Clinical therapeutics
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Clinical therapeutics · Aug 2007
Randomized Controlled Trial Multicenter StudyGoserelin acetate 10.8 mg plus iron versus iron monotherapy prior to surgery in premenopausal women with iron-deficiency anemia due to uterine leiomyomas: results from a Phase III, randomized, multicenter, double-blind, controlled trial.
Women with symptomatic uterine leiomyomas (fibroids) may have iron-deficiency anemia (IDA); therefore, surgery places them at risk of blood-borne morbidity from perioperative transfusions. Such women might benefit from a preoperative treatment that restores hematologic normality and alleviates fibroid symptoms. ⋯ A single, preoperative injection of goserelin acetate 10.8 mg in addition to PO iron 325 mg TID was associated with improved Hb levels in these premenopausal women with IDA due to uterine leiomyomas.
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Clinical therapeutics · Aug 2007
Randomized Controlled TrialPharmacokinetic and pharmacodynamic properties of buprenorphine after a single intravenous administration in healthy volunteers: a randomized, double-blind, placebo-controlled, crossover study.
Buprenorphine is used as an analgesic for postoperative and chronic pain. The usual sublingual dose is 0.2 to 0.8 mg, and the usual parenteral dose is 0.3 mg for acute postoperative pain. The pharmacokinetic and related pharmacodynamic properties of buprenorphine at these doses have not been characterized. ⋯ A clinically relevant analgesic dose of 0.002 mg/kg (0.15 mg/70 kg) of buprenorphine had a significant effect on nociception and psychomotor performance in these healthy male volunteers. A 2-compartment model satisfactorily characterized buprenorphine pharmacokinetics, and we found evidence of enterohepatic circulation.
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Clinical therapeutics · Aug 2007
Randomized Controlled TrialThe effect of simvastatin on erythrocyte membrane fluidity during oxidative stress induced by cardiopulmonary bypass: a randomized controlled study.
Abnormal erythrocyte deformability can cause severe complications during cardiopulmonary bypass (CPB) surgery, including both hemolysis and perfusion abnormalities. ⋯ The results of this study suggest that among these patients undergoing CPB surgery, use of simvastatin for 3 weeks before the surgery had significant beneficial effects on erythrocyte membrane fluidity, lipid peroxidation, and anion permeability.
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Clinical therapeutics · Aug 2007
Randomized Controlled TrialTransdermal buprenorphine patches applied in a 4-day regimen versus a 3-day regimen: a single-site, Phase III, randomized, open-label, crossover comparison.
In 2001, a transdermal matrix patch formulation of buprenorphine was approved for the treatment of moderate to severe cancer pain and severe pain that is unresponsive to nonopioid analgesics. The primary recommendation contained in the prescribing information was that transdermal patches be worn for a 3-day period before application of a new patch. ⋯ Analgesic efficacy, patients' satisfaction with the quality of treatment, and skin tolerability did not differ significantly between 3 and 4 days of patch application in these patients with chronic pain who had been previously stabilized on transdermal buprenorphine.
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Clinical therapeutics · Aug 2007
Comparative StudyDoes statin therapy initiation increase the risk for myopathy? An observational study of 32,225 diabetic and nondiabetic patients.
Estimates of myopathy rates in the literature are based on adverse events reported in clinical trials, which may not be representative of the clinical practice setting. ⋯ Statin initiation was associated with an approximate doubling of the risk for any myopathic event but did not appear to be associated with an increased risk for rhabdomyolysis in these patients. Because clinically significant elevations of creatine kinase levels were rare, statins appeared to be well tolerated in diabetic and nondiabetic patients who used them.