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Purpose Acne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose of this article was to review the clinical data regarding the safety and efficacy of topical clascoterone for the treatment of acne vulgaris in male and female subjects aged >12 years. Methods A literature search of PubMed, EMBASE, and MEDLINE was conducted for clinical trials published between January 2014 and March 2021 in the English language using the key words Winlevi, clascoterone, and acne vulgaris. Articles were selected if they were related to the approval by the US Food and Drug Administration of clascoterone or provided novel data regarding this drug entity. Findings Two Phase III randomized controlled trials (NCT02608450 and NCT02608476) were ultimately selected, as these trials provided pivotal information to the US Food and Drug Administration for the approval of topical clascoterone. Implications The findings of this review show that topical clascoterone is likely an effective and safe option for the treatment of acne vulgaris. It offers efficacy rates similar to those of current medications through a novel mechanism of action. Its place in therapy remains unclear, but it might be placed ahead of other androgen receptor antagonists such as spironolactone due to its avoidance of systemic side effects.

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. Trials from the CLEAR series were selected, as they played a pivotal role in the establishment of FDA approval, along with additional trials published after FDA approval, which provided novel evidence on the use of bempedoic acid in the treatment of hypercholesterolemia. Publications that were not randomized, controlled trials were not included in this review. Only randomized controlled trials in which ezetimibe was used in conjunction with bempedoic acid were included in this review as they were relevant to the new FDA approval of bempedoic acid. Findings The findings of the present review show that bempedoic acid is both an effective and well-tolerated option for the treatment of hypercholesterolemia when used without ezetimibe in addition to standard therapy. It also appears that the combination with ezetimibe increases the cholesterol-lowering effect more than either agent alone when added to standard therapy. Implications Hypercholesteremia continues to be a major contributing factor leading to ASCVD. Bempedoic acid is an additional treatment option, along with both statins and diet and exercise, for reducing cholesterol levels and ASCVD events. With the new FDA approval, bempedoic acid may offer an effective therapy for reducing low-density lipoprotein cholesterol in patients at high risk for cardiovascular events due to established ASCVD or heterozygous familial hypercholesterolemia.

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. Semaglutide is the first oral option in this life-saving medication class. The purpose of this article was to review the pharmacology, clinical trials, safety profile, along with recommended dosing and costs, of oral semaglutide used for managing patients with T2DM. Methods A search through the PubMed, MEDLINE and Cochrane libraries was conducted for literature published from January 2017 through December 2020, using the key word semaglutide. Articles were selected if they were related to the approval of oral semaglutide or provided novel clinical information regarding this drug entity in its oral dosage formulation. Findings Three Phase II studies of the pharmacokinetic properties and Phase III trials from the PIONEER series were ultimately selected, as these trials were thought to provide pivotal information to the US Food and Drug Administration for the approval of oral semaglutide. Implications On review of the literature, it appeared that semaglutide is a viable option in treating T2DM. The use of this medication has been associated with glycosylated hemoglobin lowering similar to that with the injectable medication in its same class. Semaglutide was also showed some potential in preventing cardiovascular events as well as increasing weight loss.

Background Type 2 diabetes, dyslipidemia, and obesity continue to be common disorders that many clinicians and patients struggle to control. There are likely numerous reasons for poor control of these diseases, including medication efficacy and adverse effects, access to medications and health care, poor adherence, and lack of lifestyle changes by patients. Several new and emerging medications may help resolve these issues. Objective The goal of this article is to review new and emerging medications for type 2 diabetes mellitus, dyslipidemia, and obesity. Methods The Food and Drug Administration drug approval list for 2011 and 2012 was searched to identify newly approved drugs for type 2 diabetes, dyslipidemia, and obesity. New drug entities or existing drug entities with a new indication were included. To identify emerging therapies, we performed targeted searches on clinicaltrials.gov using the listed disease states and Phase III studies. PubMed was searched with these drug names to identify clinical trials for inclusion in this review. Preclinical trials and non–English-language publications were excluded, as were trials not evaluating the efficacy of these agents. The websites goodRx.com and rxpriceverify.com were used to identify pricing. Results For type 2 diabetes, exenatide extended-release causes fewer adverse effects and better efficacy than the daily exenatide formulation. The new sodium-glucose cotransporter 2 inhibitor drug class has a unique mechanism of action, hemoglobin A 1c reductions near 1%, and seemingly few adverse effects. With respect to dyslipidemia, icosapent ethyl effectively lowers triglyceride levels by ∼20% to 45% (depending on baseline triglyceride level), with little effect on LDL-C. For treatment of obesity, lorcaserin is a novel anorexic agent that results in an ∼5.5-kg mean weight loss, and phentermine-topiramate controlled-release reduces weight by ∼12.2 kg. Conclusion Although these agents certainly add to our armamentarium, none appear to offer significant advantages over currently available options. High costs will likely prevent these novel agents from being used as first-line agents in most patients. Further studies will help to more clearly define their roles in therapy.