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Tuesday, August 26, 2008

Musty Mold, Pesky Pests, or Stinky Stenches in Your Home?

Jeff May’s Healthy Home Tips, a new paperback book, provides many hundreds of tips on how to detect the source of these indoor air quality problems and then eliminate them. His wife, Connie, a former English teacher, provides practical comments and true short stories throughout the book, adding some humor and making her Harvard graduate husband’s science more palatable. Jeff is probably the most experienced indoor air quality expert in the United States, and certainly the most widely published. This is Jeff’s fourth book on the topic, but my favorite remains My House Is Killing Me, published in 2001, when I began working on indoor air quality projects for the National Institute for Occupational Safety and Health (NIOSH).

If you have an allergic nose or allergic asthma (or both), you will find dozens of practical ideas for sleuthing inside and outside your sick home, apartment, or office. Most people who’ve become sensitized to aero-allergens are allergic to both outdoor allergens (such as pollens) and indoor allergens, such as molds, house dust mites, cockroaches, and perhaps cats or dogs. Molds, mites, and roaches proliferate in moist buildings, so Healthy Home Tips concentrates on finding and fixing the sources of moisture in your indoor environments. An expensive book from the National Academy of Sciences in 2004 exhaustively reviewed the evidence that “damp indoor spaces” often worsens nasal allergies, sinusitis, and asthma, so Jeff and Connie don’t spend much time discussing the “cause and effect” relationships – they assume that you bought the book because you are suffering from the effects.

Much of the book is devoted to handy guys who enjoy weekly trips to the Home Depot or Lowe’s, and many of the solutions and repairs (aka remediations) are expensive, such as adding a layer of concrete to a basement or crawl space floor which is currently covered in dirt. Some are inexpensive, such as buying a better quality of air filter; many are free, such as always running the exhaust fan in the bathroom when you take a shower; and a few save you money, like “don’t buy electrostatic or electronic room air cleaners” and don’t pay to have your air ducts “sanitized.”

The diagrams provided by Mr. Fix-It (Tom Fezia) were superb, and I would like dozens more. All of the case-studies were fascinating, such as the stinking dead squirrel in the hot water heater vent pipe of a gourmet cook. However, I found the workbook style formatting difficult to read. There are “Do” and “Don’t” checklists on most pages, and redundancy within and between chapters. Candid reviews of the resources, supplies, equipment, other books, and websites would have been a great addition. Perhaps Jeff can add these to his website.

In summary, if your nose gets congested, you develop a sinus headache, or your asthma often gets worse after an hour or two at home or at work, buy one of Jeff’s books to find the cause and a way fix it (and he didn’t pay me to say this).

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Posted by: Paul Enright MD at 11:15 am

Wednesday, July 2, 2008

Smoke Gets In My Eyes…and Lungs!

If you have asthma or COPD, which is worse:

  • smoke from 4th of July fireworks
  • smog from automotive exhaust
  • smoke from a nearby wildfire
  • ash from a volcano
  • living with a smoker

When a person with asthma or COPD inhales smoke and fumes from any of these products of combustion, their airways will become more inflamed for at least 24 yours after the exposure is over. Bronchospasm, or airway narrowing, will begin with the first breath of smoke, and will last for at least an hour. Airway inflammation, with mucus production and airway swelling will begin within a few hours, and will last for up to two days without treatment.

Starion, who frequents the WebMD asthma message board, and her family all have asthma. If they stay in Honolulu during New Year’s Eve celebrations, they all experience asthma exacerbations due to the heavy smoke from Chinese fireworks in the city, so they stay in a motel in rural Oahu or Kauai. It’s common for emergency department physicians to treat a larger number of patients with asthma or COPD on the 4th or July or New Year’s Day due to inhalation of smoke from fireworks. If you must go to see the fireworks, make sure that you have taken your asthma controller inhalers, stay upwind from the fireworks displays, and keep your albuterol rescue inhaler handy.

Wildland fires usually rage during the summertime throughout the United States. Some occur near the urban-forest interface, so the smoke and fumes from the fires are often blown over highly populated areas. Those with asthma or COPD (or both) have “twitchy” airways which are more sensitive than others to the effect of smoke inhalation. The Department of Environmental Quality (DEQ) in most states operates air quality monitors. When the concentration of respirable particles in the air (PM-10, PM2.5, or simply smoke) exceeds thresholds, they issue health alerts to the media. If your nose isn’t congested, go outside and you can often smell the smoke, and see it in the air.

While most of us who fly frequently have become accustomed to a Code Orange terrorist “alert,” if you (or a child or grandparent for whom you are the caretaker) has asthma or COPD, Code Orange or Code Red air quality notices are alerts from the government that you should take seriously. Use the media to determine the source of the smoke. The National Weather Service can track the direction of the smoke plume, so find out if it’s headed in your direction.

If your asthma is poorly controlled that day, strongly consider a mini-vacation to stay with friends or relatives, or even a motel, in a location away from the smoke. If you must stay in the smoky area, start taking those inhalers faithfully again. Refill those prescriptions if you’ve run out again. Find the written asthma action plan that your doctor gave to you. Consider asking that she call a prescription for five days of prednisone (for example, twenty 20mg pills) in case your asthma control falls from the green zone into the yellow, orange, or red zones.

If you must stay in a smoky area outdoors, consider wearing an N-95 respirator (NIOSH-approved dust mask). When worn appropriately, these will remove 95% of the smoke particles from the air that you are inhaling. If you are staying indoors (or in a newer model vehicle), run the air conditioner on recirculate (which does not introduce outside air). Many new cars and SUVs have a HEPA air cleaner “for the cabin” (like those used in modern aircraft). The standard air filters for home air conditioners are designed to merely keep dust and hair from clogging the motor and coils, but you can retrofit them with better filters which will remove some smoke particles. Better yet, buy a large and quiet HEPA room air cleaner and run it continuously in the room in which you are working or sleeping. These filters remove almost all of the smoke in a room every six minutes. If air is blowing from them, they are working.

To finish answering my original question, studies following the Mt. Saint Helens volcano eruption found that inhaling the cool grey ash was relatively harmless. Dozens of studies of urban smog caused by vehicles in the United States show only a modest effect on children with asthma. Of course, smog levels in many developing countries are much worse than those now experienced in the U.S. At the other end of the spectrum, living with a smoker is without a doubt, the worst – probably because the second-hand exposure is constant for many hours day and night, for many years. It’s nearly impossible to escape if you are an infant or child. Whenever I see a baby in a car seat with a smoker at the wheel, I feel like calling Child Protection Services, because it ought to be a crime.

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Posted by: Paul Enright MD at 10:11 pm

Thursday, April 24, 2008

The Best Antihistamines for Sneezing and Nasal Congestion

Photo Credit: Jon Lebkowsky

About 1 in every 5 people suffer from hay fever, also known as allergic rhinosinusitis by doctors, and I am one of them. Some people suffer all the time (perennial, persistent, constant), usually due to allergies to indoor allergens such as dust mites, molds, animal dander, or cockroaches. Others have allergic symptoms only during certain seasons, because they have become sensitized to grass, tree, or weed pollens. I’ve had hay fever since preschool days — a rather typical case.

When we lived in Minnesota, I only had symptoms during the summer, especially when I cut grass or raked leaves, but after moving to southern Arizona, I now have perennial allergic rhinitis (PAR), since weeds release pollen into the air almost any time of the year. After I get a cold or after I am exposed to a high dose of allergens (such as using a line-trimmer to cut weeds), my allergic rhinitis often worsens to include sinusitis.

As a child, my mom gave me Benadryl or Chlor-Trimeton pills. They worked for a few hours to suppress my sneezing, stuffy nose, and itchy eyes, but made me drowsy — probably a good side-effect from the viewpoint of my mother, considering my hyperactivity. In fact, these first generation antihistamines are also sold OTC (over-the-counter) as sleeping pills. I also got allergy shots and injections of my own urine (from a quack allergist), which “cured me” from complaining anymore about my allergies. I did avoid exposure to grass and weeds (also called secondary prevention) by not playing field sports (baseball, football, soccer) and by refusing to cut the grass.

I can’t tell you “what 9 out of 10 doctors recommend for hay fever,” but I can tell you what I’ve done, and tell you what’s been published from research studies (controlled clinical trials) of antihistamines. For many years, I got prescriptions for a second-generation, once-a-day, non-sedating antihistamine. They cost about 3 dollars per pill and even with insurance, the co-pay was over $100 per year, so I took them only when I had symptoms. Many others must have done the same, since the U.S. market for prescription antihistamines was then over 4 billion dollars per year.

Everything changed around Christmas, 2002 when the patent for Claritin expired and Wellpoint successfully petitioned the FDA to switch non-sedating antihistamines to OTC. Since then, I’ve taken generic loratidine every morning; and it only costs $20 a year (for a small bottle of 300 little white pills). Despite the doom and gloom prophecies of allergists and big pharma in 2001, it became a win-win situation. The quality of my life and others improved because we rarely have allergy symptoms anymore, and the profits of the manufacturers of loratidine improved (with 30% market share and 1.4 billion dollars in annual sales).

Allergy sufferers got another Christmas present in 2007 when the patent on Zyrtec, another non-sedating antihistamine, expired. Zertec is now available OTC for about a dollar a pill for the brand name product, while the generic cetirizine costs only $15 to $45 for a bottle of 90 tablets — enough to get through 3 months of the allergy season for those with seasonal allergic rhinitis. It’s also available as a chewable tablet or liquid for children (at a lower dose) and combined with a Decongestant in a capsule.

As an allergy sufferer in the United States, your choices have now been expanded: You can buy generic Claritin OTC, generic Zyrtec OTC, or ask your doctor for a prescription for Clarinex or Xyzal. To determine which is best antihistamine, I read the most recent studies, which are summarized in an excellent review by Doctors Lehman and Blaiss from the University of Tennessee (in the journal Drugs 2006), and a similar review, written for physician assistants, which you can download without cost.

In summary, second-generation antihistamines are the first-line therapy for both seasonal and perennial allergic rhinitis (SAR and PAR). They are very effective, very safe, and last for more than 24 hours. They are much less likely to cause sedation (drowsiness or fatigue) when compared to the old first generation antihistamines. For any of these drugs, the higher the dose, the more likely sedation will be noticed. At the recommended doses for adults, Zyrtec and its twin brother Xyzal are more likely to cause sedation (5-10%) when compared to the others (1-2%).

A small advantage for Zyrtec and Xyzal is that their onset of action may be shorter (about an hour) when compared to the others (1-3 hours). However, a somewhat slower onset of action is not a problem when these drugs are taken every morning (when you brush your teeth) to PREVENT the release of histamine in your nose and eyes later in the day. Antihistamines are much less effective if you wait to take them until you have symptoms.

Allegra (fexofenadine, still by prescription only) is slightly more effective in relieving itchy, watery, red eyes, and less likely to cause sedation at higher (off-label) doses, when compared to Claritin and Clarinex. Blood levels of Allegra are increased by about 40% if you take it with grapefruit juice, erythromycin (an antibiotic), or ketoconazole (an antifungal), but these drug-drug interactions are unlikely to significantly increase the risk of sedation from Allegra.

Bottom line, I will continue to take generic Claritin every morning, because it’s effective, doesn’t cause sedation at the recommended dose, and cheap. I may try generic Zyrtec when the cost drops towards that of generic Claritin. I will still keep a bottle of generic Benedryl for insect stings and severe allergic reactions, realizing that after taking it I will feel like a space cadet or sleepy. Despite heavy advertising, I personally see no reason to ask my doctor for a prescription for Clarinex, Allergra, or Xyzal, but I am sure that a few patients will feel that these expensive antihistamines are more effective.

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Posted by: Paul Enright MD at 6:59 pm

Monday, February 4, 2008

Are Chantix Side Effects Worth the Risk?

The risks of continuing to smoke far outweigh the risks of trying to quit. Consider these facts:

  • One billion people will die from smoking in this century.
  • Half of persistent cigarette smokers are killed by their habit.
  • Smoking cessation at age 50 cuts this risk in half.
  • Smoking cessation before age 30 avoids almost all of the risk.
  • The success of smoking cessation improves by using nicotine gum; improves more by using Xyban; and improves even more by using Chantix.
  • About half of those who take Chantix remain non-smokers one year later.

Before Chantix (varenicline) was released by the FDA in the United States (in June 2006), it was clear that it caused minor side effects such as nausea, mood alterations, drowsiness, vivid dreams, or an allergic rash in up to one-third of patients. Many patients have reported these symptoms on Internet message boards. Now, after about 4 million smokers have taken Chantix, about 40 suicides have been reported to the FDA associated with Chantix and about 400 cases of suicidal thinking or behavior. In industry talk, these are called SAEs (serious adverse events), but individuals who experience an SAE (or their loved ones) appropriately use much stronger words.

All drugs have side effects, so doctors and patients considering starting a drug must always weigh the potential benefits against the risk of side-effects. (You can do the math using the above statistics.) Once you notice a side effect (or one is found by your doctor using laboratory tests), the severity of your side effects must be weighed against the benefit obtained by continuing the drug. Sometimes you and your doctor compromise by lowering the dose of the drug or switching to a different drug.

If you are an adult and feel blue (depressed), switching from Chantix to Zyban may be a good idea since Zyban is a low dose of an antidepressant (bupropion). If you get an itchy rash while taking Chantix, stop taking it until you can discuss this with your local pharmacist (free) or physician (good luck). Allergic reactions to drugs can become life-threatening if you ignore them and keep taking the drug.

This week, an FDA spokesperson said that “health care professionals should closely monitor patients for behavior and mood changes if they are are taking this drug.” However, in my opinion, it is much more reasonable to advise the patient and their family and friends about this risk. The press and legal community have already done an excellent job of warning people (judging from their websites). It is encouraging that the FDA has responded much more rapidly in releasing the preliminary results of “post-marketing surveillance” for newly released drugs (such as Chantix) since the Vioxx/Celebrex fiasco.

However, their surveillance system is passive, waiting for doctors and patients to report drug side effects. This means that the SAE rates are probably seriously underreported. Perhaps only 1% of SAEs which occur are reported to the FDA after a drug is approved for sale.

Many experts believe that to better protect the public, surveillance should be proactive, with costs and responsibilities to be shared by the FDA and the company which profits from sales of the drug. In my opinion, in the case of Chantix, pro-active surveillance could easily have been paid for by spending a small fraction of the 25% profit from the $681 million in 2007 sales of Chantix.

Smoking cessation is a process for most smokers, who are addicted to nicotine. Before turning to drug therapy, I suggest trying to quit with the help of a support group. Call the smoking cessation helpline in your state or country, such as 1-800-QUITNOW in the United States.

Now for some interesting disclosures. Most of the smoking statistics I listed at the top are from a research paper which you can download for free and read. The renowned first author of this paper, Sir Richard Doll, died at age 92, one year after it was published in the British Medical Journal. After his death, it was disclosed that he had received, but not reported, large consulting fees from chemical companies during his career.

Over the past 3 years, I have been paid a total of about $20,000 by Pfizer for reviewing the quality of spirometry tests done for a study of the effectiveness of Chantix in patients with COPD. My consulting for them on this project continues. Last year, Pfizer also paid me about $4,000 for helping them to produce educational videos to describe how spirometry should be used to evaluate diabetic patients for whom Exubera was being considered. To learn more about the fate of Exubera, click here.

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Posted by: Paul Enright MD at 5:36 pm

Thursday, January 17, 2008

A New Study of Inhalers to Prevent COPD: Flies in the Ointment

The treatment of chronic obstructive pulmonary disease (COPD, formerly known as emphysema or chronic bronchitis with airway obstruction) is a rapidly expanding 5 billion dollar per year market for inhaler manufacturers. Large COPD public awareness (promotional) campaigns were started in 2007 by the U.S. National Heart, Lung, and Blood Institute (NHLBI), and the manufacturers of the two inhalers which have been approved by the FDA for COPD: Spiriva (tiotropium) and high dose Advair (a combination of 500 mcg fluticasone and 50mcg salmeterol).

The results of INSPIRE, the second of three very large, international COPD treatment studies were published in the January 2008 issue of the most prestigious pulmonary journal (AJRCCM, aka “the blue journal”). INSPIRE directly compared the effectiveness and safety of these two inhalers in over 1300 patients with severe treated COPD for two years.

Twice as many patients randomly selected to take Spiriva died during the two years of the study when compared to those randomly selected to take Advair. In the patients who also had some type of heart disease or hypertension when they started the study (about half of them), there were 24 deaths in those taking Spiriva, but only 9 deaths in those taking Advair. The higher death rate in those taking Spiriva was apparent just three months into the study. Unfortunately, sudden death from heart disease in individual patients with COPD is rarely even considered as possibly due to a side-effect of their inhalers, because smoking is the most common cause of death from heart disease.

Over 8 million patients with COPD have been prescribed Spiriva since it became available five years ago. Spiriva temporarily relieves shortness of breath in about half of patients with severe COPD, and may slightly reduce the risk of a subsequent exacerbation in those who have previously required hospitalization for a COPD exacerbation. Some adults with asthma are prescribed Spiriva, but the evidence that it helps them is so scanty that the FDA has not approved it for asthma.

More than 15 years ago, I was an investigator of the NHLBI-sponsored Lung Health Study in which 5000 smokers with mild to moderate COPD were randomized to take Atrovent (ipratropium) or a placebo for five years. We reported that study participants taking Atrovent were twice as likely to die, and more likely to be hospitalized with a serious cardiac arrhythmia (heart rhythm disturbance) than those taking the placebo inhaler. Since then, other investigators have also reported that patients with COPD taking Spiriva were more likely to experience a cardiac arrhythmia. Spiriva and Atrovent are both anticholinergic bronchodilator inhalers, but Spiriva is ultra long-acting.

More than one-third of the patients who were enrolled into the INSPIRE study were current cigarette smokers — the cause of their severe lung disease. The study sponsors apparently did nothing to help them to stop smoking, although smoking cessation is the only treatment proven to halt the rapid progression of COPD. On the other hand, the study investigators did not include a placebo comparison group because “it was deemed unethical to withhold known effective therapies.”

I worry that prescribing expensive inhalers for patients with COPD who continue to smoke makes them think that they are “getting the cure” and don’t need to quit. All smokers should be helped with the process of smoking cessation.

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Posted by: Paul Enright MD at 12:50 pm

Tuesday, November 13, 2007

Asthma Inhaler Price Relief

The Only Cheap ($4/month) Asthma Quick Relievers Left in the United States

I just got back from an asthma conference in Phoenix, with 20 experts from around the United States. Dr. Stuart Stoloff, an active member of the committee which wrote the new EPR-3 asthma clinical practice guidelines, decried the lack of a generic asthma controller medication in the United States.

Sadly, as I’ve mentioned here before, the FDA and the inhaler manufacturers have worked together during the past couple of years to ensure that new patents for all asthma inhalers which contain an inhaled corticosteroid (ICS) will not expire for another 15 years. The prices of $100 to $300 per month for an ICS will be maintained since no generics will be introduced.

Another speaker, well connected with the FDA and major inhaler manufacturers, showed the expected FDA approval dates for about 8 new ICS or combination ICS plus LABA inhalers during the next 8 years. All of these are “me too” inhalers, with any differences between them and existing ICS or combo inhalers possibly exaggerated in an attempt to gain a slice of the $10 billion per year worldwide market for asthma and COPD inhalers. Of course, all of these new inhalers will be priced about the same as the existing ones ($100 to $300 per month). No truly innovative inhalers are “in the pipeline” (in phase II or III clinical trials). This is a sad situation for under-insured folks in the United States with asthma (or a child with asthma).

Okay, back to the title of this blog. Asthma drugs can generally be categorized into 1) controllers (which you take every day), and 2) quick relievers, which are bronchodilators which are to be used only to temporarily relieve asthma symptoms. Once inhaled, they “kick-in” in less than 5 minutes, and last about an hour or two. These puffers contain beta-2 agonists (aka short-acting bronchodilators); albuterol (called salbutamol outside of the U.S.) is the most popular. It’s available as a metered-dose inhaler (MDI, aka an asthma puffer), a solution to be placed in a nebulizer, and a pill. Albuterol MDIs are wildly popular because they are very small, take less than a minute to take a couple of puffs, and are relatively cheap. The albuterol solution is more cumbersome, since it must be placed in a nebulizer and takes 5-10 minutes to inhale the 2-3 milliliters of the liquid. Very few asthma experts ever use albuterol pills, because they are much more likely to cause side-effects (rapid heart rate, nervousness, and tremor), and they take 20-30 minutes to become effective.

Generic albuterol MDIs have been available in the U.S. for several years, and have cost as little as $6 each (less than most insurance copays). Sadly, the FDA has decreed that they be banned, starting in December, 2008. Already, it is rare to find them, as wholesale houses deplete their inventory and don’t buy more. The FDA also plans to ban Primatine Mist (quick relief) inhalers, which are currently over the counter (without a prescription) for about $16 each. The new branded HFA MDI inhalers (Ventolin, Proventil, ProAir, and Xopenex) now cost between $30 to $65 each. There is no convincing evidence that any of them are more effective or are less likely to cause side-effects when compared with each other or generic albuterol.

What’s left for poor folks? Wal-Mart, Target, and Dey Pharmaceuticals have “come to the rescue,” but their solutions (pun intended) are not ideal. Dey makes generic albuterol and generic ipratropium single dose vials with 2.5 mL of liquid to pour into a nebulizer, and Wal-Mart and Target pharmacies sell a “typical” one month supply of these vials (60-75) for only four dollars! Wow, that’s about one-tenth the price of the branded albuterol MDIs. What’s the catch? Well, you need to have a compressor which plugs into the wall ($20 to $120 each, depending whether you buy it at a local pharmacy or DME store versus Ebay) and some nebulizers ($3 to $30 each, again depending on the source). An alternative is a battery-powered, hand-held ultrasonic nebulizer, which cost from $30 to $150 each, depending on the source. These solutions require larger equipment when compared to an MDI and a handful of vials, and take longer to administer the drug, but silver lining is that the nebulizer+compressor combination is the same as the bronchodilator treatment you will get in most emergency rooms.

So what about the generic ipratropium solution from Dey, which was just added to Wal-Mart’s $4/month program? Ipratropium has been around for decades, branded by Boehringer (a German drug company) as Atrovent. Ipratropium has two major disadvantages as an asthma rescue medication when compared to albuterol: 1) it takes 45 minutes to an hour to take effect, and 2) it only works for a relatively small minority of children or young adults with asthma. However, ipratropium brings temporary relief of shortness of breath for about half of patients with COPD due to smoking. For those in whom it is effective, it lasts for 4 to 6 hours. The bronchodilator effect of ipratropium adds to the bronchodilator effect of albuterol, so many years ago, Boehringer introduced a combination MDI inhaler called Combivent. They apparently fell behind in the development of an HFA or DPI inhaler to replace the old CFC Combivent (and thus get another 15 year patent), so they have petitioned the FDA for an delay (beyond 2008) in the ban on CFC Combivent. Meanwhile, the Mothers of Asthmatics have attacked compounding pharmacies for substituting low cost generic combinations of ipratropium and albuterol solutions for the expensive Combivent brand name solution for nebulizers.

If you are concerned that the $4 per month generic short-acting bronchodilators may be less effective than the branded versions, get a peak flow meter (or even better a PiKo-1 pocket spirometer to measure your FEV1) and compare the improvement between the cheap and the expensive solutions (after ten minutes for albuterol and after 45 minutes for ipratropium or the combination. Of course, always, always work with your doctor when contemplating a change in your asthma treatments.

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Posted by: Paul Enright MD at 3:44 pm

Tuesday, September 25, 2007

Managing Mild Asthma

Singulair versus Flovent versus Advair for Mild Persistent Asthma?

There is no question that in general Advair is more effective than Flovent and that Flovent is more effective than Singulair for controlling asthma. Most patients with mild asthma only go to see a doctor during an asthma exacerbation – that’s certainly not optimal, but that’s human nature. There are so many other responsibilities in life that you tend to ignore problems unless they become severe. The doctor then prescribes what she knows are the most likely drugs to “get you back on your feet” as soon as possible. That usually means a combination asthma controller inhaler (Advair or newcomer Symbicort) and, if your asthma severity is really worrisome, or if you’ve previously needed hospitalization for an asthma attack, she will prescribe a burst of prednisone.

[Strangely enough, the 10-14 days of prednisone (the strongest medication) will cost less than ten dollars, while each inhaler will cost somebody up to $200. ]

Anyway, within a few weeks, you will be feeling better and back into the yellow zone, and several weeks after that, you will probably be back into the green zone, demonstrating that your asthma is back in good control. What then? What asthma controller medications should you then be “stepped down” to? There are several options.

A new, large study addressed just that question. The investigators randomly assigned 500 children and adults with well-controlled mild asthma to step down to one of three options:

  1. Advair (100mcg fluticasone plus 50mcg salmeterol once each night);
  2. Flovent (100mcg fluticasone twice a day); or
  3. Singulair (a 5 or 10mg monteleukast pill every night; 5mg for kids, 10mg for adults).

About one-third of the patients had experienced an asthma exacerbation during the previous 12 months. About two-thirds of the patients also had allergic rhinitis. This study started in the summer of 2003 at 19 sites in the United States, and was funded by Glaxo (the company that makes Advair and Flovent inhalers) and the American Lung Association (published in NEJM May 2007). A colleague and friend of mine, Dr. Robert Wise at Johns Hopkins, was the principal investigator at the coordinating center. The measures of successful treatment were:

  • the number of days before another asthma exacerbation
  • the percentage of days free from asthma symptoms.

So what happened during the 4 months of follow-up for each study participant?

The percentage of asthma-free days was about 80% for all 3 groups, which means that on the average, they didn’t need to take albuterol for asthma symptoms for 4 of every 5 days.

About 20% of those who took the low dose Advair once-a-day and 20% of those who took the low dose Flovent every night had an asthma exacerbation, compared to 30% of those who only took a Singulair pill every night. There were 8 different events which were considered an asthma exacerbation (aka an event), including urgent care visits for asthma, the need for a burst of prednisone, the need for an excessive amount of albuterol for two or more days in a row, or a worrisome fall in lung function (FEV1 or peak flow). Half of the exacerbations were because the FEV1 had decreased more than 20% from the beginning of the study (even though the patient may have felt fine).

Side-effect rates (aka adverse events) were similar in the 3 groups, except that those taking Singulair reported fewer upper respiratory infections (27% versus 38%), fewer lower respiratory infections (7% versus 14%), and fewer episodes of fever (15% versus 25%). Hmmm, it sounds like even a low daily dose of fluticasone substantially increased the risk of viral respiratory infections, but reduced the risk of an asthma exacerbation. Since respiratory viruses are the most common cause of asthma exacerbations, this is a paradox.

I agree with the authors’ conclusion that “individual patients and their physicians must choose a treatment regimen for asthma that balances efficacy with actual or perceived risks and maximizes adherence. No single approach will provide the best combination of these factors for all patients with asthma.”

Don’t let your doctor practice “cookbook medicine” (one size fits all) for your asthma therapy. Once your asthma is well-controlled, ask her about stepping down your therapy. Learn all that you can about your asthma and asthma medicines. WebMD provides many resources for those with asthma.

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Posted by: Paul Enright MD at 9:17 am

Friday, August 24, 2007

The High Cost of Asthma Medications in the United States

In my personal opinion, the high cost of asthma therapy in the United States (over $100 per month for each controller inhaler) is due to the greed of the big drug companies, and the costs will only get higher during the next two years. Inhalers are a ten billion dollar a year market worldwide, and growing rapidly. The profit is very, very high, even considering the inflated R&D; expenses. During the past 7 years, pharmaceutical companies have successfully lobbied the FDA and Congress to ban any generic asthma inhalers (controller or reliever).

The problem with health plans fully covering every asthma inhaler is that it would provide no incentive for the manufacturers and distributors to control (lower) prices. The inhaler manufacturers run almost all of the research on asthma inhalers, so the new ones are only compared to placebo inhalers, and no head-to-head comparisons are done (for efficacy or for side-effect rates). It’s amazing that the FDA allows such placebo-controlled studies of me-too drugs (or reformulations with new inhaler devices).

It is highly likely that all of the ICS medications (generics included) – after controlling for the dose delivered to the lungs – have roughly the same efficacy and side-effects for more than 80% of those with asthma. However, it seems as though nobody cares enough about consumers and poor folks to conduct such a study to disprove such a hypothesis.

The only non-industry people in the United States who could run such a study are

  1. the Lung Division of the NIH-NHLBI and
  2. the American Lung Association’s Asthma Clinical Research Network (ALA-ACRC).

However, the majority of the staff and investigators of these programs have been “feeding at the trough,” so I don’t think you will see such studies funded by them anytime soon – unless a new asthma/COPD patient advocacy group starts talking to the press.

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Posted by: Paul Enright MD at 2:35 pm

Friday, July 6, 2007

Asthma and Acid Reflux

Once a year, the largest pulmonary meeting in the world is held by the American Thoracic Society (ATS). This year, it was in San Francisco, with over 16,000 attendees. One of the major topics is asthma. I reviewed all of the asthma abstracts (short summaries of research done during the previous year), so during the next couple of months, I will blog about some of the highlights from the ATS meeting.

40% of patients with cough variant asthma (CVA) have acid reflux (GERD). Both of these disorders are common, but how common depends on exactly how one defines mild disease and how many medical tests are done to confirm an abnormality and rule out other possible causes for the symptoms of cough and heartburn.

For decades, people who over-indulged with food got heartburn and just treated it with cheap antacids, like TUMS. Then expensive, and somewhat more powerful acid-blocker pills became available. An a couple of years ago, an even more expensive proton pump inhibitor (PPI) that blocks all stomach acid production went off-patent and over-the-counter.

Now patients with heartburn symptoms are sought by multi-million dollar ad campaigns, which suggest that only an expensive PPI should be used for GERD.

Over half of people with asthma are over-weight. Obesity makes acid reflux much more likely. Both asthma and GERD can cause a chronic cough; therefore, asthma and GERD often co-exist. GERD can sometimes (but certainly not more than half of the time) worsen asthma.

So should everyone with asthma and a chronic cough take a PPI every day? Should everyone with a chronic cough get a 500 dollar, 24 hour pH test for acid reflux?

I think that a more reasonable approach is to try a PPI for several weeks to see if it makes a substantial reduction in coughing and generally improves asthma control. For an objective comparison, you should maintain a daily asthma symptom diary for two weeks before you start the PPI and for two weeks while using the PPI.

Please help others by posting your experience on our WebMD asthma message board.

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Posted by: Paul Enright MD at 5:17 pm

Wednesday, June 13, 2007

Why One COPD Medication Instead of Another?

Why Take a Bronchodilator? Bronchodilator inhalers and pills relax the airways, making them wider so that you can breathe more easily. The goal of bronchodilator therapy is to reduce shortness of breath. If you are not short of breath, or if they don’t noticeably relieve your shortness of breath, then perhaps you don’t need to take a bronchodilator regularly. Discuss this with your doctor.

What Side-Effects are Possible from Bronchodilators? Bronchodilator inhalers and pills are stimulants, like the caffeine in coffee and tea. Thus you may experience nervousness (anxiety), shakiness (tremor), a more rapid pulse, insomnia, or stomach upset (nausea). These will only last for the duration of the effect of the bronchodilator (2 to 4 hours for short-acting inhalers, but 12-24 hours for long-acting inhalers). If you also have heart disease, you may experience palpitations (worrisome cardiac arrhythmias), or angina. If this happens, contact your doctor and discuss it.

Why Take an Inhaled Corticosteroid? These inhalers are designed to reduce airway inflammation and swelling. This beneficial effect takes several days of daily use. These inhalers are often used when some degree of asthma is also present along with COPD. When taken every day, these inhalers may reduce the risk of an exacerbation (temporary worsening) of COPD.

What Side-Effects are Possible from Inhaled Corticosteroids? Many people develop yeast (Candida) infections in their throat (thrush) after using them for several weeks or more. These yeast infections are not serious, but often cause a sore throat, a sore tongue, a white coating at the back of the throat and tongue (which you can see by shining a light at the back of your throat and looking in a mirror). These yeast infections sometimes extend to your vocal cords, causing a change in your voice (hoarseness). Use of a spacer and gargling after taking the inhaler can reduce the risk of thrush. Antifungal lozenges (Nystatin, TM) can be prescribed to kill the Candida yeast.

High daily doses of inhaled corticosteroids (1000 mcg or more) taken for long periods of time may also cause some of the side-effects of prednisone (see that box). Poverty is also a possible side-effect, if you have to pay for these brand-name inhalers out of your own pocketbook.

Why Take Prednisone? Prednisone pills are strong medicine, but very inexpensive since they are generic. They reduce the airway inflammation caused by viral respiratory infections. Prednisone (or its expensive cousin, prednisolone) is often given to treat a COPD exacerbation (worsening).

What are the Side-Effects of Prednisone? Because it is so strong, and distributed to the entire body, prednisone causes some side-effects in most patients. The higher the dose, the more likely side-effects will occur, so most doctors like to stay below 60 mg per day. The longer the time that prednisone is taken, the more likely that serious side-effects will occur, so most doctors like to give only “bursts” of prednisone for 5 to 14 days.

When taken for only a few days, prednisone may cause changes in mood (good or bad) or increased appetite. When taken for months to years, prednisone may cause serious side-effects, such as adrenal suppression (so you must not stop it cold turkey), fluid retention (a moon-shaped face), thinning of the bones (osteoporosis), cataracts, immune system suppression (increased risk of infection), and many other possible side-effects.

Why One Inhaler Versus Another? The primary goal of inhalers is to deliver most of the medication deep into the lungs, where it will be most effective. A secondary goal of inhaler devices is to minimize the amount of drug deposited at the back of the throat.

Small inhalers which you can put in your pocket or purse are generally preferred by patients. These are called metered-dose inhalers (MDIs). Over the last decade, they have evolved to become easier to use, more efficient, and more expensive. In 2007, the FDA eliminated generic albuterol, which used freon as a propellant, so it has been replaced by HFA propellants or by dry powder inhalers (DPIs). The best new inhalers are breath-activated, triggering themselves automatically when you begin to inhale deeply. This makes it more likely that most of the medication will be delivered deep into your lungs. Dry powders and spacers reduce the amount sticking to the back of your throat.

Why Use a Nebulizer Instead of a Pocket Inhaler? The primary advantage of a nebulizer is that you only breathe quietly. Some doctors also believe that nebulizers are more effective for some patients. Nebulizers to deliver a mist of medication have been around for more than 100 years. The air pressure needed to nebulize the liquid medication was first generated by a hand-bulb, then a tank of oxygen, then an electric pump (compressor), and most recently by ultrasound. Usually, about 3cc (about a teaspoon) of the medication solution is placed into the nebulizer. Then you breathe quietly from the nebulizer mouthpiece for a few minutes.

The Disadvantages of Nebulizers:

  1. you have to pour the medication into the nebulizer;
  2. it takes longer to deliver the medication;
  3. the device is more expensive;
  4. compressors are noisy and must be plugged into the wall;
  5. the nebulizers should be cleaned routinely.

On the other hand, the primary disadvantage of most pocket inhalers is that technique is important — you have to figure out how to trigger the inhaler at the beginning of a slow and very deep inhalation and then hold your breath for several seconds. Sometimes you are not confident that the pocket inhaler actually delivered the medication into your lungs, because you can’t see the mist or powder.

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Posted by: Paul Enright MD at 5:10 pm

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