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Patient Global Assessment (patient + global_assessment)
Selected Abstracts(204) Rofecoxib Was More Effective than Codeine with Acetaminophen in the Treatment of Acute PainPAIN MEDICINE, Issue 3 2001David J. Chang Rofecoxib (VIOXX®) is a selective inhibitor of cyclo-oxygenase-2 and is indicated for the treatment of acute pain. Prior acute pain studies showed similar analgesic efficacy of rofecoxib 50 mg compared with analgesics doses of non-selective NSAIDs. We performed a randomized, double-blind trial to evaluate the efficacy and safety of rofecoxib, a standard fixed formulation of codeine with acetaminophen, and placebo in the treatment of acute pain. Three-hundred ninety-three patients with moderate or severe pain after surgical extraction of at least two 3rd molars were randomized to receive a single dose of rofecoxib 50 mg (n = 182), codeine 60 mg with acetaminophen 600 mg (n = 180), or placebo (n = 31). Efficacy was assessed at 11 pre-specified time points after dosing by pain relief and pain intensity scores. Patient global assessment of study medication was also performed. Baseline characteristics were similar among the groups. The mean age was 21 years; 69.0% were female; and 78.6% had a pain intensity score of "moderate." For the primary endpoint, total pain relief over 6 hours, rofecoxib was more effective than codeine/acetaminophen (p < 0.001) and placebo (p < 0.001). Proportion of patients who rated the study medication as good, very good, or excellent at 6 hours was 64.6% on rofecoxib, 36.4% on codeine/acetaminophen, and 10.3% on placebo (rofecoxib> codeine/acetaminophen; p < 0.001). The time to rescue medication was longer for rofecoxib compared to codeine/acetaminophen (p < 0.001). More patients on codeine/acetaminophen experienced clinical adverse events than rofecoxib (p < 0.05). Patients receiving codeine/acetaminophen versus rofecoxib had higher incidences of nausea (25.0% vs 6.0%; p < 0.001) and vomiting (18.3% vs 3.8%; p < 0.001). In this study, rofecoxib had superior efficacy and gastrointestinal safety compared to codeine/acetaminophen, which provides support for the use of rofecoxib as an alternative option to opioid analgesics in the treatment of acute post-surgical pain. [source] Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasisBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2008D. Revicki Summary Background, Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) are important in evaluating the impact of psoriasis and its treatment. Objectives, To assess the impact of adalimumab treatment on HRQOL and other PROs in patients with moderate to severe psoriasis. Methods, A 16-week, double-blind, double-dummy, randomized controlled trial evaluated the efficacy and safety of adalimumab in 271 adults with moderate to severe chronic plaque psoriasis. Patients were randomized in a 2 : 2 : 1 ratio to adalimumab, methotrexate (MTX) or placebo. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity, plaque psoriasis and psoriatic arthritis pain visual analogue scale (VAS), Psoriasis-Related Pruritus Assessment and EuroQOL 5D (EQ-5D). Results, Statistically significant differences were observed between the adalimumab- and placebo-treated and the MTX-treated groups on mean DLQI total scores during the 16-week double-blind study (both P < 0·001). Significant differences, favouring adalimumab compared with placebo, were also observed on the Patient's Global Assessment of disease severity (P < 0·001), VAS for pain (P < 0·001), Psoriasis-Related Pruritus Assessment (P < 0·001), EQ-5D VAS (P < 0·001) and EQ-5D index score (P < 0·01). Compared with MTX, adalimumab resulted in statistically significantly greater improvements in the Patient's Global Assessment of disease severity (P < 0·001), the VAS for pain (P < 0·01) and the Psoriasis-Related Pruritus Assessment (P < 0·001). Conclusions, Adalimumab was efficacious in improving dermatology-specific HRQOL, disease control and symptom outcomes in patients with moderate to severe psoriasis. [source] Efficacy and Safety of Rofecoxib 12.5 mg Versus Nabumetone 1,000 mg in Patients with Osteoarthritis of the Knee: A Randomized Controlled TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2004Alan J. Kivitz MD Objectives: To evaluate the use of starting doses of rofecoxib and nabumetone in patients with osteoarthritis (OA) of the knee. Design: A 6-week, randomized, parallel-group, double-blind, placebo-controlled study. Setting: One hundred thirteen outpatient sites in the United States. Participants: A total of 1,042 male and female patients aged 40 and older with OA of the knee (>6 months). Interventions: Rofecoxib 12.5 mg once a day (n=424), nabumetone 1,000 mg once a day (n=410), or placebo (n=208) for 6 weeks. Measurements: The primary efficacy endpoint was patient global assessment of response to therapy (PGART) over 6 weeks, which was also specifically evaluated over the first 6 days. The main safety measure was adverse events during the 6 weeks of treatment. Results: The percentage of patients with a good or excellent response to therapy as assessed using PGART at Week 6 was significantly higher with rofecoxib (55.4%) than nabumetone (47.5%; P=.018) or placebo (26.7%; P<.001 vs rofecoxib or nabumetone). Median time to first report of a good or excellent PGART response was significantly shorter in patients treated with rofecoxib (2 days) than with nabumetone (4 days, P=.002) and placebo (>5 days, P<.001) (nabumetone vs placebo; P=.007). The safety profiles of rofecoxib and nabumetone were generally similar, including gastrointestinal, hypertensive, and renal adverse events. Conclusion: Rofecoxib 12.5 mg daily demonstrated better efficacy over 6 weeks of treatment and quicker onset of OA efficacy over the first 6 days than nabumetone 1,000 mg daily. Both therapies were generally well tolerated. [source] Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: Results of the two-year multinational knee osteoarthritis structural arthritis studyARTHRITIS & RHEUMATISM, Issue 11 2006Clifton O. Bingham III Objective Bisphosphonates have slowed the progression of osteoarthritis (OA) in animal models and have decreased pain in states of high bone turnover. The Knee OA Structural Arthritis (KOSTAR) study, which is the largest study to date investigating a potential structure-modifying OA drug, tested the efficacy of risedronate in providing symptom relief and slowing disease progression in patients with knee OA. Methods The study group comprised 2,483 patients with medial compartment knee OA and 2,4 mm of joint space width (JSW), as determined using fluoroscopically positioned, semiflexed-view radiography. Patients were enrolled in 2 parallel 2-year studies in North America and the European Union. These studies evaluated the efficacy of risedronate at dosages of 5 mg/day, 15 mg/day, 35 mg/week (in Europe), and 50 mg/week (in North America) compared with placebo in reducing signs and symptoms, as measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and patient global assessment (PGA) scores, and in slowing radiographic progression. Results A reduction of ,20% in signs and symptoms, as measured by WOMAC subscales and PGA scores, was observed in all groups, with no treatment effect of risedronate demonstrated. Risedronate did not significantly reduce radiographic progression as measured by decreased JSW or using a dichotomous definition of progression (joint space loss of ,0.6 mm). Thirteen percent of patients receiving placebo demonstrated significant disease progression over 2 years. A dose-dependent reduction in the level of C-terminal crosslinking telopeptide of type II collagen, a cartilage degradation marker associated with progressive OA, was seen in patients who received risedronate. No increase in the number of adverse events was demonstrated for risedronate compared with placebo. Conclusion Although risedronate (compared with placebo) did not improve signs or symptoms of OA, nor did it alter progression of OA, a reduction in the level of a marker of cartilage degradation was observed. A sustained clinically relevant improvement in signs and symptoms was observed in all treatment and placebo groups. [source] Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trialBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2005G.G. Krueger Summary Background, Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life. Objectives, To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy. Methods, In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form-36 Health Survey (SF-36), patient rating of pruritus, and patient global assessment of psoriasis. Results, At week 12, DLQI total score improved by 65,70% in patients receiving etanercept compared with 6% in patients receiving placebo (P < 0·0001), and improvement in DLQI was clinically meaningful (, 5-point improvement or 0 score) for 72,77% of patients receiving etanercept therapy. All DLQI and SF-36 subscales and the SF-36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks. Conclusions, Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician-reported clinical measures while providing a more complete understanding of the benefits experienced by patients with psoriasis treated with etanercept. [source] Non-ablative 1,550,nm fractional laser therapy versus triple topical therapy for the treatment of melasma: A randomized controlled split-face study,,LASERS IN SURGERY AND MEDICINE, Issue 7 2010Bas S. Wind MD Abstract Background Melasma is a uichronic, often relapsing skin disorder, with poor long-term results from all current therapies. Objective To assess efficacy and safety of non-ablative 1,550,nm fractional laser therapy (FLT) as compared to the gold standard, triple topical therapy (TTT). Study design Twenty-nine patients with melasma were included in a randomized controlled observer-blinded study with split-face design. Each side of the face was randomly allocated to either 4,5 non-ablative FLT sessions (15,mJ/microbeam, 14,20% coverage) or TTT (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream). TTT was applied once daily for 15 weeks until the last FLT session. After this last treatment, patients were asked to apply TTT twice weekly on both sides of the face during follow-up. Improvement of melasma was assessed by patient's global assessment (PGA), patient's satisfaction, physician's global assessment (PhGA), melanin index, and lightness (L -value) at 3 weeks, and at 3 and 6 months after the last treatment. Results Mean PGA and satisfaction were significantly lower at the FLT side (P<0.001). PhGA, melanin index, and L -value showed a significant worsening of hyperpigmentation at the FLT side. At the TTT side, no significant change was observed. At 6 months follow-up, most patients preferred TTT. Side effects of FLT were erythema, burning sensation, edema, and pain. Nine patients (31%) developed PIH after two or more laser sessions. Side effects of TTT were erythema, burning sensation, and scaling. Conclusions Given the high rate of postinflammatory hyperpigmentation, non-ablative 1,550,nm fractional laser at 15,mJ/microbeam is not recommendable in the treatment of melasma. TTT remains the gold standard treatment. Lasers Surg. Med. 42:607,612, 2010. © 2010 Wiley-Liss, Inc. [source] Rapamycin versus methotrexate in early diffuse systemic sclerosis: Results from a randomized, single-blind pilot studyARTHRITIS & RHEUMATISM, Issue 12 2009Tien-I Karleen Su Objective To assess the safety and efficacy of rapamycin in the treatment of diffuse systemic sclerosis (SSc; scleroderma). Methods Eighteen patients with diffuse SSc of ,5 years duration were randomized to receive rapamycin or methotrexate (MTX) in a single-blind, 48-week study. Abnormalities in clinical and laboratory parameters were compared between the 2 treatment groups. The potential efficacy of the study drugs was evaluated by comparing results of the baseline and 48-week assessments, including the modified Rodnan skin thickness score (MRSS) and the Health Assessment Questionnaire disability index. Results The baseline characteristics of the patients were similar in both groups (n = 9 in each). One patient in the rapamycin group who never received the study drug was excluded from the analysis. Three patients in each group withdrew from the study; 2 of the withdrawals were treatment-related (severe hypertriglyceridemia associated with rapamycin, and pancytopenia associated with MTX), and 4 were SSc-related. Hypertriglyceridemia was the most notable side effect associated with rapamycin, but it was generally well tolerated and treatable. The incidence and severity of other adverse drug reactions were comparable between the 2 groups. Within each group, the MRSS improved significantly from baseline. In the rapamycin group, the patient's global assessment showed a significant improvement from baseline, while forced vital capacity values declined from baseline. The disease activity scores at 48 weeks and the changes in these scores from baseline were not significantly different between the 2 groups. Conclusion Rapamycin has a reasonable safety profile in a select group of patients with scleroderma. Larger trials are needed to assess the efficacy of rapamycin in patients with early diffuse SSc. [source] Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenonARTHRITIS & RHEUMATISM, Issue 9 2002Peter A. Merkel Objective To document disease activity and functional status in patients with scleroderma (systemic sclerosis [SSc]) and Raynaud's phenomenon (RP) and to determine the sensitivity to change, reliability, ease of use, and validity of various outcome measures in these patients. Methods Patients with SSc and moderate-to-severe RP participating in a multicenter RP treatment trial completed daily diaries documenting the frequency and duration of RP attacks and recorded a daily Raynaud's Condition Score (RCS). Mean scores for the 2-week periods prior to baseline (week 0), end of trial (week 6), and posttrial followup (week 12) were calculated. At weeks 0, 6, and 12, physicians completed 3 global assessment scales and performed clinical assessments of digital ulcers and infarcts; patients completed the Health Assessment Questionnaire (HAQ), the Arthritis Impact Measurement Scales 2 (AIMS2) mood and tension subscales, 5 specific SSc/RP-related visual analog scales (VAS), and 3 other VAS global assessments. We used these measures to document baseline disease activity and to assess their construct validity, sensitivity to change, and reliability in trial data. Results Two hundred eighty-one patients (248 women, 33 men; mean age 50.4 years [range 18,82 years]) from 14 centers participated. Forty-eight percent had limited cutaneous SSc; 52% had diffuse cutaneous SSc. Fifty-nine patients (21%) had digital ulcers at baseline. Patients had 3.89 ± 2.33 (mean ± SD) daily RP attacks (range 0.8,14.6), with a duration of 82.1 ± 91.6 minutes/attack. RCS for RP activity (possible range 0,10) was 4.30 ± 1.92. HAQ scores (0,3 scale) indicated substantial disability at baseline (total disability 0.86, pain 1.19), especially among the subscales pertaining to hand function (grip, eating, dressing). AIMS2 mood and tension scores were fairly high, as were many of the VAS scores. Patients with digital ulcers had worse RCS, pain, HAQ disability (overall, grip, eating, and dressing), physician's global assessment, and tension, but no significant difference in the frequency of RP, duration of RP, patient's global assessment, or mood, compared with patients without digital ulcers. VAS scores for digital ulcers as rated by the patients were not consistent with the physician's ratings. Factor analysis of the 18 measures showed strong associations among variables in 4 distinct domains: disease activity, RP measures, digital ulcer measures, and mood/tension. Reliability of the RCS, HAQ pain and disability scales, and AIMS2 mood and tension subscales was high. The RP measures demonstrated good sensitivity to change (effect sizes 0.33,0.76). Conclusion Our findings demonstrate that the significant activity, disability, pain, and psychological impact of RP and digital ulcers in SSc can be measured by a small set of valid and reliable outcome measures. These outcome measures provide information beyond the quantitative metrics of RP attacks. We propose a core set of measures for use in clinical trials of RP in SSc patients that includes the RCS, patient and physician VAS ratings of RP activity, a digital ulcer/infarct measure, measures of disability and pain (HAQ), and measures of psychological function (AIMS2). [source] | ||||||||||