GLG News by Angiomax Prescribers for ACS (US)

Ramin EbrahimiDirector of Cardiac Catheterization LabWadsworth VA Medical Center

Risk Versus Benefit

November 23, 2007

Analysis of:Study Shows Weight-Loss Drug Rimonabant is Associated with Severe Adverse Psychiatric Events | pharmalive.com

The pooled analysis of Rimonabant trials point to a significant increase in psychiatric disorders. These studies also point to significant improvements in markers of cardiovascular risk. Risks versus benefits must be considered before the final decision is made on this class of medications.

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

Another piece of good news for a very good drug

November 8, 2007

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

By restoring function in the late Na channel and hence improving diastolic function (amongst other things), Ranexa has worked terrifically in my patients with any evidence for diastolic dysfunction. This typically manifests with shortness of breath and can be associated with an elevated level of BNP. This has not been as successful in patients without myocardial ischemia, but in those with ischemia the shortness of breath and associated chest discomfort has been helped in many. Including the most recent patient with a severe ischemic cardiomyopathy who has responded very very well with a significant increase in his functional capacity. Hopefully this news along with the safety from MERLIN and the A1C data and reduction in arrhythmias in that study will awaken docs to the benefits of Ranexa.  

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

Even more benefit.

November 8, 2007

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.

Ramin EbrahimiDirector of Cardiac Catheterization LabWadsworth VA Medical Center

Good device but not much improvement.

August 31, 2007

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 at the previous access site within 90 days of the index procedure  2. inability to promote means for primary healing of the arteriotomy site (primary healing results in much less scar formation and secondary healing that angioseal provides) and 3. relying on an intravascular component for deployment that stays within the vessel for weeks prior to its resolution  Newer devices such as the STARCLOSE that also are easy to deploy, rely on no intravascular components and potentially provide much better healing process may be the way of future.   

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

This one may hurt.

June 15, 2007

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 the near and mid-term future. This does not bode well for Sanofi, who will not have to regroup and pray for success with son of Amiodarone.

Howard WeintraubClinical DirectorNEW YORK UNIVERSITY (INC)

This one may hurt.

June 15, 2007

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 mess (with Baychol and Vioxx undertones). This is going to create a real challenge for Sanofi and make them pray for succes with the "son of amiodarone".

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