Efficacy and tolerance of naproxen instant suspension formulation: a post-marketing survey.
A multi-centre uncontrolled clinical trial was performed in 42 Italian hospitals to evaluate the efficacy and tolerance of an instant suspension of naproxen, a well known anti-inflammatory drug. A total of 390 adults of all ages with musculoskeletal rheumatic diseases or minor traumatic injuries entered the trial. Patients received 500 mg naproxen instant suspension twice daily after meals, for 1-4 weeks. Assessment of signs and symptoms was made before starting the therapy, after 3 days and at the end of the treatment period. The drug produced a rapid and progressive relief of pain and articular symptoms in most patients and was equally effective in all the diagnostic sub-groups. The efficacy of treatment was 'excellent' or 'good' in about 85% of patients, 'moderate' in 10% and 'minimal' or 'absent' in about 5%. Almost 90% of patients had no side-effects; 5% were withdrawn because of unwanted effects. No correlation between incidence or intensity of side-effects and age of the patients or duration of therapy was observed. The complaints reported are common to other anti-rheumatic drugs, e.g. epigastric pain, pyrosis, nausea, vomiting and headache. In conclusion, naproxen instant suspension is highly effective and well tolerated.
Cordaro
C I
CI
Medical Department, Recordati SpA, Milan, Italy.
Sartini
A
A
Celotti
F
F
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage* / Q000627:therapeutic use; D012216:Rheumatic Diseases / Q000188:drug therapy*; D013535:Suspensions; D014947:Wounds and Injuries / Q000188:drug therapy*
D013535:Suspensions; D009288:Naproxen