Applications of drug interaction study in new drug development and regulartory decision-making / 中国临床药理学与治疗学

Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.

Potential Drug-Drug Interactions In Heart Failure Patients

Objective: The aim of the present study was to assess the prevalence, risk rating and the severity of hazardous pDDIs (potential drug-drug interactions) in the prescribed pharmacotherapy in the hospital discharged heart failure (HF) patients, primarily with co-administered drugs with narrow therapeutic index (statins, anticoagulants, antithrombotic drugs). Methods: The prescriptions of chronic heart failure patients for one year (January-December 2014) were analyzed for pDDIs through Lexi-interact® software. DDIs belonging to the categories D (Consider therapy modification) and X (Avoid combination) and/or severity of drug interaction-major, were selected for the study. Results: After reviewing the medical records of 985 patients, 239 patients were selected based on the criteria mentioned above. The average number of prescription drugs at hospital discharge was 7.27 medications (±1.84 SD) per patient. The total number of pDDIs was 1483 or approximately 6.2 (±3.89 SD) pDDIs per patient. With respect to the risk rating, in categories D and X were detected 76 (5.12 %) and 2 (0.13 %) pDDI, respectively. The major pDDIs were 108 (7.28 %). Conclusion: HF patients are at high risk of pDDIs. Screening of prescriptions for pDDIs and monitoring of pharmacotherapy in terms of response and associated adverse drug events will contribute to patient safety.

Evaluation of hypoglycemic drug-drug interactions by software / 药学实践杂志

Objective To evaluate and analyze the drug-drug interactions(DDI)of different antidiabetic drugs.Methods DDI database Lexi-InteractionTMwas used to evaluate DDI for 28 commonly used antidiabetic medications(including insulin and 27 non-insulin preparations).Results 882 DDIs were identified for 28 drugs.Category C was the top rated DDI(69.8%). Category C,D,X were accounted for 91.2% of the total DDI.28 medication combinations belonged to category X,which should be avoided to use together.Sulfonylureas had the most DDI,followed by metformin.Alpha-glucosidase inhibitors had least DDI.Conclusion Hypoglycemic drugs with less DDI,such as α-glycosidase inhibitors,glucagon-likepeptide1(GLP-1)an-alogs and sodium-dependent glucose transporters 2 inhibitor(SGLT2i)should be considered with high priority for patients tak-ing multiple antidiabetic medications,elderly patients and patients with liver-kidney dysfunction.