The present invention relates to methods for treating diseases or conditions in which proprotein convertase subtilisin/kexin type 9 (PCSK9) expression or activity causes an impact by administration of PCSK9-specific antibodies or antigen-binding fragments thereof and preferably by additional administration of an inhibitor of 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase). The present invention further relates to PCSK9-specific antibodies or antigen-binding fragments thereof for use in the treatment of diseases or conditions in which PCSK9 expression or activity causes an impact.The present invention also relates to articles of manufacture comprising packaging material, PCSK9-specific antibodies or antigen-binding fragments thereof, and a label or packaging insert indicating which groups of patients can be treated with said antibodies or fragments, which groups of patients must not be treated with said antibodies or fragments, and which dosage regimen should be used.The present invention further relates to methods of testing the efficacy of PCSK9-specific antibodies or antigen-binding fragments thereof for the treatment of certain diseases or conditions and for the treatment of specific sub-groups of patients.本發明係有關一種治療受到前蛋白轉化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type 9)(PCSK9)之表現或活性影響之疾病或病症，其係投與PCSK9之特異性抗體或其抗原結合性片段且較佳係另外投與3-羥基-3-甲基-戊二基-CoA還原酶(HMG-CoA還原酶)之抑制劑。本發明進一步有關PCSK9-特異性抗體或其抗原結合性片段，用於治療受到PCSK9之表現或活性影響之疾病或病症。本發明亦有關一種製造物品，其包含包裝材料、PCSK9-特異性抗體或其抗原結合性片段，及指示適合使用該抗體或片段治療之患者群組、不可以使用該抗體或片段治療之患者群組、及應使用之劑量療程之標籤或包裝插頁。本發明進一步有關一種測試PCSK9-特異性抗體或其抗原結合性片段於治療某些疾病或病症及治療特定患者子群上之效力之方法。
