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.
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Clinical therapeutics · Jun 2015
Multicenter Study Controlled Clinical TrialTolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.
This study aimed to assess the tolerability of the extended use (≤35 days) of MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. ⋯ The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864.
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Clinical therapeutics · Jun 2015
Observational StudyStatin Prescribing Patterns: An Analysis of Data From Patients With Diabetes in the National Hospital Ambulatory Medical Care Survey Outpatient Department and National Ambulatory Medical Care Survey Databases, 2005-2010.
In 2008, the American Diabetes Association (ADA) recommended that patients aged >40 years with diabetes and cardiovascular disease or with ≥1 cardiovascular disease risk factor be prescribed a statin. This study assessed statin prescribing patterns in patients with diabetes, per the ADA guideline, using data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey-Outpatient Department for the years 2005 to 2010. This study also examined patients' demographic characteristics associated with statin prescribing, including sex, age, ethnicity, race, insurance type, body mass index, region, primary care provider, hypertension and hyperlipidemia. ⋯ Despite the call in the latest ADA recommendations for prescribing statins in many diabetic patients, an unexpectedly low percentage of patients were receiving them. Health disparities in age and ethnicity were also evident. The findings from this study highlight the need for further research into low statin prescribing rates.