Micardis does not Prevent Strokes Better than Other Blood Pressure Medicines

Do you remember when we talked last year about the purpose of preventive medicine?  Then you remember that the point of blood pressure medicine isn’t to lower blood pressure, it’s to prevent strokes and heart attacks.

There are now many blood pressure medicines that have been proven to prevent strokes and heart attacks and have track records of safety lasting decades.  These older medicines are also available generically and so are fairly inexpensive.  That’s a tough market to break into.

So new blood-pressure medications have to justify their higher price tags by proving that they have fewer side effects or are more effective than their older competitors.  Micardis (telmisartan) is a blood pressure medicine in a family called angiotensin receptor blockers (ARBs).  The novel mechanism of ARBs raised hopes that it would prevent strokes better than other blood pressure medicines.

A study published this week in the New England Journal of Medicine tested that hope.  Patients who had had a recent stroke were randomized to Micardis or placebo.  Other blood pressure medications were used as needed to control blood pressure.  The patients were followed to count the incidence of a second stroke.  The disappointing outcome was that the patients on Micardis had as many strokes as patients on other medications.

Just yesterday the pharmaceutical representative who gives our office samples of Micardis came by and told me how well Micardis is tolerated and how well it lowers blood pressure.  She didn’t mention that study at all.  I wonder why.

Learn More:

Washington Post article: Newer Blood Pressure Drug No Better Than Placebo in Preventing Stroke

New England Journal of Medicine article: Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events

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Healthcare Reform

The New England Journal of Medicine and the Massachusetts Medical Society released a video this week of a panel discussion on U.S. health policy.  I thought it was a fascinating and intelligent discussion by representatives of all the stakeholders in the debate.  The discussion covers many topics critical to American healthcare, including the dwindling numbers of primary care physicians, adoption of electronic medical records, providing care to the tens of millions of uninsured, and the escalating costs of healthcare.

This is a handy primer on a topic that will become increasingly important in the next decade.

The video is about an hour long, and is open to non-subscribers.

Shattuck Lecture:  Health of the Nation — Coverage for All Americans

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For Most Heart Patients Medicines are as Good as Angioplasty

Coronary angioplasty is a technical marvel.  A thin tube is threaded from an artery in the groin to the heart.  Through this tube a tiny balloon is threaded into a narrowed coronary artery.  The balloon is inflated to open the artery, and then a stent (a metal mesh tube) is placed in the newly open artery to keep it open.  About a million coronary angioplasties are done in the United States annually.

The procedure was initially developed with the hopes that opening narrow arteries would prevent heart attacks and save lives in people with chronic coronary disease (narrowing of the coronary arteries).  Alas, that’s not the case.  Every study that has compared angioplasty to optimal treatment with medications has found no difference in the rates of heart attack and death between the two.  The largest such study was published in April of last year.

This was a major disappointment for proponents of angioplasty.  Angioplasty is a proven life-saver and is the treatment of choice in acute heart attacks, so it was hoped that it would also be life-saving in people at high risk for a heart attack with chronic coronary disease.

Part of the problem is the remarkable improvements in medical treatment of heart disease.  Optimal medical treatment now includes a cholesterol-lowering medicine in the statin family, aspirin, a beta blocker and an ACE inhibitor (two different families of blood pressure medicines).  Each of these families of medicines has been proven to prevent heart attacks.  The outlook for patients on this regimen is so good that it’s difficult for a new proposed treatment to do even better.

The proponents of angioplasty then argued that though angioplasty may not be life-saving, it helps quality of life by eradicating chest pain in patients with chronic heart disease.  A follow up study published this week in the New England Journal of Medicine examined that assertion.  It randomized patients with chronic heart disease to angioplasty with optimal medications or optimal medications alone, and followed the quality of life and the amount of chest pain in both groups.

The good news is that both groups steadily improved and did well overall.  The patients who had angioplasty had less chest pain about a year after angioplasty, but that difference disappeared by three years after randomization.

The bottom line is that angioplasty should be reserved for patients having an acute heart attack or for patients with chronic chest pain whose symptoms are not well controlled on optimal medications.

Learn more:

Associated Press article: Drugs as good as stents for many heart patients

The New England Journal of Medicine article in 2007 demonstrating that angioplasty does not save lives or prevent heart attacks: Optimal Medical Therapy with or without PCI for Stable Coronary Disease

This week’s New England Journal of Medicine article: Effect of PCI on Quality of Life in Patients with Stable Coronary Disease

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New Recommendation Against Screening for Prostate Cancer in Men 75 and Older

Two years ago I wrote about the controversy of routine screening for prostate cancer.  Screening for prostate cancer is usually done with a blood test called PSA.  But whether diagnosing prostate cancer early helps patients is still unknown, and there are many serious complications that result from prostate cancer treatment.  That’s why in many cases of prostate cancer watchful waiting is a reasonable choice.

The U.S. Preventive Services Task Force recently reviewed the existing evidence for and against prostate cancer screening and published their recommendations in this week’s Annals of Internal Medicine.  Their findings drew much media attention.

The new USPSTF recommendations still state that there is insufficient evidence to recommend for or against screening for prostate cancer in men 50 to 75.  But the recommendations recommend against screening for prostate cancer in men 75 and older.

There are ongoing studies now that will answer definitively whether diagnosing prostate cancer early helps.  Until those results are available, men over 75 should review these recommendations and discuss them with their doctor before making a decision about whether to have a PSA.  The test may lead to much more harm than benefit.

Learn more:

Washington Post article:  U.S. Panel Questions Prostate Screening

Screening for Prostate Cancer: U.S. Preventive Services Task Force Recommendation Statement

Some of my previous posts about prostate cancer:
The Controversies of Prostate Cancer Screening
Fighting Prostate Cancer by Doing Nothing

Tangential miscellany:

Last week’s post, The Exercise Transformation, elicited many responses.

Three readers suggested that being accountable to someone else is the key to making exercise a habit.  To that end, they recommended hiring a personal trainer, so that each episode of exercise is an appointment with someone else and is therefore harder to postpone or cancel.

Two readers thought that recommending 30 minutes of exercise on most days is a very intimidating goal for someone sedentary, and that success would be more likely to be achieved with a less ambitious initial goal, for example 10 minutes three times a week.  Once this easier schedule becomes a habit, the duration and frequency can slowly be increased.

My only disagreement with that reasonable suggestion is that I’ve had several patients tell me that the only way to make something a habit is to do it almost every day.  Even though the cardiovascular benefits of exercise only require 30 minutes of exercise three times a week, this may be harder to sustain psychologically than a daily habit.  Ultimately, I would recommend whatever works for each person.  If doing something every day seems like an insurmountable initial goal, start slower.

Finally, a reader wrote to extol the power of just showing up.  She said that when she doesn’t feel like exercising, she talks herself into it by just putting on the swimsuit and getting to the pool.  Once there, the actual swim doesn’t seem as daunting.

I’m grateful to everyone who emailed.

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The Exercise Transformation

I usually write about an item in this week’s news or in the recent medical literature.  Forgive me from straying from that path this week to share some personal reflections.

For sedentary patients there is an enormous psychological barrier to exercise.  All primary care doctors face that barrier daily.  We encourage, cajole, practically shove our patients to become more physically active.  The vast majority of the time, despite the patient’s and the doctor’s best intentions, no change occurs.  The patient never starts exercising, or abandons his efforts after two or three days.  Habits are very hard to change.

This is very frustrating for both the physician and the patient.  Physicians knows that cardiovascular exercise lowers blood pressure, lowers blood glucose, improves mood and energy, lowers cholesterol (while increasing, HDL, the good cholesterol), decreases anxiety and improves sleep.  The scientifically proven benefits of cardiovascular exercise exceed those of many medicines and tests that we use routinely.  Patients know this too.  They know they should be exercising, but they can’t overcome the sedentary inertia.

Patients always have excellent reasons why they can’t exercise.  Usually they’re too tired or too stressed.  This is a trap, a spiral that inevitably leads to less and less activity which causes more fatigue and more stress.  The irony is that the most effective remedy for fatigue and stress (assuming serious medical and psychiatric problems are ruled out) is exercise.  So the only way to break out of the trap is to start exercising despite the fatigue and despite the stress.  “Just start exercising anyway”, doctors beg.

Don’t misunderstand; I’m not trying to get patients to compete in triathlons or climb mountains.  I just want them to start walking for 30 minutes on most days.  Shopping, chasing your kids and walking around in the office do not count.  You have to be walking just to walk.

Then, in a tiny number of cases, through psychological processes that are completely mysterious to me, a miracle happens.  A patient starts exercising.  The transformation is unbelievable.  His blood pressure drops a few points.  A few pounds are shed.  Her heartburn resolves.  And even more impressive than the physical effects are the mental benefits.  Patients tell me they can concentrate better.  They’re less anxious.  They feel great!  After a few months, they can’t imagine skipping their exercise.  It just feels too good.  It’s as much a part of their routine as showering and dressing.  It’s a habit.  Habits are very hard to change.

In the last year I’ve told three of my patients that they are on the borderline of developing diabetes.  They have each, in his own way, made the exercise transformation.  All three are more active, leaner and happier.  For the time being, none of them needs medications for diabetes.

How can doctors better encourage that transformation?  I wish I knew, and I’d love your suggestions.  All I can recommend is that you pick something you like, start slowly, do it for at least 30 minutes almost every day, and start today.

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Breast Self-Exam: Still Unproven After All These Years

When I was a resident (over ten years ago!) we were taught that there was no evidence that breast self-examination saved lives.  A new review puts another nail in the coffin of breast self-examination.  This week the Cochrane Review published a re-analysis of a review of the scientific studies on breast examination.  The conclusion: women who perform breast self-examination undergo more breast biopsies but die of breast cancer at the same rate as women who do not examine themselves.  The same applies to periodic breast examination by a clinician.  The authors’ conclusion is quite clear.

“Data from two large trials do not suggest a beneficial effect of screening by breast self-examination but do suggest increased harm in terms of increased numbers of benign lesions identified and an increased number of biopsies performed. At present, screening by breast self-examination or physical examination cannot be recommended.”

It’s important to note that any lumps or other breast changes that are noted should still be reported to a doctor.  The message of this finding is simply that it doesn’t help to look for such changes periodically.

This review has generated much attention in the general press this week.  (See the link to the WebMD article below.)  Interestingly, despite the clear conclusions of the study, the American Cancer Society doesn’t recommend for or against breast self-examination, but rather says that it remains “an option”.  What kind of position is that?  Of course it’s an option.  Stuffing marshmallows in my ears is an option too.  Are they for it or against it?  Given that the evidence is entirely lopsided against it, why won’t they advise women not to examine themselves and spare them the needless biopsies?

The answer is that the American Cancer Society derives its mission (and its funding) from diagnosing and treating cancer.  Their recommendations are consistently skewed towards recommending more testing than the evidence supports, since more testing leads to the diagnosis of more cancer cases.  That is an important reason to rely on recommendations from groups that are entirely unbiased and whose income doesn’t depend on whether they recommend for or against any intervention.  The Cochrane Review and the US Preventive Services Task Force are such groups.

Learn More:

WebMD: Breast Self-Exams: No Survival Benefit

Cochrane Review: Regular self-examination or clinical examination for early detection of breast cancer

US Preventive Services Task Force recommendations for breast cancer screening

Tangential Miscellany:

There won’t be a medical news post next week.  Posting will resume in two weeks.  I’ll miss you too.

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A Family of Antibiotics Linked to Tendon Rupture

This week the Food and Drug Administration (FDA) requested a new warning on a family of antibiotics called fluoroquinolones.  This family includes ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox) and others.  The warning has to do with the increased risk of tendonitis and tendon rupture due to these antibiotics.

This information is not new.  The increased risk has been known for a few years, but as additional cases have been reported, the FDA chose to act.

This complication is more frequent in patients over 60, patients taking corticosteroid medications, and patients who have had an organ transplantation.  It is a rare complication (though I couldn’t find a numerical estimate of its frequency) but in the case of tendon rupture can be quite disabling and can require surgery.  In my practice, this complication has happened exactly once (to a patient who is probably reading this!).

Doctors and patients will almost certainly continue to rely on this family of antibiotics.  Doctors should be more cautious in higher-risk patients.  Patients should know to call their doctor immediately and discontinue the antibiotic if they develop tendon pain, and to avoid exercising the sore area.

Though in general the medications available to us have steadily become safer and more effective, we should not hold our breaths for an era of perfect safety.

Learn more:

Wall Street Journal article:  FDA to Add Warning to Antibiotics

FDA press release:  FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

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Summer Swimming Safety

“Summertime,
And the livin’ is easy”
— George Gershwin

Summer is here, and especially in Southern California, that means opportunities to enjoy lots of outdoor activities including fun days at the beach and in the pool.  Unfortunately that also means more accidental drowning.  In 2005 there were 3,582 drowning fatalities in the United States, a quarter of them in kids 14 and under.

So this is a good time to remind ourselves never to leave children unattended in or near a pool.  With kids younger than 5 an adult should be within arm’s reach.  Teach your kids to swim.  Learn CPR.  Fence your pool.

So let’s all enjoy America’s two hundred thirty-second birthday in a way that will keep us around for the next one too.  Oh, and wear sunscreen.

Learn more:

The Centers for Disease Control and Prevention Water-Related Injuries Fact Sheet

American Academy of Pediatrics Pool Safety for Children

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Antipsychotic Medication Overused in Dementia Patients

Dementia is not a single disease.  Dementia is a family of diseases that cause progressive memory loss, usually in older patients.  The most common cause of dementia is Alzheimer’s disease.  Dementia is progressive, and while some treatments exist, their efficacy is only modest.  In addition to memory loss, patients frequently suffer personality and behavior changes.

Dementia is common, affecting 3.4 million Americans as of 2002, and this number is sure to increase as our population ages.

The most difficult problem in the management of dementia is managing the agitation and hallucinations that patients frequently experience.  Besides being obviously disturbing to the patients, agitation and psychotic symptoms contribute significantly to caregiver stress and burnout.  It’s no surprise then that antipsychotic medication — medication developed for use in patients with schizophrenia and other psychotic disorders — has a long history of use in patients with dementia.  There’s only one problem; they don’t work.

Randomized studies have shown that patients with dementia and psychotic symptoms are no more calmed by antipsychotic medication than by placebo.  Worse than that, in elderly patients some antipsychotic medications increase the risk of stroke.

Despite this evidence, faced with an agitated patient with dementia, many physicians (sometimes me included) out of desperation reach for an antipsychotic medication.  A New York Times article last week summarized the controversy well.

There are therapies that have been proven to help with agitation in patient with dementia, but they’re not medicines.  The therapies are behavioral: calmly redirecting the patient, reorienting him to where he is, distracting him with a less stimulating activity, etc.  This is more effective but requires more caregiver time, a resource that will certainly become scarcer in the future.  Unless better treatments are developed, caring for dementia patients will become increasingly challenging in the next decades.

(Thanks to Michelle H. for sending me the article.)

Learn More:

New York Times article: Doctors Say Medication Is Overused in Dementia

Neuroepidemiology article: Prevalence of Dementia in the United States

Tangential Miscellany:

Two years ago I wrote about the looming shortage of primary care doctors and their increasing dissatisfaction with the practice of medicine.  A New York Times article last week reiterates the point that a lot of doctors no longer enjoy what they do:  Eyes Bloodshot, Doctors Vent Their Discontent.

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Only 4% of American Physicians Have Electronic Health Records

This week, a large national survey of physicians’ use of electronic health records (EHRs) was published in the New England Journal of Medicine.  The results generated a lot of attention in the general media.

The good news is that physicians with EHRs are largely very satisfied with them and believe that EHRs improve patient care.  The bad news is that nationally only 4% of doctors use EHRs.  The largest barrier cited as preventing physicians from adopting EHRs is the expense.

In any other industry, that would be unthinkable.  Imagine if a hotel came up with an easier way for guests to make a reservation.  If the new technology was very expensive, only those hotels with the most resources would be able to afford it initially.  But eventually the price of the new technology would drop and almost all hotels would use it.  Within a few years the older way of making reservations would be gone.  That’s why you can’t listen to an LP record anymore or find a public phone booth or send a telegram.  Better technology spreads like wildfire through a marketplace, regardless of how expensive it is initially.

So if EHRs are better for patients, why the slow adoption?  For that matter why haven’t CT scans dropped in price?  Or pacemakers or MRIs?  Most medical technology should be dirt cheap.  My son’s laptop is much more powerful than the desktop PC I had in high school and cost less.

The answer is that the insurance model corrupts the incentives that work in other marketplaces.  By fixing the price for care, insurance companies make it impossible for doctors to make more money by providing better care.  Doctors in the insurance model can only make more by seeing more patients.  In such a system there’s no reason to invest in an EHR, because the investment will not lead to increased revenue.

The same perverse incentives keep prices high.  Since the insurance company sets the price for a CT scan, there’s no incentive to drop the price for a CT to compete against other providers.  The incentive is to get as many patients through the scanner as possible.  So while Dell keeps making better computers cheaper, CT scan prices stay the same.

Now academicians and lobby groups are clamoring for insurance companies and government to pay doctors to adopt EHRs.  But insurance companies and government got us in this mess.  Having them subsidize EHRs misses the point, and would keep EHRs expensive forever, like CTs.

A few doctors dedicated to excellent care have already taken the financial risk to invest in an EHR.  Some of us have abandoned our relationship with insurance companies so that we can work for our patients.  Some patients who are also discriminating consumers have looked for such physicians and are willing to pay more to see them.  More doctors and patients, increasingly dissatisfied with the insurance model, will hear about us and follow our lead.  That’s the solution.

Learn more:

New York Times article:  Most Doctors Aren’t Using Electronic Health Records

New England Journal of Medicine article:  Electronic Health Records in Ambulatory Care — A National Survey of Physicians

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