年11月9日,美国AHA科学年会公布了EVITA试验结果,该结果同时在线发表于《循环》杂志。其结果显示,在发生急性冠脉综合征(ACS)后于院内启用伐尼克兰可有效戒烟,但仍需进一步研究来明确该药在这些患者中的安全性。
不足1/3的因ACS住院的吸烟者在出院后仍处于戒烟状态。本研究旨在评估伐尼克兰是否在ACS后入院初始即可有效戒烟。为此这项多中心、双盲、随机、安慰剂对照试验将患者随机分为伐尼克兰组或安慰剂组,治疗12周。所有患者均接受低强度咨询。主要终点是在24周时通过7天回忆评估时点戒烟率,并采用呼气中一氧化碳浓度来进行生化确认。
结果显示,共例患者被随机分组(平均55±9岁,男性占75%,ST段抬高心梗占56%,非ST段抬高心梗占38%,不稳定性心绞痛占6%)。患者入院时平均每日吸烟(21±11)支,并且已平均吸烟(36±12)年。24周时,伐尼克兰组患者的戒烟率以及减烟率显著高于安慰剂组患者。伐尼克兰组和安慰剂组的时点戒烟率分别为47.3%和32.5%(P=0.,需要治疗数=6.8)。持续戒烟率分别为35.8%和25.8%(P=0.,需要治疗数=10.0),并且每日吸烟量减少≥50%的比率分别为67.4%和55.6%(P=0.05,需要治疗数=8.5)。两组停药30天内的不良事件发生率相似(严重不良事件率分别为11.9%对比11.3%,主要不良心血管事件率分别为4.0%对比4.6%)。
(英文原文)VareniclineforSmokingCessationinHospitalizedPatientsWithAcuteCoronarySyndrome
Background—Lessthanone-thirdofsmokershospitalizedwithanacutecoronarysyndrome(ACS)remainabstinentfollowingdischarge.Weassessedwhethervarenicline,begunin-hospital,isefficaciousforsmokingcessationfollowingACS.
MethodsandResults—Weconductedamulti-center,double-blind,randomized,placebo-controlledtrialinwhichsmokershospitalizedwithanACSwererandomizedtovareniclineorplacebofor12weeks.Allpatientsreceivedlow-intensitycounseling.Theprimaryendpointwaspoint-prevalencesmokingabstinenceassessedat24weeksby7-dayrecallandbiochemicalvalidationusingexpiredcarbonmonoxide.Atotalofpatientswererandomized(meanage55±9years;75%male;56%ST-segmentelevationmyocardialinfarction;38%non-ST-segmentelevationmyocardialinfarction;6%unstableangina).Patientssmokedameanof21±11cigarettes/datthetimeofhospitalizationandhadbeensmokingforameanof36±12years.At24weeks,patientsrandomizedtovareniclinehadsignificantlyhigherratesofsmokingabstinenceandreductionthanpatientsrandomizedtoplacebo.Point-prevalenceabstinencerateswere47.3%inthevareniclinegroupand32.5%intheplacebogroup(P=0.;numberneededtotreat=6.8).Continuousabstinencerateswere35.8%and25.8%,respectively(P=0.;numberneededtotreat=10.0),andratesofreduction≥50%indailycigaretteconsumptionwere67.4%and55.6%,respectively(P=0.05;numberneededtotreat=8.5).Adverseeventrateswithin30daysofstudydrugdiscontinuationweresimilarbetweengroups(seriousadverseevents:varenicline11.9%,placebo11.3%;majoradversecardiovascularevents:varenicline4.0%,placebo4.6%).
Conclusions—Varenicline,initiatedin-hospitalfollowingACS,isefficaciousforsmokingcessation.Futurestudiesareneededtoestablishsafetyinthesepatients.
来源:ACCNewsStory(November9,)
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