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GLG News by General Cardiologists (US)

November 8, 2007
Time to talk to the FDA
Analysis of: Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP (www.medicalnewstoday.com)
This trial shows the value of this previously underrated drug. Pts with elevated bnp are at higher risk than those who do not have elevated levels.  These are specifically the patients that need the most aggressive medical therapy and usually fall short on conventional treatment.
Howard Weintraub, MD, Clinical Director
New York University Medical Center
November 8, 2007
Even more benefit.
Analysis of: Ranexa(R) Significantly Reduces Incidence Of CV Death, MI Or Recurrent Ischemia In MERLIN TIMI-36 Patients With Elevated BNP (www.medicalnewstoday.com)
The good news gets better as there is now data from MERLIN that corroborates the news from CARISA showing a reduction in HbGA1C that was significant.
October 31, 2007
very bad news
Analysis of: Phase 2 Prasugrel Studies Suspended Prior to Release of Major Phase 3 Trial (www.medscape.com)
There is no reason to believe that prasugrel will be coming any time soon.  While Dr. Ware may not have given the reasons for the suspension of the trials, the only reason to stop enrollment in a study  of healthy volunteers is safety, as there is no efficacy end point. The only safety endpoint...
Analysis of: U.S. veterans dept to limit Glaxo's Avandia: report (www.reuters.com)
Another large provider votes thumbs-down on Avandia.Actos remains innocent until proven guilty.
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
Ask any patient with diabetes what they want for a therapeutic option and they'll tell you non-injectable insulin.  They understand that all the other medications are a poor substitution for the replacement of pancreatic insulin and they are tired of taking multiple pills each day. So why did...
Analysis of: Enrollment Reaches 110 Patients In Investigator Initiated, Randomized Trial Of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) (www.medicalnewstoday.com)
The failure of drug eluting stents in the eyes of the public and in the medical community is probably not a failure of the device as much as a failure of patient managment.  It is clear that atherothrombotic vascular disease requires a life-long commitment to blood pressure, cholesterol, and blood...
Analysis of: Medtronic Voluntarily Suspends Distribution Of Sprint Fidelis® Defibrillation Leads (www.medicalnewstoday.com)
1) Data only shows trend towards higher lead fracture, not statistically significant on current numbers. 2) Medtronics did the "right thing". No attempts to hide data. 3) Number of potential claims should be minimal, as this is NOT a recall. Rather, more carefull monitoring of the already implanted...
Analysis of: ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402 (www.pipelinereview.com)
The IDEAL anticoagulant is: 1. Efficacious - Prevents thrombosis 2. Safe - Low risk of bleeding 3. Titratable - Offers predictable, adjustable, therapeutic effect tailorable to individual patient needs 4. Reversible - Can be actively TURNED OFF if/when necessary (or "dialed down") 5. Convenient - Bolus...
October 10, 2007
Great potential
Analysis of: Isis Reports That ISIS 301012 is Well Tolerated in Patients Treated for Five Or More Months (www.pipelinereview.com)
I think this drug has great potential for refractory high LDL and possibly in Acute Coronary Syndrome and CAD patients.
Analysis of: Aastrom Announces Positive Interim Results From Phase I/II Study Involving Use of Vascular Repair Cells in Patients With Critical Limb Ischemia (www.pipelinereview.com)
There will be an increased impetus to start clinical trials with stem cells in peripheral vascular disease in order to avoid amputations (the same is true for osteonecrosis of the hip). As the prevalence of diabetes increases in the Western world, the demand for this type of therapies will be increasing....

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