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MARCHing Step by Step to a Healthier You!
Achieving optimal health is a lifelong journey marked by incremental progress and requiring painstaking attention to detail. In this edition of the newsletter, I have included new information to help us march arm-in-arm together to preserve your health.
John A. Schmidt, MD
Internist
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Long Awaited Outcomes Data Published for Cholesterol Lowering Antibody
Statins lower LDL (the "bad cholesterol") and reduce the incidence of heart attack and stroke in patients with one or more risk factors (smoking, hypertension, diabetes, positive family history, elevated cholesterol, and/or renal insufficiency). In 2015, FDA approved two new antibodies (Repatha
®
, Praluent
®
) targeting a protease known as PCSK9. PCSK9 strips the LDL receptor from the surface of liver cells; inhibition of PCSK9 therefore serves to protect the LDL receptor so it can remove vessel-clogging LDL from the blood. The combination of statins and an anti-PCSK9 antibody achieve extremely low LDL levels, typically 30 mg/dL. But what is the impact of very low LDL levels on heart attack and stroke?
The results of the landmark Fournier trial, published online in the March 17 issue of the New England Journal of Medicine, provide the answer. The primary endpoint was a composite of cardiovascular death, heart attack, stroke, hospitalization for angina pectoris, or coronary stenting. The secondary endpoint was the composite of cardiovascular death, heart attack, or stroke. Repatha
®
, in combination with a statin, as compared to statin alone, significantly reduced LDL cholesterol, as well as the primary and secondary endpoints over a mean follow up period of only 26 months. The treatment was extremely well tolerated.
The number of patients needed to treat (NNT) over a period of two years to prevent a single cardiovascular death, heart attack or stroke was 74. Given that the annual cost of antibody treatment is approximately $15,000 per patient per year, many analysts were disappointed causing the price of Amgen stock to decline sharply. Regardless of the impact on Amgen, the results show that lowering LDL below the current guideline of 70 mg/dL is beneficial and that the magnitude of the benefit is likely to increase with time. The take home lesson of this study, which was conducted in high risk patients, is therefore to maximize the use of generic, potent statins (rosuvastatin/atorvastatin) to lower LDL as much as possible to achieve the best results. No doubt the pharma industry is working on less expensive PCSK9 inhibitors now that the mechanism has been validated in patients. Results with Praluent, the other PCSK9 antibody, will no doubt be available soon and are expected to confirm and extend the Fournier study results.
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Pharmacological Treatment of Hypertension in Adults Aged 60 years or Older to Higher vs. Lower BP Targets: New Guidelines from the American Association of Physicians (ACP) and American Association of Family Physicians (AAFP)!
As published in the Annals of Internal Medicine on March 21, "Elevated blood pressure (BP; hypertension) remains one of the most important causes of preventable morbidity and mortality in the United States, particularly for older adults. Almost 65 per cent of U.S. adults aged 60 years or older have hypertension (defined as BP > 140/90) and only half are adequately treated. More than 15% are unaware of their condition."
The landmark SPRINT trial, published in the New England Journal of Medicine in September of 2015, by the National Institutes of Health, showed that patients over the age of 50 with even one cardiovascular risk factor should be treated to a systolic BP (top number) of 120. With a median follow up of 3.26 years, the number needed to treat (NNT) to prevent a single adverse outcome (heart attack, stroke, heart failure, cardiovascular death) was 61. As in the Fournier cholesterol treatment trial mentioned above, the more aggressively treated group did progressively better as compared to the control group suggesting that the treatment benefit would continue to increase with time.
The ACP and AAFP reviewed all of the data including SPRINT and have issued guidelines which are more moderate:
1) initiate treatment in adults 60 years or older with systolic blood pressure persistently at or above 150 mm Hg to achieve a target systolic blood pressure of less than 150 mm Hg to reduce the risk for mortality, stroke, and cardiac events;
2) intensify pharmacological treatment in adults aged 60 year or older with a history of stoke or transient ischemic attack to achieve a target systolic blood pressure of less than 140 mm Hg to reduce the risk for recurrent stroke;
3) intensify pharmacologic treatment in adults aged 60 years of older at high cardiovascular risk, based on individualized assessment, to achieve a systolic blood pressure less than 140 mm Hg to reduce the risk for stroke or cardiac events.
Thus ACP/AAFP therefore recommends matching the intensity of blood pressure lowering therapy to the risk profile of the patient. My opinion? I believe ACP and AAFP have missed the boat. In my practice, hypertension is usually accompanied by other risk factors (chronic renal disease, hypercholesterolemia, diabetes, smoking history, etc.) that make more aggressive management of hypertension the better approach for most of my patients as recommended by the Sprint investigators.
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Oral Pharmacologic Treatment of Type 2 Diabetes Mellitus: New Guidelines from the American College of Physicians
Type 2 Diabetes is second only to hypertension in prevalence among Americans and is widely misunderstood. Whereas patients with Type 1, or juvenile onset, diabetes make no insulin, most patients with type 2 diabetes make normal or elevated amounts of insulin. Why? Because type 2 diabetes is the result of insulin resistance which in turn is due to weight gain and sedentary lifestyle. The pancreas attempts to overcome insulin resistance by making more. The treatment goal in type 2 diabetes is therefore to reverse insulin resistance with exercise and weight loss. But if lifestyle measures are inadequate, there are medicines which can help. There are five classes of medicines to choose from, roughly in order of their entry into clinical practice: 1) metformin, 2) sulfonylureas, 3) thiazolidinediones, 4) DPP-4 inhibitors, and 5) SGLT-2 inhibitors. The ACP reviewers compared them in the February 21 issue of the Annals of Internal Medicine. Read the results and draw your own conclusions:
1) There are unfortunately insufficient data to choose among the five classes with respect to all-cause mortality, cardiovascular mortality, retinopathy, nephropathy, and/or neuropathy.
2) Metformin, sulfonylureas, thiazolidinediones, and SGLT-2 inhibitors are roughly equivalent in terms of their ability to reduce hemoglobin A1c, the reigning blood test for monitoring blood glucose. DPP4 inhibitors are less active. The best results are obtained by combining metformin with a medicine from another class, especially an SGLT-2 inhibitor.
3) SGLT-2 inhibitors, metformin, and DPP-4 inhibitors reduced weight more than sulfonylureas or thiazolidinediones, with SGLT-2 inhibitors performing best.
4) SGLT-2 inhibitors are the only class that lowers blood pressure when used alone or in combination with metformin.
5) Sulfonylureas carry the greatest risk of dangerous hypoglycemia.
6) SGLT-2 inhibitors occasionally cause genital mycotic infections (e.g., intertrigo).
7) Thiazolidinediones carry a risk of congestive heart failure.
Bottom line: the combination of metformin and a SGLT-2 inhibitor offers the best efficacy (lower hemoglobin A1c, weight loss, blood pressure reduction) while minimizing the risk of hypoglycemia and congestive heart failure. Intertrigo, if it occurs at all, is easily managed with topical antifungals which most people use anyway.
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New Recommendations on Fecal Immunochemical Testing (FIT) to Screen for Colorectal Cancer.
As published in the January issue of Gastrointestinal Endoscopy, the nation's leading gastroenterologists have issued new guidelines regarding use of the Fecal Immunochemical Test (FIT) to detect colon neoplasms/tumors as early as possible. The FIT is a simple inexpensive antibody test to detect blood in fecal material. Here is a concise summary of their recommendations:
1. Perform the test once every year.
2. The test should be a quantitative test with a cutoff of 20 ug/gram of stool.
3. All positive tests should be followed up with a colonoscopy; an upper endoscopy is NOT recommended unless patients have stomach pain.
4. If the test is positive, a colonoscopy should be performed promptly regardless of colonoscopy history.
5. Samples should be collected at home without a change in diet. No special storage conditions are required.
The bottom line is that annual testing is your best insurance against colon cancer. The authors did not include
Cologard
®
in their recommendations. Rather than blood, Cologard
®
detects DNA known to be associated with colonic cancers and avoids false positives due to bleeding hemorrhoids. Cologard
®
is more expensive than FIT but insurance carriers are increasingly willing to pay for it. The point is to screen more frequently with stool tests (FIT/Cologard
®
) and not rely exclusively on colonoscopy.
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Nicotine and Carcinogen Exposure in E-cigarette Users
As published in the March 21 issue of the Annals of Internal Medicine, E-cigarette users were exposed to the same amounts of nicotine as combustible cigarette users, but the exposure to toxins and carcinogens was far less provided they completely abstained from combustible cigarettes. This study is a potential game changer in the war on cigarettes and cigars. Whereas it is best to avoid combustible cigarettes/cigars and e-cigarettes altogether, this study strongly suggests that e-cigarettes are safer.
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Patient Portal Please!!
The
Follow My Health Patient Portal is one of the most efficient ways to keep in touch with us and manage your health care. Not only can you schedule appointments, but you can review your medical history, refill prescriptions, and share important health information with loved ones.
The portal gives you access to your personal health information (PHI), including Labcorp results, and it also allows you to communicate with me using encrypted, HIPAA compliant, email. You will get faster notification of your lab results.
If you do not already have a portal account, kindly ask Valerie to send you an invitation today!!!
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Practice Prescription Policy
To protect your safety, my practice will not send/mail prescriptions to pharmacies located outside of the United States and its territories.
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Now Hear This!
I am pleased to welcome Ms. Martha Martinez to my practice!! Ms. Martinez will be assisting Valerie in the front office and patients for whom Spanish is their preferred language. We have also added a second phone so that a greater percentage of your calls will be answered promptly saving you the trouble of calling back or leaving a message. Let me know if you experience an improvement!
I am also pleased to announce that Ms. Clark has been admitted to the staff of Jersey Shore University Medical Center.
Valerie, Monica, Morgan, Martha, and I wish you a glorious beginning to Spring!
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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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today!
Click here to learn more about the benefits of our
Follow My Health Patient Portal
and register today! You can make appointments and get your lab results on the portal. Simply ask Valerie to send you an invitation. Call 732-282-8166.
"The day the Lord created hope was probably the same day he created Spring."
- Bernard Williams
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