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Effects of glucosamine sulfate on the use of rescue non-steroidal anti-inflammatory drugs in knee osteoarthritis: Results from the Pharmaco-Epidemiology of GonArthroSis (PEGASus) study.

Abstract

BACKGROUND AND OBJECTIVE

The use of Symptomatic Slow-Acting Drugs in Osteoarthritis (SYSADOAs) may be expected to decrease the use of concomitant medications for rescue analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs). The Pharmaco-Epidemiology of GonArthroSis (PEGASus) study was designed to assess this possibility.

METHODS

PEGASus was a cohort study of continuous recruitment of patients with "dynamic" exposure to the investigated SYSADOA (crystalline glucosamine sulfate, glucosamine hydrochloride, chondroitin sulfate, diacerein, and avocado-soybean unsaponifiables, all at approved dosages). Investigators were rheumatologists or general practitioners randomly selected from French telephone lists. Patients diagnosed with knee osteoarthritis (OA) were recruited when consulting an investigator for a symptom flare and were prescribed, or not, one of the SYSADOAs as per clinical judgment. Follow-up visits were as per routine medical practice in the 12 months following enrollment, with telephone interviews after 1 month and at 4-month intervals thereafter up to 24 months. Use of NSAIDs was recorded, as well as the dynamism of treatment exposure consisting of continuing the prescribed SYSADOA, switching, discontinuation or initiation of a SYSADOA. Patient exposure was expressed in 2-month time units, with any NSAID use as Yes/No binary outcome during each unit. Odds ratios [OR and 95% confidence interval (CI)] of NSAID use were calculated for periods of exposure to each SYSADOA, by multivariate logistic regression for an 80% power and 95% confidence to see a decrease of at least 15%.

RESULTS

This report consists of the full data pertaining to crystalline glucosamine sulfate, while results of other SYSADOAs were summarized as available from the French Health Authority (HAS) website (www.has-sante.fr). Of 6451 patients in the PEGASus cohort, 315 patients received crystalline glucosamine sulfate, they were exposed for 481 2-month time units and had an incident use of NSAIDs of 18.7%. In the control cohort (9237 time units) NSAID incident use was 23.8%. Crystalline glucosamine sulfate significantly decreased the risk of NSAID consumption by up to 36% (OR = 0.64; 95% CI: 0.45-0.92) in the primary analysis foreseen by the protocol; OR was 0.74 (95% CI: 0.54-1.01), i.e. at the very limit of significance, in a sensitivity analysis accounting for an extension of the study and of the control cohort. None of the other SYSADOAs showed any hint of a decrease in the use of NSAIDs.

CONCLUSION

Crystalline glucosamine sulfate was the only SYSADOA that decreased the use of NSAIDs in this pharmaco-epidemiology study in patients with knee OA.

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  • Authors+Show Affiliations

    ,

    Department of Clinical Research, Rottapharm Biotech, Monza, Italy. Electronic address: lucio.rovati@rottapharmbiotech.com.

    ,

    Department of Drug Safety, Rottapharm Biotech, Monza, Italy.

    ,

    Department of Clinical Research, Rottapharm Biotech, Monza, Italy.

    Department of Biostatistics, Rottapharm Biotech, Monza, Italy.

    Source

    Seminars in arthritis and rheumatism 45:4 Suppl 2016 Feb pg S34-41

    MeSH

    Aged
    Aged, 80 and over
    Anti-Inflammatory Agents, Non-Steroidal
    Cohort Studies
    Drug Therapy, Combination
    Evidence-Based Medicine
    Female
    Glucosamine
    Humans
    Male
    Middle Aged
    Osteoarthritis, Knee
    Pain Measurement
    Treatment Outcome

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    26632505

    Citation

    Rovati, Lucio C., et al. "Effects of Glucosamine Sulfate On the Use of Rescue Non-steroidal Anti-inflammatory Drugs in Knee Osteoarthritis: Results From the Pharmaco-Epidemiology of GonArthroSis (PEGASus) Study." Seminars in Arthritis and Rheumatism, vol. 45, no. 4 Suppl, 2016, pp. S34-41.
    Rovati LC, Girolami F, D'Amato M, et al. Effects of glucosamine sulfate on the use of rescue non-steroidal anti-inflammatory drugs in knee osteoarthritis: Results from the Pharmaco-Epidemiology of GonArthroSis (PEGASus) study. Semin Arthritis Rheum. 2016;45(4 Suppl):S34-41.
    Rovati, L. C., Girolami, F., D'Amato, M., & Giacovelli, G. (2016). Effects of glucosamine sulfate on the use of rescue non-steroidal anti-inflammatory drugs in knee osteoarthritis: Results from the Pharmaco-Epidemiology of GonArthroSis (PEGASus) study. Seminars in Arthritis and Rheumatism, 45(4 Suppl), pp. S34-41. doi:10.1016/j.semarthrit.2015.10.009.
    Rovati LC, et al. Effects of Glucosamine Sulfate On the Use of Rescue Non-steroidal Anti-inflammatory Drugs in Knee Osteoarthritis: Results From the Pharmaco-Epidemiology of GonArthroSis (PEGASus) Study. Semin Arthritis Rheum. 2016;45(4 Suppl):S34-41. PubMed PMID: 26632505.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effects of glucosamine sulfate on the use of rescue non-steroidal anti-inflammatory drugs in knee osteoarthritis: Results from the Pharmaco-Epidemiology of GonArthroSis (PEGASus) study. AU - Rovati,Lucio C, AU - Girolami,Federica, AU - D'Amato,Massimo, AU - Giacovelli,Giampaolo, Y1 - 2015/10/29/ PY - 2015/10/20/received PY - 2015/10/23/accepted PY - 2015/12/4/entrez PY - 2015/12/4/pubmed PY - 2016/12/15/medline KW - Glucosamine hydrochloride KW - Glucosamine sulfate KW - Knee osteoarthritis KW - Non-steroidal anti-inflammatory drugs (NSAIDs) KW - Pharmaco-epidemiology KW - SYSADOA SP - S34 EP - 41 JF - Seminars in arthritis and rheumatism JO - Semin. Arthritis Rheum. VL - 45 IS - 4 Suppl N2 - BACKGROUND AND OBJECTIVE: The use of Symptomatic Slow-Acting Drugs in Osteoarthritis (SYSADOAs) may be expected to decrease the use of concomitant medications for rescue analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs). The Pharmaco-Epidemiology of GonArthroSis (PEGASus) study was designed to assess this possibility. METHODS: PEGASus was a cohort study of continuous recruitment of patients with "dynamic" exposure to the investigated SYSADOA (crystalline glucosamine sulfate, glucosamine hydrochloride, chondroitin sulfate, diacerein, and avocado-soybean unsaponifiables, all at approved dosages). Investigators were rheumatologists or general practitioners randomly selected from French telephone lists. Patients diagnosed with knee osteoarthritis (OA) were recruited when consulting an investigator for a symptom flare and were prescribed, or not, one of the SYSADOAs as per clinical judgment. Follow-up visits were as per routine medical practice in the 12 months following enrollment, with telephone interviews after 1 month and at 4-month intervals thereafter up to 24 months. Use of NSAIDs was recorded, as well as the dynamism of treatment exposure consisting of continuing the prescribed SYSADOA, switching, discontinuation or initiation of a SYSADOA. Patient exposure was expressed in 2-month time units, with any NSAID use as Yes/No binary outcome during each unit. Odds ratios [OR and 95% confidence interval (CI)] of NSAID use were calculated for periods of exposure to each SYSADOA, by multivariate logistic regression for an 80% power and 95% confidence to see a decrease of at least 15%. RESULTS: This report consists of the full data pertaining to crystalline glucosamine sulfate, while results of other SYSADOAs were summarized as available from the French Health Authority (HAS) website (www.has-sante.fr). Of 6451 patients in the PEGASus cohort, 315 patients received crystalline glucosamine sulfate, they were exposed for 481 2-month time units and had an incident use of NSAIDs of 18.7%. In the control cohort (9237 time units) NSAID incident use was 23.8%. Crystalline glucosamine sulfate significantly decreased the risk of NSAID consumption by up to 36% (OR = 0.64; 95% CI: 0.45-0.92) in the primary analysis foreseen by the protocol; OR was 0.74 (95% CI: 0.54-1.01), i.e. at the very limit of significance, in a sensitivity analysis accounting for an extension of the study and of the control cohort. None of the other SYSADOAs showed any hint of a decrease in the use of NSAIDs. CONCLUSION: Crystalline glucosamine sulfate was the only SYSADOA that decreased the use of NSAIDs in this pharmaco-epidemiology study in patients with knee OA. SN - 1532-866X UR - https://www.unboundmedicine.com/medline/citation/26632505/Effects_of_glucosamine_sulfate_on_the_use_of_rescue_non_steroidal_anti_inflammatory_drugs_in_knee_osteoarthritis:_Results_from_the_Pharmaco_Epidemiology_of_GonArthroSis__PEGASus__study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-0172(15)00270-X DB - PRIME DP - Unbound Medicine ER -