Clinical therapeutics
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Clinical therapeutics · Sep 2010
Cost-effectiveness analysis of tapentadol immediate release for the treatment of acute pain.
Tapentadol immediate-release (IR) tablets are indicated for the treatment of moderate to severe acute pain. In clinical trials, tapentadol IR effectively reduced moderate to severe pain with improved tolerability compared with oxycodone IR at doses providing comparable analgesia. ⋯ The results of this model suggest that at doses providing comparable analgesia, tapentadol IR is a cost-effective alternative to oxycodone IR for the treatment of acute surgical and nonsurgical pain.
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Clinical therapeutics · Aug 2010
Randomized Controlled Trial Multicenter StudySafety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study.
Esreboxetine is an investigational, highly selective norepinephrine reuptake inhibitor that has been reported to have antinociceptive effects in preclinical pain models. ⋯ In this 8-week trial in patients with fibromyalgia, esreboxetine was associated with significant reductions in pain scores compared with placebo. It was also associated with improvements in outcomes relevant to fibromyalgia, including the PGIC, function, and fatigue. ClinicalTrials.gov identifier: NCT00357825.
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Clinical therapeutics · Aug 2010
Randomized Controlled Trial Comparative StudyA prospective, randomized, double-blind, placebo-controlled study to assess the antiemetic effects of midazolam on postoperative nausea and vomiting in women undergoing laparoscopic gynecologic surgery.
Postoperative nausea and vomiting (PONV) are distressing and frequent adverse effects (AEs) in women undergoing laparoscopic gynecologic surgery. Midazolam has been reported to be effective for preventing PONV in adults undergoing middle ear surgery and children undergoing strabismus surgery or tonsillectomy. ⋯ Midazolam 50 μg/kg was not significantly different from midazolam 75 μg/kg in the incidence of PONV, and both doses were associated with significantly less PONV compared with placebo during the first 24 hours after anesthesia in these Japanese women undergoing laparoscopic gynecologic surgery.
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Clinical therapeutics · Jul 2010
Randomized Controlled Trial Multicenter Study Comparative StudyTriple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study.
Patients with hypertension may require a combination of > or =2 antihypertensive agents to achieve blood pressure (BP) control. ⋯ In these adult patients with moderate to severe hypertension, triple combination treatment with OM 40 mg + AML 10 mg + HCTZ 25 mg was associated with significant BP reductions compared with dual combinations of the individual components. All treatments were generally well tolerated. ClinicalTrials. gov identifier: NCT00649389.
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Clinical therapeutics · Jul 2010
Randomized Controlled Trial Comparative StudyRelative bioavailability and pharmacokinetic properties of two different enteric formulations of esomeprazole in healthy Bangladeshi male volunteers: An open-label, single-dose, randomized-sequence, two-way crossover study.
In Bangladesh, a number of generic oral formulations of esomeprazole are marketed. Study of the relative bioavailability of these generic formulations has yet to be conducted in a Bangladeshi population. ⋯ This single-dose study found that the test and reference formulations of esomeprazole 40 mg met the FDA regulatory criteria for assuming bioequivalence in these healthy, fasting Bangladeshi male volunteers. A significant difference was found in T(max) between the 2 formulations. Both formulations were well tolerated in the studied population.