Objective: The purpose of this article is to review the available trials that led to the Food and Drug Administration (FDA) approval of berotralstat, an oral kallikrein inhibitor, for the prevention of hereditary angioedema (HAE) attacks.
Data Sources: PubMed and ClincalTrials.gov were searched using key term to identify phase III clinical trials related to the FDA approval of berotralstat from April 2018 to May 2021.
Purpose: This article discusses the pharmacology of bempedoic acid, the trials that led to United States Food and Drug Administration (FDA) approval of its use, and the overall safety and efficacy of this therapy in heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), and hyperlipidemia.
Methods: A database search of PubMed and ClinicalTrials.gov was conducted for articles published between January 2012 to September 2020 and containing the key words bempedoic acid, ezetimibe, Nexletol and Nexlizet.
Purpose: There are roughly 30 million Americans diagnosed with diabetes mellitus (DM), with nearly 95% of these cases being type 2 (T2)-DM. The American Diabetes Association continues to recommend metformin as the first-line initial treatment of T2DM, in combination with lifestyle modifications; yet, many require multiple therapies to achieve adequate glycemic control. In patients with atherosclerotic cardiovascular disease, heart failure, or chronic kidney disease, adding a glucagon-like peptide 1 receptor agonist is a preferred treatment option; however, many patients are apprehensive about injecting medications.
View Article and Find Full Text PDFAnn Pharmacother
October 2020
Objective: The purpose of this article is to review the available clinical trial data that led to the Food and Drug Administration (FDA) approval of solriamfetol as well as its role in clinical practice.
Data Sources: A MEDLINE/PubMed search was conducted (January 2000 to February 2020) using the keyword to discover appropriate clinical trials.
Study Selection And Data Extraction: Articles were included that were published in the English language and related to the FDA approval of solriamfetol or provided novel information regarding this drug entity.
To review the safety and efficacy of brexanolone for the treatment of moderate to severe postpartum depression (PPD). A literature search through PubMed was conducted (January 2012 to July 2019) using the keyword for clinical trials published in the English language. Articles were selected if they were related to the Food and Drug Administration (FDA) approval of brexanolone or provided novel clinical information regarding this drug entity.
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