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Once-daily, controlled-release tramadol and sustained-release diclofenac relieve chronic pain due to osteoarthritis: A randomized controlled trial.

Pain Res Manag. 2008 Mar-Apr;13(2):103-10

Authors: Beaulieu AD, Peloso PM, Haraoui B, Bensen W, Thomson G, Wade J, Quigley P, Eisenhoffer J, Harsanyi Z, Darke AC

OBJECTIVE: The present study was a randomized, parallel, double-blind comparison between controlled-release (CR) tramadol and sustained-release (SR) diclofenac in patients with chronic pain due to osteoarthritis of the hips and/or knees. METHODS: Patients with at least moderate pain intensity, and having received analgesics over the past three months, underwent a two- to seven-day washout of current analgesics before initiation of 200 mg CR tramadol or 75 mg SR diclofenac. During the eight-week study, patients returned to the clinic biweekly. CR tramadol doses were titrated to a maximum of 200 mg, 300 mg or 400 mg per day. SR diclofenac doses were titrated to 75 mg or 100 mg once daily, or 75 mg twice a day based on pain relief and the presence of side effects. For rescue analgesic, patients took acetaminophen as needed, up to 650 mg three times a day. RESULTS: Forty-five patients on CR tramadol and 52 patients on SR diclofenac were evaluable. Significant improvements from prestudy treatment were shown for visual analogue scale pain (P=0.0001), stiffness (P<0.0005) and physical function (P=0.0001) scores for both treatments. There were no significant differences between the two treatments in the Western Ontario and McMaster Universities subscales, overall pain, pain and sleep, or the clinical effectiveness evaluation. Overall incidence of adverse events was similar in both groups, with more opioid-related adverse events with CR tramadol, and two serious adverse events occurring with the use of SR diclofenac. CONCLUSIONS: CR tramadol is as effective as SR diclofenac in the treatment of pain due to knee or hip osteoarthritis, with the potential for fewer of the serious side effects that characterize nonsteroidal anti-inflammatory drug administration.

PMID: 18443672 [PubMed - in process]

(Source: Pain Research and Management)

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A randomized, double-blind, crossover comparison of the efficacy and safety of oral controlled-release tramadol and placebo in patients with painful osteoarthritis.

Pain Res Manag. 2008 Mar-Apr;13(2):93-102

Authors: Thorne C, Beaulieu AD, Callaghan DJ, O'Mahony WF, Bartlett JM, Knight R, Kraag GR, Akhras R, Piraino PS, Eisenhoffer J, Harsanyi Z, Darke AC

OBJECTIVE: To compare the efficacy and safety of controlled-release (CR) tramadol (Zytram XL, Purdue Pharma, Canada) and placebo in patients with painful osteoarthritis. METHODS: Patients underwent analgesic washout for two to seven days before random assignment to 150 mg daily of CR tramadol or placebo, and were titrated weekly to 200 mg, 300 mg or a maximum of 400 mg once daily. After four weeks, patients crossed over to the alternate treatment for another four weeks. Plain acetaminophen was provided as a rescue analgesic. All patients who completed the crossover study were eligible to receive open label CR tramadol for six months. RESULTS: Seventy-seven of 100 randomly assigned patients were evaluable for efficacy. CR tramadol resulted in significantly lower visual analogue scale pain intensity scores (37.4+/-23.9 versus 45.1+/-24.3, P=0.0009). Western Ontario and McMaster Universities osteoarthritis index subscale scores for pain (189.0+/-105.0 versus 230.0+/-115.4; P=0.0001) and physical function (632.4+/-361.3 versus 727.4+/-383.4; P=0.0205) were significantly better with CR tramadol. Total pain and disability (22.8+/-14.5 versus 27.2+/-14.8; P=0.0004), and overall pain and sleep (104.7+/-98.0 versus 141.0+/-108.2; P=0.0005) scores in the Pain and Sleep Questionnaire were significantly lower for CR tramadol. Short-form 36 Health Survey scores were significantly better during CR tramadol treatment for the pain index (38.8+/-10.8 versus 35.6+/-9.0; P=0.0100), general health perception (46.5+/-11.2 versus 44.4+/-11.6; P=0.0262), vitality (43.1+/-13.2 versus 40.2+/-13.7; P=0.0255) and overall physical components (40.8+/-8.9 versus 37.8+/-7.7; P=0.0002). CR tramadol treatment was preferred by 55.8% of patients (P=0.0005) versus 20.8% and 23.4% of patients who chose placebo or had no preference, respectively. These improvements were sustained for up to six months, and 86.5% of patients reported at least moderate benefit from CR tramadol during long-term treatment. CONCLUSION: CR tramadol is effective for the management of painful osteoarthritis.

PMID: 18443671 [PubMed - in process]

(Source: Pain Research and Management)

While there is an inexpensive, generic medication that can stop severe pain and the need for blood transfusions associated with sickle cell disease, few patients receive the treatment, Reuters reports. An NIH consensus panel discussed the issue on Wednesday.

Systemic lupus erythematosus (SLE), commonly known as lupus, can affect nearly any part of the body, including the joints, skin, kidneys, heart, nervous system, and brain. Along with joint pain, muscle pain, unexplained fever, extreme fatigue, and skin rashes, neurologic and psychiatric events often accompany this autoimmune disease. Depending on the study, between 37 and 95 percent of SLE patients experience signs and symptoms of neuropsychiatric (NP) disease.

Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, announced that a New Drug Application (NDA) has been submitted for EMBEDA?, a pharmacological abuse-deterrent, extended-release morphine product candidate. "Today's announcement is an important one for all stakeholders in Alpharma," commented Dean Mitchell, President and Chief Executive Officer.

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Milestone Scientific Inc. (OTC Bulletin Board: MLSS), the recognized leader in advanced injection technologies, reported that earlier this month the Company hosted the First International Computer-Controlled Local Anesthetic Delivery (CCLAD) Summit in New Orleans.

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