Clinical therapeutics
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Multicenter StudyFentanyl buccal tablet for the relief of breakthrough pain in opioid-tolerant adult patients with chronic neuropathic pain: a multicenter, randomized, double-blind, placebo-controlled study.
Patients with chronic noncancer pain, including neuropathic pain, may have transitory exacerbations of pain (median duration, 60 minutes), termed breakthrough pain (BTP), that may reach peak intensity within minutes. Typical short-acting oral opioids may not provide sufficiently rapid relief (30- to 60-minute onset of analgesia). The fentanyl buccal tablet (FBT) provides a rapid onset of analgesia (10-15 minutes) by enhancing fentanyl absorption across the buccal mucosa. ⋯ In these opioid-tolerant patients with chronic neuropathic pain who identified an effective FBT dose, FBT had a rapid onset of action and was effective and well tolerated in the treatment of BTP.
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Multicenter Study Comparative StudyTwo multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the efficacy and tolerability of amlodipine and valsartan in combination and as monotherapy in adult patients with mild to moderate essential hypertension.
Patients with hypertension may require combination therapy to attain the blood pressure targets recommended by US and European treatment guidelines. Combination therapy with a calcium channel blocker and an angiotensin II-receptor blocker would be expected to provide enhanced efficacy. ⋯ In these adult patients with mild to moderate hypertension, the combination of amlodipine + valsartan was associated with significantly greater blood pressure reductions from baseline compared with amlodipine or valsartan monotherapy or placebo. The incidence of peripheral edema was significantly lower with combination therapy than with amlodipine monotherapy.
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Clinical therapeutics · Apr 2007
Randomized Controlled Trial Comparative StudyCodeine/acetaminophen and hydrocodone/acetaminophen combination tablets for the management of chronic cancer pain in adults: a 23-day, prospective, double-blind, randomized, parallel-group study.
Analgesics are an essential component of the treatment of cancer-associated pain. Pharmacologic treatment is usually begun with nonopioid analgesics, most frequently acetaminophen. If pain relief is not achieved, the so-called "weak" opioids, such as codeine and hydrocodone, may be used in combination with acetaminophen. Adverse effects (AEs) of the opioids include constipation, somnolence, nausea, and vomiting. Based on the results of a literature search, data comparing the effects of the opioids are lacking. ⋯ In this study, efficacy and tolerability were comparable between C/A and H/A over 23 days of treatment in these patients with moderate or severe, chronic, cancer-related pain.
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Clinical therapeutics · Apr 2007
Meta AnalysisFormation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: a pooled-data analysis of three clinical trials.
The purpose of this study was to investigate the incidence of neutralizing antibody (NAb) formation in patients with poststroke spasticity treated with a specific formulation of botulinum toxin type A (BoNTA). ⋯ Formation of NAbs was rare (1/191) in this group of adults with poststroke spasticity from three 12- to 42-week clinical trials who received >/=1 treatment with a specific BoNTA formulation at doses ranging from 100 to 400 U.