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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First patient enrolled in study testing duration of antiplatelet therapy after DES Reply

Enrollment is finally underway in the much anticipated Dual Antiplatelet Therapy Study (DAPT), according to an announcement today from the Harvard Clinical Research Institute. DAPT is the product of a unique collaboration that includes the FDA, HCRI, and the following companies, which make stents and the antiplatelet drugs clopidogrel and prasugrel:
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Lancet review: will most babies born now live to 100? Reply

If current trends continue, most babies born in this century in developed countries will live to see their 100th birthday, according to an important new review appearing in the Lancet.

A key question is whether the increase in life expectancy will also bring an accompanying delay in functional limitations and disability. There is no clear answer to this question, but Kaare Christensen and coauthors find evidence suggesting that “people are living longer without severe disability.”

According to the authors, the increase in life expectancy shows no sing of deceleration: “The linear increase in record life expectancy for more than 165 years does not suggest a looming limit to human lifespan. If life expectancy were approaching a limit, some deceleration of progress would probably occur. Continued progress in the longest living populations suggests that we are not close to a limit, and further rise in life expectancy seems likely.” However, even if there are no further gains in health and life expectancy, three-fourths of babies born in this century will reach their 75th birthday.
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REVERSE at 2 years: CRT may help prevent progression in early HF Reply

Two-year results from the REVERSE trial help support the proposition that cardiac resynchronization therapy may be beneficial in patients with class 1 and 2 heart failure. The results, which were presented initially last March at the American College of Cardiology meeting, have been published online as an expedited paper in the Journal of the American College of Cardiology. The major findings from the trial, the one year results, had been presented a year earlier at the ACC, and failed to demonstrate a benefit for CRT in this population, though trial investigators pointed to signs of reverse ventricular remodeling as an important hint of benefit.
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Invitation to Readers: My Mighty Team Reply

Dear CardioBrief Reader,

I am pleased to invite you to become one of the first users of an innovative new website, My Mighty Team, that has just entered beta testing. MIGHTY is a completely free social networking site designed to help people achieve goals such as losing weight, quitting smoking, or exercising more, by using small, focused teams to support and track their progress.
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FDA adds pancreatitis warning to Januvia label Reply

The FDA has revised the prescribing information for Januvia (sitagliptin) and Janumet  (sitagliptin/metformin), adding information about reported cases of acute pancreatitis in 88 cases. The FDA recommends that doctors monitor patients  for acute pancreatitis after initiating sitagliptin or increasing the dose.

Merck, which manufactures sitagliptin, released a statement saying it “believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.”
Click to read the FDA announcement and the statement from Merck…