Category Archives: Prevention, Epidemiology & Outcomes

Salt Report From IOM Sparks Much Heat, Only A Little Light Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

An Institute of Medicine report on salt earlier this week sparked a lot of controversy. The report concludes that there’s no evidence to support current efforts to lower salt consumption to less than 2,300 mg/day. Unfortunately, the press coverage offered little insight into the science behind the issue. On the Knight Science Journalism Tracker blog, Faye Flam deftly uncovers the almost universal shallow coverage in the media.

The one exception, the one story worth reading that “dug into the science,” according to Flam, is Gina Kolata’s story in the New York Times:

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Click here to read the full post on Forbes.

 

English: A close up of salt crystals.

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Another Disappointing Study For Fish Oil Supplements 3

by • Heart Failure, Heart Rhythms, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

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.

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

A typical softgel

FDA Approves Combination Of Ezetimibe And Atorvastatin Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , , ,

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.

Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol from 53% to 61%, depending on dosage.

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Click here to read the full post on Forbes.

 

Danish Study Finds No Increased CV Risk With Azithromycin In General Population Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published  in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls who took no antibiotics and with matched controls who took penicillin V for similar indications.

Although there was a significant increase in the risk of death from cardiovascular causes in people taking azithromycin compared with people taking no antibiotics (RR 2.85, CI 1.13 – 7.24), there was no increase in risk when compared to people taking penicillin V (RR 0.93, CI 0.56 to 1.55). The findings, write the authors, indicate “that the increased risk that was observed in the comparison with no antibiotic use was entirely attributable to the risk of death associated with acute infection (or some other adverse health characteristic in persons receiving antibiotic treatment, as compared with those not treated with antibiotics) rather than with its treatment.”

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Click here to read the full story on Forbes.

WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

There’s probably no greater public health issue than the long-term  consequences of the childhood obesity epidemic. So the Wall Street Journal should be commended for digging into some of the important science behind this problem in a feature article in today’s paper. The author, Ron Winslow, is widely regarded as the best working journalist who regularly covers cardiovascular medicine. But I’m afraid the article fails to raise several key questions about the topic and therefore misses an opportunity to educate people about its complexities.

The article deals with the “growing concerns about the cardiovascular health of millions of children in the U.S. who are considered obese or overweight” and then focuses on one recent study published in Pediatrics that “suggests there is a simple way to assess a child’s arterial health with a calculation based on an often-overlooked component of cholesterol: triglycerides.” Winslow faithfully reports the main finding of the study, which is that the triglyceride to HDL ratio corresponds closely with arterial stiffness. A stiff vessel is a sign of “accelerated aging” and “likely raises the risk of dangerous outcomes relatively early in adult life,” writes Winslow.

Winslow notes that an NHLBI panel now recommends universal cholesterol screening for children between 9 and 11, but there is no mention that some experts disagree with this recommendation.  Further, these screening tests focus on the measurement of LDL cholesterol. Winslow doesn’t discuss whether  LDL would be equally effective as triglycerides and HDL at identifying children with stiff arteries. Winslow writes, reasonably, that high triglycerides and low HDL “are a hallmark reflection of the poor diets and sedentary lifestyles that researchers say are behind the wide prevalence of obesity among both children and adults,” but there’s a big gap between that association and concrete recommendations to measure HDL and triglycerides in children and, more importantly, to take actions based on these measurements.

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Click here to read the full story on Forbes.

scale_zero

Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised 1

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , , ,

Here are two small but important changes in the anticoagulation field:

FDA approves new product for urgent reversal of anticoagulation. 

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Pradaxa label gains boxed warning.

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Click here to read the full story on Forbes.

 

English: Logo of the .

 

Unconventional Analysis Finds Threshold For LDL Reduction With Statins Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

Using an unconventional mathematical approach, a group of Japanese researchers say there may be no good reason to reduce LDL cholesterol more than 40 mg/dl. Their research letter has been published online in JAMA Internal Medicine.

According to the authors, members of the ALICE (All-Literature Investigation of Cardiovascular Evidence) Group, most meta-analyses use linear models that assume “a constantly increasing or decreasing risk as the exposure increases or decreases.” Linear models, however, can be “misleading,” they write, because they assume a specific dose-response relationship. By contrast, their new analysis utilizes “flexible” models that can more readily uncover “threshold effects.”

Click here to read the full post on Forbes.

 

Another Cleveland Clinic Study Links TMAO To Atherosclerosis Reply

by • People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

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.

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Click here to read the full story on Forbes.

Stanley Hazen

 

Study Suggests Benefit For Beta Blockers During Noncardiac Surgery Reply

by • Interventional Cardiology & Surgery, Prevention, Epidemiology & Outcomes • Tags: , , ,

The use of perioperative beta-blockade for noncardiac surgery has been declining as a result of the controversial POISE study, which turned up evidence for harm associated with extended-release metoprolol in this setting. Now a large new observational study published in JAMA offers a contrary perspective by suggesting that perioperative beta-blockade may be beneficial in low- to intermediate-risk patients. But without better evidence the debate about this topic is unlikely to be resolved.

Martin London and colleagues performed a retrospective analysis of 136,745 patients who underwent noncardiac surgery at VA hospitals, 40% of whom received beta-blockade.

Click here to read the full story on Forbes.

 

The FDA, Surrogate Endpoints, And Blood Pressure Drugs Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , ,

In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpoint– including cholesterol and other lipids, blood glucose, weight loss, and blood pressure.

Despite what some believe is a long-term trend against the use of surrogate endpoints, the FDA is actually seeking to make it easier for manufacturers of one therapeutic category, antihypertensives, to claim cardiovascular benefit for their drugs despite the absence of evidence to support most of these drugs.

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Although the actual changes proposed by the FDA are small, I thought the issue bore further exploration. I first spoke with Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products (DCaRP) in the Office of Drug Evaluation 1 at the FDA. I then asked Harlan Krumholz, Sanjay Kaul, and Franz Messerli and Sripal Bangalore to comment on this topic.

Click here to read the full article on Forbes.

Harlan Krumholz

Sanjay Kaul

More Reasons Why Health Hype Stories Are Bad Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

In response to my post yesterday about why health stories should nearly always be received with caution, I received the following comment from a distinguished cardiovascular researcher:

One lost point is the role of the investigators and media in hyping their research. Hazen (principal investigator of the first study) is a bright and thoughtful guy, but through the Cleveland Clinic PR department, his nice hypothesis-generating research got turned into the missing link between red meat and heart disease, which obviously is a huge leap. The paper itself is much more measured than the press release and subsequent coverage. Same for the carnitine meta-analysis It is a meta-analysis of small studies published in a 3rd tier medical journal. I haven’t read the original article, but I bet it is pretty measured in its discussion and conclusion. But then comes the press release and the media, and boom, we have a cure for heart disease that conflicts with a cause for heart disease. Both studies are hypothesis-generating and non-conclusive. They are important additions to our medical knowledge base, but offer nothing for the public right now.

So here I blame the PR departments, but the investigators go along with this, so they get some of the blame, as well as the media who hype it. By the way, from the standpoint of the investigators, the institutions, and the journals they published in, this media frenzy was considered a huge success. For the rest of the medical community and the patients, it was a nuisance, a distraction, led to confusion, and then phone calls to doctors.

Hype shot glass

I’d like to offer one additional caveat about the L-carnitine metaanalysis. This is a perfect example of a topic that might be seriously distorted by publication bias. In other words, a potentially important finding– in this case, a result showing that carnitine is beneficial after a heart attack– is much more likely to be published than a negative finding. This doesn’t mean that the metaanalysis is necessarily wrong, but it does provide yet another reason why we should always be careful when looking at studies like these.

 

 

Related articles

FDA Schedules Another 2 Day Avandia Advisory Panel Reply

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to  ”discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.”

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Click here to read the full story on Forbes.

 

Recording vinyl to CD

 

Partial Rosiglitazone/RECORD Chronology

Is Red Meat A Fish Story? Why You Should Never Believe Health Headlines 2

by • People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

Don’t believe the the hype! That’s the cardinal rule to obey when reading health news. “Breakthroughs” and “cures” are rare, and should always be viewed with caution and skepticism.

This week was a great example. Last Sunday, the New York Times, the major networks, and a host of other media outlets (including this one) reported on a paper in  Nature Medicine about the discovery of a novel and potentially significant pathway linking red meat to heart disease. Briefly, the research suggested that carnitine, which is found naturally in high concentrations in red meat, can lead to atherosclerosis when it is converted by gut bacteria to a chemical called TMAO. Almost immediately I received a lot of comment from experts who raised serious questions about the research. Then today, a separate study was published with an entirely different perspective on carnitine. Although the two studies don’t directly contradict each other, they suggest that the real truth about carnitine is likely to be quite complex and will never be adequately summarized in a headline.

Click here to read the full story on Forbes.

Hype shot glass

 

Researchers Find New Pathway Linking Heart Disease To Carnitine 1

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

A new line of preliminary research has turned up a novel pathway linking atherosclerosis to red meat and a common supplement contained in energy drinks. If the research is upheld, the findings may have important implications for dietary recommendations and our understanding of atherosclerosis. The research also provides a quite surprising example of the previously unsuspected health effects of bacteria in the intestine.

Published online in Nature Medicine, the new studies suggest a possible major role in atherosclerosis for carnitine, which is commonly added to energy drinks and is found naturally in high concentrations in red meat. The new theory combines several lines of evidence from studies in both animals and humans.

Led by Stanley Hazen, researchers at the Cleveland Clinic and elsewhere found that digestive tract bacteria metabolize carnitine into trimethylamine-N-oxide (TMAO), which has previously been linked to atherosclerosis in mice, though the exact mechanism is still unknown. The researchers found that these bacteria were able to flourish, and produce large amounts of TMAO, only in an environment of a carnitine-rich diet. For instance, after taking carnitine supplements, or eating a steak rich in carnitine, vegetarians produced far less TMAO than omnivores.

Click here to read the full story on Forbes.

mmmm Steak

Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran Reply

by • Heart Rhythms, Prevention, Epidemiology & Outcomes • Tags: , , , ,

As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American College of Cardiology (see note at bottom of story), provides more real-world information that helps to confirm the safety and efficacy of the new drug.

Using data from the Danish Registry of Medicinal Product Statistics, researchers compared 4978 patients treated with dabigatran to 8936 matched patients who received warfarin. They found similar rates of stroke or systemic embolism and major bleeding with dabigatran and warfarin. In addition, mortality, intracranial bleeding, pulmonary embolism,and myocardial infarction were significantly lower in the dabigatran-treated group.

Here are the adjusted hazard ratios (and 95% confidence intervals) for dabigatran 110 mg and 150 mg, respectively, compared with warfarin:

  • Stroke: 0.73 (0.53 -1.00), 1.18 (0.85 – 1.64)
  • Systemic embolism: 0.60 (0.19 – 1.60), 1.00 (0.26 – 3.35)
  • Death: 0.79 (0.65 – 0.95), 0.57 (0.40 – 0.80)
  • MI: 0.30 (0.18 – 0.49), 0.40 (0.21 – 0.70)
  • Pulmonary embolism: 0.33 (0.12 – 0.74), 0.24 (0.06 – 0.72)
  • Intracranial bleeding: 0.24 (0.08 – 0.56), 0.08 (0.01 – 0.40)
  • Major bleeding: 0.82 (0.59 -1.12), 0.77 (0.51 – 1.13)

The authors concluded that ”previous concerns about an excess of bleeding events or myocardial infarction amongst dabigatran treated patients were not evident in this propensity-matched comparison against warfarin in a large post-approval registry study.” However, they noted one limitation of their study: The Danish AF patients included in the study were at lower risk and had a lower event rate than the patients studied in the pivotal RE-LY randomized trial of dabigatran.

Note to readers: This study is now available on Science Direct and the manuscript has been posted on CardioSource. Due to technical problems the article will be published online in the Journal of the American College of Cardiology website on Wednesday, April 10.

 

FDA Approves First SGLT2 Inhibitor For Diabetes 1

by • People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , ,

The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes including metformin, sulfonylurea, pioglitazone, and insulin.

Click here to read the full post on Forbes.

English: Logo of the .

Controversial NIH Chelation Trial Published In JAMA Reply

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Final results of the troubled NIH-sponsored TACT trial testing chelation therapy for coronary disease have now been published in JAMA. Last November, when the preliminary results were presented at the American Heart Association meeting, the positive finding in favor of chelation therapy surprised many observers, though the investigators and senior AHA representatives expressed considerable caution  about the proper interpretation of the results. Full publication of the main results should now allow for a more thorough consideration of the trial.

The Trial to Assess Chelation Therapy (TACT) was initially funded by the NIH more than a decade ago to test chelation therapy with EDTA, an alternative medicine therapy received by more than 100,000 people every year but with no evidence base for support. The highly controversial trial was temporarily suspended in 2008 in response to ethical concerns but was then allowed to resume. The trial was also hampered by slow enrollment, eventually resulting in a downsizing of the trial population. To maintain the trial’s power to achieve a meaningful result the follow-up time was increased. (Because of this change, and because the data and safety monitoring board reviewed the data multiple times over the course of the study, the threshold for statistical significance was lowered to 0.036.)

TACT was a double-blind study testing active or placebo infusions of chelation in 1,708 stable patients with a history of MI.  The primary endpoint of the trial– the composite of death, MI, stroke, coronary revascularization, or hospitalization for angina– was significantly lowered in the chelation group:

  • 26% in the chelation group versus 30% in the placebo group (HR 0.82, 0.69-0.99, p=0.035)

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Nissen

Steve Nissen

The editorial by the JAMA editors is itself evidence of the extraordinary sensitivity of the TACT trial. The JAMA editors, in a highly unusual situation, discuss their detailed review of TACT and explain their decision to publish the trial. Although they acknowledge multiple limitations of the trial, they defend its value: “reports of rigorous investigations should not be censored because of preexisting ideological positions,” they write.

In his editorial, Steve Nissen agrees with the JAMA editors decision to publish the trial but issues a fierce indictment of the trial and its conduct. The TACT paper, Nissen writes, “represents a situation in which many important limitations in the design and execution of a clinical trial compromise the reliability of the study and render the results difficult to interpret. Unfortunately, the efforts of these investigators fell short of the minimum level of quality necessary to adequately answer the question they sought to investigate.”

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Daniel Mark

Daniel Mark

TACT investigator Daniel Mark provided CardioBrief with the following detailed response to Nissen’s criticism. (Nissen declined to respond to Mark.)

In his editorial, Dr. Nissen asserts that the “logical” explanation for the greater withdrawals in the placebo group is that patients were unblinded. He further implies that the CAM sites were more likely to be responsible for such unmasking.

His editorial is written from the perspective of someone who is absolutely sure that the trial results are wrong and his mission is to identify where the flaws originate.

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Click here to read the full story on Forbes.

CHMP And FDA Diverge On Mipomersen And Rivaroxaban Reply

by • Heart Rhythms, People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected– for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the same indication. In contrast, although the FDA recently approved the new cholesterol-lowering agent mipomersen (Kynamro, Isis and Genzyme), CHMP, after reviewing its previous negative position, reaffirmed today that it would not recommend approval of the drug in Europe.

Click here to read the full post on Forbes.

 

European Medicines Agency

 

High Potency Statins Linked To Increased Risk For Acute Kidney Injury Reply

by • Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Although the beneficial effects of high-potency statins have been well-characterized in clinical trials, these same trials have lacked the power to illuminate rare but potentially important adverse events. A suggestion of one such area of concern, acute kidney injury, was first raised in the JUPITER trial. Now, a new study published in BMJ provides further information about this area.

Researchers in the Canadian Network for Observational Drug Effect Studies (CNODES) performed a retrospective observational analysis of administrative databases in Canada, the UK and the US containing more than 2 million patients newly treated with statins.  59,636 of the subjects already had chronic kidney disease. One-third of the subjects received high potency statins, defined as ≥10 mg rosuvastatin, ≥20 mg atorvastatin, and ≥40 mg simvastatin.

Within 120 days of starting treatment there were 4691 hospitalizations for acute kidney injury in patients without pre-existing kidney disease and 1896 hospitalizations in patients with pre-existing disease. Patients without pre-existing disease on high potency statins were 34% more likely to be hospitalized with acute kidney injury than patients on other statin regimens. Patients with pre-existing disease did not have a significant increase in risk if they were taking high potency statins.

The authors estimated that 1,700 patients without pre-existing kidney disease would need to be treated with a high potency statin instead of a low potency statin to cause one additional acute kidney injury requiring hospitalization. The findings, according to the authors, are broadly consistent with the JUPITER trial. They write:

Given what is likely to be a small magnitude of incremental cardiovascular benefit of high potency statins over low potency statins in reality, a pressing question is how to identify patients for whom the risk-benefit balance for high potency statin treatment is unfavourable.

In an accompanying editorial, Robert Fassett and Jeff Coombes write that “clinicians should use low potency statins whenever possible to provide cardiovascular benefits without the increased risk of acute kidney injury.” Further, they note, “despite extensive experience with the use of statins over many years, optimization of doses to derive benefit but minimize risk is still evolving.”

FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran 1

by • Heart Rhythms, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , , ,

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine.

“We believe that the large number of reported cases of bleeding associated with dabigatran provides a salient example of stimulated reporting,” write Mary Ross Southworth, Marsha Reichman, and Ellis Unger. “In this case, such reporting provided a distorted estimate of the comparative bleeding rates associated with dabigatran and warfarin in clinical practice.”

Click here to read the full story on Forbes.

 

Radiotherapy For Breast Cancer Increases Heart Disease Risk 1

by • Prevention, Epidemiology & Outcomes, Uncategorized • Tags: , , , , ,

A new study published in the New England Journal of Medicine offers the best look yet at the increased risk for heart disease produced by radiotherapy for breast cancer. Further, this increased risk may just be the tip of the iceberg of more radiation-related problems, warns a cardio-oncologist in an accompanying editorial.

The new study, based on data from Sweden and Denmark of women treated with radiotherapy for invasive breast cancer, found a linear increase in the rate of heart disease associated with the dose of radiation received by the heart. Starting 5 years after radiotherapy, and with no sign of a threshold,  the risk for major coronary events increased by 7.4% per gray. The mean dose of radiation was 4 Gy. Although the relative risk was consistent throughout the study, the increase in absolute risk was greatest in women with cardiac risk factors or established heart disease.

Findings from the study, according to the authors, “make it possible to estimate” a patient’s risk for heart disease related to radiation. “This absolute risk can be weighed against the probable absolute reduction in her risk of recurrence or death from breast cancer that would be achieved with radiotherapy.” The authors estimated that for a 50-year-old woman without preexisting risk factors and with a mean radiation exposure of 3 Gy, her risk for death from ischemic heart disease by age 80 would rise from 1.9% to 2.4% and her risk for an acute coronary event would rise from 4.5% to 5.4%. The risk for death by age 80 for an otherwise similar woman with existing risk factors would rise from 3.4% to 4.1%. Women exposed to larger doses of radiation would be exposed to even greater risks.

In the accompanying editorial, Javid Moslehi writes that results of the study suggest that “cardiac risk factors should be assessed and aggressively managed — starting at the time of radiation treatment (or even before) and continuing throughout survivorship.” To make matters worse, the findings “may represent just the tip of the iceberg.” Radiation may also cause increases in pericardial disease, peripheral vascular disease, cardiomyopathy, valvular dysfunction, and arrhythmias, according to Moslehi, and other breast cancer therapies, such as anthracyclines and hormonal therapies, may have “additional cardiotoxic effects.”

Moslehi, who is in the Cardio-Oncology Program at the Dana–Farber Cancer Institute, writes about the emerging new discipline of “cardio-oncology”:

Given the widespread use of radiation therapy in the treatment of breast cancer, and the continually expanding arsenal of novel therapies, the current study calls for greater collaboration between oncologists and cardiologists. An important lesson for the oncologist may be that the time to address concerns about cardiovascular “survivorship” is at the time of cancer diagnosis and before treatment rather than after completion of therapy. Similarly, cardiologists need to assess prior exposure to radiation therapy as a significant cardiovascular risk factor in survivors of breast cancer.

Another Negative Trial With Darbepoetin Alfa 1

by • Heart Failure, Prevention, Epidemiology & Outcomes • Tags: , , ,

Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

A total of 2278 patients with systolic heart failure and mild-to-moderate anemia were randomized to darbepoetin alfa (Aranesp, Amgen) or placebo. As expected, treatment with darbepoetin alfa significantly improved hemoglobin levels. However, no significant improvements in outcomes were associated with darbepoetin alfa.

Click here to read the full story on Forbes.

 

HPS2-THRIVE: A ‘Disappointing But Clear’ Result Reply

by • People, Places & Events, Prevention, Epidemiology & Outcomes • Tags: , , , ,

The results of HPS2-THRIVE were “disappointing but clear,”  said Jane Armitage, who presented the results this morning at the ACC in San Francisco.

HPS2-THRIVE randomized 25,673 high-risk patients who could tolerate niacin to either placebo or extended-release niacin plus laropiprant (Tredaptive, Merck), an anti-flushing agent, in addition to background therapy. The primary endpoint was the time to first major vascular event, defined as the composite of non-fatal MI or coronary death, any stroke or any arterial revascularization.

Major vascular events occurred in 13.2% of the niacin arm and 13.7% of the placebo arm (p=0.29), despite causing average reductions in LDL of 10 mg.dL and triglycerides of 33 mg/dL, in addition to a 6 mg/dL increase in HDL. Armitrage reported that based on data from previous trials and observational studies, “it was anticipated such lipid differences might translate into a 10-15% reduction in vascular events.”

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HPS2-THRIVE study chairman, Rory Collins, responded to a question in the press conference: “To the question is niacin dead? Well, it’s not healthy!”

Click here to read the full story on Forbes.

 

Hospitals Seeing Rapidly Growing Numbers Of Adults With Congenital Heart Disease 3

by • Prevention, Epidemiology & Outcomes • Tags: , , ,

Hospitals are treating increasing numbers of adults with congenital heart disease, thanks to tremendous progress in treatment for this condition in recent decades. A clear picture of this dramatic change emerges in a new study, presented at the ACC in San Francisco and published simultaneously in JAMA.

Jared O’Leary and colleagues analyzed data from the Nationwide Inpatient Sample and compared congenital heart disease hospital admissions from 1998 through June 30, 2004, with those from July 1, 2004, through 2010. From the first period to the second, adult admissions grew much more rapidly than pediatric admissions.

  • Adult admissions increased by 87.8%, from 331,162 in the first half to 622,084 in the second half.
  • Pediatric admissions increased by 32.8%, from 815,471 to 1,082,540.

Adults constituted a growing percentage — from 28.9% to 36.5% — of congenital heart disease admissions.

The authors wrote that the “observed trend is likely due to a number of independent forces including better congenital heart disease survival, an aging population, and accumulating comorbidities. Limited availability of quality outpatient services may also contribute.”

Three Experts Weigh In On The Mediterranean Diet 4

by • Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: ,

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 CardioExchange. Here 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.