Articles: analgesics.
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Int. J. Clin. Pract. · Aug 2010
Multicenter Study Clinical TrialA prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America.
The objective of this study was to evaluate the safety and efficacy of pregabalin at flexible doses of 150-600 mg/day in Latin American patients with neuropathic pain. ⋯ Flexible-dose pregabalin (150-600 mg/day) significantly reduced pain and anxiety and improved sleep and was generally well tolerated in Latin American patients with neuropathic pain.
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Multicenter Study
[Long-term efficacy and safety of pregabalin in patients with postherpetic neuralgia: results of a 52-week, open-label, flexible-dose study].
The efficacy of pregabalin was demonstrated in a randomized double-blind placebo-controlled 13-week trial in 371 Japanese patients with postherpetic neuralgia (PHN). In this study, we evaluated the long-term efficacy and safety of pregabalin for relief of PHN. ⋯ These results suggest that long-term treatment of pregabalin may be beneficial in patients with PHN.
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Randomized Controlled Trial Multicenter Study
Exposure-response analyses of the effects of pregabalin in patients with fibromyalgia using daily pain scores and patient global impression of change.
Data from 4 phase 2/3 studies were pooled to characterize the exposure response of daily pregabalin (150-600 mg) in patients with fibromyalgia using self-assessed daily pain scores (PAIN) and end-of-treatment patient global impression of change (PGIC). The exposure responses of both endpoints were characterized by an Emax model using nonlinear mixed-effects modeling (NONMEM). Drug effect on PAIN relative to placebo was significant with additional maximum effect of 1.51 points on the logit scale and EC50 of 1.54 ng/mL (dose of 174 mg) and a rapid onset (half-life of 11 hours), consistent with the half-life of the drug. ⋯ Drug response in fibromyalgia was dependent on age and sex, with greater PAIN reduction in older patients, in addition to the effect of creatinine clearance, and in females. For PGIC, administration of pregabalin resulted in an increase in the proportion of patients reporting improvement with an ED50 of 228 mg. The analyses support the recommended dose of pregabalin in patients with fibromyalgia of 300 to 450 mg/d.
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Postgraduate medicine · Jul 2010
Randomized Controlled Trial Multicenter StudyMorphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain.
To assess the efficacy and safety of morphine sulfate and naltrexone hydrochloride extended release capsules (EMBEDA; MS-sNT), which contain morphine sulfate pellets with a sequestered naltrexone core, in treating patients with chronic, moderate-to-severe osteoarthritis (hip or knee) pain. ⋯ MS-sNT provided effective analgesia in patients with chronic, moderate-to-severe osteoarthritis pain, with a safety profile typical of morphine-containing products. Naltrexone sequestered in MS-sNT had no clinically relevant effect when MS-sNT was taken as directed.
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Randomized Controlled Trial Multicenter Study
Treatment of restless legs syndrome with pregabalin: a double-blind, placebo-controlled study.
To assess the therapeutic efficacy, required dose, and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS). ⋯ This study provides Class II evidence that pregabalin is effective for the treatment of restless legs syndrome and improves sleep architecture and periodic limb movements in placebo-unresponsive patients.