本帖最後由 yanjw2000 於 2009-7-31 19:49 編輯
作者：Neil Osterweil
出處：WebMD醫學新聞
July 16, 2009 — 美國食品藥物管理局（FDA）今天宣布，一項評估omalizumab（Xolair，Genetech/諾華藥廠）使用於中重度氣喘病患的臨床研究期中分析結果顯示，相較於控制組，這個藥物可能與特定心臟血管不良反應發生率增加有關。
這項期中分析是來自正在進行的Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma（EXCELS）研究，研究結果顯示，使用omalizumab的受試者，相較於控制組，缺血性心臟疾病、心律不整、心肌病變與心臟衰竭、肺高壓、腦血管疾病、栓塞、形成栓子、栓塞靜脈不良事件發生率顯著增加。
FDA並不建議更改Xolair的安全性標示，而臨床醫師也不需停止使用這個藥物。
根據MedWatch(FDA的安全性資訊與不良反應通報系統)所發出的一項警訊，直到EXCELS研究完成之前，健康照護者與病患們應該注意仿單資訊中標示的風險與好處，以及正在進行的EXCELS研究中，可能的心血管與腦血管不良反應風險。
Omalizumab是一種免疫球蛋白E抗體，被核准使用於中重度氣喘成人與12歲以上的青少年病患，且必須經過檢測長期對空氣傳播過敏原呈陽性反應，或是使用吸入性類固醇後仍然沒有穩定控制症狀的病患。
更多的資訊請造訪MedWatch網站。
與Omalizumab有關的不良反應通報到MedWatch，以電話1-800-FDA-1088或傳真到1-800-FDA-0178，線上通報至http://www.fda.gov/medwatch、或是郵寄到5600 Fishers Lane, Rockville, Maryland 20852-9787。
Omalizumab May Be Linked to Cardiovascular Adverse Events
By Neil Osterweil
Medscape Medical News
July 16, 2009 — Results of an interim safety analysis of a clinical trial evaluating omalizumab (Xolair, Genentech/Novartis) in patients with moderate to severe asthma suggest that use of the drug may be associated with a disproportionate increase in the incidence of certain cardiovascular adverse events compared with control subjects, the US Food and Drug Administration (FDA) announced today.
The interim safety findings were from the ongoing Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial, indicating increases in the incidence of ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared with control subjects, FDA announced.
The FDA is not recommending changes to safety labeling for for Xolair, and clinicians do not need to take their patients off the drug.
"Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
Omalizumab, an anti-immunoglobulin E monoclonal antibody, is approved for the treatment of moderate to severe persistent asthma in adults and adolescents older than 12 years who test positive for reactivity to a perennial airborne allergen and who do not achieve adequate control of symptoms with inhaled corticosteroids.
More information is available on the MedWatch Web site.
Adverse events associated with omalizumab may be reported to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787. |
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