September/2018
Issue: 80

September: More on Low Dose Aspirin
Those of you who regularly read this newsletter know that last month was dedicated to a discussion of two low dose aspirin studies published on August 26 in the New England Journal of Medicine and Lancet.  The results were mixed but I ended by citing the current guidance of the United States Preventive Services Task Force as follows:

In adults aged 50-59 years of age with a 10-year cardiovascular risk greater than or equal to 10%, USPSTF recommends initiating low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer in patients who are not at increased risk of bleeding, have a life expectancy of at least ten years, and are willing to take low-dose aspirin daily for at least 10 years.

In adults aged 60-69 years of age with a 10-year cardiovascular risk greater than or equal to 10%, USPSTF recommends initiating low dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer in patients who are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take low dose aspirin for at least ten years.

The USPSTF says data are insufficient in adults younger than 50 and older than 70 (but see below!).

By the way, the heart risk calculator used by the USPSTF can be found at  cvriskcalculator.com.  If you are between the ages of 50 and 70, calculate your 10-year heart risk today to help decide if you should take aspirin for primary prevention of cardiovascular disease and colorectal cancer!  

John A. Schmidt, MD 
Internist
New Data on Primary Prevention with Aspirin in Healthy Persons 70 and Older
Now comes a new large randomized study by Mc Neil, et al, conducted in healthy adults aged 70 or older and published online in three parts in the New England Journal of Medicine on September 16.  Keep in mind that this was a primary prevention trial, meaning that the subjects had not suffered a heart attack, stroke, or TIA and had no prior history of coronary stents, diabetes, or peripheral vascular disease.  

The study enrolled community dwelling persons in Australia and the United States who did not have cardiovascular disease, dementia, or disability.  Participants were randomly assigned to receive 100 mg of aspirin or placebo. In the first part of the study, higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death, a big and disappointing surprise!

In the second part of the study, the authors tested how many patients treated with low dose aspirin or placebo suffered a major hemorrhage and how many went on to develop cardiovascular disease defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure.  Surprisingly and disappointingly, the use of low-dose aspirin resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo.

The third part of the study showed that low dose aspirin, as compared to placebo, did not reduce the likelihood of death, dementia, or persistent physical disability.

Conclusion: Primary Prevention with Aspirin for Patients 70 and Older

As a result of the negative and disappointing results published by McNeil, et al., I will no longer recommend low dose aspirin for my healthy patients 70 and older.  For patients between the ages of 50 and 70, I will continue to follow the recommendations of the US Prevention Services Task Force, as summarized above. 
Immunotherapy for Treatment of Lung Cancer
As discussed in previous newsletters, immunotherapy is having a major impact on the treatment of cancer.  Tumor cells express a molecule known as PD-L1 (programmed death ligand 1) which inactivates would-be killer T lymphocytesMonoclonal antibodies that block this interaction restore T cell function so they can kill cancer cells more effectively. 

Three new studies have now been published online in the New England Journal of Medicine on September 26 showing how such antibodies can be helpful in the treatment of lung cancer, the most common fatal cancer in the United States.

In the first study by Paz-Ares, et al.,  patients with previously untreated metastatic squamous Non Small Cell Lung Cancer (NSCLC) with at least 50 percent of the tumor cells expressing PD-L1 were randomized to chemotherapy alone or chemotherapy supplemented with an anti-PD-L1 monoclonal antibody known as pembrolizumab® .  The median overall survival was 15.9 months in the combination group versus 11.3 months in the chemotherapy alone group, a modest but highly statistically significant difference.

The second study, conducted by Horn, et al., was similar in design and compared another anti-PD-L1 monoclonal antibody, atezolizumab® in combination with chemotherapy to chemotherapy alone in patients with extensive Small Cell Lung Cancer (SCLC), a much less common and more aggressive form of lung cancer.  The median overall survival was 12.3 months in the combination group versus 10.3 months in the chemotherapy alone group, a modest but highly statistically significant difference.

In the third and most important of the three studies, patients with stage III, unresectable non-small cell lung cancer (NSCLC) who were previously stable after treatment with radiation and chemotherapy (" chemoradiotherapy") were randomized to receive yet another anti-PD-L1 monoclonal antibody known as durvalumab® or placebo.  The 24-month survival was 66.3 percent in the durvalu mab ®  group, as compared with 55.6 percent in the placebo group.  Median progression free survival was 17.2 months in the durvalumab ®  group and 5.6 months in the placebo group.  The median time to death or distant metastasis was 28.3 months in the durvalumab ®  group and 16.2 months in the placebo group. 15.4 per cent and 9.8 percent of patients discontinued the trial regimen because of adverse side effects in the treatment and placebo groups, respectively.

For cancers that have largely defied medical therapy, these are encouraging results and demonstrate, yet again, that combining modalities is the best way to tame and ultimately defeat cancer.  Living with cancer has become a reality.  We owe a debt of gratitude to the patients who agreed to participate in these important trials, not knowing if they would be in the treatment or placebo arms of the trial.
Transcatheter Mitral-Valve Repair in Patients with Heart Failure  
Severe valvular heart disease is usually treated surgically but not all patients with severe valvular heart disease are healthy enough to undergo open heart surgery.  Bioengineers, working closely with cardiologists and surgeons, have therefore devised technologies to repair valves using catheters.  The best current example is known as TAVR which stands for Transcatheter Aortic Valve Replacement.  In TAVR, a collapsed stent carrying a pig aortic valve is placed across the patient's stenotic aortic valve with a  catheter and then abruptly opened, thereby replacing the patient's aortic valve with a pig valve in a single deployment.  This technique is now practiced at Jersey Shore University Medical Center and other major cardiac centers and has enjoyed considerable success.

Now comes catheter technology to repair leaky mitral valves in patients where dilatation of the left ventricle pulls the anterior and posterior leaflets of the mitral valve apart ("secondary mitral regurgitation").  Using catheters, a clip is placed across the mitral leaflets creating a double orifice valve.  As published online in the New England Journal of Medicine on September 23 by Stone, et al., of Columbia University Medical Center, in patients with heart failure and moderate to severe mitral regurgitation who remained symptomatic despite the use of maximal doses of guide-line directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization (35.8 percent vs. 67.9 per cent) and lower all-cause mortality  (29.1 per cent vs. 46.1 percent) after 24 months as compared to medical therapy alone.  The complication rate was low.  
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Nobel Prize in Medicine is Awarded to Two Cancer Immunotherapy Researchers
As reported in the New York Times on October 1, The Nobel Prize in Physiology or Medicine was awarded to James P. Allison of the United States and Tasuku Honjo of Japan for their work on unleashing the body's immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. You can watch the announcement here.
Medicare Part D Open Enrollment
All Medicare patients are required by law to purchase medication coverage (Part D).  Unfortunately, many of my Medicare patients opt for cheap plans and then end up paying large out-of-pocket sums for the medicines they deserve. October 15th marks the beginning of Medicare Open Enrollment.  I advise all Medicare recipients to visit  Medicare.gov and click on the part D tab.  Enter your zip code and medications and sign-up for the plan that best meets your needs and your pocketbook!
Now Hear This!
Our oldest doctor daughter and her wonderful physician husband are expecting their third child and our sixth grandchild within the month!!  Our fifth grandchild just turned two months old and is fabulous!

Valerie, Stephanie, Ms. Clark, Ms. Catong, Ms. Sentner, and I wish you a wonderful autumn season full of color and spice!
In This Issue
September: More on Low Dose Aspirin
New Data on Primary Prevention with Aspirin
Immunotherapy for Treatment of Lung Cancer
Transcatheter Mitral-Valve Repair in Patients with Heart Failure
Nobel Prize in Medicine Awarded to Two Cancer Researchers
Medicare Part D Open Enrollment
Now Hear This!
  
John A. Schmidt Jr., M.D.
Board Certified Internist
 
Dr. Schmidt is one of the leading internists in Monmouth County offering  Medical Home  services.  
 
He is an attending physician at Jersey Shore University Medical Center.
 
Dr. Schmidt is enrolled in the Maintenance of Certification Program of the American Board of Internal Medicine
 
  
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"Notice that autumn is more the season of the soul than of nature."

- Friedrich Nietzsche


          
 
 
 

















 
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John A. Schmidt Jr., MD
Meaningful Medicine in Your Medical Home
2006 Highway 71, Ste. 3, Spring Lake Heights, NJ 07762
 
Phone:  732-282-8166  
Fax:  732-280-0147 
  
  
Disclaimer: The articles in Healthy Living are for general information only and are not medical advice.
Discuss all medical concerns and treatment options with your physician.