Safety & Efficacy of Lowering Lipids in the Elderly

I am bombarded regularly by older patients, their adult children and various elements of the media with complaints that elderly are taking too many medicines. Poly pharmacy is the word they use and the first prescription medications they want eliminated are their cholesterol lowering drugs – either a statin (Lipitor, Zocor, Pravachol, Crestor , Livalo or their generic form), Zetia ( Eztimebe) or the newer injectable PCSK9 inhibitors Repatha and Praluent. Is there an age that we should stop these medications? Is there benefit in the elderly to continue taking them? Should we start these medications in the elderly if we discover they have high cholesterol and vascular disease?

A recent study was published in the prestigious Lancet medical journal. The authors looked at 29 trials with 244,090 patients. From this pool there were 21,492 patients who were at least 75 years old. Half of them were on oral statin drugs and the others were on Eztimebe or PCSK9 inhibitors. They were followed from 2 – 6 years.

The results showed that for every reduction of LDL cholesterol of 1mmol/L there was a 26% reduction of in major adverse vascular events. These numbers were similar to those in younger patients. The data also pointed out that these patients had a significant reduction in cardiovascular deaths, myocardial infarction (heart attacks), strokes and the need for heart surgical revascularizations. It was extremely clear that if you are on a cholesterol lowering drug you should stay on that medication despite your age!

A study in JAMA internal medicine, authored by LC Yourman, answered the question of whether you are too old to start on a cholesterol lowering drug. They found that it took 2.5 years before the cholesterol lowering medicine reduced your risk of a major cardiovascular event. Their conclusion was that if you are 70 or older, and your lifespan appears to be greater than 2.5 years, you should start the medicine.

Obstructive Sleep Apnea Surgery vs. CPAP? Daytime Anti-Snoring Device?

Obstructive sleep apnea is now epidemic in a population where it runs hand-in-hand with obesity, which is also an epidemic. The consequences of untreated sleep apnea include daytime somnolence, cardiovascular, neurological and endocrine complications.   One of the hallmark signs of obstructive sleep apnea (OSA) is snoring. 

The US Food and Drug Administration (FDA) recently approved an oral device to be worn during the daytime to reduce and/or eliminate snoring. The device is called eXciteOSA made by Signifier Medical Technologies.  The device is a prescription item which will be used by sleep specialists, dentists and ENT physicians.  It has four electrodes that deliver a series of electrical stimuli to the tongue with rest periods in between. The stimulation over time improves tongue function preventing the tongue from collapsing backward into the airway and obstructing it during sleep.  The device is used for 20-minutes once a day, while awake, for six weeks and then once a week thereafter. It is designed to be used in adults 18 years of age or older with snoring and mild OSA. Think of it as physical therapy for the tongue.

The device was tested on 115 patients, 48 of whom had mild obstructive sleep apnea plus snoring. The others were all snorers. The snoring was reduced in volume by more than 20% in 87 of the 115 patients. In the group of patients with the diagnosis of OSA and snoring, the apnea-hypopnea index score was reduced by 48%

It is recommended that a thorough dental exam be performed prior to trying this device. The major side effects noted from its use were excessive saliva production, tongue discomfort or tingling, metallic taste, jaw tightening, tooth filling sensitivity.  No mention of the cost was included in the printed review.

The online journal Practice Update reviewed a JAMA Otolaryngology publication on the use of surgery to treat Obstructive Sleep Apnea versus using a CPAP machine. There are many patients who just can not wear the CPAP mask which is the first-line “gold standard” for treating OSA.  Most patients who spend 90-days adjusting to the mask sleep far better and look forward to using the device to obtain a restful night’s sleep. The study looked at patients who were at high risk for not being able to adhere to a CPAP use regimen. Soft tissue surgery to the uvula was found to reduce the rates of cardiovascular, neurological and endocrine systemic complications compared with prescriptions for CPAP in patients less likely to adhere to or use the CPAP mask. 

The takeaway message is clear. When a patient is unlikely to adhere to CPAP mask use offering soft tissue oral surgery should be offered early while treating the disease.

PreDiabetes in The Elderly – Not to Worry

As physicians and educated adults we realize that developing diabetes increases our risks of heart disease, narrowing of our arteries or vascular disease, injury to the retina of our eyes leading to poor low vision or blindness, peripheral neuropathy or burning pains in our feet and elsewhere. We additionally have been taught the correlation between controlling our blood sugars and trying to reduce the risk of developing these complications.

In my early years in practice if a patient came in for fasting bloodwork and their glucose level was elevated above 110 on two occasions they met the legal definition of diabetes. Patients always had an excuse. “It was my birthday so I had cupcakes at work, cake and mixed alcoholic drinks at home, etc.” There were always rational reasons for being a human being, enjoying life and not being a disciplined diabetic patient.

The development of the hemoglobin A1c eliminated those excuses. It recognized that the higher your daily average blood sugar the more sugar would bind with a hemoglobin molecule and increase your hemoglobin A1C. That has given us a measure of your average blood sugar over the previous 90-days. Normal values were established as well as values in the diabetic range. The intermediate values were labeled “pre-diabetes”.

The question became “How do you keep “pre-diabetics” from becoming diabetics and risking all those complications.” Did the same rules apply to middle aged adults as to the elderly?

For the most part I counseled pre-diabetics that they had an increased risk of developing diabetes but if they stayed active, kept their weight down and improved their dietary choices they would be fine.

A research paper in Journal of the American Medical Association (JAMA) online edition now supports that position. Mary Rooney, PhD of the Bloomberg School of Public Health at Johns Hopkins University, published her data looking at 3,142 individuals 70 -90 years old with 44% being diagnosed with prediabetes. They were followed for six years.

During that time-period, only 9% of them went on to become diabetic. Thirteen percent (13%) improved into the normal glycemic range. Nineteen percent (19%) died of other causes.

The message is clear. If you are 70 years of age or older, and your hemoglobin A1C moves into the 5.7 or greater range, you are considered pre-diabetic. Stay fit and active. Keep your weight down. Meet with a dietitian and learn how to eat well and healthy, stop smoking and go for regular checkups. Diabetes will not do you in!

Do Cipro and Levaquin Cause Abdominal Aortic Aneurysms?

Melina Kibbe, MD, of the University of North Carolina Medical Center at Chapel Hill published an article in JAMA Surgery reviewing any possible relationship between taking fluoroquinolones antibiotics such as Cipro or Levaquin and the subsequent development of an abdominal aortic aneurysm.  An aneurysm is a weakening in the wall of a blood vessel that balloons out like the defect on a damaged tire or basketball and has the potential to rupture causing exsanguination and sudden death. Dr Kibbe is also the editor of JAMA Surgery.

The study looked at health insurance company data on antibiotics and aneurysm diagnosis and repair.  They found that 7.5 aneurysms formed per 10,000 fluoroquinolone prescriptions filled at 90 days. This was significantly higher than the 4.6. per 10,000 aneurysms formed after patients took non-fluroquinolone antibiotics.  Patients filling fluroquinolone prescriptions were more likely to undergo repair of aneurysms than those who took other types.

The study used data from IBM MarketScan health insurance claims from 2005 to 2017 in adults aged 18-64.  The study included data on 27,827,254 individuals. The data did not include smoking or hypertensive history or family history of vascular disease. The authors were hoping the FDA would require a warning or caution to high-risk individuals for developing an aneurysm.

We already see an increase in ruptured tendons in patients taking fluroquinolones – especially women who have taken corticosteroids. They are also associated with C difficile colitis, nerve damage, emotional health issues and low blood sugar events. 

Despite these known draw backs to these medications, patients continually demand to have Cipro or Levaquin on hand in case they develop a urine infection or upper respiratory infection or are travelling and concerned about traveler’s diarrhea. 

More research is needed to determine the exact risk of prescribing these medications. Should we be doing scans on patients with hypertension and or smoking history who frequently use these drugs to screen for an abdominal aortic aneurysm?  This is a question that will be addressed by a study soon.  While the research is in process, we need to make sure that our prescribing of these antibiotics is the safest choice for our patients.

COVID-19 & Local Disease

We receive periodic updates on the census and status of the COVID unit at Baptist Health Boca Raton Regional Hospital. There have been under 25 COVID-19 patients per day for several weeks now. As of Friday, October 23, there were no patients with COVID-19 in the ICU.

On the downside, they are still very short on chemical reagents and nasal swabs to perform quick accurate on site COVID tests limited to about 30 per day and are sending out most tests to BioReference Labs. BioReference has a 48 – 72-hour turnaround time and is dealing with unexpected false positive tests.

In discussion with an official of Holy Cross Medical Center, they are very pleased with the accuracy of their four hour in house COVID detection test and have sufficient chemical supplies so that they do not send out any COVID tests. I have no idea why Holy Cross is flush in supplies and Baptist Health system short.

Lately, the number of respiratory cases showing up at the Emergency Department is increasing. The number of diagnosed cases of COVID locally is increasing. The number of positive tests performed, regardless of which method is used, is increasing. Hospitalizations in Florida are increasing.

As a result, I suspect in 3 – 4 weeks we will be discussing hospital bed availability, bed capacity and elective surgery. I’m sure this will be discussed during our morning staff educational zoom meetings regarding our local COVID status.

At the current time, Boca Raton Regional is participating in studies with remdesevir, dexamethasone, mesenchymal stem cells, convalescent plasma, radiation to the lungs of COVID-19 pneumonia patients and Regeneron monoclonal antibodies. The high-tech treatments you read about are available locally if you qualify.

The ballyhooed Abbot $5, 15-minute, testing kits are reported to have been distributed to local state testing sites. If you find them, please let me know where.

In a major review of quick COVID-19 tests published in JAMA this week, it is made clear that this was never meant to be a screening test. It is meant to be used on patients who are ill with symptoms. There are far more false negative tests with this product than are acceptable for screening situations. The last thing you want is a contagious person to test negative and then behave in a social setting as if they are free and clear of disease.

Palm Beach County Commissioners extended their Executive Order mandating wearing of masks at all indoor facilities. Be considerate, save some lives, wear a mask please.

PLCO Data Support Protective Effect of Aspirin in Preventing Deaths

In recent months, the US Preventive Task Force has recommended adults without diabetes or documented coronary artery disease avoid taking baby aspirin to prevent heart attacks and strokes. They believe the risk of bleeding outweighs the benefit derived. They still recommend aspirin prevention in men with known cardiovascular, cerebrovascular disease and diabetes.

The Prostate, Lung, Colorectal and Ovarian Cancer Trial (PLCO) just made the decision-making much more complex. In their study, reported in this month’s JAMA Network Open, they found that taking aspirin as infrequently as 1 to 3 times per month reduced the risk of all-cause and cancer related mortality compared to no aspirin in their study with 146,152 patient participants.

Weekly use of aspirin significantly reduced the risk of mortality from both GI and colorectal cancer and all mortality endpoints irrespective of how heavy you were. When the study looked at 12.5 years of aspirin use 1 to 3 times a month, compared to none, the all-cause mortality was reduced by 16%. The results were even more encouraging when aspirin was taken three or more times per week.

The PLCO Cancer Screening Trial involved participants aged 55-74 who were randomized to a cancer screening group or a control group at 10 United States Medical Centers. This review looked at men and women 65 years or older at baseline. While this study showed a beneficial effect of aspirin in the elderly, other recent studies have been less favorable. The ASPREE study, Aspirin in Reducing Events in the Elderly, found that individuals taking 100 mg of aspirin daily were at increased risk for all-cause mortality compared to those taking a placebo.

The decision to take low dose aspirin, or not, is something you should discuss with your physician so that you can tailor the situation and risks to your personalized needs.

Talcum Powder Does Not Cause Ovarian Cancer

Katie O’ Brien, PhD, of the National Institute of Environmental Health Sciences in North Carolina reported a study in nearly 250,000 women over an 11 year span that showed that talcum powder does not contribute to the development of ovarian cancer, The study was published in JAMA, the Journal of the American Medical Association.

The study found that in women who used talcum powder in the genital area, a total of 61 cases per 100,000 persons years was detected. When they compared that to women who never used talcum powder in that area, they found 55 cases of ovarian cancer per 100,000. The difference between users of talcum powder developing ovarian cancer by age 70 compared to nonusers was just 0.09%.

The concern about talcum powder use and cancer occurred in 1976 when asbestos was found in talcum powder. Most talcum powder is felt to be asbestos free today.

Hypertension Guidelines Versus Life Experiences

One of the advantages of practicing clinical medicine, and seeing patients daily for many years, is you develop your own long-term study regarding certain medical health issues. In the area of hypertension, I have been taught by the best since my internship with pioneers such as Eliseo Perez Stable and Barry Materson at the University of Miami affiliated hospitals, Jackson Memorial Program, ensuring that their trainees were up to the task.

The goals and guidelines have changed. Lifestyle changes including salt restriction (sodium chloride), weight reduction, smoking cessation, reducing alcohol intake and regular exercise will always be mainstays of non-pharmacologic treatments.  We used to be taught to keep the systolic blood pressure at less than 140 and the diastolic blood pressure at less than 85.  These numbers have changed over the years, having been lowered, with everyone over 120 systolic now being classified as having some degree of increased risk of cardiac, cerebrovascular or vascular disease and hypertension.

We originally were taught to start with a diuretic and keep raising the dosage until the blood pressure was controlled or the patient developed adverse effects. We learned that when we used one medication, pushing it to its limit inducing adverse effects along the way, patients just stopped taking their medications. This resulted in a change in strategy to using several medicines each with another pathway to controlling blood pressure but all at a lower dosage which did not produce any ill feeling adverse effects.  The downside of more medications was additional costs and more pills to remember to take.  As hypertension experts pushed us to lower systolic blood pressure to 120 or less in our geriatric population I was concerned that lowering the pressure that much would again create adverse effects which were as or more troublesome than the risk  of having a BP between 120 and 140 systolic.  An article in JAMA Internal Medicine looked at this issue. They looked at patients over 65 years of age who were hospitalized for non-cardiac related problems and whose blood pressure was over 120. They studied these patients at Veterans Administration hospitals over two year period. Patients with elevated blood pressure above 120 were given more medications and higher dosages to bring their pressure down to meet the more stringent guidelines. The result was that there were no fewer cardiac events than anticipated and no better blood pressure control at a year.  In addition, these patients suffered from an increased number of re-admissions to the hospital and “serious“ adverse events within 30 days.

The new guidelines for blood pressure control may be applicable in a younger healthier population.  In the geriatric population we may need to readjust our goals to account for the physiologic changes that occur in men and women who age in a healthy manner. More specific data on why there were more re-admissions and what serious adverse effects occurred needs to be made public to determine if the effort to tightly control blood pressure is to blame.

Sunscreen Ingredients are Absorbed says FDA

For years public health officials, dermatologists and primary care physicians have been encouraging people to apply sunscreen before going out into the outdoors to reduce the risk of sunburn and skin cancers.  We are taught to apply it in advance of exposure by about 30 minutes and to reapply it every few hours especially if we are sweating and swimming.   Living in South Florida, sun exposure is a constant problem so we tend to wear long sleeve clothing with tight woven fabrics to reduce sun exposure.  My 15-month old grandson, visiting last weekend was smeared with sunscreen by his well-meaning parents before we went out to the children’s playground nearby.

These precautions seemed reasonable and sensible until an article appeared in JAMA Dermatology recently.  An article authored by M. Mata, PhD. evaluated the absorption of the chemical constituents of sunscreen after applying it as directed four times per day.  The article was accompanied by a supporting editorial from Robert M. Cliff M.D., a former commissioner in the FDA and now with Duke University School of Medicine and K. Shanika, M.D., PhD.

The study applied sunscreen four times a day to 24 subjects. Blood levels were drawn to assess absorption of the sunscreen products avobenzene, oxybenzone and octocrylene.  The results of the blood testing showed that the levels of these chemicals far exceeded the recommended dosages by multiples. The problem is that no one has evaluated these chemicals to see if at those doses it is safe or toxic causing illness?

The editorial accompanying the findings encourages the public to keep using sunscreen but cautions that the FDA and researchers must quickly find out if exposure to these levels is safe for us?  We do know that the chemical oxybenzone causes permanent bleaching and damage to coral reefs in the ocean from small amounts deposited by swimmers coated with sunscreen. The state of Hawaii has actually banned sunscreens containing oxybenzone to protect their coral reefs.

The fact that these chemicals have been approved and are strongly absorbed with no idea of the consequences is solely the result of elected officials wanting “small government” and reducing funding to the oversight organizations responsible for making sure what we use is not toxic.  It is a classic example of greed and profit over public safety.  The research on the safety of these chemicals must be funded and addressed soon. The American Academy of Pediatrics and Dermatology need to advise parents of youngsters whose minds and bodies are in the development and growth stages what is best to do for their children – sooner rather than later.

Keep Moving for Cardiovascular Benefits

We keep extolling the benefits and virtues of regular exercise and fitness. Some research studies have documented the intensity and duration of exercise programs with cardiovascular events and mortality. Those who do more and are fitter apparently do much better which surprises few of us.

It comes down to the “which came first the chicken or egg “question?  Are people genetically able to exercise at a high level living longer and healthier because they exercise at a high intensity and duration or vice versa?

It is quite comforting to read the recent study in JAMA by Andrea LaCroix, PhD, MPH and colleagues from the University of California, San Diego that shows the benefits of even modest movement and exercise.  The study was conducted under the umbrella of the Women’s Health Initiative and put pedometers and accelerometers on women to measure activity during waking hours.  Light physical activity was defined as less than 3 metabolic equivalents (Walking one mile in about 22 minutes expends about 3 Metabolic Equivalents of Activity).  They noted that for each hour per day increment in light activity there was a 14% lower risk of Coronary Heart Disease and 8% lower risk of cardiovascular disease.

The researchers evaluated 5,861 women with a mean age of 78.5 years. Average follow-up spanned 3.5 years with study members having 570 cardiovascular disease events and 143 coronary heart disease events. The study group was diverse with there being 48.8% Caucasian women, 33.5 % Black women and 17.6% Hispanic women.

The study’s results and message was clear. Keep moving. Even modest exercise is beneficial in reducing heart attack and stroke risk.