Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial

Andrea Barranjard Vannucci Lomonte,Sebastião Cezar Radominski,Cristiano Augusto De Freitas Zerbini,Morton Aaron Scheinberg,Antônio Carlos Da Silva,Antônio Carlos Ximenes,Emerson Gimenez

doi:10.1186/s42358-021-00165-9

Abstract

ObjectivesTo compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA).MethodsIn this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)—Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale—were randomized to receive GS/CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score. The secondary endpoints included the following: WOMAC total and subscale scores, overall assessment of the disease by the patient and the investigator, SF-12 score, OMERACT-OARSI response rate to the treatment, and rescue medication use.ResultsMean reductions of WOMAC pain score were − 35.1 (sd = 23.2) mm in the GS/CS group and − 36.5 (sd = 24.9) mm in the RP group. The difference between the adjusted means of both treatments confirmed the non-inferiority of GS/CS versus the RP. Improvement was observed in pain, stiffness, physical function and total WOMAC score, as well as in overall OA assessment by the patient and the investigator for both groups. No improvement was observed in SF-12. The rate of OMERACT-OARSI responders was 89.4% in GS/CS group and 87.9% in the RP group. Headache and changes in glucose tolerance were the most frequent treatment-related adverse events.ConclusionsThe new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin sulfate was non-inferior to the RP in symptomatic treatment of knee OA, with a high responder rate and good tolerability profile.Trial registrationClinicalTrials.gov; Registration number NCT02830919; Date of registration: July 13, 2016; First randomization date: December 05, 2016).

Highlights

Osteoarthritis (OA) is an important cause of morbidity and functional impairment [1]
A total of 314 patients were assigned to the glucosamine sulfate (GS)/chondroitin sulfate (CS) group and 313 patients were assigned to the reference product (RP) group
All patients received the treatment to which they were randomized, except for a patient who was randomized to the GS/CS group but received the reference drug at V3

Summary

Introduction

Osteoarthritis (OA) is an important cause of morbidity and functional impairment [1]. An increase of 31.4% in disability-adjusted life-years (DALYs) was observed for musculoskeletal diseases, including OA, from 2007 to 2017 [2]. The functional impairment caused by this disease has a significant socioeconomic impact: a review of studies published between 2006 and 2016 addressing the economic impact of OA showed that the average per patient direct costs of the disease in the United States ranged from US$ 1442 to US$ 21,335 per year [3]. The current treatment algorithm of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposes the early introduction of symptomatic slow-acting drugs for OA (SYSADOAs), among which glucosamine sulfate and chondroitin sulfate are included [6]

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