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Author: Stephen J. Klemawesch, MD

Bronchodilators evolve better and safer

Bronchodilators evolve better and safer

Dear Dr. K:  I recently heard that the “black-box” warnings on LABAs (long-lasting bronchodilators) has been removed.  Is that true, and are LABAs safe?

These are two great questions.  The answer to both is “yes”.  It’s best, however, that we explain a few things.  The two most common of these bronchodilators are Formoterol and Salmeterol.  They are basically long-acting forms of Albuterol.  When they first became available about 20 years ago they could be used as a single agent to treat asthma.  It soon became apparent this was not a good idea in moderate-to-severe asthmatics because they don’t treat the underlying inflammation that causes the asthma in the first place.

Until this was understood there were some asthmatics who were hospitalized or even died because of severe exacerbation of their asthma.  This led the FDA to do two things:  No. 1. To require the black-box labeling, and No. 2. To issue specific guidelines never to use LABAs by themselves, but only in combination with an inhaled steroid.

Once these guidelines were instituted, a number of academic studies have shown that these medications not only help control moderate and severe asthma, but also reduce hospitalizations and mortality.

It is for this reason that the FDA decided to do what is rarely done, and that is to remove the black-box warning.  Their rationale for doing so is to eliminate patients’ fear of taking a medicine that could truly help (and not harm) them.

An allergy shot for Alzheimer’s? In the pipeline. . .

An allergy shot for Alzheimer’s? In the pipeline. . .

By:  Sasha Klemawesch, RN, MD

Well…sort of.  Alzheimer’s has been and continues to be one of the most frustrating diseases for researchers, patients, and caregivers alike.  But there may be hope on the horizon.

A new immune therapy called Aducanumab – an antibody against B-Amyloid – is undergoing human testing right now.  B-Amyloid leads to plaque creation and deposition in the brain, and those plaques, along with neurofibrillary tangles  caused by the Tau protein, are the two key pathologic findings in the neuro-degeneration seen in Alzheimer’s.

The early data is promising; the drug has shown to significantly decrease plaque burden in the recipients’ brains, and many of those same patients showed delay in cognitive decline based on a simple mental status test.  However, they did not have similar clinical improvements in cognition scores on more complex/comprehensive testing.  It is also not known whether this drug may be able  to prevent high-risk populations from developing the disease in the first place.

Obviously, more testing needs to be done, but this drug has been hailed by many Alzheimer’s researchers as “very exciting”  and overall, the best news we’ve had in 25 years of Alzheimer’s clinical research.

In the meantime, there are a few basic things you can do that have already been proven to help decrease your risk for dementia:

Exercise: Staying active helps in several ways; angiogenesis neurogenesis, and synaptogenesis.  In lay terms, exercise improves blood flow (and therefore oxygen) to and in the brain, helps prevent brain cell loss and improves the connection between brain cells.

Sleep:  The B-Amyloid we just talked about?  The body normally clears it out while you sleep, and studies have shown that even one night of sleep deprivation can lead to an increase in that protein.

Wear a helmet:  sustaining certain types of traumatic brain injuries may increase the risk for developing Alzheimer’s and other forms of dementia.

Eat right:  heart healthy diets like the DASH or Mediterranean diets are good, not only for your heart, but evidence has shown they can protect the brain as well.

Don’t worry, be happy:  multiple studies have shown that older adults who are depressed are more than 50% more likely to develop dementia.

Eczema med Dupixent may also offer major benefits to asthmatics

Eczema med Dupixent may also offer major benefits to asthmatics

In a previous newsletter we discussed the new biologic drug Dupixent (Dupilumab) as a true “Godsend” for severe eczema.  By way of reminder, it is a monoclonal antibody that blocks the interleukin-4 receptor, and thereby prevents the inflammation that causes eczema.  This medicine has proven to be both safe and effective, and the injections can be done at home.

Because interleukin-4 also plays a big role in asthmatic inflammation, researchers at Washington University have studied its benefits in severe steroid-dependent asthmatics.  Their study showed it to be both safe and effective for this disease also.

Dupixent use saw a 70% decrease in need for systemic steroids, and 59% fewer asthmatic attacks.

If other scientists confirm these finding it might allow the FDA to approve Dupixent for asthma therapy.  At present the monoclonal antibodies for severe asthma (Xolair, Fasenra, Cinqair and Nucala) work very well, but must be administered in a doctor’s office.  Dupixent may offer an at-home alternative.

Summer means lots of swimming fun, but remember to stay alert and aware

Summer means lots of swimming fun, but remember to stay alert and aware

Bathing in warm sulfur spring water has been touted for its potential health benefits, but some susceptible individuals – especially allergic people who may tend to have dry skin or eczema – may turn up with a severe skin rash from exposure to this water.

Typically, the rash appears suddenly about 24 hours after the water exposure.  The rash is red with a look of “punched out” ulcers and pits.  It is caused by the acidic nature of the hydrogen sulfide, sulfate and sulfur that are in the water.

Many of the aquifers here in Florida are rich in these natural sulfur compounds.

Care also needs to be taken if area health authorities post warnings of bacteria risks if warm, shallow lake water gets inhaled.

Just be cautious and enjoy those summer splashes!

Q – Tips : Summer is here

Q – Tips : Summer is here

Summer is grass pollen season in Florida and throughout the United States.  This summer’s weather pattern has led to higher than usual pollen levels.  One simple measure to reduce grass pollen is to mow the lawn more frequently.  The pollen comes from tall “overgrown” grass stalks that contain the flowering plant heads.

 

Q Tips: NAC

Q Tips: NAC

If you’re looking for help with breaking up thick mucus in the sinuses or lungs, try N-Acetyl-Cysteine (NAC).  NAC is a stable form of the amino acid L-cysteine and has a wonderful benefit of loosening and lessening thick mucus.  Because it is basically an amino acid (a building block for proteins), it is considered a food supplement and is safe to use.

New drug goes after major cause of asthma — eosinophils

New drug goes after major cause of asthma — eosinophils

Maybe you’ve seen the ads on TV lately for Fasenra, also known as Benralizumab, a new monoclonal antibody to help treat asthma. Fasenra blocks the proliferation of asthma-causing bad guys called eosinophils. The decreasing of these white blood cells helps prevent asthmatic inflammation.

The new Fasenra antibody is “selective for interleukin-5 (IL-5),” counteracting this chemical mediator that causes the proliferation of eosinophils — the major cause of asthma.

It is indicated for severe asthmatics 12 years old or older. Clinical trials have resulted in marked improvement in asthma control and in reduction of asthma exacerbations. It is administered as an injection in the arm, thigh or abdomen, and is given every four weeks for the first three doses; then every eight weeks.

Two other monoclonal drugs that also target IL-5 are Nucala and Cinqair. Nucala is also given by injection but every four weeks. Cinqair is given intravenously every four weeks. No head-to-head trials have been conducted comparing these three medicines. Nucala and Cinqair are given more often than Fasenra, but Fasenra is twice as expensive, so all three cost about the same.

Causes clearer for this eczema than relief

Causes clearer for this eczema than relief

Dyshidrotic eczema is a common condition that is still poorly understood. In fact, there is as much confusion with its name(s) as with its etiology.

The condition is a type of eczema that is characterized by pruritic vesicles (itchy, tiny blisters) that erupt in the fingers, palms and sometimes feet. It affects both children and adults, and can range from a rare, self-limiting problem to a chronic, severe and sometimes debilitating one.

Unfortunately, it also tends to be resistant to many forms of treatment.

The term dyshidrotic refers to the hypothesis that sweat glands dysfunction and cause the tiny blisters. But when a research group did biopsies of the palms of affected patients they did not find a problem with the sweat glands. Yet, it is known that people with hyperhidrosis (super-sweaters) are very prone to the condition. Also, Botox injections which help people with hyperhidrosis in their arm pits also help hand/foot eczema if the Botox is administered there.

Two other names for the condition: pompholyx (which means “bubble”), or pedpompholyx (if the rash appears only on the feet); and also, acute and recurrent vesicular hand and foot dermatitis.

The tiny blisters itch intensely, then pop and cause the skin to peel. Over time the skin can become thickened and fissured. About 50% of persons with this condition also have allergic problems. Also shown is a strong familial tendency for the condition.

Certain metals if ingested can cause the problem; most common are nickel and cobalt. Websites can detail the metal content of various foods and beverages.

Emotional stress is a well-recognized aggravator of the misery, but episodes also can be precipitated by environmental factors such as changes in temperature and humidity.

Although resistant to therapies, most people benefit by intensive efforts to moisturize the hands. A simple therapy that often works is Vaseline petroleum jelly applied to the hands, and then covered with white cotton gloves at night.

A variety of OTC and prescription steroid creams, lotions and ointments are effective to speed healing.

Finally, soaking the hands in cool water for 10-15 minutes stops the itch and can re-hydrate the skin.

Diabetes med Metformin quite a multi-tasker

Diabetes med Metformin quite a multi-tasker

Dear Dr. Sasha K: I read that the Metformin I take for my Type II diabetes has an anti-cancer benefit. Is this true?

In a word: yes. Metformin is an old drug that keeps making itself new. Metformin’s origins go back to medieval Europe where the French lilac plant was used to treat diabetes. The lilac contains biguanide, the main component of Metformin.

This drug works for diabetes by reducing the amount of glucose the liver makes by decreasing the amount of glucose the intestines absorb, and by enhancing patients’ sensitivity to their own insulin.

In addition to its anti-diabetic effects, Metformin is good for the cardiovascular system – lowering blood pressure and lipids, and lessening atherosclerosis. Some research centers are using Metformin in nondiabetics for these cardiovascular benefits.

Another application is in polycystic ovarian syndrome (PCOS). This condition is a problem for many women because it causes infertility, a tendency to diabetes and hirsutism (excess hair growth) and acne. Metformin has helped many young women obtain a desired pregnancy, while also helping them lose weight and reduce unwanted hair growth and acne.

Metformin has been found to play a role in the coagulation system; lessening unwanted clotting and improving the endothelium (the inner lining) of blood vessels so plaque does not accumulate as fast. In the brain Metformin can help the insulin resistance of brain cells in patients with Alzheimer’s. It also decreases oxidative stresses on brain cells and therefore, may have value in ALS, Parkinson’s and some cancers.

Finally, to answer your question, it’s Metformin’s potential as an anti-cancer therapy that has researchers most excited. It seems that this is because of its anti-inflammatory and anti-oxidant roles. For instance, Metformin has been shown to cause cancer cells to self-destruct. Of course, much further research is needed.

Pharma companies give free meds for school adrenalin emergencies

Pharma companies give free meds for school adrenalin emergencies

The two pharmaceutical companies that produce the two available forms of auto-injector adrenalin to deal with anaphylactic (allergic) shock are offering a program of free epinephrine doses to schools. The companies are Mylan, which makes the EpiPen, and Kaléo, maker of Auvi-Q.

Epinephrine, as many know, must be on hand to treat food allergy and insect sting emergencies.

Even with insurance coverage, these drugs have become very expensive. For some families this expense limits the purchase of the adrenalin to a single unit at home, but not one at school. Through this program, the medication can be placed in a child’s school, but access would be allowed to any student in peril.

Each company will provide both doses of epinephrine – the .15mg and the .30mg.  Mylan offers the medicine to all schools — public or private — and to all grade levels. Kaléo offers it to public grade schools. To request the medications be placed at your child’s school, visit EpiPen’s site at info@bioridgepharma.com and you’ll find info on the EpiPen4Schools program. For Auvi-Q: https://www.allergicliving.com.

You’ll need to give the name and address of the school and send a physician’s prescription with the request.