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1.	Ahrén, Bo, et al. (författare) Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities? 2014 Ingår i: Diabetes therapy : research, treatment and education of diabetes and related disorders. - : Springer Science and Business Media LLC. - 1869-6953. Tidskriftsartikel (refereegranskat)abstract In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased hypoglycemia with glimepiride was driven by the 6 mg/day dose; it was therefore of interest to assess whether the risk of hypoglycemia is also different between vildagliptin and a low (2 mg/day) dose of glimepiride.
2.	Dosne, Anne-Gaëlle, et al. (författare) Model averaging for robust assessment of QT prolongation by concentration-response analysis 2017 Ingår i: Statistics in Medicine. - : Wiley. - 0277-6715 .- 1097-0258. ; 36:24, s. 3844-3857 Tidskriftsartikel (refereegranskat)abstract Assessing the QT prolongation potential of a drug is typically done based on pivotal safety studies called thorough QT studies. Model-based estimation of the drug-induced QT prolongation at the estimated mean maximum drug concentration could increase efficiency over the currently used intersection-union test. However, robustness against model misspecification needs to be guaranteed in pivotal settings. The objective of this work was to develop an efficient, fully prespecified model-based inference method for thorough QT studies, which controls the type I error and provides satisfactory test power. This is achieved by model averaging: The proposed estimator of the concentration-response relationship is a weighted average of a parametric (linear) and a nonparametric (monotonic I-splines) estimator, with weights based on mean integrated square error. The desired properties of the method were confirmed in an extensive simulation study, which demonstrated that the proposed method controlled the type I error adequately, and that its power was higher than the power of the nonparametric method alone. The method can be extended from thorough QT studies to the analysis of QT data from pooled phase I studies.

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Typ av publikation: tidskriftsartikel (2)

Typ av innehåll: refereegranskat (2)

Författare/redaktör: Heimann, Guenter (2); Ahren, Bo (1); Karlsson, Mats O. (1); Dejager, Sylvie (1); Schweizer, Anja (1); Foley, James Edward (1); visa fler...; Akacha, Mouna (1); Shao, Qing (1); Dworak, Markus (1); Bergstrand, Martin (1); Dosne, Anne-Gaëlle (1); Renard, Didier (1); visa färre...

Lärosäte: Uppsala universitet (1); Lunds universitet (1)

Språk: Engelska (2)

Forskningsämne (UKÄ/SCB): Medicin och hälsovetenskap (1)

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