Clinical therapeutics
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Clinical therapeutics · Feb 2012
Randomized Controlled TrialTolerability and pharmacokinetics of a new P-glycoprotein inhibitor, HM30181, in healthy Korean male volunteers: single- and multiple-dose randomized, placebo-controlled studies.
HM30181 is an oral P-glycoprotein (P-gp) inhibitor developed to enhance the oral bioavailability of P-gp substrate drugs. ⋯ HM30181 was well tolerated after oral administration within the dose range evaluated, with the exception of the repeated administration of 360 mg, for which gastrointestinal disorders were frequently reported. The systemic exposure of HM30181 was relatively low, and dose proportional properties of HM30181 were not observed.
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Clinical therapeutics · Feb 2012
ReviewBiosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innovator biologics, as well as an increase in the number of these products reaching patent expiry, the development of a process for approving biosimilar products has become a crucial regulatory issue in the United States. ⋯ This commentary provides evidence that current EU guidelines have resulted in the approval of biosimilar therapeutics with comparable efficacy and safety profiles for the recommended indications of their respective reference originator biologics. It is anticipated that these precedents will serve as a starting point in the development of a process for approving biosimilars in the United States and worldwide to provide efficacious and tolerable biotherapeutics with a significant cost advantage for national health care programs and consumers.
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Clinical therapeutics · Feb 2012
Effect of statins on total cholesterol concentrations, cardiovascular morbidity, and all-cause mortality in chronic obstructive pulmonary disease: a population-based cohort study.
The benefit of statin use on total cholesterol (TC) concentration has not been studied previously in patients with chronic obstructive pulmonary disease (COPD). ⋯ In patients with COPD, statins were protective from CV events and CV mortality in SP but not PP, and statins improved all-cause mortality in both PP and SP.
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Clinical therapeutics · Jan 2012
Rates of 5 common antidepressant side effects among new adult and adolescent cases of depression: a retrospective US claims study.
Antidepressants are the first-line treatment for depression, yet medication-related side effects may be associated with antidepressant discontinuation before reaching a period of exposure believed to result in effectiveness. There is a gap in knowledge of the prevalence of side effects across commonly prescribed antidepressants and the effect of the type of antidepressant on the likelihood of side effects in real-world clinical practice. ⋯ Prevalence and risk of the 5 side effects varied across types of antidepressants for both adults and adolescents. Results from this study were consistent with prior clinical trials, suggesting that variation in side effect profiles exists in a more generalized managed care population.
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Clinical therapeutics · Jan 2012
Randomized Controlled Trial Multicenter StudyThe effect of a 12-week course of omega-3 polyunsaturated fatty acids on lipid parameters in hypertriglyceridemic adult HIV-infected patients undergoing HAART: a randomized, placebo-controlled pilot trial.
Hypertriglyceridemia is common in patients with HIV treated with highly active antiretroviral therapy (HAART). ⋯ PUFA therapy with DHA/EPA reduced triglyceride levels significantly compared with placebo in HIV-infected patients with HAART-associated hypertriglyceridemia.