Elsulfavirine: First Global Approval

<div>Compliance with Ethical Standards</div><div><br></div><div><i>Funding: </i>The preparation of this review was not supported by any external funding.</div><div><br></div><div><i>Conflicts of interest:</i> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Zaina T. Al-Salama is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.</div><div><br></div><div>Additional information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>Elsulfavirine (Elpida®) is a new-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Viriom for the treatment and prevention of human immunodeficiency virus (HIV) infections. It is the prodrug of the active compound VM-1500A, a small molecule selective NNRTI, which prevents HIV replication. In June 2017, elsulfavirine received its first global approval in Russia for the treatment of HIV-1 infections in combination with other antiretroviral medicines. Other formulations of this drug are also being evaluated in preclinical and phase II studies for the treatment of HIV infections and/or pre-exposure and post-exposure prophylaxis. This article summarizes the milestones in the development of elsulfavirine leading to this first approval in HIV-1 treatment. Access to the full article can be found <b><a href="https://link.springer.com/article/10.1007/s40265-017-0820-3">here</a>.</b></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017</div><div><br></div

Ticagrelor: A Review in Long Term Secondary Prevention of Cardiovascular Events

<div>Compliance with Ethical Standards</div><div><br></div><div><i>Funding</i>: The preparation of this review was not supported by any external funding.</div><div><br></div><div><i>Conflicts of interest</i>: Zaina T. Al-Salama, Gillian M. Keating and Susan J. Keam are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.</div><div><br></div><div>Additional information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>Ticagrelor (Brilique®) is an orally administered P2Y12 inhibitor. A long-term (maintenance) regimen of ticagrelor 60 mg twice daily is indicated in the EU for coadministration with low-dose aspirin 75–150 mg/day for the secondary prevention of atherothrombotic events in high-risk patients with a history of myocardial infarction (MI) of at least 1 year. Approval is based on the results of the PEGASUS-TIMI 54 trial that compared ticagrelor with placebo (in conjunction with low-dose aspirin) in stable patients who had had a spontaneous MI 1–3 years prior to enrolment and were at high risk of atherothrombotic events. At 3 years, the composite primary efficacy endpoint of cardiovascular (CV) death, MI or stroke occurred in significantly fewer ticagrelor 60 mg twice daily than placebo recipients. Long-term ticagrelor had a manageable tolerability and safety profile. The risk of TIMI major bleeding (primary safety endpoint) was significantly increased in ticagrelor 60 mg twice daily versus placebo recipients; however, the risk appeared to decline after the first year of therapy. Landmark analyses have demonstrated that patients with a history of MI remain at a persistent high risk of the composite primary endpoint up to 5 years after the event. Furthermore, these analyses demonstrated that the efficacy of ticagrelor 60 mg twice daily was maintained over time, with less excess in bleeding after the first year. Thus, long-term dual antiplatelet therapy with ticagrelor 60 mg twice daily and low-dose aspirin is a valuable new option for the secondary prevention of atherothrombotic events in stable, high-risk patients with a history of MI of at least 1 year. Access to the full article can be found <b><a href="https://link.springer.com/article/10.1007/s40265-017-0844-8">here</a>.</b></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017 </div