Although statins have been shown to reduce LDL-C and coronary heart disease (CHD) morbidity and mortality, it is not uncommon for patients to fail to reach the treatment goals recommended by the National Cholesterol Education Program (NCEP) guidelines. Some statins cannot lower LDL-C sufficiently in FDA-approved doses; other statins cannot be titrated optimally due to potential drug interactions and adverse effects. Ezetimibe/simvastatin(Vytorin, Merck/Schering-Plough) is an intestinal cholesterol absorption inhibitor and statin combination product that received FDA approval in July 2004. The combination has been found to reduce LDL-C and triglycerides by an additional 22% and17%, respectively, and to increase HDL-C by up to 5% compared to statin monotherapy. The 40 mg simvastatin/10 mg ezetimibe dose of the combination product is one of onlya few cholesterol-lowering regimens that can reduce LDL-C >55% and is also one of the most economical. Adding ezetimibe to a statin does not reduce tolerability. Since ezetimibelacks cytochrome P450 isoenzyme interactions, the additional drug interaction risk with combination therapy is low.
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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Trelegy and Breo Offer Incremental Improvement Over Generics
March 3rd 2025The Institute for Clinical and Economic Review has prepared a special report on Trelegy and Breo, two therapies that treat patients with chronic obstructive pulmonary disease that are part of CMS's drug price negotiation program.
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