Statin Use and Diabetes in Older Women

Older women who take statins may be at an increased risk of developing Type 2 Diabetes Mellitus (adult onset). In a study published in the Archives of Internal Medicine, Dr Ma, of the University of Massachusetts School of Medicine, looked at the 154,000 women in the Women’s Health Initiative who did not have Diabetes when the study began in 1993.  Seven percent (7%) of them were on statins at the time through follow-up, 12 years later.  At that point, 10,242 cases of new cases of diabetes were reported. They theorize that this computes to an almost 50% increase in becoming a Diabetic if you are on a statin as compared to women who are not. Surprisingly, this occurred far more frequently in thin women taking a statin than in heavy or obese women.

The salient points taken out of this research are that women on statins need their liver enzymes monitored frequently they need their blood sugars monitored as well. The overriding message is that as physicians and patients we need to make a monumental effort to control elevated lipids by diet , exercise and weight loss without statins if humanly possible.

This also raises the question of whether we should be measuring HDL and LDL subtypes an Lpa levels on all patients before instituting statin therapy?  While this raises doubt about a popular class of drugs that are a crucial part of the prevention of cardiovascular disease, it does not yet make it clear what the clinical implications are for postmenopausal women on statins.

I will reevaluate all my female patients on statins as I see them for follow-up visits.

Pradaxa: More Concerns. More Myocardial Infarctions?

Pradaxa is part of a new group of anticoagulants (thrombin X inhibitors) that eventually will allow anticoagulation by the pill route without requiring patients to alter their food and medication intake and avoid foods and medications that interfere with the anticoagulant as patients must do with Warfarin. Pradaxa additionally eliminates the need to take blood tests (INR/ PT) to monitor the dosage as one has to do with Warfarin (Coumadin).

There is a large commercial advertising campaign underway on TV and print media to encourage patients with atrial fibrillation to ask their doctors to switch them from Coumadin to Pradaxa (Dabigatrin).  The campaign bases its claims on the RE-LY trial of 18,000 patients at 80 medical centers throughout the world who took the 150 mg dosage and had significantly fewer strokes than patients taking Warfarin.  The original study was criticized because many of the patients in the Warfarin (Coumadin) group were not on enough Warfarin or at a therapeutic PT/INR to prevent embolic strokes so the comparison with Pradaxa may not be valid. Another criticism involved the fact that Pradaxa can cause major bleeding and there is no antidote to stop the bleeding. Patients on Pradaxa who are bleeding are advised to undergo hemodialysis to remove the drug from their system because there are no medications or treatments available to stop Pradaxa related bleeding.

One wonders how the Food and Drug Administration approved this product for general use under these circumstances without conducting further testing?  The issue becomes even more confusing with the addition of data presented by Ken Uchino, MD, and Adrian Hernandez MD, PhD of the Cleveland Clinic in the online version of the Archives of Internal Medicine. They claim that by reviewing the RE-LY data there is a 38% relative increase in the risk of a myocardial infarction (MI) or heart attack in the Pradaxa group. In an accompanying editorial in the same journal, clinicians at the Hadassah- Hebrew University Medical Center in Jerusalem wrote, “The robust finding that Dabigatran is associated with increased rates of MI (heart attack) is alarming and emphasizes the need for continued critical appraisal of new drugs after phase III trials.”

In my practice I generally will not switch to a new or controversial medication until it has been on the US market for at least one year. I make exceptions for orphan drugs, products to treat incurable diseases with no other choices available. The 12 months gives the medical and scientific community a chance to see how the medication performs and what unexpected adverse effects may be associated with it.

Thrombin X inhibitors are the wave of the future. With no way to stop the bleeding, and data on their safety and efficacy still accumulating, they are just not ready for prime time yet.

What’s New in Dementia, Alzheimer’s

Alzheimer’s Disease is a form of dementia and considered to be a progressive, fatal neurologic disease. Medications to slow it down are successful in about 50 % of patients for a very limited amount of time (6 -12 months).  As Baby Boomers age and move into the retirement sector, we are always looking for positive data regarding the disease to offset the expected epidemic of dementia.  We have a limited amount of good news to report.

Japanese researchers report that they have developed several types of contrast material for imaging studies which will allow doctors to see accumulating plaque in the brain and possibly the tangles of neurons associated with the disease at a much earlier stage.  At the same time researchers now claim to be able to do a spinal tap and, by examining the spinal fluid, make an earlier and more accurate diagnosis. At this point there might not yet be an advantage to early detection of the disease but as research proceeds it may become an important advantage.

The British Medical Journal is reporting that cognitive decline actually starts in midlife. They studied a mix of 7,300 men and women at five years intervals beginning in 1997 and found a decrease in intellectual functions beginning at 45 years old. They concluded that “what is good for our hearts is also good for our heads.”  They stressed the importance of controlling hypertension, obesity and abnormal cholesterol as a way to prevent dementia.

You might ask why I consider the fact that dementia begins in midlife a positive?  It’s a positive because we have the ability to control our weight, blood pressure, cholesterol and exercise level. Anytime a disease is modifiable by how we live our life we are given the chance to prevent it or limits its impact. This fact is supported by a recent study published in the Archives of Neurology looking at individuals with a genetic variant which predisposes them to develop Alzheimer’s Disease.  They found that older adults with the genetic predisposition for Alzheimer’s Disease who exercised regularly, at or above the American Heart Association recommended levels, developed “amyloid deposits” on scans of their brain less than expected and in line with the general public who did not have a genetic predisposition to develop the disease.

These are small but positive steps in facing dementia. We can find it earlier and slow down or turn off genetic predisposition by living a healthy life.

It’s Only a Cold …

As a concierge medical practice we pride ourselves on being available to help our patients with access to the doctor by phone and same day appointments. At this time of year we are faced with daily phone calls regarding cold or flu like symptoms.  Thus, I thought it appropriate to share some topical information which should be useful in helping anyone decide whether they should “ride out the storm” or give their doctor a call.

There are at least 1,500 different known viruses that lead to a viral upper respiratory tract infection sometimes known as “the common cold”.   With these, a high sustained fever of 101 degrees Fahrenheit is rare.  Aches and pains, nasal discharge with runny nose and post nasal drip are common. Dry cough advancing to a barking cough productive of clear, yellow and often greenish phlegm is common as well.  You’ll most likely feel miserable. Your sinus and head congestion make you feel like you are in a tunnel, a sound chamber, or wearing a deep sea diving helmet. Your appetite waxes and wanes. You are exhausted with the activities of daily living.  Getting out of bed to wash your face and groom yourself may seem as challenging as a 26.5 mile race up a hill.

Currently, there is no cure for the common cold. Antibiotics do not work.  A “Z Pack “does not speed up the process. An injection of antibiotic does not make it go away faster. The infection could care less if you have a high school reunion to go to in Philadelphia, a grandchild’s bar mitzvah or baptism, or a flight to Paris for a combined work/pleasure excursion. Frankly, once you have this type of viral infection you will most likely have to ride out the storm.

Furthermore, going to the ER and sitting and waiting to be seen doesn’t make the infection go away quicker. Paying for a visit at a walk in center or urgent care center where you are more likely to negotiate successfully for an unwarranted or needed antibiotic will not help either.

In most instances, your recovery from the virus will take 7-14 days providing you drink plenty of warm fluids, rest when you are tired and use common sense. Cough medicine may ease the cough. Saline nasal solution may clear the nasal congestion. Judicious use of a nasal decongestant under your physician’s supervision may help as well.  It will take time. You are contagious. No you should not go to the gym if you are feeling poorly. Chicken soup, tincture of time, hot tea with honey, plenty of rest and common sense are recommended remedies.

If at any point you still feel you have the plague, dengue fever, the bird flu or the Ebola virus come on in. We will take a look, evaluate your symptoms and likely tell you, “It’s a cold.”

Deep Vein Thrombosis Prophylaxis, Safety and the Joint Commission on Accreditation of Hospitals

Over the last few years, great emphasis has been placed on preventing blood clots from forming in the legs and pelvis of all hospitalized patients. These blood clots can break off and travel to the lungs causing life-threatening breathing problems and fatal heart arrhythmias and sudden death. Preventing these “venous thromboembolic events” has been a priority of quality organizations like the Joint Commission on Accreditation of Hospitals which inspect hospitals and offer certification if the hospital meets their criteria.

The movement to prevent these clots and sudden death has become so strong that you cannot admit a patient to the hospital without addressing these issues. Physicians must either choose to give injections below the skin with the blood thinner heparin three times a day or the low molecular weight heparin twice a day. You are additionally asked to prescribe mechanical compression stockings to the legs to further reduce the risk.

If you choose not to institute these orders you must clearly write out and outline your objections and reasons for not taking these measures. Even if you document your reasons for not instituting these measures you’re assured of receiving a call from your hospital’s quality care organization.

This all becomes newsworthy because two recent studies called into question the practices. One study concluded that mechanical compression stockings added nothing to the use of blood thinners in preventing deep vein clots. The other study cited that for every 1000 patients treated with blood thinners to prevent pulmonary emboli; you prevented three non-fatal pulmonary emboli at the expense of causing nine bleeding events – four of which are major.  I suspect this data will be discussed in our medical journals and at scholarly meetings and a consensus opinion will be reached on how to proceed. Letters will be written to journals criticizing the methods of these studies and other letters will be written defending them and, ultimately, a common sense approach will be reached.

In the meantime, it would be far more interesting to look at the Joint Commission on Accreditation of Hospitals and determine how they got so powerful that they can mandate procedures which may not have any value and may do harm?  Who are they?  How do they generate income and how much goes to who and why?

It is a fact that in the state of Florida, private insurers like Blue Cross Blue Shield, Aetna, Humana, will not contract with a hospital or institution unless it receives certification from this organization.  A study should be done to see if these JCAHO inspections costing $7-8 million dollars every other year resulted in any reduction of in-hospital errors, iatrogenic illnesses, death rates and serious illness?

Insurers and employers who pick up the “lion’s share” of our health care costs are always asking for accountability and efficiency and want to pay for what works. It would be nice to know if their relationship with JCAHO has made the patient safer or healthier over the last 15 years.