Women and MI: increasing incidence but improved survival Reply

Two new studies provide important new details about the complex situation regarding women and MI. On the one hand, middle-aged women over the last 20 years have developed an increased risk of MI. (The trend for men of the same age has been improving, by contrast, though men still have a higher absolute risk than women.) On the other hand, women who do have an MI have achieved larger larger gains in mortality than men.
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FDA advisory committee to review primary prevention indication for Crestor (rosuvastatin) Reply

On December 15 the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will evaluate AstraZeneca’s application for a primary prevention indication for rosuvastatin (Crestor). The application is based on the results of JUPITER. Click here for the FDA announcement.
Click to read the text of the Notice of Meeting from the Federal Register…

Duke cardiologist to be new president of Gladstone Institutes Reply

Roberts Sanders “Sandy” Williams will be the next president of the Gladstone Institutes, the Institutes announced yesterday. Sanders, a Duke Univeristy cardiologist, most recently served as the senior vice chancellor for academic affairs at Duke University Medical Center. Williams succeeds the Gladstone’s founding director and president, Robert Mahley, who is stepping down after 30 years, according to the announcement, “to pursue his research into the biology of apolipoprotein E in heart disease and Alzheimer’s disease.”
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Lancet: liraglutide shows considerable promise in weight loss trial 1

Can liraglutide go where rimonabant couldn’t? Can it safely and effectively help to mitigate the effects of the obesity and metabolic syndrome pandemic? Results of a new trial with liraglutide may well help restart speculation and refuel the rumor mill. But the chief limitations to liraglutide are the current absence of robust long term data and the fact that because it is a peptide it can only be given as an injection.

According to a new study from Europe appearing in the Lancet, liraglutide is more effective than both placebo and orlistat in reducing weight and improving risk factors. The startling results prompted George Bray, in an accompanying comment, to  say of liraglutide and other  GLP-1 analogs that he is “optimistic that their promise for the treatment of obesity will be fulfilled.”

Arne Astrup and colleagues reported on 564 overweight subjects who were randomized to either open-label orlistat, placebo, or one of four doses of liraglutide. At 20 weeks weight loss was significantly greater in all of the liraglutide dose groups than in the placebo or orlistat groups.

Mean weight loss (kg) % of pts w/ >5% weight loss
Liraglutide 1.2 mg 4.8 52.1
Liraglutide 1.8 mg 5.5 53.3
Liraglutide 2.4 mg 6.3 60.8
Liraglutide 3.0 mg 7.2 76.1
Orlistat 120 mg 4.1 44.2
Placebo 2,8 29.6

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FDA turns down King’s NDA for CorVue (binodenoson) Reply

The FDA has issued a completed response letter in response to King Pharmaceuticals NDA for CorVue (binodenoson). The company has not disclosed the content of the letter. Binodenoson is a pharmacologic stress agent for use as an adjunct in SPECT (single-photon-emission computed tomographic) cardiac imaging.

The FDA response is not entirely unexpected, as the FDA’s cardiorenal advisory panel failed to recommend the agent in July. Here are links to our earlier coverage:
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Hospitals getting with the guidelines are not getting with aldosterone antagonism Reply

Only a third of heart failure patients who have a guideline-based indication for an aldosterone antagonist are actually receiving one, according to a new study appearing in JAMA. Ironically, the observational analysis  of 43,625 heart failure patients took place in  241 hospitals participating in the Get With The Guidelines–HF quality improvement registry.
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Medco launches 14,000 patient head-to-head observational comparison of clopidogrel and prasugrel 2

Medco announced today that it is launching a large head-to-head prospective, observational study comparing clopidogrel (Plavix) and prasugrel (Effient) in more than 14,000 patients. The study, GeCCO (Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study), is designed to assess whether clopidogrel given to patients who are CYP2C19 extensive metabolizers is noninferior to prasugrel on the composite primary endpoint of CV death, nonfatal MI, or nonfatal stroke.
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Telmisartan gets FDA approval for CV prevention in ACE inhibitor-intolerant patients Reply

Update: October 23– Boehringer Ingelheim announced in a press release that CHMP had issued a positive opinion for telmisartan as the first treatment in its class to reduce the risk of cardiovascular morbidity in high CV risk patients.

Telmisartan (Micardis) has received FDA approval for the prevention of MI, stroke, or death from cardiovascular causes in high risk patients who are unable to take ACE inhibitors. Boehringer Ingelheim announced the new indication this morning, as well as approval of aNDA for Twynsta, the combination of telmisartan and amlodipine for the treatment of hypertension alone or in combination with other agents.
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More allegations about ENHANCE fiasco laid out in Vytorin lawsuit complaint 3

A 200+ page complaint filed in the Schering-Plough/ENHANCE lawsuit provides the closest glimpse yet of the inner workings and details of the ENHANCE trial fiasco, at least from the perspective of the company’s critics. The lengthy document provides a detailed chronology of the trial’s history and the interactions of the company and the trial’s academic investigators and consultants.

One potentially explosive new development: the document includes many details based on testimony from several insiders within Schering-Plough, though for now these confidential witnesses remain anonymous, and they have not been deposed or cross-examined by opposing attorneys.

A spokesman for Schering-Plough sent the following response to CardioBrief:

There is nothing new in this filing.  These allegations have been made and responded to before.  We are confident the company will ultimately be vindicated.

Click here for links to the complaint and other resources…

Study raises concerns about trauma treatment in growing population on warfarin Reply

A large observational study raises concerns that the growing population of patients on warfarin is more likely to die because of trauma. The new study, which included 36,000 warfarin users among 1.2 million people in the National Trauma Databank, was presented at the 2009 Clinical Congress of the American College of Surgeons.

The finding is not especially surprising, but it has not been examined previously in a large sample, according to the authors. The growing population of elderly people taking warfarin means this is a potential problem of increasing urgency.
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IOM report: smoking bans cut heart attacks in smokers and nonsmokers Reply

The Institute of Medicine has released a report, Secondhand Smoke Exposure and Cardiovascular Effects: Making Sense of the Evidence, that provides strong evidence to support the effectiveness of smoking bans.

The report found strong evidence that exposure to secondhand smoke increases the risk of coronary heart disease among both men and women. The existing data was not sufficient to estimate the size of the effect, however.
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Meta-analysis suggests statins may help fight infections Reply

Statins may help prevent and fight infections, according to a systematic review and meta-analysis appearing in Archives of Internal Medicine.

The researcher found that patients with infections taking statins had a better outcome, including an improved chance of survival, than patients not taking statins. Statin use was similarly associated with a significant beneficial reduction in preventing infections.
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10 years after, Columbia heart surgery study still causing problems Reply

A study that started in 1999 and ended in 2001 is still causing problems for Columbia University Medical Center, according to a detailed investigation by Jeanne Lenzer and Shannon Brownlee in the Huffington Post.

Lenzer and Brownlee report that Columbia has performed three separate internal reviews of the study which “raised serious questions about the drug trial’s design, management and oversight” but found no evidence that patients were harmed and concluded “that there was no need to provide the patients with additional information about the study.”

Now, however, the US Office of Human Research Protections has determined that “at least some of the subjects appear to have suffered harms that were a function of the design and procedures of the study.” OHRP is “demanding that Columbia track down the patients and their families, and acknowledge that they never were informed about the ‘true nature’ of the drug study, the risks they faced or the consequences of their participation.”
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Study finds increased use of glucose lowering treatments at the expense of statins and antihypertensives Reply

Physicians have the wrong priorities when treating patients with diabetes, according to a research letter  in the Archives of Internal Medicine.

Mann et al looked at data from diabetics participating in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2006. During the course of the study period the use of medications to treat glucose, cholesterol, and hypertension increased broadly, although the most impressive changes occurred in glucose control. By the end of the study more than half the patients had HbA(1c) levels lower than 7%, compared to only 43% who had controlled cholesterol and 39% who had controlled hypertension.
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October thought experiment: suppose the World Series were covered like the Nobel Prize Reply

October brings the Nobel Prize announcements and the World Series. No one will mistake media coverage of one for the other. Each Nobel Prize will get one article and 10 seconds on the evening news. A soft feature will quote the new Nobel recipient’s complete surprise at the 4 AM phone call.

By contrast, baseball, like all major sports, is covered in great depth, by legions of sports reporters. Coverage is continuous during the long baseball season, reaches a near-hysterical peak in October, and continues generously even during the off-season.

Let’s try a thought experiment. Imagine for a moment that newspapers covered baseball the way they cover science. What would happen? What kind of articles would we see and what kind of stories would we miss?
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Elizabeth Taylor twitters the news she’s about to get an Evalve MitraClip mitral valve 2

Update–October 8: Elizabeth Taylor sent a tweet on Thursday announcing that her procedure had been a success. Here is the tweet: “Dear Friends, My heart procedure went off perfectly. It’s like having a brand new ticker. Thank you for your prayers and good wishes.”

Update–October 7: CardioBrief has heard from a reliable source that Taylor will undergo her procedure today.

Providing proof positive that we live in a world no one could possibly have imagined only a few short years ago, Elizabeth Taylor today twittered the news that she was about to enter the hospital and receive an Evalve MitraClip mitral valve clipping procedure.

CardioBrief has learned that Cedars-Sinai Medical Center is the only hospital in the Los Angeles area that is working with the Evalve device.
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9 nontraditional risk factors fail to gain USPSTF recommendations; CRP comes close Reply

Nine nontraditional risk factors have not been shown to improve risk stratification of people at intermediate risk for coronary heart disease, according to three new papers from the US Preventive Services Task Force (USPSTF) appearing in Annals of Internal Medicine. CRP came closest to receiving a recommendation. The authors found “moderate, consistent evidence that adding CRP to risk prediction models among initially intermediate-risk persons improves risk stratification” but did not find sufficient evidence “to assess whether reducing CRP levels prevents CHD events.”
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Hypertension in China causes 1.27 million premature deaths a year Reply

Updated with a comment from Franz Messerli– Results of a large prospective cohort study suggest that in 2005 there were approximately 153 million people with hypertension in China, leading to 1.27 million premature deaths from cardiovascular disease. Not surprisingly, the authors argue that “prevention and control of this condition should receive top public-health priority in China.” The results have been published online in the Lancet.
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Onglyza (saxagliptin) gains European approval; demonstrates noninferiority to sitagliptin in phase 3b trial Reply

Following FDA approval in the US earlier this year, Onglyza (saxagliptin) received European marketing authorization, according to a press release issued by Bristol-Myers Squibb and AstraZeneca.

According to the companies, Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control:
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