EMEA investigating increased cardiovascular risk with sibutramine 4

The European Medicines Agency (EMEA) said that it’s Committee for Medicinal Products for Human Use (CHMP) has started a review of sibutramine (Meridia) to investigate data from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial) suggesting a possible increased risk of serious cardiovascular events.
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EINSTEIN at ASH: rivaroxaban (Xarelto) prevents recurrent VTE, but bleeding may be a concern Reply

EINSTEIN-Extension, which will be presented as a late-breaking clinical trial at the American Society of Hematology meeting in New Orleans on December 8, demonstrates that rivaroxaban (Xarelto), the direct oral factor Xa inhibitor, is effective in the long-term prevention of recurrent venous thromboembolism. But a high bleeding rate may dampen enthusiasm for the new oral anticoagulant.

The trial randomized 1,197 patients who had already completed 6-12 months of anticoagulant treatment for a first acute episode of VTE to either rivaroxaban or placebo for an additional 6-12 months. Symptomatic recurrent VTE occurred in  42 (7.1%) of placebo patients and 8 (1.3%) of rivaroxaban patients, representing a highly significant 82% relative risk reduction. When therapy was stopped, after a mean duration of 190 days, there were 6 new events in each group in the following month.
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AHA: Ken Baughman dies after a traffic accident in Orlando 7

Ken Baughman, 63, has died as a result of a traffic accident on Monday in Orlando, FL. Baughman, the former head of the division of cardiology at Johns Hopkins, was the Director of the Advanced Heart Disease Program at Brigham & Women’s Hospital.
The Boston Globe reports that Baughman was hit by a car at 6 AM while jogging at the intersection of Sand Lake Road and Universal Boulevard in Orlando.

Here are statements from Baughman’s family, the president of Brigham and Women’s Hospital, and from the AHA:
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FDA issues public health advisory on interaction between clopidogrel and omeprazole 2

Updated: The FDA has issued a public health advisory to highlight updated safety information regarding an interaction between clopidogrel (Plavix) and omeprazole. The label change, which was made on Friday, was reported first by CardioBrief yesterday.

An FDA official explained that the label changes were based on data from a new study performed by the sponsor: Here are the study details as written in the new label:
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AHA: 58% survival rate at 2 years with HeartMate II continuous flow LVAD 1

The HeartMate II continuous flow LVAD outperformed its older cousin, the HeartMate XVE pulsatile flow LVAD, according to the results of the HeartMate II Destination Therapy Trial presented today at the AHA and published online in the New England Journal of Medicine.

The trial randomized 200 patients with advanced heart failure who were not eligible for transplantation. The primary endpoint, survival at two years free from disabling stroke or re-operation for device repair or replacement, was reached in 46% of patients who received the continuous flow (CF) device compared to only 11% who received the pulsatile flow (PF) device, a highly significant difference (p<0.001).
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AHA: early repolarization on ECG associated with increased risk of cardiac death Reply

Early repolarization, long thought to be benign, is associated with an increased risk of death from cardiac causes, according to a new study presented here at the AHA and published online in the New England Journal of Medicine. Finnish investigators examined the ECGs of 1,864 middle-aged people to assess the prognostic significance over 30 years of early repolarization (defined as an elevation of the QRS-ST junction– J point– in leads other than V1 through V3).
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Sunday at the AHA: ARBITER’s wild roller coaster ride in Orlando 2

[Updated. See bottom of story for postscript on CNBC TV reporter Mike Huckman's embargo break.]

The early release of the ARBITER 6 trial on Sunday was a roller coaster ride in more ways than one. In addition to the drama in the newsroom at the AHA as the embargo was lifted, the hastily assembled news conference couldn’t get underway until one very important participant could be summoned from a family outing at Disney’s Animal Kingdom.
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AHA: Niacin to take center stage as it beats ezetimibe in ARBITER 6 5

Following a frenzied build-up (on Wall Street, at least– not so much in the medical community) the results of ARBITER 6 have now been presented at the AHA and published online in the New England Journal of Medicine. The bottom line: niacin but not ezetimibe caused a significant reduction in CIMT.

Although its HDL raising properties have been known for decades, niacin is about to experience its 15 minutes of fame as an overnight success. Whether its fame and notoriety will last longer will depend on more data than ARBITER 6 can provide.
Click to continue reading, including extensive commentary from Steve Nissen, Roger Blumenthal, and Sanjay Kaul…

AHA: Biventricular pacing preserves LV shape and function 1

Biventricular pacing may prevent the adverse left ventricular modeling and reduction in LV function often seen with RV pacing, according to results of the PACE Trial presented at the AHA and published online in the New England Journal of Medicine.

Chinese investigators randomized 177 patients with bradycardia and preserved LV function to biventricular pacing or RV apical pacing. At 12 months, LV EF was 54.8% in the RV pacing group compared to 62.2% in the Biventricular pacing group, a highly significant difference (p<0.001). LV end systolic volume was 35.7ml vs 27.6 ml, a relative difference of 25% that was highly significant.
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AHA: cangrelor fails to find a championship season Reply

Negative results of the CHAMPION PCI and CHAMPION PLATFORM trials have put a damper on hopes for cangrelor, the potent intravenous, reversible platelet blocker under development by the Medicines Company. But investigators say the drug might not have been used properly in the trials, and say they hope to find ways to make use of the drug’s potency and rapid on and off action.

The results of the two trials were presented today at the American Heart Association in Orlando and published simultaneously in the New England Journal of Medicine. These findings follow an announcement last spring that the Medicines Company was discontinuing the CHAMPION clinical trial program.
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AHA: Ticagrelor found beneficial in STEMI subset of PLATO 2

Results from the 8,430 STEMI patients enrolled in the PLATO trial (presented last summer at the ESC and published simultaneously in the Lancet) are consistent with the main 18,000 patient trial and show that ticagrelor reduced the primary endpoint of MI, stroke or vascular death without causing an increase in major bleeding complications when compared to clopidogrel. The trial was presented by Philippe Gabriel Steg at the AHA.
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The empire strikes back: Merck’s Richard Pasternak downgrades ARBITER 6 1

In response to the growing frenzy on Wall Street and in the media over the upcoming presentation of ARBITER 6 on Monday morning, Merck’s Richard Pasternak (formerly a cardiologist at Massachusetts General Hospital) sent a lengthy critique of the trial to CardioBrief (see below). Pasternak also wrote a detailed response to an article about ARBITER 6  in the New York Times and published the letter on Merck’s website.

Whatever else happens with ARBITER 6, Merck says it remains committed to cardiovascular research (unlike some other very large pharmaceutical companies that we won’t mention now). Here’s the press release Merck issued today.
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Editorial: Why ARBITER 6 is important– and not important 1

Arbiter-6 is big news. CNBC will be reporting live from the convention hall on Monday when the results are released. Just in the last day or so the New York Times and the Wall Street Journal have discussed the significance– or lack of it– of the trial. On the one hand, most cardiologists I speak with don’t believe the trial is a big deal. On Wall Street, on the other hand, the feeling is very different, since analysts believe the trial might further threaten the embattled multibillion dollar Vytorin/Zetia franchise (and perhaps give a boost to Abbot’s niacin franchise).

At first glance, ARBITER-6 just isn’t important. From a purely scientific perspective ARBITER 6 doesn’t have much going for it. It’s a small trial with a surrogate endpoint. It won’t definitively answer any relevant clinical questions. So we might actually agree with the Merck PR person who asked CNBC reporter Mike Huckman: “Why are you making this such a big deal? It’s a 200-patient study.”
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26,000 patients enrolled in TIMI-50 trial of novel antiplatelet agent Reply

CardioBrief doesn’t usually cover routine announcements that companies make when trials get started or when enrollment is completed, and we’re especially busy now getting ready for the AHA, but the attached announcement from Merck about the completed patient enrollment of the TIMI 50 trial of a novel antiplatelet agent will likely be of interest to our readers. Merck (and the former Schering-Plough) have been taking plenty of beatings lately– much of them well-deserved– but that doesn’t negate the interest and excitement over SCH 530348. We used to refer to this as TRA, for “thrombin receptor antagonist,” but I guess that didn’t sound scientific and obscure enough so they’re now calling it a “antiplatelet protease activated receptor-1 (PAR-1) inhibitor.”
Click here to read the Merck press release…

Get ready for the AHA in Orlando Reply

The AHA begins this weekend in Orlando. Here are a few useful resources:

William Ganz, co-inventor of catheter and early promoter of thrombolysis, dead at 90 1

William Ganz, a Cedars-Sinai cardiologist who  helped change the entire field of cardiology more than once, died on Tuesday at the age of 90.

Ganz is perhaps best known today because of the Swann-Ganz catheter, which he co-invented in 1970 with Jeremy Swan, who was then the chief of cardiology at Cedars-Sinai. But Ganz’s more important contribution may well be the key role he played in ushering in the age of reperfusion, which transformed the role of cardiologists.
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FDA sends warning letter to UCLA cardiologist Charles McKay Reply

The FDA has sent a strongly worded warning letter to UCLA cardiologist Charles McKay concerning his conduct as the principal investigator of a clinical trial. The letter was originally reported in a story  by William Heisel in Reporting on Health.

The warning letter, dated 10/23/2009, concludes that McKay “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations,” and includes many details about serious lapses in the conduct of the trial, though only 5 patients were enrolled at the site.

CardioBrief spoke briefly with McKay, who said that a “response letter has been drafted and each issue will be addressed.” McKay would not provide further details about the response, or the particular drug or company involved with the research. (The name of the drug and the company involved are redacted along with patient information in the posted version of the letter.) In 2002 McKay became the chief of cardiology at Harbor-UCLA Medical Center, though he is no longer listed as such on the center’s website. (Kenneth Narahara is now listed as the division chief. It is unclear when this change too place.)
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NEJM: Study finds risks but no benefits for renal revascularization 1

Will ASTRAL do for the renal arteries what COURAGE did for the coronary arteries? The first large, randomized trial to compare renal revascularization to medical therapy found no sign of benefit, and increased risk, for the interventional approach. The results of the ASTRAL trial are published today in the New England Journal of Medicine.
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JAMA studies: statins reduce gallstones, simplified lipid assessment without fasting Reply

Two lipid-related studies appearing in JAMA today will be of interest to many CardioBrief readers:

In the first study, researchers found that long term statin use (the effect didn’t kick in until after a year or a year and a half of treatment) was associated with a reduced incidence of gallstone disease and cholecystectomy. It won’t be a big surprise, since most gallstones are composed largely of cholesterol, but this is the biggest and best study yet of this important subject.

In the second study, researchers found that lipid assessment can be greatly simplified by measuring–without fasting– either total and HDL cholesterol levels or apolipoproteins.
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ARBITER-6 Family Feud: And the survey says… 3

If cardiology and medicine were as simple as Family Feud then ARBITER-6 would already be decided. (For those of you not familiar with it, Family Feud, as described by Wikipedia, is a TV game show “that pits two families against each other in a contest to name the most popular responses to a survey-type question posed to 100 people.”)

Now a Wall Street analyst is analyzing ARBITER 6 along the lines of Family Feud. According to a survey of 103 US physicians (31 cardiologists, 72 primary care physicians)  51% of the the primary care doctors and 80% of the cardiologists predicted that Niaspan would be superior to Zetia– although the validity of their opinion may be open to question since less than 35% of the physicians were even aware of ARBITER 6.
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Boston Scientific issues statement on the death of Donald Baim Reply

Here is the statement from Boston Scientific on the death of Dr. Donald Baim:

Baim BSX

It was with shock and great sadness that we learned of the death of Dr. Donald S. Baim, Boston Scientific’s Chief Medical and Scientific Officer. Dr. Baim passed away November 6 of complications of surgery for treating newly-diagnosed adrenal cancer. He was 60.

Dr. Baim served Boston Scientific with enormous dedication, distinction and effectiveness. He was the chief advocate and champion for millions of patients who were helped by our products, technologies and clinical science.
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Observational study finds increased adverse outcomes with increased usage of carotid stenting Reply

Following Medicare approval of widespread reimbursement for carotid stenting in 2005, usage of  the procedure quickly quadrupled in the Medicare population. Unfortunately, according to a new observational, retrospective study appearing in the Journal of Vascular Surgery, the increased use of carotid stents was accompanied by an increased rate of adverse events.
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