Studies Suggest You Can Help Your Heart By Walking More And Eating More Fiber 1

It probably won’t come as a surprise, but walking more and eating more fiber are probably good for your heart. That’s the conclusion of two new studies, but because the studies relied on observational data it should be emphasized that they are incapable of demonstrating cause and effect. And it’s by no means clear that most people are willing to undertake the effort needed to achieve effective lifestyle changes like these.

Walking

In the first study, published in the Lancet, researchers analyzed data from 9,300 people with impaired glucose tolerance (and therefore at high risk for developing diabetes) and with existing cardiovascular disease or at high risk for CV disease.

Eating

In the second paper, published  in BMJ, investigators performed a systematic review of studies examining the effect of dietary fiber on cardiovascular and coronary heart disease.

Click here to read the full post on Forbes.

 

Keep Moving 

 

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New Guideline Recommends Conservative Treatment for Heart Patients with Anemia Reply

The American College of Physicians (ACP) is recommending more conservative use of transfusions and erythropoiesis-stimulating agents (ESAs) in anemia patients with heart disease. But the authors of the new clinical practice guidelines, published in the Annals of Internal Medicine, acknowledge that the evidence base is too flimsy to support firm conclusions.

“Overall,” wrote the authors, “despite the epidemiologic and biologically plausible association of anemia with poor outcomes, we did not find consistent evidence that anemia correction improves outcomes in patients with heart disease…” The poor outcomes of heart patients with anemia have prompted aggressive treatment strategies, but “it is unclear whether these strategies improve outcomes.”

Click here to read the full post on Forbes.

 

FDA Removes Restrictions On Avandia Reply

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death.

The FDA said its actions were “consistent with the recommendations of expert advisory committees.” In June of this year an FDA panel reviewed re-adjudicated data from the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial and concluded that the trial had not found an elevated risk of heart attack or death associated with rosiglitazone.

Click here to read the full post on Forbes.

 

Controversy Erupts Over Accuracy Of Cardiovascular Risk Calculator For Guidelines Reply

In the face of a highly critical story in the New York Times by Gina Kolata about the new cardiovascular guidelines, authors of the guidelines and leaders of the American Heart Association and the American College of Cardiology defended the value and integrity of the guidelines.

The Times story claims that the cardiovascular risk calculator used to assess individual risk in the new guidelines is deeply flawed. “In a major embarrassment to the health groups, the calculator appears to greatly overestimate risk, so much so that it could mistakenly suggest that millions more people are candidates for statin drugs.” The story quotes former ACC president Steve Nissen: “It’s stunning. We need a pause to further evaluate this approach before it is implemented on a widespread basis.”

But the guideline authors and AHA/ACC officials strenuously defended the guideline at a news conference Monday morning at the American Heart Association meeting in Dallas. They said  the new risk calculator is far superior to previous efforts, incorporating far more data that now includes stroke assessment and for the first time provides specific predictions for African Americans.

The assembled officials rejected any call to delay implantation of the guidelines, but one author, Donald Lloyd-Jones said that “over time we will modify the risk scores so that they get better and better.”

“We think we’ve done our due diligence,” said AHA president Mariell Jessup. “We have faith and trust in the people who developed the guidelines.”

Click here to read the full story on Forbes.

 

Press Conference

The Italian Research Scandal Grows: New Questions And More Confusion Reply

New questions are being raised about yet another published study from an embattled Italian research group. It also appears that despite attempts by some of the participants to respond to some of the previous questions and accusationst there is little likelihood that the growing scandal will be resolved anytime soon.

The new allegations are the latest episode in an ongoing saga that began last year with the arrest of 9 Italian cardiologists as part of a broad investigation into serious medical misconduct at Modena Hospital (Policlinico di Modena). The most prominent figure arrested was Maria Grazia Modena, the former head of cardiology. Since the arrests last year I have reported about numerous errors and other problems related to 2 studies by many of the same cardiologists published in the journals Heart and the American Journal of Cardiology.

The new questions concern a paper published in Circulation Cardiovascular Inteventions. Specifically, the paper claims that the study enrolled all consecutive STEMI patients from 2002 to 2008, obtained informed consent from all patients, and achieved 100% followup at 1 year. In addition, I found 2 mathematical errors in Table 2, including the apparent paradox of a subgroup of low risk men (n = 548) being larger than the entire group of men (n = 522). (Click to enlarge the image of the Table.)

The question about the enrollment of all STEMI patients is further complicated by the fact that (at least) 2 previous papers (the Heart and  AJC papers mentioned abovehave claimed to enroll, obtain consent, and achieve complete followup of the same STEMI population from the same hospital at the same time. Do the authors claim that informed consent was obtained for each of these studies and from each of the patients?

A Weak Defense

In response to my story about the American Journal of Cardiology paper the first author of that study, Daniel Monopoli, sent a lengthy response. (I have reprinted the entire response at the bottom of this post.) Readers should of course judge for themselves, but I do not believe Monopoli has satisfactorily resolved any of the questions raised about the paper. In some instances I think he has, inadvertently, worsened his position.

Click here to read the full post on Forbes.

 

 

 

Should You Be Worried About The Treatment For Low-T? Reply

The ubiquitous ads ask: “Should I be worried about Low-T”? But now there’s a good chance there’s a more important question: “Should I be worried about the treatment for low-T?”

A new study published in JAMA raises the distinct possibility that testosterone therapy may increase the risk of death, heart attack, and stroke. The findings are hardly definitive, but may raise significant questions about the enormous increase in the use of testosterone in recent years, especially  given the absence of any evidence demonstrating the safety of testosterone therapy.

Click here to read the full post on Forbes.

 

 

 

Flu Vaccine May Help Prevent Cardiovascular Events Reply

A new meta-analysis published in JAMA offers the best evidence yet that the flu vaccine may help prevent cardiovascular events.

Jacob  Udell and colleagues analyzed data from 5 published clinical trials in which 6,469 patients were randomized. People who received the flu vaccine had a significantly lower risk of cardiovascular events. The protective effect was largely restricted to people who had had a recent acute coronary syndrome (ACS). Cardiovascular events occurred in 2.9% of people in the vaccination group versus 4.7% of controls (RR 0.64, CI 0.48-0.86, p = .003).

Click here to read the full post on Forbes.

 

People Who Live Near Airports At Increased Risk For Cardiovascular Disease Reply

Most previous research on the health effects of noise has focused on road noise. Now two new observational studies published in BMJ extend the research to noise from airports and provide fresh evidence that people who live near airports are at increased risk for cardiovascular disease.

In the first paper, Anna Hansell and colleagues in the UK analyzed data from 3.6 million people living near Heathrow airport in London. People who lived in the noisiest areas had an elevated risk for stroke, coronary heart disease, and cardiovascular disease. …

Click here to read the full story on Forbes.

 

NEAR LOGAN AIRPORT-AIRPLANE COMING IN FOR A LA...
 (Photo credit: Wikipedia) 

News From Our ‘Statin Civilization’: High-Dose Statins Found To Reduce Gum Disease Inflammation Reply

In addition to their well-known benefits in heart disease, high-dose statins appear to reduce gum inflammation caused by periodontal disease, a new report published in the Journal of the American College of Cardiology shows. The findings offer more evidence that heart disease and gum disease may be linked, and also help support the view that statins achieve at least some of their effect not through their cholesterol-lowering effect but through separate inflammation-fighting mechanisms.

Researchers reported findings from 59 patients with cardiovascular disease or at high risk for cardiovascular disease who had evidence  of arterial inflammation on a  PET scan. The patients were randomized to a low (10 mg per day) or high (80 mg per day) dose of atorvastatin. After 12 weeks there was a significant reduction in periodontal inflammation as measured by PET in patients taking high dose atorvastatin. The effect was greatest in those patients who had active periodontal disease. There was evidence of a significant effect as early as 4 weeks. Furthermore, there was a strong correlation between reductions in periodontal inflammation and atherosclerosis, though the authors acknowledged that the precise nature of the association remains undefined.

Click here to read the full story on Forbes.

English: Periodontal bone loss shown in X-Ray ...

Periodontal bone loss shown in X-Ray image. (Photo credit: Wikipedia)

Studies Suggest Most Widely Used Cardiac Imaging Technique Is Overused Reply

Echocardiography is a safe, noninvasive tool to image the heart without the use of radiation. For this reason it has become the most frequently used method to look at the heart for a wide variety of medical indications. Now two new studies suggest that, despite its popularity, transthoracic echocardiography is often not beneficial. One study finds that in most cases echocardiography does not change the treatment of patients. A second study suggests that using echocardiography to screen low-risk people for heart disease is not warranted.

In the first study, published in JAMA Internal Medicine,  Susan Matulevicius and colleagues reviewed the patient records for 535 consecutive  standard echocardiograms performed at their hospital (the University of Texas Southwestern Medical Center) in one month. Although the vast majority of cases were indicated according to current appropriate use criteria (AUC) — 91.8% were deemed appropriate, only 4.3% were deemed inappropriate, and 3.9% were deemed uncertain — less than a third of cases resulted in an active change in care…

In the second paper, also published in JAMA Internal Medicine, Norwegian researchers studied nearly 7,000 people who were already participating in the Tromsø observational study. The patients were randomized to receive an echocardiography screening examination or to a control group and were then followed for 15 years. Of the screening group patients, 7.6% ultimately received a diagnosis of a cardiac or valvular disorder.

Click here to read the full story on Forbes.

 

Another Disappointing Study For Fish Oil Supplements 3

Another large study has failed to find any benefits  for  fish oil supplements. The Italian Risk and Prevention Study, published in the New England Journal of Medicine, enrolled 12,513 people who had not had a myocardial infarction but had evidence of atherosclerosis or had multiple cardiovascular risk factors. The patients were randomized to either a fish oil supplement (1 gram daily of n-3 fatty acids) or placebo.

After 5 years of followup, the primary endpoint– the time to death from cardiovascular causes or admission to the hospital for cardiovascular causes– had occurred in 11.7% of the fish oil group versus 11.9% of the placebo group (adjusted hazard ratio 0.97, CI 0.88-1.08, p=0.58). There were no significant differences in any of the prespecified secondary endpoints.

Click here to read the full post on Forbes, including comments from James Stein and Dariush Mozaffarian

A typical softgel

Another Cleveland Clinic Study Links TMAO To Atherosclerosis Reply

A new study from the Cleveland Clinic research group headed by Stanley Hazen offers more evidence in support of the hypothesis that TMAO (trimethylamine-N-oxide) may play a role in the development of heart disease. The new research, published in the New England Journal of Medicine, follows closely on a related study published recently in Nature Medicine that received broad public attention.

The Nature Medicine paper demonstrated that digestive tract bacteria metabolize carnitine into trimethylamine-N-oxide (TMAO), which had previously been linked to atherosclerosis in animals. The new research in NEJM focuses on another pathway that leads to TMAO production and provides for the first time a credible association between TMAO and cardiovascular disease in humans.

Click here to read the full story on Forbes.

Stanley Hazen

 

Emerging Biomarkers: How Reliable Is The Evidence? Reply

Novel biomarkers are the subject of intense controversy, with a bewildering variety of factions and perspectives seeking to elevate or dismiss any of a large number of proposed new measures. Now a new examination of the literature published online in JAMA Internal Medicine suggests that the evidence base used to evaluate novel biomarkers may be seriously compromised by selective reporting bias.

John Ioannidis led a team of researchers who analyzed 56 meta-analyses of new candidate cardiovascular biomarkers. 49 of the studies had statistically significant results, but 9 studies were compromised by very large heterogeneity, 13 studies were compromised by small-study effects, and 29 studies had an excess of studies with statistically significant results. Only 13 studies had more than 1,000 cases, achieved statistical significance, and had none of the other deficiencies listed above. The meta-analyses that emerged unscathed examined the associations of  glomerular filtration rate and albumin to creatinine ratio in general and high-risk populations with cardiovascular disease mortality and of non–high-density lipoprotein cholesterol, serum albumin, Chlamydia pneumoniae IgG, glycosylated hemoglobin, nonfasting insulin, apolipoprotein B/AI ratio, erythrocyte sedimentation rate, and lipoprotein- associated phospholipase mass or activity with coronary heart disease.

The authors summarized their finding as suggesting that “the effect of biomarkers is exaggerated because the largest studies— which one would expect to produce the most stable estimates— consistently showed smaller effects. In most meta-analyses, too many single studies had reported ‘positive’ results compared with what would be expected on the basis of the results of the largest studies. This suggests that small studies with ‘negative’ results remain unpublished or that their results are distorted during analysis and reporting to seem more prominent.”

In an invited commentary, Steve Nissen writes that evidence-based medicine has been put on a “golden pedestal” but publication basis “is a dark secret that corrupts nearly every aspect of our profession and undermines societal efforts to promote evidence-based medicine.” He cites carotid intima-medial thickness and apolipoprotein B as just two biomarkers in which “the magnitude of the association is probably much smaller than suggested by the definitive meta-analysis.”

Nissen urges investigators to register their studies with ClinicalTrials.Gov, but points out that the site does not support large data sets. “Therefore,” he argues, “society must consider funding the National Library of Medicine to create a public website where authors can post the detailed results of findings that they were unable to publish despite submitting to multiple journals. Finally, we must emphasize to colleagues and trainees that all studies contribute to scientific understanding. We have a moral obligation to our patients to make all research findings available to the broader scientific community.”

 

Three Experts Weigh In On The Mediterranean Diet 4

Over on CardioExchange three world-class experts– Walter Willett, Arthur Agatston, and Alice Lichtenstein– discuss the PREDIMED trial that earlier this week gave a big boost to the Mediterranean diet. I highly recommend you read the entire discussion on CardioExchangeHere are a few excerpts.

Walter Willett:

Many practitioners have not given enough emphasis to diet for prevention and management of cardiovascular disease. It is good to keep in mind that the effect of this diet was comparable to that of statins, and there are many beneficial side effects compared with statins…

[The Mediterranean diet] stands as the gold standard. One of the real advantages of the Mediterranean diet is that it is enjoyable and offers great variety, so people are able to stay with it for many years, in contrast to most more restrictive diets.

 Arthur Agatston:

Unintended experiments — such as America’s low-fat, high-carbohydrate movement that ushered in low-fat, processed carbohydrate foods with no precedent in traditional diets — turned out to play an important role in today’s obesity and diabetes epidemics. It is just not feasible to perform trials of the efficacy of truly new diets… The Mediterranean diet, which has stood the test of time, has the advantage of being palatable and, thus, being adopted as a lifestyle with sustained positive outcomes.

The early separation of events between the recipients of the Mediterranean interventions and the controls was impressive…. Therefore, the Mediterranean diet’s effects may be anti-inflammatory rather than just antiatherogenic. That possibility tends to make me more aggressive in recommending the diet for both short- and long-term benefits.

Alice Lichtenstein:

The study confirms what we have known for more than a decade — namely, that the total fat content of the diet has little effect on cardiovascular outcomes and that the important variable is the type of fat.

We don’t know from this study whether other vegetable oils or foods rich in PUFAs or MUFAs, when integrated with a characteristically Mediterranean diet, would have had the same benefit. It is likely they would.

CABG Highly Cost Effective In Diabetics With Multivessel Disease Reply

In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI.

Elizabeth Magnuson and colleagues  found that although CABG initially cost nearly $9,000 more than PCI ($34,467 versus $25,845), over the long term it was more cost effective. At five years, greater follow-up costs in the PCI group, in large part due to a greater number of  repeat revascularization procedures, reduced the difference so that CABG cost only $3,600 more than PCI. The researchers calculated that CABG had a lifetime cost-effectiveness of $8,132 per QALY (quality-adjusted life-year) gained, which is considered highly cost effective. The finding was consistent across a broad range of assumptions.

The authors concluded “that CABG provides not only better long-term clinical outcomes than DES-PCI but that these benefits are achieved at an overall cost that represents an attractive use of societal health care resources. These findings suggest that existing guidelines that recommend CABG for diabetic patients with multivessel CAD remain appropriate in current practice and may provide additional support for strengthening those recommendations.”

“With great concerns about escalating healthcare costs, it’s very important when setting policy to understand the benefits gained from additional expenditures over the long run,” said Magnuson, in an AHA press release. “This is especially true in cardiovascular disease where many interventions tend to be very costly up front.”