Another piece of good news for a very good drug
November 8, 2007
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.
November 8, 2007
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.
June 15, 2007
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.
June 15, 2007
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".
December 4, 2006
Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis | content.nejm.org
This study investigated carotid endarterectomy versus carotid stenting in patients with severe carotid stenosis. The study was stopped prematurely due to safety and futility. The 30-day incidence of stroke or death was 3.9% versus 9.6% for endarterectomy versus carotid stenting. This data implies that carotid stenting with cerebral protection is inferior to surgical endarterectomy, and therefore will not be as widely adopted as previous thought.
The forecast clears for drug eluding stents.
December 4, 2006
Trading restenosis for Thrombosis? New questions about drug-eluding stents. | content.nejm.org
This is a general commentary regarding coronary stent thrombosis and highlights the difficulties which Medtronic (Endeavor), Abbott (Xience V and Conor Medsystem (CoStar) may soon face with FDA approval of their new stents which are currently unavailable in the US. It also highlights that drug-coated stent sales have decreased while bare metal stents sales have accelerated.
Increased use of ventricular assist devices
December 4, 2006
Left Ventricular Assist Device and Drug Therapy for the Reversal of Heart Failure | content.nejm.org
In a series of 15 patients, the Thoratec ventricular assist device was utilized with associated medical treatment for severe non-ischemic heart failure. Eleven of the fifteen patients recovered and avoided transplantation. Key implications include increased utilization of ventricular assist devices for the indication: "bridge to recovery." This could allow patients to avoid transplantation by temporary use of a left ventricular assist device.
Percutaneous valves: the future is upon us!
December 4, 2006
AHA Scientific Sessions - Percutaneous Devices for Aortic Valve Disease | www.cardiosource.com
Percutaneous valves are technically feasible.
Complications are currently not comparable to the traditional open valve replacement/repair.
September 19, 2006
NEJM Articles on DES in MI | content.nejm.org
Implications:
- primary percutaneous interventions provide improved reperfusion therapy for acute myocardial infarction compared to thrombolysis
- many medical centers are focusing on the time it takes to actually perform PCI as a major focus for both patient care and a marketing technique
- Data are limited regarding the safety and efficacy of drug eluding stents in this setting, but they are clearly associated with an improved restenosis rate vs. uncoated bare metal stents
- The primary end point (target-vessel failure at 1 year after the procedure) was significantly reduced in the sirolimus-stent group compared to the uncoated stent group
- Drug eluding stents significantly reduce the risks of both restenosis and target-vessel revascularization after PCI due to acute myocardial infarction which could greatly expand the use of drug eluding stents
August 18, 2006
Daptomycin versus standard therapy for bacteremia and endocarditis caused by staphylococcus aureus | www.nejm.org
Daptomycin which is essentially the sole agent made by Cubist was recently evaluated for blood stream and heart infections caused by staph. and found to be as effective as traditional antibiotics used. The medication was also found to have less side effects when used for this indication. More patients who received the standard treatment compared to daptomycin also had kidney problems including kidney failure.
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