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.

Can Smartphones & Fitbits Interfere with your Pacemaker or Defibrillator?

The February 8^th edition of Medpage Today, an online magazine, published the concerns of cardiologist and electrophysiologist Joshua Greenberg, MD, about the magnet arrays in the new Apple iPhone 12 interfering with the function of pacemakers and defibrillators.

When a patient goes to their doctor, cardiologist, electrophysiologist, etc., and the physician wishes to turn off their pacemaker to look at the heart’s normal electrical activity, they normally place a magnet over the implanted device to deactivate it. The new iPhone 12 apparently uses an array of magnets around a wireless charging coil.

Dr Greenberg used the iPhone 12 to disable a Medtronic ICD. Once he brought the phone over the patients left chest the device deactivated. His findings were published in January in a letter to the editor of the journal Heart Rhythm. “This is a big deal because if the patient were to go into ventricular tachycardia or fibrillation during this time, they would just drop dead without receiving a life-saving shock from the ICD.”

Separately, electrophysiologist M. Eskander, MD tweeted a video showing an iPhone12 shutting off a pacemaker as well as if a magnet had been placed over it. Wristband magnets in Fitbit and Apple iWatches have been reported to deactivate Medtronic ICDs from 0.9” away due to their wristband magnets.

Phil Mar, MD , an electrophysiologist at Saint Louis University School of Medicine agrees that this is a previously unrecognized issue that needs to be dealt with. He suggests patients with implanted pacemakers and ICDs avoid purchasing an iPhone with magnets. He encourages their spouses or bed partners to follow the same advice to prevent deactivation when they roll over and get close. He emphasizes that this was not an issue with earlier model iPhones which didn’t have an array of magnets and was not seen in Apple iWatches without the magnetic wrist bands for charging. He is concerned that any cell phone, wrist band or watch using wireless charging may cause the same deactivation.

The author of the article, Anthony Pearson, MD made the suggestion that patients with pacemakers and ICDs should have their cardiologist or electrophysiologist routinely test their cell phones, Fitbits and iWatches’ effect on their devices at a planned routine visit and certainly immediately after implantation. He reminded us this does not occur in devices that do not have a magnet array which is most cell phones and watches.

There has always been a recommendation that if you have a pacemaker or AICD you use your cellphone in the ear opposite your pacemaker or device pocket and never bring it within six inches of the device.

Blood pressure measurement, its importance in reducing vascular disease & remote patient monitoring

An article published in the prestigious journal Hypertension looked at following blood pressure over a decade and the reduction in heart attacks, strokes and deaths if you were able to keep blood pressure under control. It talked about extending your life by over four years and the preventing vascular disease from developing for at least five years.

The authors looked at multiple blood pressure trials and noted the difficulty in relying on one office visit measurement periodically. They too noticed that certain patients were always higher in the office than at home and noted the problems with home blood pressure monitors including trying to decide if they were accurate and being recorded correctly. The result was that whatever reading they obtained at your visit, when looked at over a 10-year period, influenced your survival and cardiac events.

We too have struggled with this issue in our office. We ask patients to bring in their home blood pressure equipment so we can correlate the readings they get in our office on our equipment and their equipment. Just last night a patient with no symptoms and feeling well took his blood pressure and found it elevated. Rather than contact me or his cardiologist he ran to the Emergency Room. He waited hours, had multiple tests and by that time his blood pressure lowered they referred him to his doctors without intervening at all.

When needed, we have a patient use a 24-hour ambulatory blood pressure monitor. They wear it on their arm like a blood pressure cuff and it inflates six times per hour during daytime and four times per hour during sleep while measuring their pressure. There is a small recording device worn on their belt. After 24 hours, it is returned to our office and we print out the readings and obtain averages to help us determine just what your blood pressure really is. The equipment has a diary so the patient can note when stressful events occur and we can correlate it with the readings. The minor drawbacks to the equipment are its bulkiness, the need to keep it dry and the disturbance to sleep it causes as the cuff inflates and deflates.

To improve measurements, as well as capture other health metrics, we are introducing a remote monitoring smart wristband. We have identified a vendor who will supply you with the high-tech wrist band at no out-of-pocket expense to you. The wristband interacts with your iPhone or android phone.

The device measures and captures pulse, heart rhythm, blood pressure, blood oxygen level, and steps.  It even has built-in fall detection. The 2021 model, which will be introduced in a few months, has an EKG component to help us follow patients who get dizzy, faint or have documented heart issues. It will also capture body temperature. There is an optional blood glucose sensor monitoring device. The wristband is water resistant so you may shower with it.

Due to the Pandemic, and development of tele-health, Medicare pays for the monitoring if you wear the device a minimum of 16 days each month. Patients are asked to identify emergency contacts so that if you fall or if you have an arrhythmia, abnormal blood pressure, abnormal blood sugar, the monitoring call center contacts your emergency contact on record.

Your physician can view all the data on our computers. Certain private insurances pay for these services as well as Medicare. I will start wearing one and my wife will as well.

I will personally discuss this with each of you whom I feel will benefit from wearing the wristband as remote monitoring is proven to reduce hospital admissions and ER visits. If you have a chronic condition, disease or certain risk factors; it’s likely I will encourage you to wear the band.

Some patients have asked if the band has a panic button for you to push if you feel you need to such as after a fall. The technology senses if you fell and have not gotten up or if you are ill and calls your emergency contacts but it does not have a unique panic button to push.

We look forward to introducing this new remote high technology to improve your health, safety and peace of mind.

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.

New Drug Shows Weight Loss Promise – Just in Time for the Holidays

Thomas Walden, PhD of the Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania presented data on weight loss at a Bariatric Medicine meeting held remotely called ObesityWeek. It was reported this week on Medscape Medical News.

Using the diabetic drug semaglutide (Ozempic), they demonstrated that 75% of the 611 participants lost 10 % or more of their baseline body weight. When they used the higher diabetic dosage, 55% of the participants lost more than 15% of their initial body weight and 36% lost greater than 20%.

Diabetic drugs have been used off-label for years for weight loss. Byetta and Trulicity work to reduce weight as well. The real problem with these medications is cost – with a month of Ozempic costing $800 – $900 while the other two (Trulicity and Byetta) are more expensive than that.

We know weight loss helps diabetics and hypertensives improve their control and health but there are a limited number of drugs you can safely give a 55 year-old with these types of medical conditions. I was surprised and perplexed when a local bariatric specialist started my 64 year-old patient on an amphetamine for three weeks with their heart rate accelerating and blood pressure elevating characteristics.

In patients, 55 or older, I believe in nutritional counseling first. We have experienced dietitians locally both at our hospitals and private practice who will teach you how to eat correctly and work you to develop a personal weight loss plan.

The retail diets like Weight Watchers, Jenny Craig and NutriSystem work and are safe. However, not all retail diets provide behavioral coaching which is a crucial component for losing weight safely and maintaining the weight loss (not yo-yo dieting).

I have twice now experienced great success with OPTAVIA.  The program incorporates Healthy Habits which is an innovative and proven lifestyle approach which gets your mind and body working together.  A health coach provides you with personalized guidance for maximum effectiveness.

Their plan uses five of their “fueling meals” plus one “lean and green meal” you prepare per day.  Following their plan, I have lost more than 35 pounds, in just three months.

I have recently signed up to be an OPTAVIA coach for those patients interested in this program and requiring help and encouragement along the way. Losing the weight is always easier than keeping it off for a “foodaholic” like me but with their maintenance program, and hopefully some discipline, I will keep it off this time.

Happy Holidays to all my patients, colleagues and friends. If you would like to shed those extra pounds, and live healthier, just give me a call. We will discuss the program and how you would benefit from it.

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.

Good News on Treatment & Prevention of COVID-19

A study in the New England Journal of Medicine (NEJM) examined the effects of a new vaccine which uses mRNA injections to stimulate an immune antibody response against the coronavirus. The published study looked at two potential dosages while looking at younger patients and those over 65 years old.

Both doses of the injection vaccine produced an antibody response in the younger patients and senior adults. Side effects were minimal – mostly injection site irritation and soreness. Some patients ran low grade fevers and had myalgias. The vaccine is now in a larger Phase 3 trial.

This vaccine and another mRNA product in testing and production both have the drawback of requiring storage at -40 to -80 centigrade which most pharmacies and physician facilities do not routinely provide. It is hoped this vaccine will be available by the end of year 2020. There have been no challenge tests with this vaccine, meaning vaccinated individuals who develop antibodies have not been directly exposed to the coronavirus to see if those levels of immunity are protective.

On the same day of the publication of the NEJM study on the mRNA vaccine, the pharmaceutical company Regeneron released a shareholder report on its Phase1 and 2 IV anti COVID-19 monoclonal antibody. They took antibodies from recovered COVID-19 patients, identified the most important ones and then synthetically created duplicates of two of the more important antibodies in a form that is infused by IV administration. This product blocks the P spike on the coronavirus from working, preventing the coronavirus from attaching to and entering human cells.

They enrolled COVID-19 infected patients with symptoms but not severe enough to require hospitalization. They found that those with a low viral load of the disease developed an immune response with IgG antibodies to COVID-19. Those who had few or no antibodies were overwhelmed by the virus and had high viral loads measured. They found that the Regeneron product worked best in those with a high viral load and few or absent antibodies to COVID-19 virus and more symptoms. These patients cleared the virus quicker with the monoclonal antibody product than non-medicated patients receiving standard care. They had alleviation of symptoms quicker and tolerated the infusion and product well.

In addition to this trial on non-hospitalized patients there is currently an ongoing trial in hospitalized patients in Phase 2 and 3.There is additionally a trial in family members of COVID-19 positive patients to see if the Regeneron monoclonal antibodies can prevent them from acquiring the virus in close household contact.

There is light at the end of the tunnel. We just need to continue to social distance, wear masks in public settings, hand wash frequently and remain patient because these products are very close to release.

Honey Reduces Upper Respiratory Symptoms

The British Medical Journal published a thorough review of the medical literature reviewing the beneficial effects of honey in reducing the intensity and severity of coughs in viral upper respiratory tract infections. The study was performed at Oxford University by Abuelgasm, Albury, Lee and associates. They reviewed fourteen published studies on the subject and then ran that data through their own stringent tests to assure the hypothesis was accurate. We are heading into the fall-winter cold and flu season with cold weather forcing individuals to remain indoors. We can add to this the ongoing Covid-19 respiratory pandemic as a source of coughing. For years now doctors, scientists and public health officials have tried to convince their colleagues and the public that antibiotics do not lessen the course or duration of a viral upper respiratory tract infection. There are dozens of over the counter non- prescription cough preparations sold in pharmacies and groceries. We read regularly about these products causing severe illness, deaths and adverse effects in children and the elderly. Honey solves these issues.

In an online review accompanying the article experts suggest mixing 1.5tablespoons of honey with 6-8 ounces of oolong tea. Let it cool down so it isn’t too hot and it is a great cough suppressant and source of hydration for children one to five years old. The darker the tea the more nutrient rich antioxidants the patient gets from the tea leaves along with caffeine. They suggest later in the day switching to a chamomile tea to avoid all that caffeine. Younger children will benefit from 2-3 servings per day providing hydration plus cough suppression. Adults and older kids can use two tablespoons of honey and consume a larger volume of warm fluids.