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Wednesday, November 12, 2008

Power to the patient! (with your encouragement)

The theme of several late-breaking trials today seems to be, very loosely, patient empowerment. To wit:

One study compared atrial fib/heart valve patients on warfarin who were monitored monthly at a clinic with those who did weekly home INR testing. There was no difference in the primary outcome-- time to death, major bleed or stroke.

This is a case where a negative outcome isn't really bad. It's good to know, the author said, that patients can test at home just as well as in a clinic, especially for those who live in remote areas or have other barriers to getting to a clinic. Plus, patients were happier with the home testing approach, and Medicare covers it for AF, heart valve and VTE patients.

Next comes a sub-study of yesterday's HF-Action study on exercise and heart failure (see earlier post for main study). This one found patients who did exercise training reported significantly better health status (quality of life, symptoms and physical/social limitations) at three months, and the difference lasted for three years.

Quality of life is important in heart failure patients, because HF is a chronic, incurable disease, discussant Anne Taylor, MD said. She noted that in this study, the subjects were receiving optimal medical therapy, and were 59 years old on average-- while in the general population, heart failure patients don't always get OMT, and are older. Study author Ileana Pina, MD, responded that the group did plan to analyze the results in an older cohort, so stay tuned.

Finally, Lori Mosca, MD, reported on her group's creative study in which researchers screened and counseled the relatives of hospitalized patients about their health risk factors. The control group got a handout about reducing risks, while the intervention group got immediate feedback on screening tests, and a year of diet and exercise counseling.

LDL levels declined in both groups after a year-- a testament to how motivating it is to see a loved on get sick, Dr. Mosca said-- but there was no difference between groups. The intervention group had a significantly better diet score and exercised more, and their HDL went up slightly, while the control group's HDL declined. Both groups significantly decreased their saturated and trans fat consumption.

Given that both groups improved their behaviors after some level of intervention, hospitals have a unique opportunity to educate, motivate and help patients' relatives, observers noted. A lot of these relatives were unaware they had CV risks, Dr. Mosca said, and that awareness alone might have spurred them to action.

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Scared straight

I've got a suggestion for how to get your patients to exercise and eat well. Send them to a cardiology conference.

After four days of hearing about all the things that can go wrong with one's body, I'm convinced I need to train for a marathon and eat mostly raw produce and grains. Stat.

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Can you trust the medical literature?

Just went to a session on this topic led by Joseph Ross, MD, the author of an April 2008 JAMA study on ghostwriting. He said research indicates that editors prefer studies with positive findings, that studies from U.S. and/or "prestigious" institutions are more likely to be accepted, and that industry-sponsored trials are accepted more often by journals.

In cardiovascular research, studies are 37% more likely to favor newer treatments than existing treatments. In general research, published studies are two times more likely to be associated with pro- than anti- drug industry findings, he said. How does this happen? Some of the culprits include:
--Industry designs studies in such a way as to bias them toward favorable findings
--Industry analyzes results in favorable ways, and displays/states results misleadingly
--Industry suppresses unfavorable findings, choosing to submit positive trials for publication
--Industry supports ghostwriting, in which a reputable person is often brought in at the last minute to edit a study rather than participate in it or its analysis, yet is listed as the lead author.

How to fix the problem? Dr. Ross suggests:
--Prospective public registration of all clinical trials
--Public reporting of all safety/efficacy outcomes
--Improve integrity of study authorship. For one, the principal investigator should be listed as the lead author on studies.

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Tuesday, November 11, 2008

File under "Why not?"

I'm off to a session about how listening to "joyful music" might improve endothelial function. This is one of those things-- like doing yoga, or drinking green tea-- that I put into the "might as well" category.

You don't want your patients trading exercise or medication for listening to happy songs and regular tea breaks, but these things can't hurt, so why not try them? As Dr. Mehmet Oz said yesterday, he doesn't prescribe yoga to his patients, but he does tell them he recommends yoga to his family members.

The joyful music study is far from rigorous-- it involved 10 healthy subjects with an average age of 35.6 years. Seven were male. Over a period of 30 minutes, they listened to joyful music, anxiety-producing music, funny video clips and relaxation tapes. The researchers measured a baseline brachial artery flow mediated dilation, and then measured it again during the study.

The results? Flow mediated dilation increased 26% during the joyful music, decreased 6% during the anxious music, increased 19% during the funny bits, and increased 11% during relaxation. So, ideally, I guess you should find a song that is happy and hilarious, yet relaxing.

I must say, I'm curious about how they classified the music. I've noticed one person's joyful music can be another's schlock, and a song that produces anxiety in me might be motivational to someone else. I'll report back after the session on what the experts say you should plug into your MP3 player, and you can judge for yourselves.

Update: Turns out the joyful music was of the subject's own choosing, as was the anxious music. Heavy metal was most often chosen as anxious music, while country was most often chosen as joyful (really? Isn't country known for its "tear in my beer" lyrics?). Oh, and the "laughter clip" included Saturday Night Live skits and sections of the movie "There's Something About Mary." I bet Cameron Diaz has no idea she's contributed to cardiology research.

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Heart failure, part two

Now it's time for the bummer news about heart failure (HF).
Historically, there's been no treatment that improves outcomes for those HF patients who have an ejection fraction of greater than or equal to 45%. And, we learned today, there still isn't.

Researchers studied whether treating these patients with irbesartan (an ARB) might lower death and hospitalizations for HF, MI, stroke and arrhythmia. It was the largest study of an ARB for this condition, ever, with 4,128 subjects and a 4.5 year follow-up. The average patient age was 72 years and 60% were women-- appropriate given that that this condition mostly affects women and older folks.

There was a difference in those who took irbesartan vs. placebo, but it wasn't significant. At least, the researchers said, the study showed the drug was safe, which means it could be a good substitute for patients who can't tolerate other hypertension drugs. But, as Philip Poole-Wilson, MD, said in his inimitable English accent about the exercise and heart failure study: "Safety without benefit is a bit dull, really."

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Heart failure and exercise

It's heart failure day at AHA Scientific Sessions-- at least in terms of the late-breaking trials.

During a press conference about some of these trials, several physicians bemoaned the fact that the general public knows little about the common problem of heart failure. Milton Packer, MD, of the Univ. of Texas Southwestern Medical Center, quipped "We've been trying to find spokespeople for heart failure, but they are too short of breath to speak!" (Maybe that was funnier in person.)

One study looked at whether structured exercise training for HF patients reduced hospitalization or death rates. The results weren't statistically significant in the main analysis, but an adjusted analysis showed an 11% reduction in deaths/hospitalization, and a 15% reduction for CV mortality or HF hospitalization (a secondary endpoint).

The regimen in the study involved 36 supervised sessions of 30 mins of exercise 3x/week. At the 18th session, patients began to transition into exercising at home for 40 mins 5x/week by giving them a treadmill or exercise bike (wonder if they got to keep them once the study ended?) All patients were receiving optimal medication therapy.

There was some debate about how seriously to take the results, given that they were only significant after adjustment. The author, Dr. Christopher O'Connor of Duke, argued that since the adjustments were pre-specified, the analysis was "fair". He and several others also discussed how much more difficult it is to measure the effects of lifestyle interventions than, say, a drug-- suggesting one should cut this kind of study a little slack.

Dr. O'Connor also noted that the hazard ratios weren't much different in the two primary analyses: HR of 0.93 for main and 0.89 for adjusted. (The variables in the adjusted analysis, by the way, were CPX exercise duration, LVEF, Beck Depression Inventory and history of HF.)

It's also important to note there were no more adverse events-- like heart attack, angina or arrhythmia-- in the HF patients who exercised vs. those who got usual care. Both doctors and patients are often wary of prescribing exercise for HF patients, for fear of bad consequences, O'Connor said, so this provides some reassurance.

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Monday, November 10, 2008

Don't forget your history

Twice today I've heard pleas for doctors to do a better job of collecting family histories. One came as an aside from an audience member at Dr. Oz's lecture, and another from Allen Taylor, MD, who spoke at a seminar about when to order various imaging tests. He was tasked with talking about patients with intermediate risk of heart disease.

Dr. Taylor noted that the classic definition of "intermediate risk" for CAD is 10%-20% on the Framingham, yet this misses some patients because the Framingham doesn't take family history into account. As such, his definition of "at risk" is a patient with a Framingham of 6% or greater and a family history of premature coronary artery disease.

When taking family history, you should go deep, he said. Ask about first and second degree relatives. Ask about the age that relatives developed CAD, and how many relatives had CAD. The more relatives, and the younger those relatives were when they developed CAD, the greater the risk. Especially if they are siblings.

Those deemed at risk by family history should undergo coronary artery calcium testing, he said, especially middle-aged and older patients, for whom it's been shown to be a stronger risk predictor than carotid IMT tests. IMT might make more sense for primary care offices, however, for practical/convenience reasons, he said.

It's really important to identify those at intermediate risk, he noted, because they are a big group-- and also the most likely to improve with therapeutic intervention. It's a message I've heard several times at this conference.

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SIMM City

Talk about energy conservation. A team of UK electrophysiologists have created a "microgenerator" that is powered by a beating heart, and produces nearly 17% of the electricity needed to operate a pacemaker.

This technology could eventually lead to smaller pacemakers that last longer and do more to monitor the heart, they said. The official name of the generator? "The self-energizing implantable medical microsystem", or SIMM.

Somehow, the gadget helps the heart produce more than enough energy per beat than is needed to pump blood. The extra energy is then "harvested." (Not surprisingly, the faster the heartbeat, the more energy is created.) Implanting and "harvesting" the energy didn't significantly injure the heart lining, by the way. Which is good.

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The view from Oz

Dr. Mehmet Oz-- the infamous author, Oprah guest and cardiologist, spoke to a packed audience today about how to get patients to listen to advice about lifestyle changes. Some tidbits he offered:

--Make health fun, or at least engaging. Don't tell patients that smoking is bad. Show them a picture of a diseased lung (and yes, that falls more into the "engaging" than "fun" category).
--Keep it simple, when you can. Rather than explaining BMI, tell your patient his waist size should be half his height in inches.
--Give 'em tips. Tell those who need to lose weight to eat a handful of nuts about 30 minutes before they eat a meal. It takes 30 minutes to lower ghrelin levels-- which should then curb the amount the patient eats at the meal. Emphasize the importance of sleep for all your patients, and advise those who don't sleep well to dim lights, wear loose clothing, get a good mattress, and reduce ambient noise.
--Make sure the educational materials you give patients are engaging. Dr. Oz's office made a video on health for patients to watch before and after their cath labs-- because what else are they going to do during that time?

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Sunday, November 9, 2008

It's a brave new world

I just went to a session on personalized genomics, and the speakers seemed pretty unified in feeling that this is an exciting but slightly worrisome time in the field. The reason for excitement is obvious-- personalized medicine and such-- while the concern is mostly that things are moving too fast for doctors. (This, as opposed to concerns about some dystopic sci-fi reality. "I don't think we're going to see genetically-enhanced Super Heart Men in the future," quipped Hank Greely, a Stanford law professor).

When Mr. Greely asked the 200+ audience if a patient had ever brought in a personal genetic test, only a few hands were raised. Yet he predicts this will change soon. "We are within 2-5 years of a full sequence genome for under $1,000," Mr Greely said. "And you will be on the hook to explain it to your patients."

The nation's 800,000 doctors aren't ready for the coming onslaught of patients armed with their own DNA code, said Eric Topol, MD. (Anyone can now get genetic tests for as little as $400.) "Most doctors would probably say 'What's a SNP?' if asked by a patient to look at their genetic test results," Dr. Topol said.

The nation's 3,000 genetic counselors can't fill in the gaps for everyone. So what's the solution? Professional societies need to step up and figure out a way to educate physicians about the clinical significance of genetic variants, Mr. Greely said.

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Medical news of the not-so-obvious

Need another reason to push flu shots on your patients? Turns out, the shot might lower one's risk of blood clots (in addition to lowering the chances of feeling like a punching bag from the flu.) Overall, the risk of VTE was 26% lower for those who got the shot compared to those who didn't, a study presented at the AHA conference found. For people under age 52, the risk was 48% lower. (researcher: Joseph Emmerich, MD)

And it seems headphones for MP3 players might interfere with pacemakers and ICDs. Researchers tested eight MP3 headphone models by putting them directly over 60 patients' chests, to see whether the magnets in the headphones would interact with the devices. Fourteen of the patients (23%) had interference-- with the ICD patients more likely to have a problem.

The problems were scary: the pacemakers started beating without regard to the patient's own heart rhythm, while the defibrillators were temporarily deactivated. So does this mean no more music for your patients? Not really, the researchers said: Patients just need to keep their headphones at least 1.2 inches from their pacemaker or ICD. (researcher: William H. Maisel, MD)

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What to eat...and not to eat

New Orleans is an eatin' town, so it's apt that a slew of research is being presented on nutrition and heart health. Here's the scoop:

EAT!:
--Vegetables, soy, wine, green/black tea and fish. People who ate these things were less likely to have left ventricular dysfunction than those who ate processed meat/cheese and added fats. (researcher: Longjian Liu, MD)

--Non-soy legumes, like pinto beans, chickpeas and navy beans. Eat a bunch of these and there's a good chance your LDL will drop. (researcher: Lydia A.L. Bazzano, MD)

--Hibiscus tea, if you're mildly hypertensive (129+ systolic). You'll have to drink three cups a day, but if you follow the path of those studied, your systolic BP will drop 7.2 points in six weeks. (researcher: Diane McKay, PhD)

--Folic acid. People who took 2 mg/day along with 1 mg of Vitamin B12 had no extra risk of cancer or other adverse events. They weren't protected against CVD, either-- which was kind of a bummer, since the researchers hoped the B12 would lower homocystine levels and thus CVD risk. But at least the fortified bread is safe. (researcher: Dr. Jane Armitage)

--Fruits and veggies. "Well, duh", you say. What's fairly new in this study is the finding that, for each portion of fruit or vegetable, blood flow in hypertensive folks improved about 6%. So if your patients won't do it for the all the other reasons there are to eat healthfully, hit 'em with the vascular argument! (researcher: Damian McCall, PhD)

DON'T EAT:
--Vitamins E and C... at least if you're doing so to avoid heart problems. The 14,641-subject Physician's Health Study found neither supplement protects against cardiovascular disease when taken separately. Sure, antioxidants have been studied to death, but this study was large and long-term, with an average follow-up of 8 years. (researcher: J. Michael Gaziano, MD)

--Animal and industrial trans fats, which seems fairly obvious. Whether the source is animal or man-made, these acids give you a double shot of nastiness, raising your LDL and lowering your HDL in one fell swoop. (researcher: Ingeborg Brouwer, PhD)

No word yet on the healthful properties of jambalaya and gumbo.

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News from JUPITER (and New Orleans)

I'm at the AHA Scientific Sessions conference in New Orleans, and I'd be remiss if I didn't write about the big news of the day--the JUPITER trial.

Briefly, the trial randomized 17,802 patients with normal LDL but high hsCRP to either rosuvastatin or placebo. The patients had no history of cardiovascular disease, though some had risk factors like hypertension, obesity and smoking. The authors found that those who took rosuvastatin had:
-54% fewer heart attacks
-48% fewer strokes
-46% lower need for revascularization
-20% fewer deaths.

These findings held up across gender, race, ethnicity and Framingham scores greater than or less than 10%; there were no differences in cancer rates or serious side effects between the groups, either. There was also no difference in patients who had a BMI above or below 25.

The results are a big deal, of course, because half of stroke events and heart attacks are in people whose cholesterol seems fine, so doctors want to figure out a way to identify these people in advance.

Lead study author Paul Ridker, MD, said at a press conference that the results indicate providers could prevent 250,000 deaths over a five-year period. But discussant Andrew Tonkin, MD, said he'd like to see an absolute risk reduction done for various subgroups, as well as a cost analysis, before anyone starts ordering CRP labs willy-nilly.

"I do think we need to review the guidelines of where CRP sits in risk evaluation," Dr. Tonkin said.

The research still doesn't answer the question of whether lowering LDL or lowering CRP is the most important action, Dr. Tonkin added. Either way, said Dr. Ridker, the study provides some serious support for the safety and efficacy of statins.

"We have so many patients who are nervous about taking statins," Dr. Ridker said. "But the overwhelming evidence is that these drugs, as a class, are highly effective at lowering hard end points."

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American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

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A collaborative medical blog started by Neil Shapiro, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

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Robert M. Centor, FACP, contributes short essays contemplating medicine and the health care system.

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EverythingHealth is designed to address the rapid changes in science, medicine, health and healing in the 21st Century.

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A roundup of health policy news drawn from a database of hundreds of Web sites.

Interact MD
Michael Benjamin, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

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The alter ego of Kevin Pho, ACP Member, is the closest thing to royalty in the medical blog world.

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