[Impact of combined therapy using glucosamine sulfate and anti-inflammatory agent on pain severity in patients with osteoarthritis: prospective, non-controlled postmarketing study].

Unlabelled: Pain is one of the major symptoms of the osteoarthritis (OA). The objective of the study was to evaluate impact of combined therapy with diclofenac, aescin and original glucosamine sulfate on pain severity in patients with OA of different localizations in real life clinical settings in Russia and Ukraine.

Methods: Design--prospective, non-controlled, before and after post-marketing study. Study was performed in 38 cities across Russia and Ukraine in 2012. Registered anti-inflammatory and symptomatic slow acting drugs were used according to the registered indications and dosages. In Russian sites combined therapy A using diclofenac ("Dorosan" formulation, Rottapharm S.p.A., aerosole 1%, 3-4 times/day) for two weeks, original glucosamine sulfate ("Dona" formulation, Rottapharm S.p.A.) intramuscular (ampule 200 mg/ml, 2 ml 3 times/week) for 4 weeks and per os (powder 1500 mg, once/day) for 8 weeks was used. In Ukraine sites (scheme B) diclofenac was substituted with topical aescin ("Reparil-Gel" formulation, Madaus AG, tube 400 mg, 2-3 times/day) anti-inflammatory product. Physicians were free to change therapy and study organizers had no impact on prescribing and management practice. Patients with OA of different localizations were included into the study. Pain severity was assessed using numeric rating scale. Total duration of the study was 8 weeks. Questionnaires were distributed to patients via physician out-patient offices. The only endpoint was the difference in median pain severity at the end of the study compared with the baseline level.

Results: In total 4931 patients were included into the study (mean age 57 +/- 12 years, 75% were females). Scheme A was used in 3956 patients and scheme B in 975 patients. The median pain severity decreased from 0.7 at the baseline (interquartile range +/- 0.2) to 0.2 (interquartile range +/- 0.2) after 8 weeks of the study in both treatment regimens (p < 0.001). Limitations of the study include absence of the control group, collection of the questionnaires from physician offices, rather than directly from patients, limited range of clinical data collected and use of single instrument to assess pain severity.

Conclusions: Post-marketing study of combined therapy of OA of different localizations using diclofenac, aescin and original glucosamine sulfate in Russia and Ukraine demonstrated decrease of the pain severity, assessed by numeric rating scale, after 8 weeks of the treatment.