Slide Lecture with Audio
This activity is based on a 45-minute slide lecture presented by Dr. Elena Umland & Dr. Michael Blaiss. This program is available as read only and with accompanying audio.
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Slides 1 and 2: Welcome to Evidence-Based Approaches to the Management of Allergic Rhinitis: An Educational Initiative for Managed Markets.
This activity is jointly sponsored by Medical Education Collaborative and Princeton CME, and is supported by an educational grant from Schering-Plough Corporation.
Slides 3 and 4: I am Dr. Elena Umland, associate dean for academic affairs and associate professor of clinical pharmacy at the Jefferson School of Pharmacy at Thomas Jefferson University in Philadelphia, Pennsylvania. I will be your presenter, along with Dr. Michael S. Blaiss, clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, Tennessee.
Slide 5: The case today is a 15-year-old high school softball player who presents to the emergency department complaining of difficulty breathing and chest tightness, nasal congestion, itchy, watery eyes. She has missed several days of school over the past week, and has had difficulty sleeping.
On physical examination, she is 5 ft. 4 in. tall, and weighs 51 kg. Her blood pressure is 114/74 mm Hg, heart rate is 88 beats per minute, and respiratory rate is 24 per minute. She has moderate wheezing at mid- to end-expiration on physical examination, and also has positive nasal congestion, watery eyes, and allergic shiners. Her medical history is significant for mild persistent asthma for the past 5 years.
Slide 6: Our 15-year-old patient is taking chronic asthma medications including fluticasone metered dose inhaler, 110 mg per dose, 2 puffs once daily; albuterol metered dose inhaler, 1 to 2 puffs as needed.
Social history. She is a nonsmoker and is physically active at least 1 to 2 hours per day, and her family history is noncontributory.
Slide 7: Questions for consideration relative to this patient case include: Is the clinical presentation of allergic rhinitis in asthma common in patients with the noted respiratory presentation? What pharmacologic and nonpharmacologic allergic rhinitis treatment options are available for this patient? If drug therapy for allergic rhinitis is warranted, what is the most appropriate regimen, and how should it be monitored?
As you read Dr. Blaiss’ presentation, think about what therapies could be considered for patients such as this experiencing allergic rhinitis.
Slide 8: Thank you, Dr. Umland.
This is an important topic for managed care market physicians and pharmacists because of a high prevalence rate of allergic rhinitis in the population and the numerous serious comorbidities that can be associated with this condition.
Slide 9: In the United States, we tend to divide allergic rhinitis into 2 major categories—seasonal and perennial—primarily due to what is triggering the patient’s problem.
Seasonal allergic rhinitis patients experience an IgE-mediated reaction that is due to a seasonal allergen. We know that this is a major problem in patients who suffer from grass pollens, which occur during the summer; tree pollens, which occur during the spring; weed pollens, which occur during the fall; and fungal or mold spores, which primarily in the northern parts of the United States occur during the summer. Patients with seasonal allergic rhinitis have a lot of water rhinorrhea, nasal congestion, repetitive sneezing and a great deal of itching of the eyes, nose, ears, and throat, and watery eyes. In fact, many times patients with allergic rhinitis complain of their eye symptomatology as much as their nasal problems.
In contrast, we also have a group of patients with perennial allergic rhinitis. These are patients that have year-round symptomatology either intermittent or continuous. Their allergens are primarily indoor, including such things as house dust mites, animal dander, cockroaches, and mold spores. Patients with perennial allergic rhinitis tend to have much more prominent and severe nasal blockage and congestion and complain a great deal of postnasal drainage. Rhinorrhea and sneezing in general are less prominent than what we see in patients with seasonal allergic rhinitis.
Slide 10: In the rest of the world, we have what is called the ARIA (Allergic Rhinitis and its Impact on Asthma) classification for allergic rhinitis. This was developed by the World Health Organization, and allergic rhinitis is classified depending on the duration of the disease during the year. Patients with intermittent allergic rhinitis have symptoms for less than 4 days a week or for less than 4 weeks out of the year, and patients with persistent allergic rhinitis have symptoms for more than 4 days a week and for more than 4 weeks out of the year.
They are also classified depending on the severity of the condition. If the condition is mild, we are talking about patients whose allergic rhinitis does not affect their quality of life. They tend to have normal sleep, no impairment in daily activities, sports or leisure, normal work and school patterns, and no troublesome symptoms. This is in contrast to patients with moderate-to-severe allergic rhinitis who have issues that impact their ability to function normally, such as abnormal sleep, impairment of daily activities, sports and leisure, abnormal work in school, and troublesome symptomatology.
Slide 11: The prevalence of allergic rhinitis continues to increase not only in the United States, but just about in every developed country throughout the world. In fact, it is estimated that up to 40 million Americans now suffer with allergic rhinitis. Data from the US Department of Health and Human Services show allergic rhinitis to be the sixth most prevalent chronic condition in the adult population.
If you review studies about the prevalence rate of allergic rhinitis in both adults and children in the United States, we do get somewhat different numbers, because they are done in different ways and in different types of surveys. The prevalence rate estimated in the adult population is somewhere around 10% to 30%, with the pediatric population showing as high as 40%. We know that allergic rhinitis is the most common chronic condition in the pediatric population.
Slide 12: We know that there is no mortality associated with allergic rhinitis, and, unfortunately, for that reason, this illness is not taken seriously. There is significant morbidity associated with this condition and at least a very poor quality of life of patients suffering with allergic rhinitis. We know allergic rhinitis is associated with significant fatigue and daytime sleepiness, and this can lead to daily activity impairment. We also know that there is a significant decrease in work productivity when patients are suffering with allergic rhinitis.
In studies in the adult population, we have been able to show that untreated allergic rhinitis can lead to impaired cognitive function. There are several studies in the pediatric population that show allergic rhinitis can lead to reduced learning abilities.
One of the major problems associated with allergic rhinitis is related to impaired sleep. I believe that it is this impaired sleep that leads to so many of the problems during the day for the patient suffering with allergic rhinitis, all of this really leads to a poor quality of life associated with allergic rhinitis in our patient population.
Slide 13: The next study is out of France and was recently published in the Archives of Internal Medicine. This population study of patients with moderate-to-severe persistent allergic rhinitis looked at the impact of allergic rhinitis on sleep. When compared to a control group of individuals, what one can see here is that the patients with allergic rhinitis had a much higher rate of difficulty in falling asleep, nocturnal awakening, feelings of lack of sleep, snoring and insomnia, and, obviously, if that patient is not getting a good night’s sleep, they are not going to function well.
We have data with allergic rhinitis really showing that patients do not get a good night’s sleep. They have less REM sleep. They have more microarousals in the middle of the night. Allergic rhinitis has a major impact on sleep in the patient population.
Slide 14: Also very important is how allergic rhinitis affects the ability of children to learn. This next study by Walker was published in the Journal of Allergy and Clinical Immunology in 2007. It looked at seasonal allergic rhinitis associated with detrimental effects on exam performance in United Kingdom teenagers.
This was a case-control study of 1834 students who were sitting for their national exams in the United Kingdom. The cases were those who had dropped 1 or more grades in any of 3 core subjects, that being mathematics, English, and science, between the practice period, which was in the winter, then they had the spring hay fever season, and then the final in the summer. Controls were those whose grades were either unchanged or improved.
What they wanted to do is look at the association between allergic rhinitis symptoms, clinician-diagnosed allergic rhinitis, and allergic rhinitis related to medication use recorded immediately before the examination. These were assessed using a multilevel regression model.
Slide 15: If we look at the results from this study, if you compare the group of children that had a decrease in grades compared to the control group, there was a statistically higher rate of allergic rhinitis symptoms, allergic rhinitis medication use, and the use of sedating antihistamine medication used during examination. These were the children who were having more problems with their allergic rhinitis and requiring more treatment.
Slide 16: Also very important is a survey that was done in January 2006, and this is the Allergies in America survey, and, in fact, I was one of the physicians that helped to develop this landmark survey on nasal allergy sufferers in the United States. This survey looked at the burden of allergic rhinitis in the adult population and comorbid conditions and the effect of allergic rhinitis on productivity and quality of life of these individuals.
This was a national sample of 2500 adults, 18 years of age and older, diagnosed with allergic rhinitis by a healthcare professional, who experienced symptoms consistent with allergic rhinitis within the past 12 months and were on treatment for their allergic rhinitis symptoms or were having symptomatology of allergic rhinitis. They were interviewed about their condition and past and current treatment regimens.
Slide 17: We can look here at the degree of discomfort from allergic nasal allergies and the question asked to these 2500 sufferers of allergic rhinitis, “In general, when you have a nasal allergy attack, would you say that your discomfort is usually something you can ignore, you cannot ignore but you can tolerate, or you cannot tolerate without relief?”
Only 6% of these sufferers said that they can ignore their symptomatology, that the vast majority of these patients can tolerate but cannot ignore, and they cannot tolerate without relief. So these patients are suffering related to their nasal allergy.
Slide 18: The next pie graph from this study looks at work interference from nasal allergies. They asked, “Have you missed work in the past 12 months due to your nasal allergy? Aside from actually missing work, have your nasal allergy symptoms in the past 12 months interfered with your performance at work?”
A majority of the patients that were employed full time. That was 1315 in this survey. 10% missed work only, or absenteeism; 22% had decreased productivity, what we also now call presenteeism, that the patient is at work, but because of suffering from the condition, they are not able to perform their job as efficiently as they would be able to if they were not suffering and both absenteeism and presenteeism was seen in 20% of these patients. So we can see that this can lead to indirect cost associated with allergic rhinitis in the workplace.
Slide 19: Another very interesting thing that we asked these individuals was, “Thinking about your productivity on a scale of 0 to 100 where 100 means 100% productivity, where would you rank your productivity on days when you do not have nasal symptoms and the same scale when your nasal allergies are at their worst?”
Notice here that when there were no symptoms, in fact, they rated their productivity out of that 100-point scale at 95, but when their symptoms were at their worst, it dropped down to 72, almost a 25% decrease in productivity when these patients were suffering with their nasal allergy.
Slide 20: It is also very important to understand that this is a high-cost condition. A very interesting study published in the Journal of Occupational and Environmental Medicine, looked at the cost in 7 large corporations in the United States with over 300,000 individuals surveyed, looking at both inpatient and outpatient costs, emergency department costs, medication costs, looking at presenteeism in the workplace, and getting an idea of the annual cost per patient for these large corporations. What they found in this particular survey, as you see on this graph, is that allergy was the fifth most costly physical and mental health condition. In fact, the cost per allergy for these businesses was higher than asthma, any cancer, diabetes, migraine headaches, or respiratory infection. So, even though no one dies from nasal allergies, it is still a high-cost condition for American businesses.
Slide 21: Also very important to understand is that allergic rhinitis is not a condition that affects just the nose. There is not just sneezing, nasal itching and rhinorrhea. There is significant comorbidity associated with this condition. In fact, we know that allergic rhinitis is a risk factor for developing asthma. Even in the adult population, adults with allergic rhinitis are 3 times more likely to go on to develop asthma as there is a united airway between the upper and lower airway. Numerous studies have now shown that if one does not treat the upper airway disease in the asthmatic population, one will not be able to control their asthma adequately.
We also know that allergic rhinitis can lead to chronic sinus disease. Some surveys have suggested that up to 20% of patients suffering with chronic sinusitis—which we know leads to a lot of antibiotic use, which can lead to significant surgical procedures—that this can be related to allergic rhinitis.
And in the pediatric population, it is estimated that anywhere from 10% to 15% of children with chronic otitis media with effusion may, in fact, be related to their nasal allergy. Studies have shown, in fact, that the Eustachian tube can act as an allergic shock organ.
Other things associated with allergic rhinitis include nasal polyposis, upper respiratory infection, and hearing and speech development problems in the pediatric population. Studies have even shown significant severe snoring and sleep apnea associated with allergic rhinitis.
I think it is very important to realize that allergic rhinitis is not an isolated condition but that there are significant comorbid conditions associated with them that lead to high cost in medicine.
Slide 22: In the next slide, we are presenting a study by William Schoenwetter looking at the proportion of patients with allergic rhinitis who have a selected comorbid condition. Again, you see the high right here of chronic sinus disease, 67.5%; asthma, 21.3%; otitis media with effusion, 20.8%; and recurrent nasal polyposis, 2.2%.
Slide 23: Looking at this a different way, you can notice the proportion of patients with selected comorbid diseases that also have allergic rhinitis and you can see the high rate of allergic rhinitis in the asthma population, 85.7%. In fact, other recent studies have suggested it is probably closer to 95%. Chronic sinusitis, 65.7%. Otitis media with effusion, 50%. Recurrent nasal polyposis, 37.5%.
Slide 24: We are seeing the close relationship of allergic rhinitis and other serious comorbid conditions in our patient population. As I mentioned previously, allergic rhinitis is a risk factor for the development of asthma. Recent experimental data mainly obtained from specific nasal or bronchial allergen challenges have confirmed that there is a link between the nose and the bronchi that is bidirectional. We call this systemic immunologic crosstalk, and it has now been shown in several different studies.
Stimulation of nasal mucosa can result in contractile response of the bronchi or an increase in bronchial hyperresponsiveness. In patients with perennial allergic rhinitis alone, we frequently can display bronchial hyperreactivity and changes in spirometric measurements in those patients even without symptoms of asthma. So we really have a united airway here and need to remember that one has to treat the upper airway to get good control of lower airway disease.
Slide 25: These findings have been recognized in several new guidelines published in 2007. Recently, the National Asthma Education and Prevention Program Expert Panel Report 3 published guidelines for the diagnosis and management of asthma and recommended that clinicians evaluate patients with asthma for allergic rhinitis symptoms and appreciate the connection that it plays in asthma management.
The latest update to the ARIA guidelines, from the World Health Organization, emphasizes the link between persistent rhinitis and asthma and recommends that clinicians combine the treatment of both conditions whenever possible.
Slide 26: Let us move on now and spend the rest of our time talking about the management of allergic rhinitis; which is really a 4-fold approach. One method is try to avoid the allergen or allergens that are triggering the patient’s symptomatology and, ideally, we would be extremely pleased if every patient with cat allergy could remove the cat from the home, but we know that it is not always possible. And, again, we cannot have patients completely avoid the outdoors during the pollen season.
Unfortunately, complete avoidance measures are usually not possible in the patient with allergic rhinitis, and this leads us, as we will talk about, to proper pharmacologic therapy. In patients who have moderate-to-severe perennial or seasonal allergic rhinitis, the role of allergen immunotherapy to desensitize them of what they are allergic to is the only disease-modifying treatment for patients with allergic rhinitis.
And with all of this, we need to properly educate the patient or the caregiver about the condition. We must point out that this can be a chronic condition and that it can lead to significant comorbidity. They need to understand the disease itself and the proper management of the condition so that we can then decrease the burden and improve their quality of life.
Slide 27: If we look at the pharmacologic management options for the treatment of patients with allergic rhinitis, there is a long list of medications that can be efficacious in their treatment. They include the oral antihistamines, both first and second generation, intranasal antihistamines, intranasal corticosteroids, leukotriene-receptor antagonists, oral decongestants, intranasal decongestants, and intranasal anticholinergics.
Slide 28: Let us look at these particular treatments—first, the antihistamines—and we have the oral antihistamines, in fact, divided into 2 generations. The first generation includes medications such as diphenhydramine, promethazine, and others; and the second generation includes cetirizine, loratadine, desloratadine, fexofenadine, and levocetirizine. In the United States, at this time, we have 1 intranasal antihistamine, azelastine.
Slide 29: What are the differences between the first- and second-generation antihistamines? First-generation antihistamines—in fact, diphenhydramine was developed around World War II—are highly lipophilic and can rapidly cross the blood-brain barrier.
Unfortunately, there are histamine receptors in the CNS (central nervous system), and these medications can lead to impairing of CNS function. Also, these medications tend to be short acting and need to be given as many as 4 times a day to be efficacious. These agents can block the adrenergic, serotoninergic and dopaminergic receptors and have less of a safety profile. In fact, one can see adverse events due to these because of lack of selectivity to the H1 receptor, especially the anticholinergic effects of these drugs.
They can lead to dry mouth, tachycardia, urinary retention and gastrointestinal disturbance. As I mentioned, they cross the blood-brain barrier and can lead to significant sedation and impairment of psychomotor and cognitive functioning. Even when patients do not feel that they are sedated, studies show that they have decreased psychomotor function. Even if they take these medications in the evening, they can still be impaired the next day.
Slide 30: The next group of medications are the second-generation antihistamines. It is my feeling now that these really are the first-line treatment for patients with intermittent or mild allergic rhinitis. They are long-acting, therefore, they can usually be given once or twice a day; they have much greater selectivity, so they do not have that anticholinergic activity that we see in the first-generation drugs; and there is almost little or no CNS penetration. These are large molecules and they are very lipophobic. When one looks at comparative studies, they are equal to or of greater efficacy than the first-generation medication.
These drugs are effective for sneezing, nasal itching, and rhinorrhea, but have minimal decongestive effect. As I mentioned, as far as safety, they have less sedation than first-generation drugs. However, with some of these agents, if one uses higher than the recommended dose, sedation can occur.
Slide 31: We also have 1 intranasal antihistamine, azelastine. This medication, which is sprayed into the nose, does have some mild anti-inflammatory activity. Studies show improved total nasal symptom scores and more rapid onset of action compared to oral cetirizine.
As far as safety, there are 2 side effects that are usually associated with this medication. One, it does have a very bitter taste, and many patients, unfortunately, cannot tolerate it. And for a small percentage of patients, there is systemic absorption of this antihistamine, which can lead to sedation.
Slide 32: Next is a study by Jonathan Corren that compared azelastine to the oral antihistamine cetirizine. This was a 2-week double-blind study of 299 patients with moderate-to-severe seasonal allergic rhinitis. The study participants range in age from 12 to 74 years. Group 1 received azelastine nasal spray, 2 sprays per nostril twice daily, plus placebo tablets, and the other group received cetirizine, 10-mg tablets once daily, plus placebo saline nasal spray. Within 2 weeks, both groups had significant improvement in their total nasal symptom scores compared to baseline. Overall change in total nasal symptom score was significantly greater with azelastine nasal spray compared to cetirizine at 60 and 240 minutes after the initial dose. With this particular medication, one sees a quicker onset of action.
In conclusion, azelastine nasal spray was well tolerated and produced significantly greater improvement in total nasal symptom scores compared with cetirizine, at least in the first day of treatment. After several days of treatment, in fact, they are of equal efficacy.
Slide 33: We also have a large group of intranasal corticosteroids that are available in the United States. They include triamcinolone acetonide, fluticasone propionate, flunisolide, budesonide, fluticasone furoate, mometasone furoate, and ciclesonide. Ciclesonide is approved by the FDA, but it has not been released as yet in the United States.
Slide 34: What are the characteristics of intranasal corticosteroids? Well, in fact, they interfere with allergic inflammation at several points. Also, they block both the early- and late-phase allergic responses in the nasal tissue.
How do they do this? They exert their effect by vasoconstriction, reduction of mucosal edema, and inhibition of expression of cytokines and other mediators that lead to the allergic response in the nasal tissue. These drugs have been shown to be very effective as far as controlling the 4 major symptoms associated with allergic rhinitis, those being sneezing, rhinorrhea, nasal itching, and nasal blockage.
Slide 35: The next study is a meta-analysis of intranasal corticosteroids versus oral antihistamines. This looked at 2267 subjects with allergic rhinitis in 16 studies, and in comparing these 2 medications, the end points they looked at were nasal blockage, nasal discharge, sneezing, nasal itch, postnasal drip, nasal discomfort, total nasal symptoms, nasal resistance, eye symptoms, and global rating. The bottom line here is what worked best as far as controlling the symptomatology in our patients with allergic rhinitis
Slide 36: If we review the results of the study, looking at total nasal symptoms score, you can see here that there was significantly greater favor with intranasal corticosteroids than what one saw with antihistamines
Slide 37: When you look at individual symptom scores, the intranasal corticosteroids produce significantly greater relief than oral antihistamines for nasal blockage, sneezing, nasal discharge, nasal itch, and as I showed you, the total nasal symptoms score. The authors of these data supported the use of intranasal corticosteroids over oral antihistamines as first-line agents in the treatment of patients with allergic rhinitis.
Slide 38: A very interesting study published in 2004 by Jonathan Corren in the Journal of Allergy and Clinical Immunology looked at rhinitis therapy and the prevention of hospital care for asthma, a case-control study. Previously I mentioned the united airway and that the upper airway disease can worsen lower airway disease in our patient population.
This study was to determine whether treatment with intranasal corticosteroids and/or second-generation antihistamines is associated with changes in rates of asthma exacerbation resulting in emergency department visits and/or hospitalizations in patients with asthma and allergic rhinitis. There were 361 patients treated in emergency departments or hospitalized with asthma compared to 1444 controls in a large managed care organization.
Slide 39: Let us look at the results of this study. First, we are going to look at the effect of the rhinitis therapies on emergency department visits for asthma. If we look at the different treatments in the adjusted odds ratio, and what one can see here is for intranasal corticosteroids, the adjusted odds ratio is 0.75. When we look at the coefficient interval, it did not cross 1, so it was statistically significant. In other words, when using intranasal corticosteroids, the patient has significantly less emergency department visits for their asthma.
When one looks at second-generation antihistamines, the odds ratio was 0.88, but it did cross 1, so it is not quite statistically significant. But the combination of the 2 medications, in fact, was statistically significant with an odds ratio of 0.37.
Slide 40: Looking at the next part of the study—the effect of rhinitis therapies on hospitalizations for asthma—we see similar results. The patients who used intranasal corticosteroids or a combination of intranasal corticosteroids and second-generation antihistamines had significantly less hospitalizations for their asthma. Again showing the treatment of the upper airway is important in controlling lower airway disease.
Slide 41: One of the big concerns on intranasal corticosteroids is safety. Unfortunately, there is still a lot of steroid phobia in the patient population. Potential concerns are local adverse effects on nasal mucosa or the possibility of these medications being absorbed systemically and leading to systemic activity. In fact, there are numerous studies that show a low risk of localized changes in nasal mucosa biopsy studies, and these have been done with mometasone, fluticasone propionate, and budesonide.
Also, when they have looked at systematic bioavailability with mometasone furoate, fluticasone propionate, and recently some data with fluticasone furoate, studies show that they have very low systemic bioavailability.
Slide 42: What about effects on the eyes? That has always been a concern with corticosteroids. Well, a study published in the Journal of Allergy and Clinical Immunology by Derby et al, looked at a UK study of cataract risk among users of corticosteroids. This information comes from the UK’s General Practice Research Database. This was a study of over 286,000 patient records. Of these, over 88,000 were using intranasal corticosteroids; over 98,000 oral corticosteroids; and over 98,000 neither form of corticosteroid.
In this group, there were 1059 cases of cataracts. There were 217 in the intranasal corticosteroid group, 629 in the oral corticosteroid group, and 213 who had not received either form of corticosteroid. So, when one looks at the incidence in the intranasal corticosteroid group and the unexposed group, in fact, it was exactly the same, 1 per 1000 patients, but the incidence with oral corticosteroids was very high at 2.2 per 1000 people. Comparing the incidence of cataracts with the number of prescriptions for intranasal corticosteroids use, the rate was 0.9 per 1000 subjects with 2 to 9 prescriptions, and 1.0 per 1000 subjects with 10 or more prescriptions.
Thus, from this study, there was no apparent increased risk as the number of prescriptions increased. So the data are very reassuring as far as eye effects of intranasal corticosteroids.
Slide 43: Another concern with intranasal corticosteroids is the possibility of growth retardation. The FDA now mandates that makers of intranasal corticosteroids do 1-year growth studies on children to show the safety of the medication.
This is one of those studies, focusing on mometasone furoate. These were prepubertal children between the ages of 3 and 9 who were followed over a 1-year time frame. They received either mometasone, 100 mg once a day, or a placebo. Stadiometry was done on a monthly basis.
Slide 44: As you can see here, there was no significant effect with mometasone versus placebo. In fact, at 12 months, the mometasone group had a somewhat statistically higher growth rate than what was seen in the placebo group. Again, this is very reassuring as far as the safety of these medications.
Other studies that have looked at growth have dealt with fluticasone and triamcinolone. In a study of fluticasone propionate, 100 mg administered twice daily for 1 year to children 1 to 3 years of age showed no significant effect on growth.
And another 1-year study in children 6 to 14 years of age with triamcinolone acetonide showed no effect on growth velocity. A comparative study of triamcinolone, 110 mg and 220 mg once daily, and fluticasone propionate, 200 mg once daily, in children showed no significant statistical difference in mean growth velocity compared with placebo.
Slide 45: The next drug class I would like to look at are the leukotriene-receptor antagonists. In the United States, montelukast is indicated for seasonal allergic rhinitis in patients 2 years of age and older and for perennial allergic rhinitis in those 6 months of age and older. In large pivotal studies, montelukast has been shown to be equal in efficacy to the second-generation antihistamine loratadine. In 1 study, montelukast plus loratadine appeared to be less effective than an intranasal corticosteroid alone.
Slide 46: We also have decongestants, and these medications are prescribed for both short- and long-term therapy, though in general they really should be recommended only for short-term therapy. One can have significant side effects associated with the use of decongestants. They can include irritability, dizziness, headaches, tremor, insomnia, and tachycardia, and can lead to elevated blood pressure. They may also lead to urinary retention, in those males who have underlying prostate enlargement. Also, these drugs need to be used with care in patients with glaucoma, hyperthyroidism, or cardiovascular disease.
Slide 47: Another very important medication is an intranasal anticholinergic, ipratropium bromide. This medication has low lipid solubility, so when it is sprayed into the nose, it does not cross the blood-brain barrier and, therefore, does not have systemic distribution or systemic side effects. Unfortunately, this medication only relieves 1 symptom of allergic rhinitis, and that is rhinorrhea. It is not very effective as far as nasal itching, sneezing, or nasal blockage.
The most common side effects are local and they are dose-related, primarily nasal dryness and bloody nasal discharge. These medications should be administered about 2 to 3 times per day to control rhinorrhea.
Slide 48: The next slide shows a chart looking at the estimated symptom efficacy of agents used in the management of allergic rhinitis. Here we are looking at sneezing, itching, nasal congestion, rhinorrhea, and ocular symptoms. As we can see from this chart, one sees good relief with oral antihistamines, but minimal effect as far as congestion. The intranasal antihistamines are about the same and the decongestants are only effective for congestion.
Intranasal corticosteroids are the group of medications that really have the highest efficacy with sneezing, itching, congestion, rhinorrhea, and, as some recent studies have shown, they can also have an effect as far as decreasing ocular symptomatology, so not by a systemic method.
Then we see the anticholinergics for rhinorrhea and the leukotriene-receptor antagonists that have mild improvement in the nasal symptomatology and ocular symptoms that we have mentioned.
Slide 49: We have a lot of very good medications for the treatment of allergic rhinitis, but there is another very important point to stress here: It does not matter how good these medications are if the patient does not adhere to treatment.
We see especially with intranasal corticosteroids that patient preference can make a difference. And there was a very interesting study, a survey of 63 adult patients with both allergic and nonallergic rhinitis that were treated with the intranasal corticosteroid triamcinolone acetonide.
In this survey, 49 patients, over 77%, reported forgetfulness of using the medication 1 to 5 times during the treatment period. Less than 50% compliance was reported by 1 patient, but detected, in fact, in 7 patients when they examined the weight of the medication consumed.
There was a significant improvement in mean total nasal symptom score from before to after treatment in patients who complied with treatment. With greater than 50% of the weight of the medication consumed, the positive predicted values of relief in our patients for rhinorrhea was 78%; for nasal itch, 70%; for nasal obstruction, 67%; and for sneezing, 65%.
So the bottom line is that one needs good compliance to control the patient’s allergy symptoms.
Slide 50: Lastly, I would like to talk to you about the ARIA guidelines and their stepwise approach as far as the management of patients with allergic rhinitis. These are the allergic rhinitis and asthma guidelines as published by the World Health Organization. And if you remember, it was divided as far as the severity of asthma as either intermittent or persistent symptoms.
Slide 51: First, we are looking at patients with intermittent symptoms, and, again, very importantly allergen avoidance. Again, if one can avoid the allergen or allergens that are triggering the problem, then that is going to significantly decrease symptoms. Patients with mild problems should benefit from the use of an antihistamine and/or a decongestants and patients with moderate-to-severe symptoms, that is when the intermittent symptoms are affecting their quality of life, would benefit from an antihistamine and/or decongestant or the use of an intranasal corticosteroid. Also, in this group, they suggest the possible role of allergen specific immunotherapy.
Slide 52: In the patients with persistent symptoms, first, again, is allergen avoidance. Patients with mild persistent symptoms should benefit from an antihistamine and/or decongestant or an intranasal corticosteroid. Patients with persistent moderate-to-severe symptoms would benefit from intranasal corticosteroids. If they are still having itching and sneezing, an antihistamine; rhinorrhea, ipratropium bromide; blockage, decongestant or a short burst of oral corticosteroid. They suggest in all patients with persistent allergic rhinitis that one needs to look at the role of allergen-specific immunotherapy.
Slide 53: Hopefully, I have been able to give you important information on allergic rhinitis, as it has a significant effect on patients’ quality of life and leads to high healthcare costs. Allergic rhinitis can lead to worsening of other inflammatory diseases, such as asthma and sinusitis, and effective treatment of the patients’ allergic rhinitis can reduce the symptoms of these comorbid conditions. The data show that intranasal corticosteroids show improvement over the other available medications as far as management of patients with both seasonal and perennial allergic rhinitis.
I will now turn the program back over to Dr. Umland for a discussion of the case study presented at the beginning of this activity.
Slide 54: Thank you, Dr. Blaiss. Now, let us revisit the case.
Slide 55: On case review, we have a 15-year-old woman who presents with symptoms of allergic rhinitis as an asthma exacerbation. Her history includes mild, persistent asthma for the past 5 years that is currently treated with inhaled corticosteroids and an as-needed inhaled β-agonist.
Slide 56: The primary care provider diagnoses this patient with a mild asthma exacerbation. The find is mild due to her symptoms of chest tightness, heart rate less than 100 beats per minute, and the moderate wheezing at mid- to end-respiration, as well as a slightly increased respiratory rate.
This exacerbation is triggered by seasonal allergic rhinitis, most likely trees and pollen, and her symptoms that indicate allergic rhinitis include difficulty in sleeping, nasal congestion, watery eyes, allergic shiners, and she has missed some school.
The concomitant existence of asthma and allergic rhinitis is quite common. In fact, 85.7% of patients with asthma have allergic rhinitis. Inadequate treatment and management of this combination leads to increased exacerbations, increased visits to the emergency department, and subsequent hospitalizations per Dr. Blaiss’ presentation and as is the case with this patient.
Slide 57: On resolution relevant to management of allergic rhinitis, the nonpharmacologic treatment, includes avoidance, which, in reality, is very difficult for this young patient, who plays softball and goes outside.
Other options that certainly must be considered would be prescription treatment. Allergen immunotherapy would not be an immediate consideration for this patient, given her mild asthma exacerbation, the fact that it appears to be seasonal, and that this is the first time that she is presenting with allergic rhinitis. However, proper education of the patient is imperative, particularly relative to the close link between the allergic rhinitis and asthma.
Slide 58: Intranasal corticosteroids would be key in a treatment plan for this patient and her allergic rhinitis. Meta-analyses have shown that overall steroid treatment is favored versus antihistamines for symptoms, but additional therapy and adding a second-generation antihistamine is actually more appropriate for this patient, knowing that there is a 63% reduction in emergency department visits for patients with asthma and allergic rhinitis when the combination is used together, and a 78% reduction in hospitalization for asthma when the combination of intranasal corticosteroids and second-generation antihistamines are used together.
In addition, a topical decongestant for 3 to 5 days would no longer be helpful for this patient in aiding to immediately relieve her congestion.
For her asthma treatment for the acute exacerbation, of course it would include increasing the inhaled corticosteroid dose for a short period of time, and perhaps increased use of the scheduled β-agonist. Chronic management is imperative and includes the treatment plan noted above for chronic asthma, plus optimizing her allergic rhinitis treatment and management.
Overall, in monitoring this plan for efficacy, we would anticipate that the patient’s heart rate and respiratory rate were reduced to within normal limits, that her wheezing resolves, and that she certainly has improvement in her sleep, itchy, watery eyes, nasal congestion, and that hopefully we are able to avoid emergency department visits and hospitalizations for her, as well as reducing her missed school days.
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