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İnklisiran ile ilişkili olarak VictORION çalışma programı başlığı altında yaklaşık 30 farklı klinik çalışma bulunmaktadır. Bu çalışmaların bir kısmı tamamlanmış ve bir kısmı ise devam etmektedir. Çalışmalar ile ilgili ayrıntı bilgi almak için [email protected] e-posta adresine başvurabilirsiniz.

İnklisiranın etkililiği, aterosklerotik kardiyovasküler hastalığı (ASKVH) (koroner kalp hastalığı, serebrovasküler hastalık veya periferik arter hastalığı), ASKVH risk eşdeğerleri (tip 2 diyabet, ailesel hiperkolesterolemi veya Framingham Risk Skoru veya eşdeğeri ile değerlendirilen kardiyovasküler olaya ilişkin 10 yıllık riskin %20 veya daha fazla olması) ve/veya ailesel hiperkolesterolemisi (FH) olan hastalarda üç faz III çalışmada (ORION-9, 10, 11) değerlendirilmiştir. Hastalar maksimum dozda tolere edilebilen statin tedavileri ile birlikte veya birlikte olmadan lipit düşürücü tedavi alan ve ilave LDL-K düşüşüne ihtiyaç duyan diğer bir ifade ile tedavi hedefine ulaşamayan hastalardan oluşuyor. Hastaların yaklaşık %17’sinde statin intoleransı vardı. Hastalara 1. gün, 90. gün, 270. gün ve 450. günde 284 mg inklisiran veya plasebo subkutan enjeksiyon ile uygulanmıştır. Hastalar 540. güne kadar izlenmiştir. 

İnklisiranın kardiyovasküler morbidite ve mortalite üzerindeki etkisi henüz belirlenmemiştir.

Birleştirilmiş Faz III analizinde, subkutan uygulanan inklisiran, LDL-K’yı 90. gün kadar erken bir dönemde %50 ile %55 arasında düşürmüş olup bu etki uzun süreli tedavi sırasında devam etmiştir. En fazla LDL-K azalması, ikinci bir uygulamayı takiben 150. günde elde edilmiştir. %65’e varan küçük ancak istatistiksel olarak anlamlı daha fazla LDL-K azalmaları; daha düşük başlangıç LDL-K seviyeleri (yaklaşık <2 mmol/l [77 mg/dl]), daha yüksek başlangıç PCSK9 seviyeleri ve daha yüksek statin dozları ve statin yoğunluğu ile ilişkilendirilmiştir.

 

 

 

 

 

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  • Lyptimzia Kısa Ürün Bilgisi (Onay tarihi 02.08.2024)
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