Nimesulide does not interfere with airway responsiveness in allergic asthma.

The clinical use of nonsteroidal anti-inflammatory drugs (NSAIDs) in asthmatic patients is limited by the possibility that these drugs may aggravate asthma by increasing the production of leukotrienes. Nimesulide, an NSAID with a weak inhibitory activity on prostaglandin synthetase, has been hypothesised to be safer than other NSAIDs in asthma. We have recently demonstrated in asthmatics who were allergic to the house dust mite that nimesulide neither alters the bronchial response to allergen nor aggravates the allergen-induced increase in airway responsiveness.

Nimesulide and diclofenac in the control of cancer-related pain. Comparison between oral and rectal administration.

64 patients with pain associated with advanced cancer were treated with either nimesulide or diclofenac as initial analgesia. Patients were randomly allocated to 1 of 4 treatment groups: oral nimesulide 300 mg/day; oral diclofenac 150 mg/day; rectal nimesulide 400 mg/day; and rectal diclofenac 200 mg/day. After 1 week of treatment, both drugs provided an adequate degree of pain relief and allowed an increase in sleep duration. There were no significant differences in efficacy between the drugs or routes of administration. Fewer side effects were observed with nimesulide, giving this agent a better therapeutic index than the reference compound.

Nimesulide in the treatment of advanced cancer pain. Double-blind comparison with naproxen.

The analgesic efficacy and tolerability of nimesulide and naproxen were compared in 68 patients with advanced cancer who needed to be treated with nonsteroidal anti-inflammatory drugs according to the first step of the pharmacological analgesic scale of the WHO. Patients received either nimesulide 200mg or naproxen 500mg twice daily. The analgesic efficacy and tolerability of the 2 drugs appeared to be similar. Both drugs were effective and were associated with a low incidence of adverse reactions.

A double-blind comparison of nimesulide and ketoprofen in dental surgery.

The efficacy and tolerability of nimesulide were compared with those of ketoprofen when administered rectally in a double-blind investigation of 46 patients scheduled for dental surgery. Nimesulide was more effective and more rapid than ketoprofen in ameliorating the painful inflammatory symptoms (pain at rest and upon mastication) and signs (swelling and hyperaemia) associated with the operation. These effects were accompanied by improved quality of sleep and recovery of masticatory and swallowing function, which was superior for nimesulide-treated patients.

Efficacy of nimesulide in the prevention of inflammatory complications after laser treatment of ocular diseases.

A total of 40 patients with various ocular diseases were treated with nimesulide 200 mg/day or ketoprofen 150 mg/day for 7 days after laser therapy. The incidence of ocular complications was lower in patients treated with nimesulide than with ketoprofen. With regard to posterior segment changes, retinal oedema was reduced in patients treated with nimesulide. After laser treatment, anterior segment changes were modest. These preliminary results stress the efficacy of nimesulide in preventing oedema and also its anti-inflammatory effects on the retina after ocular laser therapy.

A multicentre double-blind investigation comparing nimesulide and naproxen in the treatment of minor sport injuries.

A total of 660 patients with minor traumatic sport-related lesions of soft tissues were recruited to a randomised double-blind 7-day study to evaluate the efficacy and the tolerability of oral nimesulide (300 mg/day) in comparison with naproxen (750 mg/day). Both drugs were similarly effective in reducing the degree of oedema and intensity of pain, with most patients experiencing remission, which allowed resumption of regular sporting activities. Both drugs were generally well tolerated, although gastrointestinal intolerance was more frequently associated with naproxen therapy.

A comparison of nimesulide and diclofenac in the treatment of acute superficial thrombophlebitis.

In a double-blind study, the efficacy and tolerability of nimesulide (100mg twice daily) were compared with those of diclofenac (50mg twice daily) when administered orally to 50 patients with acute superficial thrombophlebitis of the lower limbs. Pain relief and amelioration of inflammation were apparent in patients treated with either nimesulide or diclofenac; however, gastric intolerance was noted more frequently in those receiving diclofenac. The results of this study suggest that nimesulide should be considered as an alternative to diclofenac and other first-line NSAIDs in the treatment of acute superficial thrombophlebitis.

A multicentre clinical study of nimesulide in inflammatory diseases of the ear, nose and throat.

940 male and female patients aged 15 to 77 years were enrolled in a multicentre noncomparative study in order to assess the efficacy and tolerability of nimesulide in otorhinolaryngological inflammatory diseases. 309 patients were affected by otitis media and 631 by upper respiratory tract inflammation. All the patients were treated with orally administered granular nimesulide 100mg twice daily for a mean period of 10 days. Nimesulide significantly reduced the intensity of signs and symptoms, thus allowing functional recovery. The drug was well tolerated, and of the 75 patients who reported adverse effects, only 26 had to be withdrawn from treatment.

Nimesulide in the treatment of mastalgia.

Sixty patients with mastalgia, either idiopathic or secondary to dysplastic lesions, were treated with oral nimesulide (100mg tablets twice daily) for 15 days. Breast tension and pain, assessed at baseline and on completion of the treatment period, improved or resolved with therapy. Indeed, breast pain (which most likely manifests as a consequence of periductal inflammation) was most noticeably reduced. The drug was well tolerated in nearly all patients. These results support the usefulness of nimesulide and other nonsteroidal anti-inflammatory drugs in the treatment of mastalgia.

Nimesulide in the treatment of menstrual migraine.

In a controlled double-blind clinical trial, 30 patients aged 18 to 45 years, with menstrual migraine, were randomly assigned to 2 parallel treatment groups of 15 patients each. One group received granular nimesulide 100mg 3 times daily and the other group received placebo. Each treatment was given for 10 days, starting from the onset of migraine symptoms, and was repeated for the 2 following menstrual cycles. The overall assessment of efficacy in the 2 groups was based on hourly self-evaluation of pain during each study day. In patients treated with nimesulide, pain intensity and duration were significantly reduced compared with placebo (p = 0.0001) during all the menstrual cycles in the study.

A controlled clinical study of the efficacy and tolerability of nimesulide vs naproxen in maxillo-facial surgery.

The anti-inflammatory and analgesic efficacy of nimesulide was assessed and compared with that of naproxen in the postoperative treatment of inflammatory complications of maxillo-facial surgery in a double-blind study. A total of 60 patients were randomly assigned to treatment with nimesulide (100mg twice daily) or naproxen (250mg twice daily) for 6 to 14 days. Treatment with either drug prevented the development of, or ameliorated the signs and symptoms associated with, the inflammatory process (spontaneous pain, difficulty in chewing and swallowing, swelling, hyperaemia, muscle contracture, poor sleep quality). Indeed, most patients experienced complete resolution of their signs and symptoms. The efficacy of nimesulide was considered to be superior to that of naproxen, although both drugs were tolerated equally well.

A comparison of nimesulide and ketoprofen in the prevention and treatment of painful postoperative inflammatory complications of ear, nose and throat surgery.

In a randomised double-blind clinical study, 76 patients undergoing major ear, nose or throat (ENT) surgery (including 45 for cancer) were treated with nimesulide (200mg twice daily) or ketoprofen (100mg twice daily) administered rectally for 5 days. Pain intensity was significantly and similarly reduced in both treatment groups compared with baseline (p = 0.0001). A significant reduction in oedema and hyperaemia was observed on the second day for nimesulide-treated patients and on the third day for those treated with ketoprofen, with complete relief being noted for almost all patients by the fifth day. Fever was resolved in all patients. Adverse events attributable to treatment were observed for 1 patient in each group. These results suggest that nimesulide provides a worthwhile alternative to other NSAIDs in the treatment of postoperative pain and inflammation associated with ENT surgery.

Clinical efficacy and tolerability of nimesulide compared with naproxen in the treatment of posthaemorrhoidectomy pain and inflammation.

The efficacy and tolerability of nimesulide and naproxen were compared in a randomised double-blind study of patients with pain and inflammation after haemorrhoidectomy. Both drugs appeared similarly effective in reducing pain and oedema and no adverse reaction was detected. These data extend the information on the anti-inflammatory and analgesic efficacy of nimesulide in the postoperative setting.

A comparison of nimesulide and placebo in the treatment of minor traumatic soft tissue lesions in children.

A total of 40 children with minor traumatic injuries of soft tissues were randomly assigned to oral treatment with nimesulide (50mg twice daily) or placebo for 5 days in a double-blind investigation. Results demonstrated that therapy with nimesulide was associated with a significant resolution of symptoms (pain at rest and during movement) and signs (oedema, immobility and haematoma), which was statistically superior to that demonstrated for placebo. Furthermore, nimesulide was well tolerated by all patients and was not associated with gastrointestinal problems. These findings suggest that nimesulide is a suitable therapy for children with minor traumatic lesions.

Double-blind evaluation of nimesulide vs lysine-aspirin in the treatment of paediatric acute respiratory tract infections.

70 children aged 4 to 12 years with acute infection and inflammation of the respiratory tract (laryngitis, tracheitis, bronchitis, pneumonia) were enrolled in a double-blind investigation and randomised to treatment with nimesulide (50mg granules twice daily) or lysine-aspirin (360mg granules twice daily) for 5 days. The drugs were similarly effective in reducing cough, asthenia and dyspnoea, although nimesulide-treated patients experienced fewer gastrointestinal adverse events. These results confirm the efficacy of nimesulide in the treatment of respiratory inflammation and provide preliminary evidence of its value in children.

A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children.

The efficacy and tolerability of nimesulide were compared with those of paracetamol in a nonblind randomised study that recruited 110 children (64 males, 46 females; aged 3 to 6 years) with inflammation of the upper respiratory tract and fever. Nimesulide suspension (1.5 mg/kg 3 times daily) or paracetamol syrup (10 mg/kg 4 times daily) were administered orally until fever resolved. Body temperature was recorded and local pain and general discomfort assessed. Three patients treated with nimesulide and 6 patients treated with paracetamol withdrew from the study as a result of adverse events, and 1 paracetamol-treated patient discontinued because of a requirement for therapy with steroids. Nimesulide was as effective as paracetamol in reducing fever, local pain, and general discomfort. Nimesulide therefore appears to be at least as effective as paracetamol in terms of antipyretic and anti-inflammatory activity in children with inflammation of the upper respiratory tract and fever.

An assessment of the efficacy and tolerability of nimesulide vs paracetamol in children after adenotonsillectomy.

The efficacy and tolerability of nimesulide were assessed and compared with those of paracetamol in the treatment of 35 children with pain and inflammation following adenotonsillectomy. The antipyretic and analgesic efficacy of the 2 drugs was similar, although more patients had complete remission of pain after 4 days of treatment with nimesulide. Both drugs were well tolerated, even though occasional elevation of transaminase enzymes and alkaline phosphatase was noted in the nimesulide-treated group. It is postulated that this effect may have been attributable to the volatile anaesthetics used during surgery.

Nimesulide in the treatment of chronic bronchitis.

Hypersecretion of mucus is the main feature of chronic bronchitis and is associated with an increased susceptibility to bronchial infections. Although airway inflammation is present in patients with chronic bronchitis and is recognised as a contributing factor in the development of bronchial hyper-reactivity and obstruction, the role of anti-inflammatory drugs in the treatment of chronic bronchitis has not been established. Nimesulide is a nonsteroidal anti-inflammatory drug that can modulate the function of neutrophils and block the effects of several inflammatory mediators. We found that a 3-week treatment course of nimesulide in patients with chronic mucus hypersecretion decreased sputum viscosity, thus significantly improving symptoms. The effect of nimesulide on the rheological properties of mucus was slower and weaker than that of classic mucolytics and was more likely to be related to a reduction in bronchovascular permeability. The clinical usefulness of nimesulide in chronic bronchitis deserves further investigation.

A comparison of nimesulide vs paracetamol in the treatment of pyrexia in the elderly.

The efficacy and safety of rectally administered nimesulide 200mg and paracetamol 500mg were assessed in a double-blind study. The study was conducted in 39 elderly inpatients with infections of the upper or lower respiratory tract associated with fever; 18 patients received nimesulide and 21 received paracetamol. Both treatments were given for 2 consecutive days and provided adequate therapy for pyrexia, with significant reductions in body temperature being observed. Both drugs were well tolerated. Only 1 patient in the nimesulide-treated group could not complete the study because cutaneous erythema occurred with itching; this resolved spontaneously upon treatment withdrawal. It is concluded that nimesulide is as active and safe as paracetamol for the treatment of pyrexia in the elderly.

Nimesulide in the treatment of pelvic inflammatory diseases. A multicentre clinical trial conducted in Campania and Sicily.

400 patients aged 18 to 71 years took part in a multicentre noncomparative study designed to assess the clinical efficacy and tolerability of nimesulide in gynaecological inflammatory disease: adnexitis (72 patients), cervicitis (78 patients), endometritis (18 patients), myometritis (22 patients), and combined disorders (210 patients). All patients were treated with nimesulide 100mg twice daily in granular form for an average of 19.5 days. The treatment produced good results in all types of diseases considered, with a significant decrease in severity of symptoms being observed. The drug was well tolerated.