Vardenafil (Levitra, Bayer AG/GlaxoSmithKline) is a selective inhibitor of phosphodiesterase 5 (PDE5) currently under review by FDA for the treatment of erectile dysfunction (ED). If approved, vardenafil will become the third PDE5 inhibitor to be marketed in the United States and the fourth oral agent approved for the treatment of ED. Vardenafil has been studied in subjects of various ages (<45 and >65 years of age), with different etiologies and different baseline severity of ED. Studies evaluating vardenafil have determined it to be safe and effective at doses of 5 mg to 40 mg, including subjects with diabetes mellitus and subjects who have undergone radical prostatectomy. Vardenafil has a pharmacokinetic profile similar to that of sildenafil (Viagra, Pfizer). The drug appears to be well tolerated. In clinical trials, headache, dyspepsia, and flushing were the most common adverse effects reported by subjects taking vardenafil. No adverse hemodynamic or visual effects have been reported during clinical trials of vardenafil; however, further investigation, including post-marketing surveillance, will be required. Further research and clinical experience with the newer PDE5 inhibitors (vardenafil and tadalafil [Cialis, Lilly/ICOS]) will be needed before their roles in the treatment of ED can be determined.
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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ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19th 2024The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
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