FDA asks panel of heart doctors for help reviewing blood-thinning drug prasugrel.The Wall Street Journal (1/2, Rockoff, subscription required) reports that the Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee is set to meet on Feb. 3, and while details of the panel's agenda were not available, Eli Lilly and partner Daiichi Sankyo say that the body will discuss "whether to finally approve prasugrel," the company's "powerful anti-clotting drug and would-be competitor to blockbuster Plavix. ... Early this year, lots of folks were brimming with anticipation for prasugrel, a more powerful clot-fighter than Plavix. But the Lilly medicine also carried a higher risk for life-threatening bleeding. Perhaps no surprise then that there was a three-month delay in FDA's review earlier this year, then another with a less clear timetable for action, as the agency weighed what to do." The Journal predicts that the drug will soon be on the market in Europe, but expressed doubt that the FDA will automatically follow suit. The AP (1/2) also reports on the upcoming meeting, noting that prasugrel is "a potential blockbuster drug that has been plagued by regulatory delays." Prasugrel "is considered crucial to Lilly as it faces a wave of patent expirations in the next few years. Lilly previously told investors it expects to begin selling prasugrel in the first half of 2009, but declined to set a specific date for FDA approval." BNP-Guided vs Symptom-Guided Heart Failure TherapyThe Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure (TIME-CHF) Randomized Trial JAMA Vol. 301 No. 4, January 28, 2009Matthias Pfisterer, MD; Peter Buser, MD; Hans Rickli, MD; Marc Gutmann, MD; Paul Erne, MD; Peter Rickenbacher, MD; Andre Vuillomenet, MD; Urs Jeker, MD; Paul Dubach, MD; Hansjurg Beer, MD; Se-Il Yoon, MD; Thomas Suter, MD; Hans H. Osterhues, MD; Michael M. Schieber, MD; Patrick Hilti, MD; Ruth Schindler, RN; Hans-Peter Brunner-La Rocca, MD; for the TIME-CHF InvestigatorsJAMA. 2009;301(4):383-392.Context It is uncertain whether intensified heart failure therapy guided by N-terminal brain natriuretic peptide (BNP) is superior to symptom-guided therapy.Objective To compare 18-month outcomes of N-terminal BNPguided vs symptom-guided heart failure therapy.Design, Setting, and Patients Randomized controlled multicenter Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure (TIME-CHF) of 499 patients aged 60 years or older with systolic heart failure (ejection fraction 45%), New York Heart Association (NYHA) class of II or greater, prior hospitalization for heart failure within 1 year, and N-terminal BNP level of 2 or more times the upper limit of normal. The study had an 18-month follow-up and it was conducted at 15 outpatient centers in Switzerland and Germany between January 2003 and June 2008.Intervention Uptitration of guideline-based treatments to reduce symptoms to NYHA class of II or less (symptom-guided therapy) and BNP level of 2 times or less the upper limit of normal and symptoms to NYHA class of II or less (BNP-guided therapy).Main Outcome Measures Primary outcomes were 18-month survival free of all-cause hospitalizations and quality of life as assessed by structured validated questionnaires.Results Heart failure therapy guided