Agreed recommendations on the use of FDC budesonide/formoterol in a single inhaler (SMART) for the treatment of patients with bronchial asthma
- Authors: - -
- Issue: Vol 13, No 3 (2016)
- Pages: 15-29
- Section: Articles
- Submitted: 10.03.2020
- Published: 15.12.2016
- URL: https://rusalljournal.ru/raj/article/view/355
- DOI: https://doi.org/10.36691/RJA355
- ID: 355
Cite item
Abstract
Conclusion paragraphs were discussed at the Advisory Board and adopted by majority of votes during voting. After Advisory Board the initiative group edited the draft opinion in accordance with the received comments and suggestions. The final draft of conclusion has been agreed by all experts of the Advisory Board.
Full Text
References
- Reddel H.K., Taylor D.R., Bateman E.D. et al. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am. J. Respir. Crit. Care Med. 2009, v. 180, p. 59-99.
- Общая заболеваемость взрослого населения в 2014 г., данные Минздрава РФ.
- Итоги проекта GARD. Академик РАМН, профессор А.Г.Чучалин; http://pulmonology.ru/about/gard/totals.php.
- From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2016. Электронный ресурс 17.05.2016г. Available from: http:// www.ginasthma.org.
- Rabe K.F., Vermeire P.A., Soriano J.B., Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur. Respir. J. 2000, v. 16, p. 802-807.
- Demoly P., Gueron B., Annunziata K. et al. Update on asthma control in five European countries: results of a 2008 survey. Eur. Respir. Rev. 2010, v. 19, p. 150-157.
- Price D., Fletcher M., van der Molen T Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim. Care Respir. Med. 2014, v. 24:14009. doi: 10.1038/npjpcrm.2014.9.
- Белевский А.С., Архипов В.В., Цой А.Н. SMART - новая концепция применения Симбикорта у больных бронхиальной астмой. Практическая пульмонология (ранее -«Атмосфера. Пульмонология и аллергология»). 2007, № 2, с. 28-32.
- Цой А.Н., Архипов В.В., Чапурин С.А. и соавт. Фарма-коэкономическое исследование новой концепции при менения Симбикорта у больных бронхиальной астмой. Пульмонология. 2007, № 3, с. 34-40.
- Wark PA.B., Gibson P.G. Asthma exacerbations 3: Pathogenesis.Thorax. 2006, v. 61, p. 909-915.
- Bateman E.D., Boushey H.A., Bousquet J. et al. GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am. J. Respir. Crit. Care Med. 2004, v. 170, p. 836-844.
- Архипов В.В., Цой А.Н. SMART новая концепция применения Симбикорта для терапии больных бронхиальной астмой. Рус. мед. журн. 2006, № 7, с. 525-529.
- Инструкция по медицинскому применению лекарственного препарата Симбикорт® Турбухалер® 80/4,5 мкг/доза, 160/4,5 мкг/доза (порошок для ингаляций дозированный) с учетом изменений № 1, 2, 3. Регистрационное удостоверение П № 013167/01 от 28.09.2011 г.
- Rabe K.F., Pizzichini E., Ställberg B.et al. Budesonide/ formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest. 2006, v. 129, p. 246-256.
- Scicchitano R., Aalbers R., Ukena D. et al. Efficacy and safety ofbudesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr. Med. Res. Opin. 2004, v. 20, p. 1403-1418.
- O’Byrne P.M., Bisgaard H., Godard P.P. et al. Budesonide/ formoterol combination therapy as both maintenance and reliever medication in asthma. Am. J. Respir. Crit. Care Med. 2005, v. 171, p. 129-136.
- Rabe K.F., Atienza T., Magyar P. et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet. 2006, v. 368, p. 744-753.
- Kuna P., Peters M.J., Manjra A.I. et al. Effect of budesonide/ formoterol maintenance and reliever therapy on asthma exacerbations. Int. J. Clin. Pract. 2007, v. 61, 725-736.
- Bousquet J., Boulet L.P., Peters M.J. et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir. Med. 2007, v. 101, p. 2437-2446.
- Vogelmeier C., D’Urzo A., Pauwels R. et al. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur. Respir. J. 2005, v. 26, p. 819-828.
- Ställberg B., Naya I., Ekelund J., Eckerwall G. Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy. Int. J. Clin. Pharmacol Ther. 2015, v. 53, p. 447-455.
- Aubier M., Buhl R., Ekström T. et al. Comparison of two twice-daily doses ofbudesonide/formoterol maintenance and reliever therapy. Eur. Respir. J. 2010, v. 36, p. 524-530.
- Sovani M.P., Whale C.I., Oborne J. et al. Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help? Br. J. Gen. Pract. 2008, v. 58, p. 37-43.
- Dasgupta R., Guest J.F. Factors affecting UK primary-care costs of managing patients with asthma over 5 years. Pharmacoeconomics. 2003, v. 21, p. 357-369.
- Horne R., Weinman J. Self-regulation and self-management in asthma: exploring the role of illness perceptions and treatment beliefs in explaining non-adherence to preventer medication. Psychology & Health. 2002, v. 17, p. 17-32.
- Edwards S.J., von Maltzahn R., Naya I.P., Harrison T. Budesonide/formoterol for maintenance and reliever therapy of asthma: a meta analysis of randomised controlled trials. Int. J. Clin. Pract. 2010, v. 64, p.
- Bateman E.D., Harrison TW, Quirce S. et al. Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps. Respir. Res. 2011, v. 12, p. 38.
- Reddel H.K., Jenkins C., Quirce S.et al. Effect of different asthma treatments on risk of cold-related exacerbations. Eur. Respir. J. 2011, v. 38, p. 584-593.
- Haughney J. Aubier M., Jorgensen L. et al. Eur. Respir. J. 2010, v. 36 (Suppl. 54): abstract No. 4491.
- Haughney J., Aubier M., Jorgensen L. et al. Comparing asthma treatment in elderly versus younger patients. Respir. Med. 2011, v. 105, p. 838-845.
- Van Schayck C.P. et al. Eur. Respir. J. 2010, v. 36, abstract No. 3119.
- Van Schayck O.C., Haughney J., Aubier M. et al. Do asthmatic smokers benefit as much as non-smokers on budesonide/ formoterol maintenance and reliever therapy? Results of an open label study. Respir. Med. 2012, v. 106, p. 189-196.
- Mercado N., To Y., Kobayashi Y. et al. p38 mitogen-activated protein kinase-y inhibition by long-acting β2-adrenergic agonists reversed steroid insensitivity in severe asthma. Mol. Pharmacol. 2011, v. 80, p. 1128-1135.
- Maneechotesuwan K., Essilfie-Quaye S., Meah S. et al. Formoterol attenuates neutrophilic airway inflammation in asthma. Chest. 2005, v. 128, p. 1936-1942.
- Demoly P., Louis R., Soes-Petersen U. et al. Budesonide/ formoterol maintenance and reliever therapy versus conventional best practice. Respir. Med. 2009, v. 103, p. 1623-1632.
- Архипов В.В., Григорьева Е.В., Гавришина Е.В. Контроль над бронхиальной астмой в России: результаты многоцентрового наблюдательного исследования НИКА. Пульмонол. 2011, № 6, с. 87-93.
- Martin R.J. Therapeutic significance of distal airway inflammation in asthma. J. Allergy Clin. Immunol. 2002, v. 109, р. 447-460.
- Sears M.R., Boulet L.P., Laviolette M. et al. Budesonide/ formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. Eur. Respir. J. 2008, v. 31, p. 982-989.
- Hozawa S., Terada M., Hozawa M. Comparison of the effects of budesonide/formoterol maintenance and reliever therapy with fluticasone/salmeterol fixed-dose treatment on airway inflammation and small airway impairment in patients who need to step-up from inhaled corticosteroid monotherapy. Pulm. Pharmacol. Ther. 2014, v. 27, р.190-196.
- Hozawa S., Terada M., Haruta Y., Hozawa M. Comparison of early effects of budesonide/formoterol maintenance and reliever therapy with fluticasone furoate/vilanterol for asthma patients requiring step-up from inhaled corticosteroid monotherapy. Pulm. Pharmacol. Ther. 2016, v. 37, p. 15-23.
- Demoly P., Louis R., Soes-Petersen U. et al. Budesonide/ formoterol maintenance and reliever therapy versus conventional best practice. Respir. Med. 2009, v. 103, p. 1623-1632.
- Kew K.M. Cochrane Database Syst. Rev. 2013, v. 12: CD009019. doi: 10.1002/14651858.CD009019.pub2.
- Cates C.J. Cochrane Database Syst. Rev. 2013, v. 4: CD007313. doi: 10.1002/14651858.CD007313.pub3.
- Sears M.R., Radner F. Safety ofbudesonide/formoterol maintenance and reliever therapy in asthma trials. Respir. Med. 2009, v. 103, p. 1960-1968.
- Sears M.R., Pauwels R.A., Campbell M. et al. Safety of for-moterol turbuhaler used as reliever in asthma: relationship with age and baseline treatment including regular long-acting ß2-agonists (the RELIEF study). Eur. Respir. J. 2002, v. 20, p. 44.
- Partridge M.R., van der Molen T., Myrseth S.E., Busse WW Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm. Med. 2006, v. 6, p. 13.
- Kasak V. et al. ERS 2012 (P2095).
- Liam C.K., Pang Y.K., Chua K.T Satisfaction level and asthma control among Malaysian asthma patients on Symbicort Maintenance and Reliever Therapy (SMART) in the primary care setting (SMARTEST study). Asian Pac. J. Allergy Immunol. 2014, v. 32, p. 145-152.
- Княжеская Н.П., Потапова М.О. Глюкокортикостероидная терапия бронхиальной астмы. Consilium Medicum. 2003, № 4, с. 184-192.
- Гамкрелидзе А.Г. Социоэкономические и фармакоэкономические особенности бронхиальной астмы в развитых и развивающихся странах мира. Астма. 2004, № 1, с. 60-72.
- Зайцев А.А., Никитина Е.В., Синопальников А.И. Основы фармакоэкономического анализа - инструмент повышения качества медицинской помощи. ГлавВрач. 2008, № 3, с. 17-22.
- Авксентьева М.В., Курбачева О.М. Оценка затрат на лекарственное обеспечение больных бронхиальной астмой при различных схемах поддерживающей терапии. Атмосфера. Пульмонол. и аллергол. 2009, № 4, с. 22-26.
- Авдеев С.Н., Григорьева Е.В. Клинические и фармакоэкономические аспекты терапии среднетяжелой и тяжелой астмы в России. Качественная клиническая практика. 2011, № 3, с. 2-7.
- Цой А.Н., Архипов В.В. Фармакоэкономический анализ терапии больных бронхиальной астмой комбинированным препаратом Симбикорт Турбухалер. Пульмонол. 2004, № 2, с. 59-64.
- Johansson G., Andreasson E.B., Larsson P.E., Vogalmeieier C.F. Cost Effectiveness of Budesonide/Formoterol for Maintenance and Reliever Therapy versus Salmeterol. Fluticasone plus Salbutamol in the Treatment of Asthma. Pharmacoeconomics. 2006, v. 24, p. 695-708.