7 research outputs found

    Efficacy and tolerability of sustained-release ibuprofen in the treatment of patients with chronic back pain

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    This was a double-blind, parallel-group, multiple-dose study designed to compare the efficacy and tolerability of the sustained-release (SR) formulations of ibuprofen and diclofenac sodium for patients suffering from chronic back pain. The patients were randomly allocated to treatment with either the recommended once-daily dosage of ibuprofen SR (1600 mg) or diclofenac SR (100 mg) for 14 days; 30 patients were treated with ibuprofen and 32 with diclofenac. Clinical assessments of the patients' back condition were made at the beginning and end of the study, and the patients themselves rated their quality of sleep, level of activity, and severity of pain each day. In terms of efficacy, the ibuprofen SR treatment resulted in a trend toward better patient responses for all variables other than quality of sleep and night pain, although differences between the two treatment groups were not statistically significant. There were eight patient withdrawals in the diclofenac SR group (six due to adverse events) compared with four patients in the ibuprofen SR group (only one attributed to adverse events). Overall, 16 diclofenac SR-treated patients reported 24 adverse events, 8 of which were recorded as definitely related to the drug. Four ibuprofen SR-treated patients reported a total of nine adverse events, and only three were considered to be definitely drug related. The difference between the groups in the number of patients reporting adverse events was statistically significant (P = 0.002). The demonstrated efficacy and superior tolerability of ibuprofen SR provide strong support for the use of this once-daily formulation in the management of patients with chronic back pain.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

    Assessment of activity limitations with the health assessment questionnaire predicts the need for support measures in patients with rheumatoid arthritis: A multicenter observational study

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    Objective: This study investigated whether the Health Assessment Questionnaire (HAQ) can be used as an instrument to assess the need for social support measures that address activity limitations and participation issues in patients with rheumatoid arthritis (RA). Methods: This multicenter observational study included patients with RA and disease duration of at least one year, consulting their rheumatologist for routine evaluation of disease activity. In the single study visit data on demographics, disease history and current treatment were collected. DAS28 values were collected to evaluate current RA disease activity. Patients were asked to fill out the HAQ and SF-36 questionnaires. Receiver Operator Characteristics (ROC) curves were constructed to evaluate the performance of the HAQ, SF-36 and DAS28 in predicting the need for nine supporting measures available for chronically ill patients in the Belgian social security system. The expert opinion of the treating rheumatologist was used as a reference. Results: The study included 316 patients with a mean age of 59.8±12.6 years, disease duration of 11.4±9.3 years, mean DAS28 values of 2.83±1.17. Mean HAQ score was 0.95±0.73, mean SF-36 score 56.5±21.3. HAQ scores >1 were observed in 39.4% of patients. The area under the HAQ ROC curve was consistently >0.7 and higher for the HAQ than for SF-36 or DAS28 for all support measures. Rheumatologists on average recommended 3.67 support measures. Conclusion: The HAQ score was found to be a good predictor of the need for social support measures in patients with RA.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

    Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial

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    Combining disease-modifying antirheumatic drugs (DMARDs) with glucocorticoids (GCs) is an effective treatment strategy for early rheumatoid arthritis (ERA), yet the ideal schedule and feasibility in daily practice are debated. We evaluated different DMARD combinations and GC remission induction schemes in poor prognosis patients; and methotrexate (MTX) with or without GC remission induction in good prognosis patients, during the first treatment year.status: publishe

    Effectiveness of methotrexate with step-down glucocorticoid remission induction ( COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach:1-year results of CareRA, a randomised pragmatic open-label superiority trial

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    Objectives Combining disease-modifying antirheumatic drugs (DMARDs) with glucocorticoids (GCs) is an effective treatment strategy for early rheumatoid arthritis (ERA), yet the ideal schedule and feasibility in daily practice are debated. We evaluated different DMARD combinations and GC remission induction schemes in poor prognosis patients; and methotrexate (MTX) with or without GC remission induction in good prognosis patients, during the first treatment year.Methods The Care in ERA (CareRA) trial is a 2-year investigator-initiated randomised pragmatic open-label superiority trial comparing remission induction regimens in a treat-to-target approach. DMARD-inexperienced patients with ERA were stratified into a high-risk or low-risk group based upon presence of erosions, disease activity, rheumatoid factor and anticitrullinated protein antibodies. High-risk patients were randomised to a COBRA Classic (MTX + sulfasalazine + prednisone step-down from 60 mg), COBRA Slim (MTX + prednisone step-down from 30 mg) or COBRA Avant Garde (MTX + leflunomide + prednisone step-down from 30 mg) scheme. Low-risk patients were randomised to MTX tight step-up (MTX-TSU) or COBRA Slim. Primary outcome was the proportion of patients in 28 joint disease activity score calculated with C-reactive protein remission at week 52 in an intention-to-treat analysis. Secondary outcomes were safety and effectiveness (ClinicalTrial.gov identifier NCT01172639).Results 98 COBRA Classic, 98 COBRA Slim (high risk), 93 COBRA Avant Garde, 47 MTX-TSU and 43 COBRA Slim (low risk) patients were evaluated. Remission was achieved in 64.3% (63/98) COBRA Classic, 60.2% (59/98) COBRA Slim (high risk) and 62.4% (58/93) COBRA Avant Garde patients at W52 (p=0.840); and in 57.4% (27/47) MTX-TSU and 67.4% (29/43) COBRA Slim (low risk) patients (p=0.329). Less adverse events occurred per patient with COBRA Slim (high risk) compared with COBRA Classic or COBRA Avant Garde (p=0.038). Adverse events were similar in MTX-TSU and COBRA Slim (low risk) patients (p=0.871). At W52, 76.0% patients were on DMARD monotherapy, 5.2% used GCs and 7.5% biologicals.Conclusions MTX with a moderate-dose GC remission induction scheme (COBRA Slim) seems an effective, safe, low-cost and feasible initial treatment strategy for patients with ERA regardless of their prognostic profile, provided a treat-to-target approach is followed.</p

    Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early Rheumatoid Arthritis: week 16 results from the randomized multicenter CareRA trial

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    Considering a lack of efficacy data in patients with early Rheumatoid Arthritis (eRA) presenting without classical poor prognosis markers, we compared methotrexate (MTX) with or without step-down glucocorticoids in the Care for early RA (CareRA) trial.status: publishe
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