 0.22] in the ibuprofen group needed electrocautery to stop postoperative bleeding. CONCLUSION: Oral nimesulide was as effective as ibuprofen in pain management after tonsillectomy, and nimesulide improved the recovery after discharge.

Nimesulide a multifactorial approach to inflammation and pain: scientific and clinical consensus.

Rainsford KD; Members of the Consensus Report Group on Nimesulide.

Biomedical Research Centre, Sheffield Hallam University, Sheffield, UK.

BACKGROUND: This paper summarises the outcome from a consensus meeting, held in Rome on 5 October 2005, that aimed to review the state of the art regarding the non-steroidal anti-inflammatory drug (NSAID) nimesulide, with reference to its chemical, pharmacokinetic, pharmacological and clinical characteristics. SCOPE: The meeting aimed to provide a continuous and up-to-date evaluation of the clinical and safety profile of nimesulide, and of its role in the treatment of inflammatory pain, in light of existing therapeutic alternatives, through a revision and critical discussion on the information available on the drug among authoritative experts in different fields of medical science. FINDINGS: The members of the Consensus Report Group on Nimesulide (CRGN) recognised that nimesulide is an NSAID which exerts its analgesic, anti-inflammatory and antipyretic activities thanks to unique chemical and pharmacokinetic characteristics, and to a multifactorial mechanism of action, which goes beyond its preferential inhibitory activity on the COX-2 enzyme. Nimesulide was found to be at least as effective, or superior, to placebo and other NSAIDs, with a particularly fast onset of analgesic action. The safety profile is in line with that expected from the class, with evidence of a better gastrointestinal safety profile. CONCLUSIONS: Based on the available evidence, the CRGN concluded that nimesulide remains an effective and safe therapeutic choice for the treatment of various painful inflammatory conditions, with a rapid onset of analgesic activity and an overall positive benefit/risk profile.

West Afr J Med. 2005 Apr-Jun;24(2):128-33.

Double blind clinical trial comparing the safety and efficacy of nimesulide (100mg) and diclofenac in osteoarthrosis of the hip and knee joints.

Omololu B, Alonge TO, Ogunlade SO, Aduroja OO.

Department of Surgery, College of Medicine University of Ibadan.

BACKGROUND: Osteoarthritis of the hip or knees is a very disabling condition in both Caucasians and Africans. A lot of medical drugs have been in use with their corresponding side effects, hence the search for newer drugs with fewer side effects. STUDY DESIGN: A double blind clinical trial comparing the safety and efficacy of nimesulide and diclofenac was carried out in the University College Hospital Ibadan. All patients referred to the outpatients department of the orthopaedic division with osteoarthritis of the hips and knees who met the criteria for inclusion in the study were used for the study. RESULTS: There were a total number of sixty-seven (67) patients. 70.6% of the nimesulide patients had only mild pain in the involved joint on completion of the eight weeks trial compared to 50% of the diclofenac group. A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week in contrast to the nimesulide group. There was a statistically significant difference in the frequency of side effects between the patients in the diclofenac group and the nimesulide group (p<0.05). CONCLUSION: Nimesulide was found to be more effective in relieving pain in osteoarthritis of the hip and knees and with less side effects than diclofenac.