Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study.
Curr Med Res Opin. 2014 Sep; 30(9):1883-93.CM

Abstract

OBJECTIVE

NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology *), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain.

RESEARCH DESIGN AND METHODS

This double-blind study enrolled patients ≥40 years of age with clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale scores ≥40 mm by visual analog scale and an OA flare (≥15 mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35 mg tid, submicron diclofenac 35 mg bid, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01461369.

MAIN OUTCOME MEASURES

Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 (primary efficacy parameter) and in average total WOMAC score over 12 weeks.

RESULTS

Submicron diclofenac 35 mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks (-44.1; p = 0.0024) compared with placebo (-32.5). Submicron diclofenac 35 mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance (-39.0; p = 0.0795) compared with placebo. Submicron diclofenac 35 mg tid (-35.9; p = 0.0002) and 35 mg bid (-30.3; p = 0.0363) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo (-23.2). The most frequent AEs in the submicron diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (OA 'flare') at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups.

CONCLUSIONS

Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain.

Authors+Show Affiliations

Weill Medical College of Cornell University and Hospital for Special Surgery , New York, NY , USA.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25050589

Citation

Gibofsky, Allan, et al. "Efficacy and Safety of Low-dose Submicron Diclofenac for the Treatment of Osteoarthritis Pain: a 12 Week, Phase 3 Study." Current Medical Research and Opinion, vol. 30, no. 9, 2014, pp. 1883-93.
Gibofsky A, Hochberg MC, Jaros MJ, et al. Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Curr Med Res Opin. 2014;30(9):1883-93.
Gibofsky, A., Hochberg, M. C., Jaros, M. J., & Young, C. L. (2014). Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. Current Medical Research and Opinion, 30(9), 1883-93. https://doi.org/10.1185/03007995.2014.946123
Gibofsky A, et al. Efficacy and Safety of Low-dose Submicron Diclofenac for the Treatment of Osteoarthritis Pain: a 12 Week, Phase 3 Study. Curr Med Res Opin. 2014;30(9):1883-93. PubMed PMID: 25050589.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. AU - Gibofsky,Allan, AU - Hochberg,Marc C, AU - Jaros,Mark J, AU - Young,Clarence L, Y1 - 2014/08/06/ PY - 2014/7/23/entrez PY - 2014/7/23/pubmed PY - 2015/5/30/medline KW - Chronic pain KW - Diclofenac capsules KW - NSAID KW - Osteoarthritis KW - Submicron SP - 1883 EP - 93 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 30 IS - 9 N2 - OBJECTIVE: NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs). Low-dose submicron diclofenac was developed using a new, proprietary dry milling process that creates submicron drug particles (SoluMatrix Fine Particle Technology *), enabling effective treatment at lower doses than other commercially available diclofenac drug products. This phase 3 study evaluated the efficacy and safety of low-dose submicron diclofenac 35 mg three times daily (tid) and twice daily (bid) in patients with OA pain. RESEARCH DESIGN AND METHODS: This double-blind study enrolled patients ≥40 years of age with clinically and radiographically confirmed (Kellgren-Lawrence grade II-III) hip or knee OA. Eligible patients were chronic NSAID and/or acetaminophen (APAP) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale scores ≥40 mm by visual analog scale and an OA flare (≥15 mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening). Patients were randomized to submicron diclofenac 35 mg tid, submicron diclofenac 35 mg bid, or placebo for 12 weeks. ClinicalTrials.gov identifier: NCT01461369. MAIN OUTCOME MEASURES: Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week 12 (primary efficacy parameter) and in average total WOMAC score over 12 weeks. RESULTS: Submicron diclofenac 35 mg tid significantly improved WOMAC pain subscale scores from baseline at 12 weeks (-44.1; p = 0.0024) compared with placebo (-32.5). Submicron diclofenac 35 mg bid provided numerical improvement in pain at week 12 that did not reach statistical significance (-39.0; p = 0.0795) compared with placebo. Submicron diclofenac 35 mg tid (-35.9; p = 0.0002) and 35 mg bid (-30.3; p = 0.0363) improved the average total WOMAC score in treated patients over 12 weeks compared with placebo (-23.2). The most frequent AEs in the submicron diclofenac-treated groups were diarrhea, headache, nausea, and constipation. The inclusion of patients with a documented requirement for analgesic therapy (OA 'flare') at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups. CONCLUSIONS: Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/25050589/Efficacy_and_safety_of_low_dose_submicron_diclofenac_for_the_treatment_of_osteoarthritis_pain:_a_12_week_phase_3_study_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2014.946123 DB - PRIME DP - Unbound Medicine ER -