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PARIS – A fixed-dose combination of glucosamine and chondroitin sulfate was as good as the cyclo-oxygenase-2 inhibitor celecoxib in relieving moderate to severe knee pain in patients with knee osteoarthritis in the double-blind, noninferiority MOVES trial.
Side effect profiles and tolerability were also similar with glucosamine/chondroitin (Droglican) and celecoxib (Celebrex), with 51% of patients overall experiencing treatment-emergent adverse events, Dr. Marc Hochberg reported at the World Congress on Osteoarthritis.
"In a group that is either contraindicated or relatively contraindicated to celecoxib, you get similar efficacy [with Droglican] at 6 months," he said in an interview.
Dr. Hochberg noted that the phase IV (MOVES) Multicentric Osteoarthritis Intervention Study enrolled patients who were consistent with the European label for celecoxib, meaning that those with prior coronary artery disease or peripheral artery disease were excluded, as were those with unstable diabetes or uncontrolled hypertension.
MOVES was designed to extend the findings of the GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial), which suggested in exploratory analyses that combination 1,500 mg daily glucosamine and 1,200 mg daily chondroitin sulfate was effective in the subgroup with moderate to severe knee osteoarthritis pain, but that either agent alone or in combination was not effective in reducing osteoarthritis knee pain in the overall cohort (N. Engl. J. Med. 2006;354:795-808).
MOVES randomly assigned 606 patients in a double-blind, double-dummy fashion to receive either two capsules of Droglican (250 mg glucosamine and 200 mg chondroitin sulfate) three times daily or celecoxib 200 mg plus five placebo capsules per day. Two-thirds of patients (62.6%) had Kellgren-Lawrence grade 2 radiological changes, and 84% were female. Their mean age was 62.7 years.
At 180 days, the mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores in the Droglican and celecoxib groups improved from 372 and 370.6, respectively, to 185.8 and 184.7.
This corresponds to a mean difference of 1.11 units (95% confidence interval, –21.99-19.76; P = .917), which met the noninferiority margin, according to Dr. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore.The results remained robust in sensitivity analyses.
There also were no significant differences between the two groups in the absolute improvement in the WOMAC stiffness and function scales and the five individual items of the WOMAC pain scale at 6 months, Dr. Hochberg reported at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Hochberg reported no conflicts. His coauthors were employees or on the steering committee for Bioiberica, the study sponsor and maker of Droglican.
PARIS – A fixed-dose combination of glucosamine and chondroitin sulfate was as good as the cyclo-oxygenase-2 inhibitor celecoxib in relieving moderate to severe knee pain in patients with knee osteoarthritis in the double-blind, noninferiority MOVES trial.
Side effect profiles and tolerability were also similar with glucosamine/chondroitin (Droglican) and celecoxib (Celebrex), with 51% of patients overall experiencing treatment-emergent adverse events, Dr. Marc Hochberg reported at the World Congress on Osteoarthritis.
"In a group that is either contraindicated or relatively contraindicated to celecoxib, you get similar efficacy [with Droglican] at 6 months," he said in an interview.
Dr. Hochberg noted that the phase IV (MOVES) Multicentric Osteoarthritis Intervention Study enrolled patients who were consistent with the European label for celecoxib, meaning that those with prior coronary artery disease or peripheral artery disease were excluded, as were those with unstable diabetes or uncontrolled hypertension.
MOVES was designed to extend the findings of the GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial), which suggested in exploratory analyses that combination 1,500 mg daily glucosamine and 1,200 mg daily chondroitin sulfate was effective in the subgroup with moderate to severe knee osteoarthritis pain, but that either agent alone or in combination was not effective in reducing osteoarthritis knee pain in the overall cohort (N. Engl. J. Med. 2006;354:795-808).
MOVES randomly assigned 606 patients in a double-blind, double-dummy fashion to receive either two capsules of Droglican (250 mg glucosamine and 200 mg chondroitin sulfate) three times daily or celecoxib 200 mg plus five placebo capsules per day. Two-thirds of patients (62.6%) had Kellgren-Lawrence grade 2 radiological changes, and 84% were female. Their mean age was 62.7 years.
At 180 days, the mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores in the Droglican and celecoxib groups improved from 372 and 370.6, respectively, to 185.8 and 184.7.
This corresponds to a mean difference of 1.11 units (95% confidence interval, –21.99-19.76; P = .917), which met the noninferiority margin, according to Dr. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore.The results remained robust in sensitivity analyses.
There also were no significant differences between the two groups in the absolute improvement in the WOMAC stiffness and function scales and the five individual items of the WOMAC pain scale at 6 months, Dr. Hochberg reported at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Hochberg reported no conflicts. His coauthors were employees or on the steering committee for Bioiberica, the study sponsor and maker of Droglican.
PARIS – A fixed-dose combination of glucosamine and chondroitin sulfate was as good as the cyclo-oxygenase-2 inhibitor celecoxib in relieving moderate to severe knee pain in patients with knee osteoarthritis in the double-blind, noninferiority MOVES trial.
Side effect profiles and tolerability were also similar with glucosamine/chondroitin (Droglican) and celecoxib (Celebrex), with 51% of patients overall experiencing treatment-emergent adverse events, Dr. Marc Hochberg reported at the World Congress on Osteoarthritis.
"In a group that is either contraindicated or relatively contraindicated to celecoxib, you get similar efficacy [with Droglican] at 6 months," he said in an interview.
Dr. Hochberg noted that the phase IV (MOVES) Multicentric Osteoarthritis Intervention Study enrolled patients who were consistent with the European label for celecoxib, meaning that those with prior coronary artery disease or peripheral artery disease were excluded, as were those with unstable diabetes or uncontrolled hypertension.
MOVES was designed to extend the findings of the GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial), which suggested in exploratory analyses that combination 1,500 mg daily glucosamine and 1,200 mg daily chondroitin sulfate was effective in the subgroup with moderate to severe knee osteoarthritis pain, but that either agent alone or in combination was not effective in reducing osteoarthritis knee pain in the overall cohort (N. Engl. J. Med. 2006;354:795-808).
MOVES randomly assigned 606 patients in a double-blind, double-dummy fashion to receive either two capsules of Droglican (250 mg glucosamine and 200 mg chondroitin sulfate) three times daily or celecoxib 200 mg plus five placebo capsules per day. Two-thirds of patients (62.6%) had Kellgren-Lawrence grade 2 radiological changes, and 84% were female. Their mean age was 62.7 years.
At 180 days, the mean WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores in the Droglican and celecoxib groups improved from 372 and 370.6, respectively, to 185.8 and 184.7.
This corresponds to a mean difference of 1.11 units (95% confidence interval, –21.99-19.76; P = .917), which met the noninferiority margin, according to Dr. Hochberg, head of rheumatology and clinical immunology, University of Maryland, Baltimore.The results remained robust in sensitivity analyses.
There also were no significant differences between the two groups in the absolute improvement in the WOMAC stiffness and function scales and the five individual items of the WOMAC pain scale at 6 months, Dr. Hochberg reported at the meeting, sponsored by the Osteoarthritis Research Society International.
Dr. Hochberg reported no conflicts. His coauthors were employees or on the steering committee for Bioiberica, the study sponsor and maker of Droglican.
AT OARSI 2014
Key clinical point: Patients with moderate to severe knee OA pain who do not have prior coronary artery disease or peripheral artery disease or unstable diabetes or uncontrolled hypertension have similar reductions in pain with either celecoxib 200 mg daily or a combination of 250 mg glucosamine and 200 mg chondroitin sulfate three times daily.
Major finding: Mean WOMAC scores improved in the Droglican and celecoxib groups from 372 and 370.6 at baseline to 185.8 and 184.7 at 180 days.
Data source: A prospective, double-blind, double-dummy trial in 606 patients with moderate to severe knee OA pain.
Disclosures: Dr. Hochberg reported no conflicts. His coauthors were employees or on the steering committee for Bioiberica, the study sponsor and maker of Droglican.
