Batran Radwa Ahmed, Sabri Nagwa Ali, Ali Ihab, Fahmy Sarah Farid
Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Department of Cardiothoracic Surgery, Cardiothoracic Surgery Academy, Ain Shams University, Cairo, Egypt.
Front Cardiovasc Med. 2022 Jul 13;9:889197. doi: 10.3389/fcvm.2022.889197. eCollection 2022.
Despite warfarin therapy had been used for decades for patients with mechanical mitral valve prostheses (MMVPs), serious and life-threatening complications are still reported worldwide with a significant economic burden. This study is aimed at assessing the clinical and the cost-effectiveness of adopting pharmacist-managed warfarin therapy (PMWT) services for optimizing warfarin treatment in Egypt.
A prospective randomized trial in which 59 patients with MMVPs were randomly assigned to receive the PMWT services or the standard care and followed up for 1 year. The primary outcome was percentage time in the therapeutic range (TTR). For the cost-effectiveness analysis, a Markov cohort process model with nine mutually exclusive health states was developed from a medical provider's perspective. A lifetime horizon was applied. All costs and outcomes were discounted at 3.5% annually.
The study results revealed a significantly higher median TTR in the intervention group as compared to the control group; 96.8% [interquartile range (IQR) 77.9-100%] vs. 73.1% (52.7-95.1%), respectively, = 0.008. A significant association between standard care and poor anticoagulation control ( = 0.021) was demonstrated by the multivariate regression analysis. For the cost-effectiveness analysis, the total cumulative quality-adjusted life-years (QALYs) and total costs per patient were 21.53 and 10.43; 436.38 and 1,242.25 United States dollar (USD) in the intervention and the control groups, respectively, with an incremental cost-effectiveness ratio (ICER) of -72.5796 for the intervention group.
The PMWT strategy was proven to provide a significantly better anticoagulation control and to be a cost-saving approach in Egyptian patients with MMVPs. Nevertheless, the dominance of this strategy is sustained by maintaining the therapeutic International Normalized Ratio (INR) control within the recommended range. Our findings will benefit Egyptian policy-makers who may seek novel health strategies for better resource allocation.
[ClinicalTrials.gov], identifier [NCT04409613].
尽管华法林疗法已用于机械二尖瓣置换术（MMVP）患者数十年，但全球仍有严重且危及生命的并发症报道，经济负担沉重。本研究旨在评估在埃及采用药剂师管理的华法林疗法（PMWT）服务优化华法林治疗的临床效果和成本效益。
一项前瞻性随机试验，将59例MMVP患者随机分为接受PMWT服务组或标准治疗组，并随访1年。主要结局是治疗范围内的时间百分比（TTR）。对于成本效益分析，从医疗服务提供者的角度开发了一个具有九个相互排斥健康状态的马尔可夫队列过程模型。采用终身视角。所有成本和结局均按每年3.5%进行贴现。
研究结果显示，干预组的中位TTR显著高于对照组；分别为96.8%[四分位间距（IQR）77.9 - 100%]和73.1%（52.7 - 95.1%），P = 0.008。多因素回归分析显示标准治疗与抗凝控制不佳之间存在显著关联（P = 0.021）。对于成本效益分析，干预组和对照组每位患者的累积质量调整生命年（QALY）总数和总成本分别为21.53和10.43；436.38美元和1242.25美元，干预组的增量成本效益比（ICER）为 -72.5796。
PMWT策略被证明能显著更好地控制抗凝，且对埃及MMVP患者是一种节省成本的方法（在维持治疗国际标准化比值（INR）控制在推荐范围内的情况下）。我们的研究结果将使可能寻求新的健康策略以更好地分配资源的埃及政策制定者受益。
[ClinicalTrials.gov]，标识符[NCT04409613]
