Clinical therapeutics
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Clinical therapeutics · Aug 2015
Randomized Controlled TrialEmpagliflozin as Add-on Therapy to Pioglitazone With or Without Metformin in Patients With Type 2 Diabetes Mellitus.
To investigate the long-term efficacy and safety of empagliflozin as add-on therapy to pioglitazone with or without metformin in patients with type 2 diabetes mellitus. ⋯ Empagliflozin 10 mg or 25 mg as add-on therapy to pioglitazone with or without metformin for 76 weeks was well tolerated and led to sustained reductions in HbA1c and weight compared with placebo in patients with type 2 diabetes. ClinicalTrials.gov identifier: NCT01210001.
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Clinical therapeutics · Aug 2015
Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.
Meeting marketplace demands for proving the value of new products requires more data than the industry has routinely produced. These data include evidence from comparative effectiveness research (CER), including randomized, controlled trials; pragmatic clinical trials; observational studies; and meta-analyses. ⋯ The biopharmaceutical industry is faced with a broad and complex set of challenges related to evidence generation for postapproval decisions by a variety of health care system stakeholders. Uncertainty remains as to how the industry and payers use postapproval studies to guide decision making with regard to pricing and reimbursement status. Correspondingly, there is uncertainty regarding whether the industry's investment in CER will have a positive return on investment in terms of reimbursement and market access.
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Clinical therapeutics · Aug 2015
Randomized Controlled TrialSafety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial.
The goal of this study was to determine if a lidocaine hydrochloride monohydrate powder intradermal system designed to provide cutaneous analgesia is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. ⋯ The needle-free powder lidocaine delivery system was well tolerated and produced superior analgesia compared with sham placebo when administered 1-3 minutes before pediatric venipuncture or peripheral venous cannulation. Treatment-related AEs occurred primarily at the administration site and were infrequent, generally mild, and resolved without sequelae. ClinicalTrials.gov identifier: NCT00140088.