Дългосрочният прием на инхалаторни кортикостероиди (ИКС) при пациенти с хронична обструктивна белодробна болест (ХОББ) е свързан с риск за пневмония, като рискът варира между 1 и 10 на 100. Не съществува значима разлика по отношение на риска между различните представители на този клас медикаменти, е заключението на ЕМА (1).
Инхалаторните кортикостероиди (beclomethasone,budesonide, flunisolide, fluticasone propionate), самостоятелно или в комбинация с други медикаменти (като дългодействащи бета2-агонисти – LABA), се прилагат широко за лечение на ХОББ.
Регулаторният орган прецени, че ползата от инхалаторните кортикостероиди при ХОББ продължава да надхвърля рисковете, и не трябва да има промяна в начина на предписването им.
Лекуващите лекари трябва да проследяват пациентите за риск за пневмония при приложението им, като се има предвид, че клиничните симптоми на пневмонията могат да се припокрият с тези на екзацербация на основното заболяване.
Решението на ЕМА е базирано на обзор на публикувани рандомизирани контролирани проучвания и на няколко мета-анализи. Към момента липсват директни изследвания за риска за пневмония при инхалаторните кортикостероиди, като основната информация е от индиректни сравнения.
Лекарствените инструкции на всички инхалаторни кортикостероиди ще бъдат актуализирани за да отразят риска за пневмония при приложението им.
Използван източник:
1. EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary diseasehttp://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2016/04/WC500205577.pdf
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