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Another Win for High Potency Statins but HDL is Not Dead.

May 31, 2011

Abbott’s Cholesterol Combo Fails to Protect Heart in Study | www.bloomberg.com

This trial was designed poorly. The lack of efficacy can be attributed just as easily to the very low LDL in the study patients (71 mg/dl) rather than the modest HDL benefits. The search for an appropriate add on to statin drugs is not over at all, but the main benefit right now should be considered the high potency statins and the CTEP drugs.

AZ makes a good move and branches out

January 5, 2010

Novexel acquisition by AstraZeneca a Win/Win | www.pipelinereview.com

AZ has not played a major role in the anti-infective market, opting for a large presence in CV, GI, respiratory and oncology. This move should help them in an area where they have little presence, especially in the face of diminishing cv status.

A Worthwhile New Idea Whose Time May Have Passed

December 22, 2009

GSK initiates second pivotal Phase III trial for investigational cardiovascular medication Darapladib | www.pipelinereview.com

While inflammation clearly plays a role in CAD and ACS, the exact mechanism remains unclear. In addition, no anti inflammation treatment has ever been shown to be beneficial in the treatment of ACS. We know that treatment with statins and lipid lowering agents in general lower indices of inflammation but as to whether this is causative or an epiphenomenon or marker has yet to be clarified.

Very little heap for lots of hype

November 30, 2009

Pfizer, Astellas to launch Caduet combo tabs in Japan on Dec 2 | www.pharmabiz.com

When Pfizer attempted the poly pill in the US despite a very entertaining marketing campaign, there was little interest in the drug.

Bad News (but not new news) for stents.

August 19, 2008

Heart Stents No Better Than Drugs for Chest Pain Over Time | www.bloomberg.com

Once again, we see that medications in most cases are as effective as stenting.  This is old news dating back to the CASS trial in the 1970's and 1980's. Every time we come up with a slick new device we test it against the standard of care and it comes up more expensive and no more effective.  First it was CABG, then PTCA (angioplasty) then stenting, then DES.  Suprisingly, it gets treated like new news everytime the wheel is reinvented.  Coronary atherosclerosis is a systemic and diffuse problem that requires to be treated in kind, rather than with local therapy.  The average stent covers 1/5,000,000 of the total area of the coronary vasculature.  Not new news that medications work.

Abbott Wants Seat At The Adults Table At Last!

August 19, 2008

Abbott signs deal to promote Crestor in U.S. | www.chicagotribune.com

As the market for branded statins dries up slowly now with generic simvastatin and lipitor poised for the same fate, the fixed dose combos are the only salvation for the branded drugs.  Abbott has failed to capitalize on the fact that they have the only safe effective and approved drug for raising HDL (niaspan) and also for lowering triglycerides in combination with statins (tricor). Clearly Abbott is moving into the cardiology world in a strong manner at present.  Sales of stents may go down with the courage trial but the medical arm of CAD treatment will increase, so they have it both ways.  The sales force at abbott has been lacking for quite some time, so now they can benefit from the battle tested AZ reps.

Different Strategy Rather Than A Difference By Agent Used

July 10, 2008

Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Total Knee Arthroplasty | content.nejm.org

The major impact of this article is that if a strategy of longer term prophylaxis is employed (6 weeks vs in hospital) that better outcomes will be seen in DVT prevention after TKA and THR.  While the drugs work differently, the difference in duration of treatment likely explains all of the difference in rates of adverse outcome.  This has been shown before in other trials, including in unstable angina with enoxaparin being the victor when used for 6 weeks.

Two for the price of one

November 20, 2007

Pramlintide and Leptin Combination Treatment Demonstrates 12.7 Percent Weight Loss in 24-Week Clinical Obesity Study | www.pipelinereview.com

No safety signal so far giving problems is obviously a good sign.  Thsi magnitude of weight loss beats all other pharmacologic weight loss options so far.

Another Nail in the Coffin

November 20, 2007

GlaxoSmithKline revises US labeling for Avandia | www.pipelinereview.com

Most diabetics have subclinical CAD, and a baseline risk of CAD equivalent to that of a person without diabetes and a prior MI.  This drug, by limiting its labelling is severely limiting its use in patients with diabetes.

Time to talk to the FDA

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

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.

very bad news

October 31, 2007

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 of note must be bleeding. 

No good news yet

June 26, 2007

Metabasis Therapeutics Announces Initiation of a Clinical Trial for MB07811, Its Novel Product Candidate for the Treatment of Hyperlipidemia | www.pipelinereview.com

This class of drug has had issues in the past, and while the study is interesting, a Phase 1b trial is hardly earth shattering.  Wait for the clinical event trials that the FDA will definitely require especially in the aftermath of Torsetrapib.

good for IM's limited use for cardiologists

June 26, 2007

Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure | pharmalive.com

Like all combo drugs, many IM's will love it, as it is convenient.  Cardiologists hate combo drugs except htn meds in combination with HCTZ.  (eg lotrel, which no cardiologist has ever given).  This is another desparate attempt on Pfizer's behalf to keep branded norvasc alive.      

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This author consults with leading institutions through GLG