https://www.youtube.com/watch?v=vX1CvW38cHA (Reuters) - Novartis has ended a late-stage clinical trial of a chronic heart failure drug early, following strong interim results, giving the Swiss drugmaker a boost after recent setbacks to another heart failure medicine. The Basel-based firm said on Monday an independent committee had unanimously recommended it close its PARADIGM-HF study ahead of time after results showed patients receiving its LCZ696 drug lived longer without being hospitalized for heart failure than those who were given enalapril, the standard care. http://www.reuters.com/article/2014/03/31/us-novartis-heartdrug-study-idUSBREA2U09720140331
Fast forward a few months. "Although the FDA did not approve, we will continue to work hard to deliver this important treatment to patients."
+1 for the humor, although methinks this case is nothing like the serelaxin submission. note the trial design. http://clinicaltrials.gov/ct2/show/NCT01035255 The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%). Condition Intervention Phase Heart Failure With Reduced Ejection Fraction Drug: LCZ696 200 mg BID Drug: Enalapril 10 mg BID Phase 3 Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Patients With Chronic Heart Failure and Reduced Ejection Fraction Primary Outcome Measures: Time to first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ] Secondary Outcome Measures: Change in the clinical summary score for HF symptoms and physical limitations (as assessed by KCCQ). [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ] Time to all-cause mortality [ Time Frame: up to 4yrs ] [ Designated as safety issue: Yes ] Time to occurrence of renal dysfunction [ Time Frame: up to 4yrs ] [ Designated as safety issue: No ]
How about this. Novartis as usual took some lame generic like enalapril OK and compared that to a COMBINATION BID regiment of diovan plus some other lame , tekturkey type 'novel' agent so why not compare this BID COMBO to say an Altace / Norvasc combo ? or their own Lotrel ? which would be once a day as an added benefit . More smoke & mirror marketing ahead & all the lemmings get pumped up to sell hype just like valturna.
hype? really? a broken clock can be right twice a day: ...the news was even better than Novartis had said in its press release. I spoke with the co-principal investigator of the trial, Milton Packer, who told me that the trial had been stopped because of a highly statistically significant reduction in cardiovascular mortality in patients taking LCZ696 instead of the current gold standard of treatment, an ACE inhibitor. Marc Pfeffer, a cardiologist at the Brigham and Women’s Hospital with long experience in heart failure, told me that he interprets “the stopping of a major clinical outcome trial for effectiveness by an experienced DSMB [Data and Safety Monitoring Board] as indicating that the final results will be both definitive and important.” The first thing to know is that a reduction in cardiovascular mortality is a really big deal. In heart failure, and in other cardiovascular conditions, there are only a few therapies that have been able to show this benefit (such as, for example, an ACE inhibitor in heart failure or a statin in coronary disease). And the presence of these established therapies makes it even harder to find new drugs with added benefit. And, as best I can recall, there’s never been a case in which another drug has been shown to be dramatically superior to one of these bedrocks of therapy. In other words, if the PARADIGM-HF trial lives up to its promise, it may lead to LCZ696 replacing the ACE inhibitors and ARBs as a cornerstone of therapy. That would be huge. http://www.forbes.com/sites/larryhusten/2014/04/01/a-new-novartis-heart-failure-drug-might-be-a-blockbuster/
You people are clowns. 10 mg of enalipril is the "gold standard" really since when ? Did they actually manage to find HF patient only on an ace? Seriously? Most are on a cocktail more akin to one or more of the following; ramapril (or ARB) amlodipine, diuretics, digoxin, aldosterone antagonists & a BB. Marc Pfeffer & Fudge Packer have been on the NVS payroll for what, over a decade & a half? The street may be clueless about these ridiculous projections (as they were serelaxin & the others) The physicians & Insurance Co's will be another matter entirely & let's not forget the current Novartis stellar reputation regardless of the H Y P E of their press releases. Listen Bozo, bring on a Study where this umpteenth Diovan Combo is also compared to other COMBO's
are you a disgruntled (former) employee? are you short novartis stock? or do you simply enjoy mindf--king the algos / people? that's cool if it's the 3rd option... ;-)
