Ana sayfa SEKTÖR Astım üzerine öncü Salford Akciğer Çalışmasının Avrupa Solunum Kongresi’nde sunulan pozitif sonuçları

Astım üzerine öncü Salford Akciğer Çalışmasının Avrupa Solunum Kongresi’nde sunulan pozitif sonuçları

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4 bin 233 hasta, 70 hekim, 130’dan fazla eczanenin katıldığı ve sonuçların oluşturulan elektronik sağlık kayıt sisteminde analiz edildiği SLS çalışmasında, Relvar Ellipta kullanmaya başlayan hastaların, normal tedavilerine devam eden hastalarla karşılaştırıldığında astım kontrollerinde iki kat iyileşme sağlandığı gözlendi.

 

GlaxoSmithKline ve Innoviva, astım üzerine yenilikçi Salford Akciğer Çalışmasının (SLS) pozitif sonuçlarının Milano’daki Avrupa Solunum Derneği (ERS) Uluslararası Kongresi’nde sundu. Çalışmayı tanıtan Baş Araştırmacı Ashley Woodcock, Relvar Ellipta 100/25 mcg (flutikazon furoat ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) tedavisine başlayan hastaların, normal tedavilerini almaya devam edenlerle karşılaştırıldığında önemli ölçüde daha fazla hastanın astım kontrollerinde iyileşme sağladığını vurguladı. Normal tedaviye monoterapi veya İKS/LABA (Uzun Etkili Beta Agonist) kombinasyonu olarak kullanılan solunan kortikosteroidler (KS) dahildir.

 

İlk sonuçlarını Mayıs 2017’de bildiren bu öncü açık uçlu, randomize çalışma, günlük klinik uygulamada kendi aile hekimleri tarafından 4233 hasta arasında gerçekleşti. 24. haftada, semptomatik astımı olan ve FF/VI tedavisine başlayan hastalarda (yüzde 71), normal tedavisine devam edenlere (yüzde 56) göre Astım Kontrol Testi (AKT) ile ölçülen astımlarını kontrol etme konusunda önemli ölçüde yüksek bir yüzdeye sahip olduğu görüldü(Olasılık oranı 2,00, yüzde 95 CI 1,70, 2,34; p<0.001). İyileşme, AKT toplam puanı ≥20 veya başlangıç seviyesinden ≥3 artış olarak belirlendi. İstatistiksel öneme sahip bulgular, 1240 ve 52. haftalarda da görüldü.

 

South Manchester Üniversite Hastanesi ve Manchester Üniversitesi, Solunum Klinik Direktörü ve Solunum Hastalıkları Profesörü olan Baş Araştırmacı Ashley Woodcock şunları söyledi: “Salford Akciğer Çalışması, doktorlara, günlük olarak insanların hayatlarını ve durumlarını yönetmede tedavilerin etkisini anlamalarına imkan sağladığı için son derece önemlidir. Geçen yıl KOAH’da FF/VI’ın günlük etkinliğini değerlendirerek başladık ve bugün astım üzerinde pozitif etkiler gördük. Daha öğrenecek çok fazla şey olduğunu bildiğimiz için çalışmanın verilerini analiz etmeye devam ediyoruz ve gelecekte bulguları paylaşmayı bekliyoruz.”

 

Bu çalışmada tedavi amaçlı (ITT) popülasyonun ciddi advers olay (SAE) insidansı her iki kol için aynıdır (FF/VI yüzde 13, normal tedavi yüzde 13). Zatürre, özel önem verilen ve Avrupa İlaç Kurumu’nun (EMA) yönetmeliğe bağlı yetkilendirme sonrası güvenlik sonlanım noktasıdır. Çalışma tasarımının özgün yönlerinden biri, çalışma sırasında hastaların tedavilerinin değiştirilmesine izin vermesidir. Bu nedenle zatürreyle ilgili olarak iki değerlendirme yapılmıştır, biri hastaların randomize edildiği kola dayalı olarak, ikincisi ise olay sırasında hastaların hangi tedaviyi aldıklarına bağlı olarak. Randomize gruba göre ciddi zatürre advers olayı 39 hastada rapor edilmiştir (FF/VI kolu 23, yüzde 1; normal tedavi kolu 16, <yüzde 1). Bu hastalarda 42 olay görülmüştür ve FF/VI ile normal bakım açısından önceden planlı eşit etkinlik analizine göre onaylanmamıştır. Bu olaylar, gerçek tedavi gören hastaların olay sırasında aldıkları ilaca göre özetlendiğinde 21 olay FF/VI ve 21 olay da normal tedavi sırasında kaydedilmiştir.

 

Çalışma tasarımı

 

Salford Akciğer Çalışması, Faz III, çok merkezli, açık uçlu randomize kontrollü çalışmadır (RKÇ). Bu çalışmanın amacı, 52 haftalık bir periyotta normal astım bakım tedavisiyle FF/VI tedavisinin başlatılmasının etkinliğini ve güvenlik profilini karşılaştırmaktır. Salford ve Güney Manchester, Birleşik Krallık bölgelerinde ve çevrelerindeki 74 birinci bakım merkezlerindeki uygun astım hastaları, bakım veritabalarından belirlenmiştir ve kendi Pratisyen Hekimleri tarafından çalışmaya katılmaları için davet edilmişlerdir. Çalışmanın birincil sonlanım noktası, birincil etkinlik analiz popülasyonunda 24. haftada ölçülmüştür.

 

Toplamda uzun etkili beta2 agonist (LABA) ile veya olmaksızın solunan kortikosteroit alan 4233 astım hastası, ya FF/VI almak için ya da mevcut astım bakım tedavilerine devam etmeleri için randomize edilmişlerdir.

 

Normal bakım hastanın aile hekimi tarafından yazılmıştır ve ya tek ya da bir LABA ile birlikte alınan İKS dahil edilmiştir. Normal bakım kolunda hastaların yüzde 36’sı yalnızca İKS ve yüzde 64’ü çalışmadaki tedavinin başladığı sırada KS/LABA kombinasyonu almıştır.

 

Salford Akciğer Çalışmasının minimum dahil etme kriteri vardır ve geniş çaplı bir hasta demografiğini içermektedir. Başlangıçta hastaların ortalama yaşı 49,8 (en az 18 yaş) ve cinsiyete göre ayrılmıştır (erkek-kadın yüzde 41/59). Çalışmaya katılmak için hastaların birincil solunum hastalığı olarak astımları olduğu Pratisyen Hekimleri tarafından tanılanmış olmalıdır ve vizitin öncesinde en az 4 hafta içinde LABA ile ya da onsuz İKS bakım tedavisi almaları gerekmektedir. Başlangıç düzeyinde hastaların yüzde 72’sinin AKT puanı 5 ila 19 arası olan kontrol edilmeyen astımları vardır.

 

Çalışma verisi toplamak için hastalar 52 haftalık bir dönemde normal klinik uygulama ortamında elektronik medikal kayıt (EMR) kullanarak, bağlı birincil basamak bakım, ikinci basamak bakım ve eczane verileriyle takip edilmiştir. Çalışma sürecince doktorların, normal klinik uygulamada olabileceği gibi herhangi bir noktada tedaviyi modifiye etmesine veya değiştirme yapmasına izin verilmiştir, bunun tek istisnası normal bakımdan FF/VI’a geçiş yapmaktır.

 

12,24 ve 40 haftalarda ciddi advers olay veya ciddi olmayan advers ilaç etkileşimi yaşayıp yaşamadıkları konusunda bilgi almak için hastalar telefonla aranmıştır. Bu telefon görüşmelerinde hastalardan AKT’ye cevap vermeleri istenmiştir. 12. ayda yüz yüze bir görüşme yapılmıştır. Telefonla 24. ve 52. haftalarda Standart Astım Yaşam Kalitesi Anketi (AQLQ[S]) de yapılmıştır.

Çalışma ekibi, elektronik sağlık kayıtları sayesinde tüm hastanelerdeki girişleri, ayakta hasta bakımı ve acil bölümü girişleriyle birlikte birinci basamak bakım merkezlerinin de verilerini görüntüleyebilmiştir (tüm sağlık sözleşmeleri, mesai dışı aktiviteler ve antibiyotik veya oral steroit reçeteleri de dahildir).

 

Tedavi amaçlı (ITT) popülasyon, randomize edilmiş ve en az bir reçete çalışma ilacı almış tüm hastalar olarak tanımlanmıştır (ör.: FF/VI veya normal astım bakım tedavisi). Birincil etkinlik analiz (PEA) popülasyonu, başlangıç seviyesinde (randomize vizit) <20 toplam AKT puanı olan tüm ITT hastaları olarak tanımlanmıştır.

Sonuçlardaki olasılık oranı, Relvar Ellipta kullanmaya başlayan hastalarda daha iyi astım kontrolü elde etme olasılığı ve normal bakıma devam eden hastaların daha iyi astım kontrolü elde etme olasılığı oranı olarak hesaplanmıştır. Bu değer, bazı kilit özelliklerde tedavi kolları arasındaki dengesizliklere göre ayarlanmıştır.

 

Çalışma tasarımı protokol metni clinicaltrials.gov adresinde bulunabilir.

 

Astım Kontrol Testi (AKT)

AKT, astım kontrolünü değerlendirmede astım tedavisi kılavuzu olarak tüm dünyada kullanılan ve iyi bilinen bir araçtır. 5 puanlı kategorik ölçekte, sen 4 hafta içinde astım kontrolünü değerlendirmek için kendi kendine uygulanan 5 sorudan oluşmaktadır. Beş sorunun tümünü cevaplayan hastalar, astımlarıyla ilgili 5 ila 25 arasında değişen bir skor alabilirler, daha yüksek skor daha iyi kontrol olduğunu gösterir.

 

5 ila 19 arası toplam AKT puanı, hastanın astımının zayıf veya iyi kontrol edilmediğini belirtir. 20 ila 25 arası toplam AKT puanı, hastanın astımının iyi kontrol ediliyor olduğunu gösterir. Toplam skor, 5 sorunun hepsine verilen puanların bütünü olarak hesaplanır, eksik puan olmadığı varsayılır; herhangi bir puan kayıp ise bu durumda genel puan eksik olacaktır. 3 puanlık bir değişim hasta için klinik olarak önemlidir.

 

Çalışma hakkında

Salford Akciğer Çalışması, sağlık uzmanlarının ve hastaların günlük hayatta ilaçları nasıl kullancaklarının göstergesi olabilecek normal klinik uygulama ortamında veri toplayarak, FF/VI’nin potansiyel değerini daha bütün bir şekilde değerlendirebilmeleri için sağlık uzmanlarına ve karar alıcılara bilgi vermeyi amaçlamaktadır. Bir ilacın güvenliliğini ve etkinliğini belirlemede kritik öneme sahip olmasına rağmen, günlük klinik bakım ortamına göre son derece seçili hasta popülasyonu ve aynı düzeyde kontrollü bir ortamda yapılan bu ilaca yönelik çift kör randomize kontrollü çalışmaların (RKÇ) mevcut veri setlerine ilave edilecektir.

 

Bu çalışma, GSK, North West e-Health (NWEH), Manchester Üniversitesi, Salford Royal NHS Foundation Trust, South Manchester Üniversite Hastanesi (UHSM), NHS Salford ve Salford, Trafford ve Güney Manchester bölgesindeki aile hekimleri ve eczanelerin işbirliğiyle yapılabilmiştir.

 

KOAH’daki Salford Akciğer Çalışması, bulguları Mayıs 2016’da bildirmiştir. Bu, bildirilen ikinci Salford Akciğer Çalışması sonuçlarıdır.

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