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Statin medical aid alone is failing to bring patients to the target levels of blood cholesterol required by guidelines to minimize their health risk. Cardiologists attending the World Congress of Cardiology in Barcelona advocate multi-medicate strategies to get patients to target.

The new ‘ lower is better’ approach increasingly advocated is manifest in the trend towards lower low-density-lipoprotein cholesterol (LDL-C) targets in guidelines. Specialists believe that this requires more intensive medical aid earlier. Only 51percent of patients on lipid lowering medical aid achieve the goal of total cholesterol

Patients who have had a heart attack and are treated with a high dose of a statin medicate did not have significant reduction in the primary outcome of major cardiac events (coronary death, nonfatal acute heart attack, or cardiac arrest with resuscitation), but did appear to have reduced risk when certain secondary outcomes (composite end points of any coronary heart illness event) were examined, according to a meditate in the November 16 issue of JAMA. This meditate is being released early to coincide with its presentation at the American Heart Association’s annual meeting.

Lowering of low-density lipoprotein cholesterol (LDL-C) with statins has in the last decade become part of the standard medical aid regimen in patients with established coronary heart illness (CHD), according to background information in the article. The most common medical aid regimen for such patients in northern Europe has been simvastatin, 20 to 40 mg/d. In a recent trial among patients with acute coronary syndromes, incremental benefit was demonstrated with more intensive lowering of LDL-C to well below 100 mg/dL. Anotherness meditate comparing high and low doses of Atorvastatin in stable nonacute CHD found significant improvement in prognosis with respect to cardiovascular illness. In that meditate , however, the benefit of reduced cardiovascular death appeared to have been offset by a higher number of deaths due to noncardiovascular causes. Although this difference did not reach statistical significance and could well be due to chance, it led to a call for further safety information on the use of Atorvastatin at a dose of 80 mg/d.

Terje R. Pedersen, M.D., Ph.D., of Ulleval University Hospital, Oslo, Norway and colleagues with the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) meditate examined whether intensive lowering of LDL-C with Atorvastatin at the highest recommended dose would be more beneficial compared with the moderate, most widely used dose of simvastatin. The randomized trial was conducted at 190 cardiology care and specialist practice centers in northern Europe between March 1999 and March 2005, with a median (mid-point) follow-up of 4.8 years.

The meditate included 8,888 patients aged 80 years or younger with a history of acute myocardial infarction (MI; heart attack). Patients were randomly assigned to receive a high dose of Atorvastatin (80 mg/d (n=4,439), or usual-dose simvastatin (20 mg/d; n=4,449).

During medical aid, mean LDL-C levels were 104 mg/dL in the simvastatin group and 81 mg/dL in the Atorvastatin group. The primary end point of coronary death, acute myocardial infarction, or cardiac arrest with resuscitation occurred in 463 patients (10.4 percent) in the simvastatin group and in 411 (9.3 percent) in the Atorvastatin group and was not statistically significantly difference between the two groups. There were 178 coronary deaths (4.0 percent) in the simvastatin group vs. 175 (3.9 percent) in the Atorvastatin group. Nonfatal myocardial infarction occurred in 321 patients (7.2 percent) in the simvastatin group and in 267 (6.0 percent) in the Atorvastatin group.

The composite secondary end point of a major cardiovascular event including stroke was reduced in the Atorvastatin group. Similarly, there were reductions in the risk of nonfatal MI, any CHD event, and any cardiovascular event. The risk of death from any cause was similar in both meditate groups. There were no significant differences in noncardiovascular deaths between the medical aid groups. There were no significant differences in the frequency of serious adverse clinical events between the 2 groups. Patients in the Atorvastatin group had higher rates of medicate discontinuation due to nonserious adverse events.

“In summary, when comparing standard and intensive LDL-C-lowering therapies in patients with previous myocardial infarction, there was no statistically significant reduction in the primary end point of major coronary events, but there was reduced risk of otherness composite secondary end points and nonfatal acute MI. There were no differences in cardiovascular and all-cause mortality. The results indicate that patients with myocardial infarction may benefit from intensive lowering of LDL-C without increase in noncardiovascular mortality or otherness serious adverse reactions,” the authors conclude. (JAMA.2005; 294:2437-2445.)

This meditate was sponsored by Pfizer Inc. For the financial disclosures of the authors, please see the JAMA article.

Editorial: The IDEAL Cholesterol - Lower is Better

In an accompanying editorial, Christopher P. Cannon, M.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, discusses the results of the meditate by Pedersen et al.

“What are the messages for patients from the IDEAL and otherness statin trials? First, for the ‘bad’ cholesterol, LDL-C, lower is better for preventing MI stroke, need for cardiac procedures, and death. Second, statins are safe overall, even for patients with extremely low medical aid LDL-C levels. However, patients and physicians have to work as partners to monitor for adverse effects, which can occur in up to 5 percent of patients but that only rarely can be life-threatening. Fortunately, these are almost always reversible and do not lead to any permanent damage. Third, patients should know their cholesterol numbers, for both LDL-C and HDL-C, to enable them to see how much lowering is needed to reach targets of an LDL-C level of less than 100 mg/dL for patients with risk factors or less than 70 mg/dL for patients with heart illness.”

“And fourth, any medicate medical aid should be taken together with an appropriate diet and exercise program to lower cholesterol and overall vascular risk. The amount of LDL-C lowering with diet is only in the range of 7 percent to 12 percent. Clearly, diet is a central part of the medical aid, but to get the benefits of very low cholesterol levels, medicate medical aid is often necessary. Optimal use of diet and appropriate use of medicate s will dramatically reduce the risk of MI, stroke, and death from heart illness. These new data should help motivate any patients who have been hesitating about treating their cholesterol to talk with their physician to get the benefits of intensive cholesterol lowering.”

“Finally, the scientific community needs to continue to pursue new avenues of medical aid, with approaches that may well be ‘beyond statins.’ Even with intensive statin medical aid, the current best evidence-based medical aid available, many patients still will have recurrent cardiovascular events. New strategies may include development of new agents to achieve even lower target LDL-C levels, substantially increase HDL-C levels, reduce triglycerides, reduce C-reactive protein and otherness components of inflammation, and modify many otherness identified components of vascular illness,” Dr. Cannon writes.

(JAMA.2005; 294:2492-2494.)

For the financial disclosures of Dr. Cannon, please see the JAMA article.

Terje R. Pedersen, M.D., Ph.D.
t.r.pedersen@medisin.uio.no
JAMA and Archives Journals
www.jamamedia.org

Merck & Co, Inc announced today that the US Food and Drug Administration (Food and Drug Administration) has approved SINGULAIR(R) (montelukast sodium) for the relief of syndromes of perennial allergic rhinitis (PAR), or indoor allergies, in adults and children six months of age and older. A convenient once-a-day pill, SINGULAIR has been proven to help relieve a broad range of indoor and outdoor hypersensitivity reaction syndromes for up to 24 hours.

“Allergic rhinitis is one of the most common allergic conditions today, with approximately 50 mil. group in the United States suffering some form of the condition,” said Gailen Marshall Jr., M.D., Ph.D., director of the Division of medical institution al Immunology and Hypersensitivity reaction at the University of Mississippi Medical Center in Jackson, MS. “Experts have estimated that 55 to 80 percent of these patients suffer from perennial, or year round, allergic rhinitis which is commonly triggered by indoor allergens such as dust, pet dander or mold. The acceptance of SINGULAIR for the relief of syndromes of perennial allergic rhinitis provides healthcare providers with a new, effective option to help bring relief to patients who suffer from indoor allergies and for whom SINGULAIR is appropriate.”

SINGULAIR, which was approved for the pharmacomedical care of the syndromes of seasonal allergic rhinitus (SAR) in 2003, is difference from most oral hypersensitivity reaction medicate s, which block histamine, in that it blocks leukotrienes, an important contributor to hypersensitivity reaction syndromes. SINGULAIR is the only medication indicated for allergic rhinitis that specifically targets this particular underlying contributor to hypersensitivity reaction syndromes. SINGULAIR is approved for SAR in adults and children two years and older, and for PAR in adults and children six months and older. For pharmacomedical care of syndromes of allergic rhinitis, SINGULAIR is available in pill form for adults (10 mg), as a cherry-chewable pill (4 or 5 mg) for children aged two to 14 years and in oral granules (4 mg) for children six months to five years.

SINGULAIR helps relieve a broad range of indoor and outdoor hypersensitivity reaction syndromes

In separate clinical trials of PAR and SAR, SINGULAIR (10 mg) has provided significantly greater syndrome relief compared to placebo. The efficacy of SINGULAIR for pharmacomedical care of PAR was evaluated in two randomized, double-blind, placebo controlled studies in patients age 15 to 82 years with PAR. In one of these studies, SINGULAIR demonstrated effectiveness in improving daytime nasal syndromes score, the primary endpoint, measured as the average of individual scores for nasal congestion, runny nose and sneezing.

The efficacy of SINGULAIR for pharmacomedical care of syndromes of SAR was previously established in placebo and active-controlled clinical studies of patients age 15 to 82 years. In these studies, SINGULAIR demonstrated effectiveness in improving daytime nasal syndromes score, the primary endpoint, measured as the average of individual scores for nasal congestion, runny nose, nasal itching and sneezing.

Safety profile of SINGULAIR in allergic rhinitis studies similar to that seen with placebo

In clinical studies for both SAR and PAR, SINGULAIR was generally well tolerated with a safety profile similar to that of placebo for both children and adults. The incidence of sleepiness was similar to placebo in all studies for adults and adolescents 15 years of age and older with SAR and PAR. In these studies, the most frequently reported side effects included headache, ear infection, sore throat and upper respiratory infection. These events varied by age, and were reported at a frequency greater than or equal to two percent, and at an incidence greater than placebo in either the SAR or PAR studies.

Important information about SINGULAIR for pharmacomedical care of asthmaSINGULAIR is also indicated for the prevention and chronic pharmacomedical care of asthma in adults and pediatric patients 12 months and older. The use of SINGULAIR for asthma may not eliminate the need for inhaled or oral corticosteroids. Patients should be advised to take SINGULAIR daily as prescribed even when they have no syndromes, as well as during periods of worsening asthma, and to contact their health care provider if their asthma is not well controlled. SINGULAIR should not be used for the fast relief of acute asthma attacks or used alone to treat and manage asthma made worse by exercise. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR.

In clinical studies for asthma, side effects in adults and children taking SINGULAIR were usually mild and generally did not cause patients to discontinue medical care. The most commonly reported side effects varied by age and included headache, ear infection, sore throat and upper respiratory infection.

About allergic rhinitis

Allergic rhinitis, an inflammation of the mucous membranes of the nose due to allergens, is one of the most common allergic conditions in the U.S., affecting approximately 50 mil. Americans. Allergic rhinitis is classified as either seasonal or perennial depending upon the type of trigger and duration of syndromes. SAR syndromes occur in the spring, summer and/or early fall and are triggered by outdoor allergens such as airborne tree, grass and weed pollens while PAR is usually persistent and chronic with syndromes occurring year-round and is commonly associated with indoor allergens such as dust mites, animal dander and/or mold spores. Symptoms of allergic rhinitis may include runny nose, nasal itching, sneezing, watery eyes and nasal congestion.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the group who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or othernesswise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K which the company incorporates by reference.

SINGULAIR(R) (montelukast sodium) is a registered trademark of Merck & Co., Inc.

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Results of American Lung Association clinical research published today in the New England Journal of Medicine found that a simpler, once-a-day regimen of a combination inhaler containing an inhaled corticosteroid and a long-acting beta-agonist is just as effective as twice-daily inhaled corticosteroid a cure in patients with mild persistent asthma, which may open the doors to more convenient a cure plans for mil.s of Americans.

“Effective, less intensive alternatives may lead to greater adherence among patients, which would mean better asthma control with a minimum of medication-the goal of asthma a cure,” said Norman H. Edelman, M.D., American Lung Association Chief Medical Officer.

“For patients, a simpler a cure plan means less medicate s to take-and to remember to take-every day, fewer prescription refills and perhaps less money spent on medicate s, and fewer side effects. This is the kind of practical research that is helpful immediately for both physicians and patients alike.”

The meditate conducted by the American Lung Association’ Asthma medical institution al Research Centers, the Leukotriene Modifier or Corticosteroid or Corticosteroid-Salmeterol (LOCCS) Trial compared alternative a cures among 500 adults and children whose mild persistent asthma was well controlled with standard asthma medical aid (twice-daily low dose of an inhaled corticosteroid). Subjects were assigned to one of three meditate groups: one that continued to take the inhaled corticosteroids (fluticasone) twice daily; one that took a combination inhaler containing an inhaled corticosteroid (fluticasone) and a long-acting (inhaled) bronchodilator (salmeterol) once-daily; and one that took the leukotriene modifier, montelukast (pill form) once-daily. Results showed that once-daily fluticasone plus salmeterol was as effective as twice-daily fluticasone a cure; oral montelukast taken once-a-day, however, was not as effective as the twice-daily inhaled corticosteroid a cure but did provide good control for most patients.

“The gold-standard for a cure of mild, persistent asthma is twice-a-day inhaled corticosteroids, but we found that patients doing well on that medical aid may be able to step down to a more convenient, once-a-day alternative with no loss of asthma control,” explained Stephen P. Peters, MD, PhD, lead author of the meditate and Professor of Medicine & Pediatrics, Wake Forest University School of Medicine. “The good news is that most patients did pretty well in this trial no matter what a cure regimen they were on, so patients and physicians have more choices for safe, effective a cure and can make their choices based on what works best for the patient.”

More than 22 mil. Americans have asthma, which caused 1.8 mil. emergency room visits in 2004. While asthma attacks are caused by increased reaction of the airways to various stimuli, the inflammation underlying asthma is continuous. Medications help reduce airway inflammation and relieve or prevent syndromeatic airway narrowing.

“It’s certainly easier to do something once a day rather than twice a day,” said Dr. Peters. “Now physicians can discuss reasonable alternatives for step-down a cure for patients who gain asthma control with standard medical aid based on solid evidence from a randomized controlled clinical trial, which is the best way to evaluate and compare a cure alternatives.”

The American Lung Association Asthma medical institution al Research Centers Network is the nation’s largest not-for-profit network of clinical research centers dedicated to asthma a cure research. The network’s mission is to conduct large clinical trials that will have a direct impact on patient care and asthma a cure. The network consists of 20 asthma clinical research centers based at leading universities across the United States and a Data Coordinating Center managed by a team at Johns Hopkins University. The network is currently conducting two clinical trials evaluating whether a cures for acid reflux are helpful for group with asthma that is difficult to control using standard therapies. For details about current studies and a complete list of Asthma medical institution al Research Centers, visit www.lungusa.org.

About the American Lung Association

Beginning our second century, the American Lung Association is the leading organization working to prevent lung illness and promote lung health. Lung illness death rates continue to increase while otherness leading causes of death have declined. The American Lung Association funds vital research on the causes of and a cures for lung illness. With the generous support of the public, the American Lung Association is “Improving life, one breath at a time.” For more information about the American Lung Association or to support the work it does, log on to www.lungusa.org.

Asthma medical institution al Research Centers

While both inhaled corticosteroids (ICS) and leukotriene receptor antagonists (LTRA) have been proven to help control mild-to-moderate persistent asthma in school-age children, a new meditate shows ICS may be the more effective pharmacomedical care.

Response Profiles to Fluticasone and Montelukast in Mild-to-Moderate Persistent Childhood Asthma is featured in the January 2006 issue of the Journal of Hypersensitivity reaction & medical institution al Immunology (JACI) and is currently available on the JACI’s Web site at www.jacionline.org. The JACI is the peer-reviewed, scientific journal of the American Academy of Hypersensitivity reaction, Asthma and Immunology (AAAAI).

The 16-week meditate was conducted as a multi-center, double-masked, 2-sequence crossover trial by the National Heart, Lung and Blood Institute (NHLBI) Childhood Asthma Research and Education (CARE) Network. Researchers, led by Robert S. Zeiger, MD, PhD, from the University of California San Diego Department of Pediatrics, administered an ICS (fluticasone propionate) twice daily or an LTRA (montelukast) nightly to more than 100 children ages 6 to 17 who had mild-to-moderate persistent asthma.

Researchers found both fluticasone and montelukast led to significant improvements in many measures of asthma control. However, similar to earlier research, they found strong evidence of greater mean improvements after 8 weeks of medical care with an ICS compared with a LTRA across many otherness outcomes.

Patients taking ICS experienced more asthma control days (ACD) in which they had no daytime or night time asthma syndromes, along with better pulmonary responses and inflammatory biomarkers. As a comparison, 29.3 percent of participants had at least one more ACD per week during pharmacomedical care with fluticasone than during pharmacomedical care with montelukast (12.2 percent).

To find an allergist/immunologist in your area, call the AAAAI Physician Referral and Information Line at (800) 822-2762 or visit the AAAAI Web site at http://www.aaaai.org.

The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and othernesss with a special interest in the research and pharmacomedical care of allergic illness. Hypersensitivity reaction/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the pharmacomedical care of asthma, hypersensitivity reaction and immunologic illness. Established in 1943, the AAAAI has more than 6,000 members in the United States, Canada and 60 otherness countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at http://www.aaaai.org .

Karen Janka
kjanka@aaaai.org
American Academy of Hypersensitivity reaction, Asthma & Immunology
http://www.aaaai.org

A small study indicates that there was no difference between an over-the-counter decongestant (pseudoephedrine) and a prescription medication (montelukast) in relieving symptoms associated with allergic rhinitis and improving quality of life, according to a study in the February issue of Archives of Otolaryngology - Head & Neck Surgery, one of the JAMA/Archives journals.

Allergic rhinitis, inflammation and congestion of the nasal passages associated with seasonal allergies, such as hay fever, affects about 40 million people in the United States. Symptoms include sneezing, runny nose, itchy nose and throat and nasal congestion, according to background information in the article. The condition also may cause more serious consequences, such as problems sleeping, daytime sleepiness and reduced productivity. Several medications, including pseudoephedrine hydrochloride (an over-the-counter preparation) and montelukast sodium (a prescription drug), are available to treat symptoms, the authors report.

Samatha M. Mucha, M.D., and colleagues at the University of Chicago compared these two pharmacotherapys in a group of 58 adults with ragweed allergic rhinitis, as documented by the results of skin agsdhfgdfing. Participants recorded their symptoms and quality of life at the beginning of the study and took one of the medications each morning for two weeks. Thirty patients received montelukast and 28 took pseudoephedrine.

Both pharmacotherapys reduced all the symptoms of allergic rhinitis, including congestion, runny nose and sneezing, and improved quality of life. Pseudoephedrine was more effective than montelukast at alleviating the symptom of nasal congestion. Both medications improved nasal peak inspiratory flow, which objectively gauges nasal congestion by measuring the amount of air flowing into the nose.

Although nervousness, anxiety, insomnia, dry mouth and palpitations have been associated with pseudoephedrine in previous studies, neither medication caused any significant side effects in this investigation. “Both medications were well tolerated, and pseudoephedrine did not lead to any of its well-known stimulant adverse effects, likely owing to its once-daily administration in the morning and lower blood levels in the later hours of the day closer to bedtime,” the authors write.


.


(Arch Otolaryngol Head Neck Surg. 2006;132:164-172. Available pre-embargo to the media at http://www.jamamedia.org/.)

Editor’s Note: Drs. Naclerio and Baroody belong to the Speakers Bureaus of Merck & Co. Inc. and Dr. Baroody has received honoraria from Merck. This study was supported in part by a medical school grant from Merck & Co. Inc. (Dr. Baroody) and Merck contributed editorial suggestions during the preparation of this article.

Contact: John Easton
JAMA and Archives Journals

Young children with attacks of sporadic, recurring asthma who were treated with the prescription drug montelukast by their parents had fewer unscheduled trips to the doctor, missed less days from school or childcare, and caused their parents to take fewer days off work for their care.

Results from this multi-center, randomized, double-blind and placebo-controlled trial appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children’s Hospital in Melbourne, Australia, and eight associates studied 202 children, ages 2 to 14, who were given either montelukast or placebo by their parents when needed for one year. All of the children had intermittent, doctor-diagnosed asthma.

By the end of the year-long study, the patients treated with montelukast had 163 unscheduled health resource visits for their illness, as compared with 228 in the placebo group.

“Symptoms were reduced by 14 percent, nights awakened by 8.6 percent, days off from school or childcare by 37 percent and parent time off from work by 33 percent,” said Dr. Robertson.

In asthma, children’s airways become chronically inflamed, with various stimuli causing episodes of airway obstruction and breathing difficulties. The disease is the most common chronic disorder of childhood and affects an estimated 6.2 million children under age 18 in the U.S.

Intermittent asthma is the most common pattern of the disease in children, accounting for attacks in 75 percent of affected youngsters.

Montelukast sodium, a specific leukotriene receptor antagonist that has been shown to be effective in children, is used to prevent mild, persistent asthma. It reduces the swelling and inflammation that tend to close airways, and relaxes the walls of the bronchial tubes, allowing more air to pass through to the lungs.

“Acute episodes of asthma in young children place a significant burden on healthcare resources,” said Dr. Robertson. “Admission to the hospital for asthma in children aged 0 to 4 years is five times more common, and for those aged 5 to 14 years, twice as common as for adults who have asthma.”

The study was designed to evaluate parent-initiated therapy with montelukast at the onset of each upper respiratory infection or asthma symptom. Pharmacotherapy continued for a minimum of seven days or until symptoms had resolved for 24 hours.

“A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work,” said Dr. Robertson. “Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family.”

The authors noted that there was no significant reduction in specialist care, hospitalizations, duration of episodes, or use of beta-agonists and prednisolone as a result of montelukast study.

An analysis of cost showed that the use of montelukast resulted in a savings of $124 Australian dollars - about $96 U.S. dollars - or 29 percent less per treated episode than the placebo controlled arm of the trial.

Founded in 1905, the American Thoracic Society is the world’s leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

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In the light of recent evidence on the role of leukotriene receptor antagonists in patients with asthma, Drug and Therapeutics Bulletin (DTB) reconsiders conclusions it reached about these pharmacotherapys in 1998.

Current British guidelines advise that leukotriene antagonists should be considered as an add-on therapy in patients whose asthma is inadequately controlled by regular inhaled corticosteroid in conventional doses.

The evidence now available suggests that the leukotriene receptor antagonists, montelukast and zafirlukast, are suitable as add-on pharmacotherapy in patients with mild or moderate asthma inadequately controlled by conventional doses of inhaled corticosteroid plus use of an inhaled short-acting beta2 agonist.

However, the average additional clinical benefit of adding such pharmacotherapy appears slight, according to DTB, and at least in adults is generally less than that of inhaled long-acting beta2 agonist therapy. Therefore, an inhaled long-acting beta2 agonist should generally be tried first.

However, only montelukast is both licensed and known to be effective in children under 4-5 years old, and so is the preferred add-on pharmacotherapy in this age group.

Leukotriene receptor antagonists are a possible option for people with exercise-induced asthma, but these symptoms may indicate inadequate control of the asthma and should prompt a broader review of asthma preventative pharmacotherapy.

Further research is needed on whether leukotriene receptor antagonists could offer added clinical benefits to particular groups of patients, such as those with seasonal allergic rhinitis, those with aspirin-intolerant asthma, and young children with recurrent wheezing.

Dr Ike Iheanacho, editor, DTB, said:

“In general, there appears to be only modest additional clinical benefit from using leukotriene receptor antagonists as add-on therapy in adults. More research is needed to investigate whether they offer added clinical advantages for specific groups of patients with asthma.”

IN THE BAG FOR GPS - a summary of the DTB article on suggested medicines GPs should carry in case of emergency while on home visits and the storage of such medicines.

Many GPs have given up responsibility for out-of-hours services, due to alternative provision by primary care trusts. However, there remains a need for many GPs to carry an appropriately stocked bag for dealing with acute situations when on home visits. So continuing its long-running series on DRUGS FOR THE DOCTOR’S BAG, DTB offers practical suggestions on what should be carried for treating child patients in a range of key clinical scenarios, including the following:

- Asthma and coup
- Infection
- Dehydration
- Diabetic emergencies
- Seizures
- Anaphylaxis
- Acute pain
- Opioid overdose
- Nausea and vomiting
- Hypoadrenalism

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Allergy season is here, and over-the-counter allergy medications are flying off the shelves. But did you know that mixing certain allergy medications with other medicines can have hazardous effects on your health?

The active ingredients of allergy products can cause over-medicating with other combination or single-entity non-prescription or prescription medications.

“By consulting with your pharmacist, consumers can make an educated choice as to which allergy medicine is right for them,” says Dr. Daniel A. Hussar, Remington professor of pharmacy at Philadelphia College of Pharmacy at University of the Sciences in Philadelphia. “Consumers should read the warnings on over-the-counter medicines and consult with their pharmacist in order to make educated decisions about which allergy medication is right for them.”

“Certain allergy medications (antihistamines) can cause drowsiness or sleepiness, and caution must be observed when participating in activities like driving or operating machinery,” Hussar noted. If this response is bothersome, the consumer should ask the pharmacist to recommend a product that does not cause this sedative effect.

Some antihistamines have a drying effect and cause annoying effects like dry mouth. “This is another situation in which the pharmacist can recommend another product that is not likely to cause this effect.”

Some allergy products contain analgesics such as acetaminophen or ibuprofen. When an allergy product containing one of these analgesics as a secondary ingredient is taken by a patient who is also using an analgesic for another purpose, an excessive response may result. Side effects may be subtle and develop slowly but, in some individuals serious stomach, kidney, or liver problems could result.

Some patients with high blood pressure may experience problems due to the decongestants included in many allergy products. Decongestants can raise blood pressure, which can be particularly dangerous in patients with high blood pressure that is not well controlled, says Hussar.

Dr. Hussar has been quoted and has published extensively on issues surrounding consumer-related pharmacy practices. Dr. Hussar is available for interviews.

University of the Sciences in Philadelphia is a private, coeducational institution founded in 1821 as Philadelphia College of Pharmacy, the first college of pharmacy in North America. It is where the founders of six of the top pharmaceutical companies in the world launched their futures. Comprising four colleges across a broad range of majors, USP specializes in educating its 2,800 students for rewarding careers through its undergraduate, graduate, and doctoral degree programs in pharmacy, science, and the health sciences.

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Researchers from Mayo Clinic have discovered that allergic rhinitis is associated with the development of Parkinson’s disease later in life. Findings will be published in the Aug. 8 issue of the journal Neurology.

“The association with Parkinson’s disease is increased to almost three times that of someone who does not have allergic rhinitis,” says James Bower, M.D., Mayo Clinic neurologist and lead study investigator. “That’s actually a pretty high elevation.”

Previous studies had shown that people who regularly take nonsteroidal anti-inflammatory drugs, such as ibuprofen, are less likely to develop Parkinson’s disease. These results prompted the Mayo Clinic investigators to look further into the links between diseases characterized by inflammation and Parkinson’s. They studied 196 people who developed Parkinson’s disease, matched with people of similar age and gender who did not develop Parkinson’s. The study was conducted in Olmsted County, Minn., home of Mayo Clinic, over a 20-year period.

The researchers examined these groups to determine if those who developed Parkinson’s disease had more inflammatory diseases. They found that those with allergic rhinitis were 2.9 times more likely to develop Parkinson’s. They did not find a similar association between inflammatory diseases such as lupus, rheumatoid arthritis, pernicious anemia or vitiligo and Parkinson’s disease. The researchers hypothesize that they may not have found significant links between these diseases and Parkinson’s disease due to the relatively small number of those in the population who have these diseases, and thus the small number with these diseases in their population sample study. They also did not find the same association with Parkinson’s disease in patients with asthma that they discovered in those with allergic rhinitis.

Dr. Bower says that this study did not examine patients’ types of allergies or when they developed allergies.

The investigators theorize that a tendency toward inflammation is the key link between the diseases.

“People with allergic rhinitis mount an immune response with their allergies, so they may be more likely to mount an immune response in the brain as well, which would produce inflammation,” Dr. Bower says. “The inflammation produced may release certain chemicals in the brain and inadvertently kill brain cells, as we see in Parkinson’s.”

Dr. Bower explains that this study does not prove that allergies cause Parkinson’s disease; instead, it points to an association between the two diseases. He advises that allergy patients can do little to reduce the potential risk for Parkinson’s.

“I wouldn’t worry if you have allergies,” he says. “Treat the allergy symptoms you have to alleviate them at the time. At this point, we have no good evidence that this treatment will protect you from possibly developing Parkinson’s disease later.”

Dr. Bower and colleagues hope, however, that the clues in this study may give scientists a strong hint about inflammation’s role in Parkinson’s.

“This is exciting, because we may be able to develop medications to block the inflammation,” he says.

Parkinson’s is a complex disease, says Dr. Bower, because many factors can contribute to its development and its causes can differ. The complexity can be compared to heart attacks, which can be caused by hypertension, high cholesterol or smoking, among other factors. Thus, allergic rhinitis would now be considered one among many possible risk factors for development of Parkinson’s disease.

Parkinson’s disease affects nerve cells (neurons) in the part of the brain that controls muscle movement. People with Parkinson’s disease often experience trembling, muscle rigidity, difficulty walking, and problems with balance and coordination. These symptoms generally develop after age 50, although the disease also affects a small percentage of younger people. The normal lifetime risk to develop Parkinson’s disease for men and women combined is 1.7 percent.

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