The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery,American Journal of Cardiovascular Drugs

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The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery
American Journal of Cardiovascular Drugs ( IF 3 ) Pub Date : 2021-07-26 , DOI: 10.1007/s40256-021-00489-3
Andre Lamy _{1,

2,

3,

4} , Wesley Tong ₅ , Rajibul Mian ₅ , Jessica Vincent ₅ , Wojciech Szczeklik ₆ , Bruce M Biccard ₇ , Emmanuelle Duceppe _{4,

8} , Maria Graza Franzosi ₉ , Sadeesh K Srinathan ₁₀ , Christian S Meyhoff ₁₁ , Joel Parlow ₁₂ , Denis Xavier ₁₃ , P J Devereaux _{4,

5,

14}

Affiliation

Population Health Research Institute, McMaster University, DBCVSRI C1-112, 237 Barton St East, Hamilton, ON, L8L 2X2, Canada.
CADENCE Research Group, Hamilton Health Sciences, Hamilton, ON, Canada.
Department of Surgery, McMaster University, Hamilton, ON, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Population Health Research Institute, Hamilton, ON, Canada.
Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.
Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.
Department of Medicine, University of Montreal, Montreal, QC, Canada.
Department of Cardiovascular Research, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Department of Surgery, University of Manitoba, Winnipeg, MB, Canada.
Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, Canada.
Department of Pharmacology, St John's Medical College and Research Institute, Bangalore, India.
Department of Medicine, McMaster University, Hamilton, ON, Canada.

Background

The Management of Myocardial Injury after Non-Cardiac Surgery (MANAGE) trial demonstrated that dabigatran 110 mg twice daily was more effective than placebo in preventing the primary composite outcome of vascular mortality, non-fatal myocardial infarction, non-hemorrhagic stroke, peripheral arterial thrombosis, amputation and symptomatic venous thromboembolism in patients with myocardial injury after non-cardiac surgery (MINS). The cost implications of dabigatran for this population are unknown but are important given the significant clinical implications.

Methods

Hospitalized events, procedures, and study and non-study medications were documented. We applied Canadian unit costs to healthcare resources consumed for all patients in the trial, and calculated the average cost per patient in Canadian dollars for the duration of the study (median follow-up of 16 months). A sensitivity analysis was performed using only Canadian patients, and subgroup analyses were also conducted.

Results

The total study cost for the dabigatran group was $9985 per patient, compared with $10,082 for placebo, a difference of − $97 (95% confidence interval [CI] − $2128 to $3672). Savings arising from fewer clinical events and procedures in the dabigatran 110 mg twice-daily group were enough to offset the cost of the study drug. In Canadian patients, the difference was $250 (95% CI −$2848 to $4840). Both differences were considered cost neutral. Dabigatran 110 mg twice daily was cost saving or cost neutral in many subgroups that were considered.

Conclusion

Dabigatran 110 mg twice daily was cost neutral for patients in the MANAGE trial. Our cost findings support the use of dabigatran 110 mg twice daily in patients with MINS.

Trial Registration

ClinicalTrials.gov identifier number NCT01661101.

中文翻译：

达比加群对非心脏手术后心肌损伤患者的成本影响

背景

非心脏手术后心肌损伤管理 (MANAGE) 试验表明，达比加群 110 mg 每天两次在预防血管死亡率、非致死性心肌梗死、非出血性中风、外周动脉血栓形成的主要复合结局方面比安慰剂更有效、非心脏手术 (MINS) 后心肌损伤患者的截肢和症状性静脉血栓栓塞。达比加群对这一人群的成本影响尚不清楚，但考虑到重要的临床意义，这一点很重要。

方法

记录住院事件、程序以及研究和非研究药物。我们将加拿大单位成本应用于试验中所有患者所消耗的医疗资源，并计算了研究期间每位患者的平均成本（以加元为单位）（中位随访时间为 16 个月）。仅对加拿大患者进行了敏感性分析，还进行了亚组分析。

结果

达比加群组的总研究成本为每名患者 9985 美元，而安慰剂组为 10,082 美元，差异为 - 97 美元（95% 置信区间 [CI] - 2128 至 3672 美元）。达比加群 110 mg 每天两次组由于较少的临床事件和程序而节省的费用足以抵消研究药物的成本。在加拿大患者中，差异为 250 美元（95% CI -2848 至 4840 美元）。这两种差异都被认为是成本中性的。达比加群 110 mg 每天 2 次在考虑的许多亚组中节省成本或成本中性。