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GLG News by Ranexa Prescribers for Angina: Cardiologists (US)

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.
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: Galvus(R) receives European approval as new treatment for type 2 diabetes with broad range of indications (www.pipelinereview.com)
The approval of Galvus in Europe increases the pressure on the FDA to approve its use in the United Status.
Analysis of: FDA Approves First Generic Versions of Coreg (www.fda.gov)
Market impact is huge for many reasons. First, carvedilol is postulated to be a more effective beta blocker in the management of CHF with reduced ejection fraction compared to other generics and name brand ones on the market. This is based on a number of clinical trials demonstrating superiority in...
Ramin Ebrahimi, MD, Director of Cardiac Catheterization Lab
Wadsworth VA Medical Center
Analysis of: St. Jude Medical Announces Japanese Approval Of The Angio-Seal STS Plus Vascular Closure Device (www.medicalnewstoday.com)
The repositioning of the hole, also present with the VIP version is a mild improvement to decrease sheath manipulation. Otherwise the device has not changed much in the past few years. While a very good device in general, its primary limitaions listed below still remain. 1. not allowing re-access...
Analysis of: Ranbaxy Receives Tentative FDA Approval For Fexofenadine Hydrochloride Tablets (www.medicalnewstoday.com)
Fexofenadine-Allegra is usually perceived as slightly less effective than Claritin for seasonal allergic rhinitis. Both of these drug are non-sedating. Zyrtec, however, with slight sedation potential is the most powerful of the group.
Analysis of: FDA Gives Go-Ahead to Once-Daily Valsartan-Amlodipine Combination Pill for Hypertension (www.medscape.com)
Newly introduced guidelines for treatment targets in hypertensive patients target lower blood pressures than  those previously suggested by JNC.  Since it has already been demonstrated that control of BP to current targets in many hypertensives requires three or more drugs, even lower targets...
Howard Weintraub, MD, Clinical Director
New York University Medical Center
June 15, 2007
This one may hurt.
Analysis of: FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors (www.medicalnewstoday.com)
It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in...
Howard Weintraub, MD, Clinical Director
New York University Medical Center
June 15, 2007
This one may hurt.
Analysis of: FDA Advisory Committee Did Not Recommend Approval Of Rimonabant (ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors (www.medicalnewstoday.com)
It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone...

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