（英文原文）FDA approves new drug to treat heart failure
The U.S. Food and Drug Administration todayapproved Entresto (sacubitril/valsartan) tablets for thetreatment of heart failure. The drug has been shown to reduce the rate ofcardiovascular death and hospitalization related to heart failure.
Heart failure is a common conditionaffecting about5.1 million people in the United States. It is a condition in whichthe heart can't pump enough blood to meet the body's needs. Heart failuregenerally worsens over time as the heart's pumping action grows weaker. Theleading causes of heart failure are diseases that damage the heart, such asheart attacks and high blood pressure.
「Heart failure is aleading cause of death and disability in adults,」 said Norman Stockbridge,M.D., Ph.D., director of the Division of Cardiovascular and Renal Products inthe FDA’s Center for Drug Evaluation and Research. 「Treatment can help peoplewith heart failure live longer and enjoy more active lives.」
Entresto was reviewed under the FDA’s priority reviewprogram, which provides for expedited review of drugs that are intended totreat a serious disease or condition and may provide a significant improvementover available therapy. It was also granted fast trackdesignation, which supports FDA’s efforts to facilitate the development andexpedite the review of drugs to treat serious or life-threatening conditionsand fill an unmet medical need.
Entresto was studied in a clinical trial ofmore than 8,000 adults and was shown to reduce the rate of cardiovascular deathand hospitalizations related to heart failure compared to another drug,enalapril. Most patients were also receiving currently approved heart failuretreatments, including beta-blockers, diuretics, and mineralocorticoidantagonists.
The most common side effects in clinicaltrial participants being treated with Entresto were low blood pressure(hypotension), high blood potassium levels (hyperkalemia), and poor function ofthe kidneys (renal impairment).
Angioedema (an allergic reaction usually appearing as swelling of the lips orface) was also reported with Entresto; black patients and patients with a priorhistory of angioedema have a higher risk. Patients should be advised to get emergencymedical help right away if they have symptoms of angioedema ortrouble breathing while on Entresto. Health care professionalsshould advise patients not to use Entresto with any drug from the angiotensinconverting enzyme (ACE) inhibitor class because the risk of angioedema isincreased. When switching between Entresto and an ACE inhibitor, use of the twodrugs should be separated by 36 hours.
Health care professionals should counselpatients about the risk of harm to an unborn baby. If pregnancy is detected,use of Entresto should be discontinued as soon as possible.
來源：ACC News Story（July 8，2015）
【179】FDA批准新藥Entresto用於治療心衰（中文摘要）
FDA 7月7日發布新聞稱，批准新藥Entresto（sacubitril/纈沙坦）片劑用於治療心衰。
在美國心衰是一種常見病，大約有510萬人受累。FDA藥物評估與研究中心心血管和腎病產品部主任Stockbridge認為，心衰是成人死亡和致殘的一個首要原因。心衰治療可有助於延長患者的生存時間並令其享受更多的日常活動。PARADIGM-HF研究（納入8000餘名成人）結果顯示，與依那普利相比，Entresto可降低心血管死亡率並減少因心衰住院的次數。多數患者目前還接受批准用於治療心衰的藥物，包括β-阻滯劑、利尿劑和鹽皮質激素拮抗劑。
Entresto最常見的副作用是低血壓、高鉀血症和腎功能受損。此外，還有血管性水腫的相關報告（黑人患者以及此前有血管性水腫史的患者發生危險較高）。如果患者服用Entresto期間出現血管性水腫症狀或呼吸困難，建議應立即尋求緊急醫療救助。醫務人員應建議患者不要同時使用Entresto和任何的血管緊張素轉換酶抑制劑（ACEI）類藥物，否則增加血管性水腫的發生危險。在Entresto與ACEI互換使用時，應間隔36小時。醫務人員應告誡患者該藥可能對胎兒有害。如果已檢出妊娠，應儘快停用Entresto。
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