2014年第50届美国临床肿瘤学会(ASCO)年会公布一项随机、对照试验显示,终末期患者停用他汀类药物并不会加速死亡,且可能改善患者生活质量。(摘要号LBA9514)
该研究入组381例预期寿命为1个月至1年的患者(49%为肿瘤患者),接受一级或二级预防已持续服用他汀类药物至少3个月。研究随机分配(1:1)患者停用或继续接受他汀治疗。
结果发现,停用和继续接受他汀类药物治疗患者60d的死亡率无显著差异(23.8% vs 20.3%,P=0.60)。而停用他汀组患者的中位生存期比继续治疗组更长(229d vs 190d)。此外,停用他汀组在二级终点生活质量方面更有优势(HR=0.26)。
加利福尼亚大学Patricia Ganz表示,改变一种患者已经长期、稳定接受的治疗方案是很困难的。需长期服用的药物多为预防用药,但当患者的生命所剩无几时,预防其实已没有实际意义了。
杜克大学医学中心Amy Abernethy指出,这是一项以患者为中心的研究。他汀药物对某些癌症(如前列腺癌或肝癌)患者的生存有益,但晚期癌症的管理策略应有所不同。
停用他汀类药物后,患者对治疗和自身总体症状的满意度轻微降低,这一阶段的患者已出现吞咽困难。停用他汀类药物也让医生思考是否可以停用更多其他药物。
多重用药在终末期疾病患者中很常见,停用他汀类药物仅使服用药物的总体数量稍有下降(10.1 vs 10.8),但节约的费用却相当可观,可达到3.37美元/患者/d,据此推算,全美每年将节约6.03亿美元的医疗费用。
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会议专题》》》2014年ASCO年会专题报道
阅读摘要原文
Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness.(Abstract No:LBA9514)
Authors: Amy Pickar Abernethy, Jean Kutner, Patrick Jud Blatchford, et al.
Session Type: Clinical Science Symposium
Background: For patients with life-threatening illness such as advanced cancer, optimal management of longstanding medications prescribed for comorbid illness is uncertain. Risks may outweigh benefits; e.g., benefits from HMG Co-A reductase inhibitors (“statins”) may take years to accrue and may not be relevant for a person with limited prognosis. Is it safe to discontinue statins for the patient with less than a year to live?
Methods: This was a multicenter, unblinded pragmatic trial. At enrollment, participants were randomized (1:1) to discontinue or continue their statin medication. Eligible patients were adults with advanced life-limiting illness on a statin for ≥3 months for primary or secondary prevention, a life expectancy of greater than one month, and evidence of recent deterioration in performance status. Outcomes measured at baseline and at least monthly included survival, cardiovascular-related events, quality of life (QOL), symptoms, and polypharmacy. Rate of death within 60 days of randomization was the primary outcome.
Results: 381 patients were enrolled (189 discontinue statins; 192 continue statins). Mean age was 74 years (SD 12); 22% were cognitively impaired; 49% had cancer as the primary diagnosis; and, 69% had used statins for >5 years. Rate of death within 60 days was not statistically different between groups (discontinue vs. continue, 23.8% vs. 20.3%, 90% CI -3.5% to 10.5%, p=0.36). The group discontinuing statins had longer median time-to-death (229 days [90% CI 186–332] vs. 190 days [90% CI 170-257]; p=0.60). Total QOL was significantly better among the group discontinuing statins (McGill QOL: 7.11 vs. 6.85, p=0.037) and there were fewer symptoms in this group (Edmonton Symptom Assessment Scale: 25.2 vs. 27.4, p=0.128). People in the discontinue statins group took significantly fewer medications (10.1 vs. 10.8, p = 0.034). Few participants in either group experienced cardiovascular events (13 vs. 11).
Conclusions: In the setting of life-limiting illness such as advanced cancer, it is unlikely that harm will accrue when statins being used for primary or secondary prevention are discontinued; these patients may even benefit. Clinical trial information: NCT01415934.