All GLG News Analyses Filed Under: Cardiology

Opening the Pandora's box again?

November 27, 2008

Analysis by: GLG Expert Contributor

Analysis of:New study: A Common Class of GI Medications Reduce Protection Against Heart Attack in Patients Taking Widely Prescribed Cardiovascular Drug | pharmalive.com

Certain number of patients taking clopidogrel have GI complications as well. Limiting the use of PPI's in those patients limits their treatment and prevention of GI complications.

A Formula for Cardiovascular Toxicity: Dose/Duration Therapy in the Elderly

November 26, 2008

Analysis by: GLG Expert Contributor

Analysis of:FDA to examine CV side effects of several meds | www.fiercepharma.com

Whether an NSAID or Avantis, if you dose the sick elderly long enough and fully the recipe for CV toxicity awaits. Since so many co-therapies (10 or more) are common in long term elderly pharmacotherapy and so much pre-existing cardiovascular brews in this cohort, it is no surprise that heart attacks, strokes and other CV complications become part of the numbers game of serious adverse events of so many agents. For the reality is that these agents do not primarily prevent such common events over time in this high risk population and become confounded with inevitabe events as a "side effect" when in realigy they may simply represent an associated event instead. The ideal is to treat healthier, younger subpopulations if you hope for the safest outcomes. Otherwise face reality with a better acceptance of inevitable risk-benefit trade offs.

Rosuvastatin in CV risk reduction

November 24, 2008

Analysis by: GLG Expert Contributor

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

Rosuvastatin, Crestor, Cardiovascular risk

Hard enpoints needed for antidiabeticdrug trials.

November 21, 2008

Analysis by: GLG Expert Contributor

Analysis of:Study: Diabetes drug fails to slow artery buildup | ap.google.com

Reduction of the intima media thickness is only a surrogate endpoint with little bearing on CVD, stroke and death. The number of different treatment options for pharmacological intervention of type 2 diabetics are groving rapidly. Many of the available oral antidiabeticdrugs and injectable glucoselowering drugs show good efficacy regarding the glucose control. Litte is known about the longterm effects, albeit some recent studies have been outcome studies (ACCORD, VADT, ADVANCE). We need to further understand and learn how to better individualize the treatment of diabetes type 2 in order not to only reduce the glucose levels or bloodpressure or lipids but to give safe and effective treatment resulting in fewer diabetic complications. The bottom line for the patients is not a good Ac1 level but a good life.

Jupiter Study: impact on Rosuvastatin

November 13, 2008

Analysis by: GLG Expert Contributor

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

Jupiter study demonstrated significant reduction of cardiovascular morbidity and mortality in patients with high hs-CRP and acceptable lipid profile. This study demonstrates that rosuvastatin might play a major role in modulating inflammation pathways predisposing to cardiovascular diseases. hs-CRP is a systemic inflammation biomarker and might not be useful in  clinical practice to identify patients at high risk of developing cardiovascular diseases. However, this study confirms the importance of identifying patients at high risk of developing cardiovascular diseases regardless the use of Framingham risk score.

Who can tolerate these doses and for how long?

November 13, 2008

Analysis by: GLG Expert Contributor

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

20 mg of Crestor is a high dose associated in many studies with a higher incidence of side effects.  Since compliance is historically poor with any maintenance medication, it will be interesting to see if patients with normal LDL with stay compliant with this statin or any statin in the higher doses in a real world population.  It is also important to note that simvastatin, another super-statin is available as a generic and should be used 1st line more often than it is today.

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC

Crestor's results in the Jupiter Study likely to change medical-economic perspectives in statin choices.

November 13, 2008

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

1:Crestor is the most potent statin in the market,yet is 3d in sales behind Zocor and Lipitor.2:The efficacy supriority together with its capacity to lower CRP levels led to the highest rate of ASCVD prevention in the shortest period of time evr documented in statin trials.3:The trial in near 18,000 patients with otherwise lower risk of ASCVD offered $0% reduction y many ascvd endpoints.4:There were no statistical differences in side effect compared to placebo.5:The dosage was 20 mg /day (an intermediate dose below the approved max dose of 40 mg/day

A closer look

November 11, 2008

Analysis by: GLG Expert Contributor

Analysis of:Taking Statins To The Next Level | www.forbes.com

The JUPITER trial showed that people with what is regarded as normal ('bad') cholesterol and elevated C-reactive protein benefit more from the choleterol lowering drug rosuvastatin (Crestor, Astra-Zeneca) than from placebo. The first question is: is this true only for this particular type of statin (rosuvastatin) or do the others have the same effect? We don't know, but the latter is probably true, even though Crestor may have the strongest effect. The second question is: should everybody start taking a statin (or specifically rosuvastatin) if their C-reactive protein is high and their bad cholesterol is normal? We don't know yet and until we understand the risk/benefit ratio better, it is useful to remember that quitting smoking, exercising regularly and eating a healthy diet can lower C-reactive protein too.

Overuse, under-focus

November 6, 2008

Analysis by: GLG Expert Contributor

Analysis of:Taking Statins To The Next Level | www.forbes.com

Little additional sales will be gained by growth in the statin market.

Medtronic Endeavour Failing to Live Up to Expectations

October 27, 2008

Analysis by: GLG Expert Contributor

Analysis of:Medtronic Endeavor Heart Stent Tied to Complications | www.bloomberg.com

The Endeavour stent appears to have a higher restenosis rate than currently marketed Drug Eluting Stents without the improved safety profile claimed by the company.  This finding is at odds with the companies marketing message to cardiologists.  These studies, along with the introduction of Xience/Promus, and the lack of a rapid exchange platform will limit Medtronics ability to break into this very competitive market.

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