NSAIDS and Heart Failure in Type II Diabetics

The European Society of Cardiology is receiving a presentation on the increased risk of heart failure occurring in Type II Diabetics over the age of 65 years with an elevated HgbA1C level. The mechanism of the heart failure is still under discussion and being researched and it is believed to be beyond the accepted increased retention of fluid that occurs when you take an oral NSAID. The risk of developing heart failure was increased by almost 50% in Type II Diabetics 65 years of age or older. It was clearly not seen in patients with a normal HgbA1C younger than 65 years of age.

The study was led by Anders Halt, MD, a cardiologist and epidemiologist, who accessed the Danish National Health Registry to obtain his raw data. In his study it was clear that older age and elevated HgbA1C were present in those patients developing heart failure and requiring treatment and/or hospitalization. In Denmark patients were using Diclofenac Sodium and Ibuprofen primarily with few using celexocab or naproxen products.

As we age, we develop joint inflammation and aches and pains that make us reach for an over-the-counter anti-inflammatory medication frequently. This study raises the question clearly “If you are a Type II diabetic over sixty-five years of age with poorly controlled sugars should you be looking elsewhere than NSAIDs for relief”. Diclofenac sodium is no longer in oral form in the USA, but ibuprofen certainly is. The study clearly outlines the need for exploration of the mechanism of the heart failure. I believe the reason heart failure occurs must be clarified but until that occurs older Type II diabetics should be wary of reaching for an NSAID for relief of aches and pains.

Driving Up the East Coast on Vacation

The Pandemic resulted in me not taking a vacation for three years. A quick trip by plane to NJ in June for a high school graduation was cancelled when COVID infected the graduate’s immediate family. The party was pushed back to August but a paucity of dog sitters to watch my disabled failing pug while we were gone complicated trip plans. I consulted our vet who just suggested we take the pups with us in the car . My three adult daughters thought my wife and I were crazy for planning this vacation but here seven days later on a wooden deck on a mountain top in Upstate NY enjoying the shade, low humidity and cool breezes.

It’s great to leave Florida by car. No flight cancellations. No lost luggage. My wife and I split the driving and stop every few hours to walk the dogs and use a clean rest room ourselves. We listen to my wife’s radio choices while she drives and vice versa.

I belly laughed up the coast because she loves comedy greats on Spotify. I laughed to comic routines by Jack Carter, Jan Murray, Hennie Youngman, Robert Klein , Robin Williams, Redd Fox and other greats I had not heard in decades. We stay in dog friendly highly recommended chain hotels which are clean, serve a breakfast and have helpful friendly staff.

At stops in Beaufort , South Carolina, Richmond , Virginia and Rockville, Maryland there is no such thing as a corona virus pandemic. We were the only ones wearing masks, eating outdoors exclusively and avoiding crowds indoors. Until we arrived here high in the Catskill Mountains the weather was Florida-like, hot and humid.

On the road I stopped to see my niece, her husband and infant little girl . My niece is a pediatric hematologist, he’s an anesthesiologist and Aria is just a beautiful captivating 18-month-old. I learned how these young docs feel about medicine and how they try and balance both professional and personal responsibilities while my niece learns that being a mom really is the toughest job in the world. I was able to see their new home and the life they are building . It was a rewarding uplifting experience to see those you love happy, healthy and living their dream.

I also got to break bread with my business associate and friend who for fifteen years has directed practice advertising, website improvement, newsletters and blogs. We usually see each other a few times each year but communications have been by phone and Facetime since the pandemic began. Getting together face to face just reaffirmed why I like and respect this gentleman.

We are currently in a farmhouse in Upstate NY, which my daughter and son in law are renovating. It’s breezy, cool, serene and plush outdoors. We are planning our return trip south with overnight stops every five hours.

See you all soon.

Flu Vaccination May Guard Against Alzheimer’s Dementia

While it is early summer here in North America, most primary care practices have already ordered their influenza vaccine for the fall of 2022. Our practice will be using the “senior” high dose quadrivalent vaccine for patients 65 years of age and older as recommended by the ACIP (American College of Immunization Practices), a division of the CDC.

While experts debate when to administer the vaccine, we prefer to do it between Halloween and Thanksgiving based on when influenza arrives in South Florida and the limited length of protection seniors get from the vaccine. Flu shots can protect against serious infection and hospitalization in most cases.

Avram Bukhbinder, MD, of the University of Texas Medical Center in Houston believes the vaccine also protects seniors against Alzheimer’s disease. His work was published in the Journal of Alzheimer’s Disease recently.

His group looked at almost one million influenza vaccinated adults and compared them over time with a similar sized unvaccinated group of senior citizens 65 years of age or older. The median age was 73.7 years and 57% were women. All were free of dementia over the six year “look back period”.

They followed these groups for 46 months and found the risk of developing Alzheimer’s Disease was 40% lower in the vaccinated group. The paper did not determine why the flu vaccine lowered the risk of developing Alzheimer’s dementia. Dr. Bukhbinder hypothesized that the vaccine may have prevented severe inflammation seen with infection reducing the development of amyloid plaques and neurofibrillary tangles. An official with the Alzheimer’s Association was quick to point out that possibly those who took flu shots were more health conscious leading to less development of Alzheimer’s Disease.

Further research is warranted but this study provides an additional incentive to obtain your flu shot this fall.

COVID-19 Burnout

I was supposed to be visiting the NY Metropolitan area this week to celebrate a family high school graduation. Children and family were traveling from all over the country for this celebration when the parents of the graduate contracted COVID-19. The graduate stayed healthy and attended the ceremony and all post ceremony celebrations. Our family gathering was postponed, and my wife and I stayed home cancelling our flights and hotel reservations. The infected group were all vaccinated months ago and young, healthy and placed on Paxlovid . They are recovering. The fact that all will recover is what is important in a scene played out in homes across the globe all dealing with COVID and family gatherings.

At the same time this was occurring the FDA approved a Pfizer three-shot vaccine and Moderna two-shot vaccine protocol for COVID for children six months to five years old. It provided great joy in my south Miami daughter’s household since her four-year-old son has been attending pre-school and summer camp with no real protection other than a mask. My grandson has been the only child in his class and group wearing a mask indoors and the school psychologist asked my daughter if he could remove it because it was a barrier to playing with the other children.

The vaccine for young kids is not a foolproof shield but at least provided protection against serious illness. The FDA approval was a great comfort to parents hoping to have their kids vaccinated prior to the start of the next school semester in August. Then, the Governor and Florida Surgeon General announced Florida was not ordering the vaccine because they believed healthy kids did not need it despite all the infectious disease, public health and virology experts reviewing the data and approving the vaccine. Morale fell to a new low.

The very next day the Governor announced that doctors and pharmacies could order the vaccine through the Florida Shots website and had that option all along. That is not the way we ordered the vaccine earlier in the pandemic. We ordered it though the Florida Department of Health.

Supporters of the Governor blamed this ordering confusion on “big government bureaucracy”. If that is the case, then why not just announce from the beginning that pharmacies, doctors and health systems can order the vaccine through the Florida Shots website?

In the political gamesmanship of placing barriers in the way of our youngest and most vulnerable children being vaccinated, did the Governor forget that most physician offices do not have freezers capable of storing the vaccine at -90 degrees Centigrade? Also ignored was the plight of those who have relied on their county or city health department to provide the vaccines for their children for years and now those public health facilities will not have the vaccines.

My office was bombarded this week with calls from patient’s testing positive for COVID-19, all with mild symptoms of fatigue and upper respiratory viral symptoms. The current treatment options are to supply supportive care such as fluids, cough medicine, Tylenol and rest or prescribe the Pfizer pill Paxlovid. The Paxlovid must be started within five days of onset of symptoms.

So many patients walk around with cold symptoms for several days before home testing that it’s difficult to start the medicine within the five day window advised by the manufacturer. Paxlovid interacts with so many popular and common prescription medications for seniors which must be discontinued and washed out of your system prior to starting Paxlovid that they can’t start the medication on time.

The best option, in my opinion, remains receiving an infusion of the monoclonal antibody Bebtolivimab within seven days of onset of symptoms. Boca Raton Regional Hospital has a program that gets you in within a few days but several patients have been so anxious and worried that they would not wait for an appointment. Several called private services to come to their homes and treat them with monoclonal antibodies. These companies have popped up out of nowhere and their reputation and reliability are relatively unknown. Are they really administering Bebtolivimab? At least at the hospital I know the product is the real thing and the monitoring staff is well trained and experienced.

Also, several patients have insisted on Paxlovid and stopped their blood pressure, cholesterol and antidepressant medicines. Two of them took the Paxlovid and improved, then rebounded with a positive test and return of all symptoms several days later. They all recovered in a few days, but the potential rebound is another reason I prefer offering the monoclonal antibody infusion.

I have not mentioned the Merck oral medication Lagevrio ( molnupravir) because it used new technology involving disrupting the genetics of the virus. I would like to see the adverse effects of this drug and its efficacy and safety profile after being on the market for twelve or more months prior to considering it.

COVID remains a “bummer”. We are in a much better place to prevent serious illness than we were three years ago but human behavior, the demonizing of science for political gain and the resilience of this virus continue to wreak havoc on my life and those around me.

Antioxidants & Dementia Risk – A New Study in Neurology

May A. Beydoun, PhD, MPH of the National Institute on Aging of the NIH in Bethesda, Maryland and associates published a study on blood antioxidant levels, food consumed and the risk of developing dementia as you aged. The study hoped to determine which foods were best to eat to limit your chances of developing cognitive impairment in later years. The researchers discovered that those individuals with the highest serum levels of lutein+ zeaxanthin and beta-cryptoxanthin at baseline were less likely to develop dementia decades later than their peers with lower levels of these protective antioxidants.

Lutein and zeaxanthin are found in green leafy vegetables such as kale, spinach, broccoli, and peas. Beta -cryptoxanthin is found in fruits such as oranges, papaya, tangerines, and persimmons. “Antioxidants may help protect the brain form oxidative stress, which can cause cell damage,” said lead author Dr. Beydoun.

The study, published in the journal Neurology analyzed 7,283 participants in the 3rd National Health and Nutrition Examination Survey who were at least 45 years old at the start of the study and were then followed for 16-17 years. The data showed the higher the serum levels of beta-cryptoxanthin at baseline the lower the risk of developing dementia. No such protection was found for lycopene, alpha-carotene, beta carotene or Vitamins A, C, or E.

This was an observational study looking at data already collected. In critiquing the study, Dr B. Hooshmand, MD, PhD and Milia Kiviipelto, MD, PhD of the Karolinska Institute, Stockholm, Sweden commented on the research noting that this was an observational study and previous studies supplementing individuals with antioxidants were disappointing and did not prevent development of cognitive dysfunction. They believe there is a more complex relationship between the foods we eat, antioxidants, socioeconomic status and lifestyle which all contribute to the development of dementia.

While there is work to be done in this field, this study certainly supported my love for a fresh orange or tangerine to start off the day. The accompanying editorial made it clear that consuming my antioxidants and vitamins in fresh fruit and produce seems to be healthier than depending on store purchased supplements.

FDA Approved LabCorp Test for COVID-19, Influenza & RSV

The FDA has approved an at-home testing kit that can differentiate between symptoms of an upper respiratory virus being caused by COVID-19, Influenza A/B or Respiratory Synctial Virus (RSV) . It is called the Pixel by LabCorp COVID-19+Flus+ RSV Test Home Collection Kit. You obtain a nasal swab and send it directly to LabCorp for testing. The results will be sent by an app that can be downloaded to a smartphone or tablet.

Since children returned to school after a prolonged isolation due to the COVID -19 pandemic, we are seeing a large number of viral upper respiratory tract infections in this group, their parents, and caregivers. “Is it COVID-19?” is always the first concern, “but if its not COVID what is it”?  This testing will  allow patients to swab themselves and obtain a diagnosis without having to first go to the doctor for a visit.

I suspect your doctor will still wish to see you or your child prior to prescribing anti-viral therapy once the diagnosis is reported,  but this is the first at-home testing approved for all three virus types. The test can be purchased online at the LabCorp website or at pharmacies.  The retail price has not yet been disclosed.

FDA Approves New Diagnostic Test for Early Alzheimer’s Disease

The Lumipulse G Beta Amyloid Ratio test, made by Fujirebio Diagnostics, detects amyloid plaques found in Alzheimer’s disease in adults 55 and older under investigation for cognitive disorders. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said, ”The availability of an invitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis. With the Lumipuls test, there is a new option that can typically be completed the same day and can give doctors the same information regarding amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.”

Currently the PET scan is used to visualize amyloid plaques to diagnose Alzheimer’s disease. The FDA says this test may eliminate the need for a PET scan, “…. a potentially costly and cumbersome option.”

As a physician, I appreciate the innovation and technical expertise required to develop a test that compares the ratio of Beta amyloid 1-42 and Beta amyloid 1-40. To do this, you first must perform a lumbar puncture or spinal tap to access cerebrospinal fluid which is the specimen used in the test.  This requires injecting an anesthetic into one’s back and spine and then inserting a needle to enter the spinal canal and drain the fluid. The needle is then removed, and the patient is required to stay immobile on their back for several hours to prevent a post spinal tap headache. Putting a needle into someone’s spine raises the risk of bleeding, post procedure leak and infection being introduced. Then, add in the cost of the procedure room and the post procedure observation costs and, suddenly, the non-invasive expensive PET scan seems reasonable.

I look forward to the day when a simple blood test based on drawing blood from your arm will be able to provide the information required to support a diagnosis of Alzheimer’s disease. I applaud the scientists and researchers who developed this product but the enthusiasm of the FDA in their statement is probably not shared by anyone who has had to undergo a spinal tap.

Vaccine for Prevention of Alzheimer’s Disease in Development

Vaxxinity has been testing an immunotherapeutic vaccine candidate that targets aggregated amyloid beta in the brain considered to be toxic and contribute to the progression of Alzheimer’s Disease. The topic was discussed in the online journal MPR early in May. The vaccine , known as UB-311 has been in human clinical trials for three years now. Volunteers have received repeated doses of the vaccine with adverse effects no worse than in the placebo group in the trial. The manufacturer in the main study ClinicalTrials.gov Identifier: NCT025518009 showed that a “ robust and durable anti-amyloid beta antibody response was elicited in their patients while no amyloid related imaging abnormalities or edema were reported in the mild to moderate Alzheimer’s patients observed. In view of the early success shown the FDA has granted this drug Fast Track designation to speed its development and production .

The development of a medication that slows down and or prevents the development of this fatal progressive neurological disorder would be a major step forward in the battle against this relentless illness.

A Dose of Reality. Rejoining the World

My wife and I flew to Chicago this past weekend to attend a wedding of a dear niece. The pandemic resulted in three previous postponements of this wedding. It was postponed for so long that there is now a family addition of a lovely eight month-old daughter.

The trip involved leaving the state of Florida for the first time in three years due to COVID and flying commercially to a busy airport and then taking a taxi to a busy downtown hotel. If that wasn’t scary enough for a couple living in isolation for two years, the wedding included 175 guests meeting inside for a Friday night reception and then a Saturday service and reception. All rules, recommendations, and suggestions for preventing the transmission of, or acquiring, COVID were basically ignored by the parents (all four professionals with post doctorate degrees), the maid of honor (graduate of an Ivy League public health program and director of an internationally recognized COVID response program) and the bride and groom (both practicing physicians).

My wife and I planned to wear our masks on our flights to and from Chicago which was easily accomplished. We planned to eat outdoors only which could not happen due to two days of pelting rains, gale force winds and temperatures in the low forties. Downtown Chicago was young, maskless and completely oblivious to the fact that a COVID pandemic was ongoing. All these young adults were talking about is how they were still working remotely due to COVID, but they were populating bars, clubs, restaurants, theaters, sports venues maskless with not a care in the world about this contagious and fickle disease. To say it was different and a bit overwhelming would be an understatement.

The Friday night reception for attendees in an overcrowded undersized private room of a large Chicago blues club resulted in us saying hello, having a drink and quickly leaving. The wedding was less crowded and cramped but there was no pre-function COVID testing. Several of the guests on the bride’s side had refused vaccination. I saw one masked guest at the wedding, a young female pregnant physician. Every precaution we had taken for the last three years was ignored – throwing caution to the wind.

All my adult daughters and their guys flew in for the festivities and it was just wonderful to be with family. The parental hosts for the wedding were warm and loving and they knew how to throw a great party. I was concerned about the consequences of being with large groups of people inside despite being vaccinated against COVID and receiving two booster shots. We flew home Sunday night getting into our residence around midnight.

I tested for COVID daily for several days. No one in my immediate family contracted COVID. We know of only one guest who turned positive the day after the wedding, and she was one of the non-vaccinated attendees. The weekend of the wedding the COVID positivity percentage in Chicago was less than 2%.

I have no idea if we were just lucky or if the vaccines and boosters work well. With the positivity rate in Broward County now 21.7%, I suspect we will soon find out

Pfizer Pill “Paxlovid” & Post-Treatment Relapses

The introduction of the Pfizer antiviral pill Paxlovid to treat COVID-19 infected patients, within five days of contracting the disease, was supposed to be a “gamechanger.”  Reviewers compared it to Tamiflu, the antiviral pill used against influenza and taken twice a day for five days.

The rollout and distribution of Paxlovid have been a problem from day one. Pharmacies objected to their reimbursement for distributing the product and doing the labor-intensive paperwork required because it is an Emergency Utilization Authorization (EUA) product – not yet FDA approved. In addition, it interacted with so many commonly taken medications that use the CYP3A4 pathway, including common antihypertensive and antidepressant drugs. The result is that very few pharmacies agreed to stock it and distribute it. The Federal government established an online locator of pharmacies that distribute it but often the pharmacies listed do not have it in stock when you call them to prescribe it.

This week a new wrinkle and complication appears to have been discovered. Patients treated with Paxlovid within the first five days, and completing the twice a day course, are now relapsing on days 9 and 10 post-infection. Quick at home antigen tests are turning positive in some. Viral loads are being detected and mild symptoms are returning. These relapsed patients still may be able to spread the infection.  

Pfizer representatives are suggesting we treat these patients with a second five-day regimen. The FDA has not yet advised treating for a second round. At this time the issue of post Paxlovid relapses needs to be studied. Those projects are now under way.

For this reason, until more is known about Paxlovid treated COVID relapse, our first line treatment for high risk COVID infected patients will be referral to the Baptist Health Boca Raton Regional Hospital Monoclonal Antibody program. Their use of bebtelovimab within seven days of infection continues to prevent the disease from progressing to the serious form.

My patients with any questions about this, should call the office at 561.368.0191.