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Dual-function medication offers hope for asthma sufferers
update
news
PSTT Vol. 3, No. 11 November 2000
Dual-function medication offers hope for asthma sufferers David Bradley, tel/fax: 144 1954 202218, Web: http://www.sciencebase.com
A medication that treats the underlying inflammation together with the bronchoconstriction associated with asthma has been approved by the FDA. The product’s manufacturer, GlaxoWellcome (Research Triangle Park, NC, USA) believes the combination of a corticosteroid, fluticasone propionate, and the bronchodilator, salmeterol, in its Advair Diskus inhaler will offer many asthma patients a more effective and convenient approach to treating their condition. First approval This is the first USA approval of such a drug combination for improving lung function and helping control symptoms in asthma. Reducing the underlying inflammation of the lining of the airways in asthma has become the preferred approach to treating the disorder. Compounds, such as fluticasone propionate inhaled in powder form can help reduce the swelling and irritation associated with this inflammation and reduce the incidence of uncomfortable and sometimes fatally dangerous bronchoconstriction in asthma patients. For many patients, however, tightening of the smooth muscle surrounding the airways leading to constriction is still problematic despite a general reduction in inflammation. Bronchodilators, such as salbutamol, although having no effect on the underlying cause of asthma, can provide immediate but shortlasting relief from associated shortness of breath, wheezing, coughing, chest tightness and other breathing difficulties. Drug combination GlaxoWellcome has combined fluticasone propionate and salmeterol in Advair Diskus for the long-term, twice-daily, maintenance treatment of asthma in patients over the age of 12 years. The product is not for the relief of acute bronchoconstriction because salmeterol is not as
372
rapid acting as salbutamol and other related bronchodilators. Patients take a single inhalation from a breath-activated powder inhaler twice a day, once in the morning and once at night. The incidence of asthma seems to have been rising steadily over the past few years, there are now approximately 3.4 million UK sufferers and 17 million in the USA. Undertreatment has become one of the more serious problems associated with the disorder. For many sufferers, poor therapeutic control leads to repeated symptoms and attacks, which ultimately results in putatively irreversible decline in lung health and function. It is felt that the medical community has an obligation to better educate sufferers about managing their disease more effectively. Moreover, according to GlaxoWellcome, easy-to-use medications are a crucial part of keeping asthma under control and lessening the impact of the disease on individuals. Most asthma treatments have been designed to either relieve bronchoconstriction, by relaxing the smooth muscle surrounding the airways, or reduce airway inflammation, by blocking the cellular processes that lead to chronic swelling and irritation of the airways. Current guidelines on asthma treatment in the USA1, the UK and elsewhere recommend that for those patients suffering daily symptoms, use of a long-acting bronchodilator with inhaled corticosteroids is one of the preferred treatment options, although not necessarily the first choice advised on diagnosis.
Clinical assessment was based on measures of lung function (forced expiratory volume), protection against worsening asthma, acute medication use (a quick and short-acting beta agonist bronchodilator, albuterol), symptoms (reduction in the percentage of symptom-free days was considered a positive), and waking at night because of symptoms and hospital visits. According to the results of the trial, the lowest dose Advair – fluticasone 100 mcg and salmeterol 50 mcg – improved the onesecond FEV by 25% compared with 15% improvement for fluticasone propionate alone and just 5% for salmeterol, at the same individual doses. Of the patients using Advair Diskus 100/50, 3% were withdrawn from the study because their asthma worsened whereas the rate was 11% for fluticasone and 35% for salmeterol. Patients taking Advair had almost twice as many symptom-free days (48%) at the end of the study relative to patients taking fluticasone or salmeterol alone. The most commonly observed side effects were upper respiratory tract infection, sore throat, viral respiratory infection, bronchitis and headache2. The company points out that although the benefits of Advair Diskus have been demonstrated in trials, the product is not intended to replace fast-acting inhalers used for acute attacks. References 1 National Heart, Lung and Blood Institute, National Institutes of Health (1999) Practical
Clinical trials The clinical trials of Advair Diskus on ~1200 patients demonstrated that simultaneously treating both components of asthma (inflammation and bronchoconstriction) led to greater control of the disorder than when either fluticasone propionate or salmeterol inhalation powders were used alone at the same dosage.
Guide for the Diagnosis and Management of Asthma 97, 4053 2 Kavuru, M. et al. (2000) Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomised, double-blind, placebo-controlled trial. J.Allergy Clin. Immunol. 105, 1108–1116
1461-5347/00/$ – see front matter ©2000 Elsevier Science Ltd. All rights reserved. PII: S1461-5347(00)00309-6
news
PSTT Vol. 3, No. 11 November 2000
Dual-function medication offers hope for asthma sufferers David Bradley, tel/fax: 144 1954 202218, Web: http://www.sciencebase.com
A medication that treats the underlying inflammation together with the bronchoconstriction associated with asthma has been approved by the FDA. The product’s manufacturer, GlaxoWellcome (Research Triangle Park, NC, USA) believes the combination of a corticosteroid, fluticasone propionate, and the bronchodilator, salmeterol, in its Advair Diskus inhaler will offer many asthma patients a more effective and convenient approach to treating their condition. First approval This is the first USA approval of such a drug combination for improving lung function and helping control symptoms in asthma. Reducing the underlying inflammation of the lining of the airways in asthma has become the preferred approach to treating the disorder. Compounds, such as fluticasone propionate inhaled in powder form can help reduce the swelling and irritation associated with this inflammation and reduce the incidence of uncomfortable and sometimes fatally dangerous bronchoconstriction in asthma patients. For many patients, however, tightening of the smooth muscle surrounding the airways leading to constriction is still problematic despite a general reduction in inflammation. Bronchodilators, such as salbutamol, although having no effect on the underlying cause of asthma, can provide immediate but shortlasting relief from associated shortness of breath, wheezing, coughing, chest tightness and other breathing difficulties. Drug combination GlaxoWellcome has combined fluticasone propionate and salmeterol in Advair Diskus for the long-term, twice-daily, maintenance treatment of asthma in patients over the age of 12 years. The product is not for the relief of acute bronchoconstriction because salmeterol is not as
372
rapid acting as salbutamol and other related bronchodilators. Patients take a single inhalation from a breath-activated powder inhaler twice a day, once in the morning and once at night. The incidence of asthma seems to have been rising steadily over the past few years, there are now approximately 3.4 million UK sufferers and 17 million in the USA. Undertreatment has become one of the more serious problems associated with the disorder. For many sufferers, poor therapeutic control leads to repeated symptoms and attacks, which ultimately results in putatively irreversible decline in lung health and function. It is felt that the medical community has an obligation to better educate sufferers about managing their disease more effectively. Moreover, according to GlaxoWellcome, easy-to-use medications are a crucial part of keeping asthma under control and lessening the impact of the disease on individuals. Most asthma treatments have been designed to either relieve bronchoconstriction, by relaxing the smooth muscle surrounding the airways, or reduce airway inflammation, by blocking the cellular processes that lead to chronic swelling and irritation of the airways. Current guidelines on asthma treatment in the USA1, the UK and elsewhere recommend that for those patients suffering daily symptoms, use of a long-acting bronchodilator with inhaled corticosteroids is one of the preferred treatment options, although not necessarily the first choice advised on diagnosis.
Clinical assessment was based on measures of lung function (forced expiratory volume), protection against worsening asthma, acute medication use (a quick and short-acting beta agonist bronchodilator, albuterol), symptoms (reduction in the percentage of symptom-free days was considered a positive), and waking at night because of symptoms and hospital visits. According to the results of the trial, the lowest dose Advair – fluticasone 100 mcg and salmeterol 50 mcg – improved the onesecond FEV by 25% compared with 15% improvement for fluticasone propionate alone and just 5% for salmeterol, at the same individual doses. Of the patients using Advair Diskus 100/50, 3% were withdrawn from the study because their asthma worsened whereas the rate was 11% for fluticasone and 35% for salmeterol. Patients taking Advair had almost twice as many symptom-free days (48%) at the end of the study relative to patients taking fluticasone or salmeterol alone. The most commonly observed side effects were upper respiratory tract infection, sore throat, viral respiratory infection, bronchitis and headache2. The company points out that although the benefits of Advair Diskus have been demonstrated in trials, the product is not intended to replace fast-acting inhalers used for acute attacks. References 1 National Heart, Lung and Blood Institute, National Institutes of Health (1999) Practical
Clinical trials The clinical trials of Advair Diskus on ~1200 patients demonstrated that simultaneously treating both components of asthma (inflammation and bronchoconstriction) led to greater control of the disorder than when either fluticasone propionate or salmeterol inhalation powders were used alone at the same dosage.
Guide for the Diagnosis and Management of Asthma 97, 4053 2 Kavuru, M. et al. (2000) Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomised, double-blind, placebo-controlled trial. J.Allergy Clin. Immunol. 105, 1108–1116
1461-5347/00/$ – see front matter ©2000 Elsevier Science Ltd. All rights reserved. PII: S1461-5347(00)00309-6