Current medical research and opinion
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Multicenter Study
A Phase III study to assess the clinical utility of low-dose fentanyl transdermal system in patients with chronic nonmalignant pain.
The transdermal fentanyl delivery system (fentanyl TTS; Duragesic) is currently widely available in patch strengths of 25, 50, 75, and 100 microg/h. However, a lower dose of 12 microg/h would allow optimal titration and fine tuning of the analgesic effect, and may be beneficial in certain patient populations such as the elderly or opioid-naïve. A 12 microg/h fentanyl TTS patch has been developed, and the clinical efficacy and safety tested in this single-arm, non-randomized, open-label, multicenter, 28-day trial in opioid-exposed and -naïve patients with moderate to severe pain for at least 6 months. ⋯ This trial demonstrated that the lower 12 microg/h dose of fentanyl TTS provided a therapeutic benefit in non-malignant chronic pain, with a similar AE rate but a lower drop-out rate than that seen in trials at higher doses. This lower dose may, therefore, be of particular benefit to elderly or opioid-naïve patients.
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Randomized Controlled Trial Multicenter Study Comparative Study
Rofecoxib 12.5 mg, rofecoxib 25 mg, and celecoxib 200 mg in the treatment of symptomatic osteoarthritis: results of two similarly designed studies.
To compare the efficacy of rofecoxib and celecoxib for the treatment of knee or hip OA over 6 weeks. ⋯ 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.
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Randomized Controlled Trial Multicenter Study
Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial.
This study evaluated the efficacy and safety of tramadol extended-release (tramadol ER) tablets once daily in subjects with osteoarthritis pain. ⋯ Tramadol ER 100-300 mg once daily was associated with significant improvement in pain intensity and physical function, and was well tolerated, despite the use of a fixed-dose study design not reflective of usual clinical practice. Tramadol ER is a useful treatment option for patients with osteoarthritis pain.
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia.
This randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia. ⋯ Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.
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Randomized Controlled Trial Multicenter Study Comparative Study
The impact of migraine on daily activities: effect of topiramate compared with placebo.
Assess the impact of migraine preventive therapy on patient-reported routine daily activities using the Migraine Specific Questionnaire (MSQ) and the Medical Outcomes Study Short Form-36 (SF-36) in patients with migraine who participated in a 26-week, randomized, double-blind, placebo-controlled trial of topiramate for migraine prevention. ⋯ Improvements in patient-reported outcomes specific for migraine (measured by the MSQ) were significantly better for patients receiving topiramate than for those receiving placebo. Improvements in the prospectively selected MSQ and SF-36 domains were significantly correlated with the decrease in mean monthly migraine frequency observed with topiramate treatment.