Clinical therapeutics
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Clinical therapeutics · Jul 2015
How Did Multiple FDA Actions Affect the Utilization and Reimbursed Costs of Thiazolidinediones in US Medicaid?
The US Food and Drug Administration (FDA) communicated the potential cardiovascular risk of thiazolidinediones (rosiglitazone and pioglitazone) in 2007 and required a Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone in 2010. It also communicated in 2010 the potential risk of bladder cancer with pioglitazone use. This study examined the effects of these multiple FDA actions on utilization and reimbursed costs of thiazolidinediones in state Medicaid programs. ⋯ The Northeast and Midwest regions reported similar patterns of changes after the FDA actions. Use and costs of rosiglitazone were substantially reduced after the 2007 FDA actions for cardiovascular risk, and this drug was rarely used after the 2010 REMS program. Conversely, use and costs of pioglitazone were substantially reduced after the 2010 FDA actions regarding the drug's possible risk of bladder cancer.
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Clinical therapeutics · Jul 2015
Randomized Controlled TrialEffect of Retosiban on Cardiac Repolarization in a Randomized, Placebo- and Positive-controlled, Crossover Thorough QT/QTc Study in Healthy Men and Women.
Retosiban is a small molecule oxytocin receptor antagonist that is under evaluation in clinical studies for treatment of spontaneous preterm labor. A Thorough QT/QTc study was conducted to evaluate the effect of retosiban on cardiac repolarization according to International Conference on Harmonization E14 guidance. This was a randomized, placebo- and positive-controlled, single-dose, crossover study of healthy men and women. ⋯ NCT01702376.
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Clinical therapeutics · Jul 2015
Randomized Controlled TrialEffects of Food Intake on the Relative Bioavailability of Amifampridine Phosphate Salt in Healthy Adults.
Amifampridine (3,4-diaminopyridine) has been approved in the European Union for the treatment of Lambert-Eaton myasthenic syndrome. Amifampridine has a narrow therapeutic index, and supratherapeutic exposure has been associated with dose-dependent adverse events, including an increased risk for seizure. This study assessed the effect of food on the relative bioavailability of amifampridine in healthy subjects and informed on conditions that can alter exposure. ⋯ At the intended dose under fasting conditions, amifampridine exposure may be increased. European Union Drug Regulating Authorities Clinical Trials identifier: 2011-000596-13.