Managing osteoarthritic knee pain.

Osteoarthritis is one of the most common forms of arthritis seen in primary care practice. Pain associated with this condition is the chief complaint of most patients, prompting them to seek medical attention. Pain can originate from the synovial membrane, joint capsule, periarticular muscles and ligaments, and periosteum and subchondral bone, among other sources. Although osteoarthritis is traditionally thought of as a noninflammatory type of arthritis, inflammatory mechanisms can be present. Therefore, management of osteoarthritic pain involves both nonpharmacologic and pharmacologic modes of therapy. Nonpharmacologic approaches include osteopathic manipulative treatment, physical therapy, exercise, use of assistive devices, and weight reduction. Pharmacologic options may be topical, intra-articular, or oral in route of administration and include acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids. Patients often benefit from combinations of therapeutic modalities. Although pain relief is a chief motivator for patients with osteoarthritis to seek medical attention, a secondary benefit of successful treatment is slowing the decrease in patients' quality of life.

Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout.

BACKGROUND AND OBJECTIVE: Disease history and clinical features can influence treatment response in patients with acute gout. The purpose of this pooled subgroup analysis was to assess the association of baseline disease and patient characteristics with response to treatment in acute gout using data from two identical studies. METHODS: Patients > or = 18 years of age with onset of acute gout within 48 h associated with moderate, severe, or extreme pain involving less than four joints were eligible for inclusion in the primary studies, and were randomized to etoricoxib 120 mg once daily (N = 178) or indomethacin 50 mg three times daily (N = 161). The primary and secondary efficacy endpoints were analyzed using an analysis of covariance model to detect potential differential treatment responses across several subgroups: joint involvement (mono-articular vs. oligo-articular), baseline pain severity (moderate vs. severe), concomitant allopurinol and/or colchicine use (users vs. nonusers), age (< 45, 45-55, and > 55 years), gender, and race (white or other). RESULTS: Overall, etoricoxib and indomethacin demonstrated comparable efficacy across all subgroups. Compared with patients with oligo-articular disease, those with mono-articular disease had significantly greater improvements in patient assessment of pain, patient global assessment of response to therapy (PGART), investigator global assessment of response to therapy (IGART), and study joint tenderness (p < 0.001 for all). Greater improvements were seen in patient assessment of pain (p < 0.001) and study joint tenderness (p < 0.05) for severe/extreme baseline pain compared with moderate baseline pain. Concomitant use of colchicine and/or allopurinol was associated with significantly worse IGART (p < 0.05). CONCLUSIONS: This pooled subgroup analysis demonstrated significantly greater response of acute gout to either etoricoxib or indomethacin among those with monoarticular disease, severe/extreme baseline pain, and non-use of colchicine and/or allopurinol. These results should be interpreted in the context of a pooled subgroup analysis with a limited sample size, and with the understanding that associations identified in such analyses do not define causation. Despite limitations, the results provide insights into the types of patients more likely to respond better to anti-inflammatory medication, and reiterate the importance of earlier effective control of the disease.

Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies.

OBJECTIVE: To compare the efficacy of rofecoxib and celecoxib for the treatment of knee or hip OA over 6 weeks. METHODS: Two similarly designed, multicenter, randomized, double-blind, placebo-controlled studies. Patients were randomly assigned 3:3:3:1 in Study 1 to once daily (QD) rofecoxib 12.5 mg (N = 456), rofecoxib 25 mg (N = 459), celecoxib 200 mg (N = 456), or placebo (N = 150) and 3:3:1 in Study 2 to QD rofecoxib 25 mg (N = 471), celecoxib 200 mg (N = 460), or placebo (N = 151). There was no rofecoxib 12.5 mg arm in Study 2. The primary outcome measure of both studies was pain at night over 6 weeks for rofecoxib 25 mg vs. celecoxib 200 mg. Efficacy comparisons with rofecoxib 12.5 mg in Study 1 were included as pre-specified study objectives but not as pre-specified study hypotheses. Secondary endpoints included Patient Global Assessment of Response to Therapy (PGART) over 6 weeks and over 1 week. Safety was evaluated through the assessment of spontaneously reported adverse experiences (AEs), evaluation of vital signs, and laboratory data reported by investigators and patients. RESULTS: For the primary endpoint, reduction in pain at night over 6 weeks in Study 1 was not significantly different between active treatments; in Study 2 rofecoxib 25 mg significantly (p = 0.023) reduced pain at night compared with celecoxib 200 mg over 6 weeks. For the secondary endpoints, in both studies, significantly (p < 0.05) more patients treated with rofecoxib 25 mg than celecoxib 200 mg had a good or excellent PGART over 6 weeks, and over the first week (p < 0.01). In both studies, there were no significant differences between active medications in the incidence of reported overall, serious, or drug-related AEs. The reported AE rates with the active treatments were generally similar to those with placebo in the two studies. CONCLUSIONS: Rofecoxib 25 mg was significantly better than celecoxib 200 mg in relieving night pain at 6 weeks in one study; this was not confirmed in the accompanying study.

Management of osteoarthritic knee pain.

Osteoarthritis (OA) is one of the most common forms of arthritis seen in primary care practice. The pain associated with this condition is the chief complaint of most patients, prompting them to seek medical attention. Pain can originate from the synovial membrane, joint capsule, periarticular muscles and ligaments, and periosteum and subchondral bone, among other sources. Osteoarthritis is traditionally thought of as a noninflammatory type of arthritis; however, inflammatory mechanisms can be present. Therefore, the management of osteoarthritic pain involves nonpharmacologic modes of therapy as well as pharmacologic agents. Nonpharmacologic therapeutic modalities include osteopathic manipulative treatment, physical therapy, exercise, use of assistive devices, and weight reduction. Pharmacologic options, categorized as topical, intra-articular, or oral, include acetaminophen, nonsteroidal anti-inflammatory agents, and cyclooxygenase type 2 inhibitors. Patients often benefit from use of a combination of these therapeutic modalities. Although pain relief is a chief motivator for patients with OA to seek medical attention, a secondary benefit of successful treatment is to delay the decreased quality of life associated with osteoarthritic pain.

Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout. METHODS: A randomized, double-blind, active-comparator study was conducted at 42 sites. A total of 189 men and women (> or =18 years of age) who were experiencing an acute attack (< or =48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n = 103), or indomethacin, 50 mg 3 times a day (n = 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial. RESULTS: Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P = 0.46), which fell within the prespecified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacin-treated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05). CONCLUSION: Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.

An analysis of osteoporosis-related hip fractures using hospital discharge data.

The purpose of this study was to assess whether physicians in practice inadequately diagnose osteoporosis in a high-risk population of postmenopausal women who have sustained hip fractures. Using the Texas Hospital Discharge Data-Public Use Data File (PUDF) provided through the Texas Health Care Information Council, the authors conducted a review of all postmenopausal women older than 55 years with fractured hips discharged from Texas hospitals during 1999. A total of 13,628 patients meeting these criteria were found using the PUDF. In their diagnoses, physicians for 2233 (16.3%) of these 13,628 women also specified the code for osteoporosis (P < .001) from the ninth revision of the International Classification of Diseases. It is estimated that between 40% and 50% of postmenopausal women have osteoporosis. Therefore, women with fragility fractures form an even more at-risk subset of the population--so much so that one would expect a majority of these women to carry diagnoses of osteoporosis. The age distribution in each group was comparable, implying that receiving a coded diagnosis for osteoporosis was not related to the age of the patient when she was admitted to the hospital. Further, when data was analyzed by race or ethnicity, percentages for each group (ie, diagnosed with hip fracture only versus diagnosed with hip fracture and osteoporosis) were comparable. In conclusion, physicians practicing in Texas during calendar year 1999 inadequately diagnosed osteoporosis in a high-risk population of postmenopausal women who were admitted to hospitals with fractured hips. Future analysis of subsequent annual databases will identify whether continuing medical education efforts cause physicians to diagnosis osteoporosis in this high-risk population more frequently.