Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on May 23rd, 2012
Failures of the heart inspire authors, musicians and directors.
Likewise, discovering new therapies for the complexities of heart failure inspires drug developers to search for new therapeutic compounds.
Once developers clear the hurdle of finding a compound with promise, the bar is set high for proving their efficacy and superiority over existing drugs to gain regulatory approval.
Most heart failure medicines have to go through a variety of different measures for efficacy. One of which is “quality of life” as measured by the American Heart Association ratings for heart failure. For example: Can bedridden patients begin to get out of bed and move around more?
The ultimate test for pending heart failure therapies are morbidity and mortality trials. Does the compound delay or prevent morbidity (the disease) as well as mortality. These comprehensive trials require patients numbering in the thousands. Studies of this scope, with high recruitment costs and long treatment periods, are an incredibly expensive investment.
Why try? According to the American Heart Association, the need is great and growing.
• An estimated 5.7 Americans, of all ages, suffer from heart disease.
• Heart failure is the fastest-growing clinical cardiac disease entity in the United States, affecting 2% of the population.
• In 2010, the estimated total cost of heart failure in the US was $39.2 billion, representing 1-2% of all health care expenditures.
Heart failure therapies may be hard to get, but for a number of our clients, these numbers make it worth the passionate pursuit.
Filed under: Drug Discovery Services, Drug Safety Services, Heart Failure |
Posted by Michael Gralinski, Chief Executive Officer at CorDynamics on November 17th, 2011
As we’ve discussed in a previous blog, Investigating the Truth About AFib, the path toward targeted efficacy is fraught with hurdles. The reports coming out of the American Heart Association’s Annual Meeting are confirming just that.
Clearly, AFib, AF, Atrial Fibrillation, while being the most common cardiac arrhythmia affecting millions of individuals, is still not commonly understood from a drug development standpoint. Dronedarone, one of the big AHA headliners, is a drug we have used in preclinical investigations as well. In fact, our abstract that was presented at the 2012 Safety Pharmacology Society meeting in Innsbruck featured the use of chronically instrumented dogs to demonstrate the doses of both flecainide and dronedarone that result in changes with atrial, but not ventricular, refractoriness.
Through these types of studies, we are finding one of the long-standing AF roadblocks has been the selectivity of compounds on atrial vs. ventricular electrophysiology. Usually, the goal is to specifically alter the electrical properties of the heart’s upper chambers (atria) while leaving the lower chambers (ventricles) alone. Not nearly enough new chemical entities have this property—thus, the limited good treatment options in this area.
I find much of drug development news features on the negative headlines of drugs that “fail.” As researchers, we learn important discoveries from each study. This ultimately leads us to more effective compounds and gives physicians, a better indication of which medications to prescribe to which patients on a case-by-case basis. Sometimes knowing what doesn’t work, is just as important as knowing what does.
Filed under: Atrial Fibrillation, Drug Discovery Services, Telemetry |