Sulaiman Khalid Al, Aljuhani Ohoud, Alkofide Hadeel, Aljohani Manal A, Badreldin Hisham A, Al Harbi Mahasen, Aquil Ghalia, Alhajaji Raghad, Alqahtani Rahaf A, Babonji Alaa, Altuwayr Maha, Alshehri Asma A, Alfaifi Mashael, Alharthi Abdullah F, Alzahrani Mohammed, Al Sulaiman Tareq, Alqahtani Nasser, Alshahrani Walaa A, Al Katheri Abdulmalik, Albekairy Abdulkareem M
Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
College of Pharmacy, Ministry of National Guard Health Affairs (MNGHA), King Saud bin Abdulaziz University for Health Sciences, PO Box 22490, Riyadh, 11426, Saudi Arabia.
Thromb J. 2024 May 22;22(1):43. doi: 10.1186/s12959-024-00613-8.
Recent guidelines recommend using direct oral anticoagulants (DOACs) as first-line agents in patients with non-valvular atrial fibrillation (NVAF). Research is currently investigating the use of Apixaban in underweight patients, with some results suggesting altered pharmacokinetics, decreased drug absorption, and potential overdosing in this population. This study examined the effectiveness and safety of standard Apixaban dosing in adult patients with atrial NVAF weighing less than 50 kg.
This is a retrospective cohort study conducted at King Abdulaziz Medical City (KAMC); adult patients with a body mass index (BMI) below 25 who received a standard dose of Apixaban (5 mg twice daily) were categorized into two sub-cohorts based on their weight at the time of Apixaban initiation. Underweight was defined as patients weighing ≤ 50 kg, while the control group (Normal weight) comprised patients weighing > 50 kg. We followed the patients for at least one year after Apixaban initiation. The study's primary outcome was the incidence of stroke events, while secondary outcomes included bleeding (major or minor), thrombosis, and venous thromboembolism (VTE). Propensity score (PS) matching with a 1:1 ratio was used based on predefined criteria and regression model was utilized as appropriate.
A total of 1,433 patients were screened; of those, 277 were included according to the eligibility criteria. The incidence of stroke events was lower in the underweight than in the normal weight group at crude analysis (0% vs. 9.1%) p-value = 0.06), as well in regression analysis (OR (95%CI): 0.08 (0.001, 0.76), p-value = 0.002). On the other hand, there were no statistically significant differences between the two groups in the odds of major and minor bleeding (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40, respectively).
This exploratory study revealed that underweight patients with NVAF who received standard doses of Apixaban had fewer stroke events compared to normal-weight patients, without statistically significant differences in bleeding events. To confirm these findings, further randomized controlled trials with larger sample sizes and longer observation durations are required.
近期指南推荐将直接口服抗凝剂(DOACs)作为非瓣膜性心房颤动(NVAF)患者的一线用药。目前研究正在调查阿哌沙班在体重过轻患者中的使用情况,一些结果表明该人群的药代动力学发生改变、药物吸收减少以及存在潜在的用药过量情况。本研究探讨了标准剂量阿哌沙班用于体重不足50kg的成年NVAF患者的有效性和安全性。
这是一项在阿卜杜勒阿齐兹国王医疗城(KAMC)开展的回顾性队列研究;将体重指数(BMI)低于25且接受标准剂量阿哌沙班(5mg,每日两次)的成年患者,根据开始使用阿哌沙班时的体重分为两个亚队列。体重过轻定义为体重≤50kg,而对照组(正常体重)包括体重>50kg的患者。在开始使用阿哌沙班后,我们对患者进行了至少一年的随访。该研究的主要结局是中风事件的发生率,次要结局包括出血(大出血或小出血)、血栓形成和静脉血栓栓塞(VTE)。根据预定义标准采用1:1比例的倾向评分(PS)匹配,并酌情使用回归模型。
共筛查了1433例患者;其中,277例符合纳入标准。在粗分析中,体重过轻组的中风事件发生率低于正常体重组(0%对9.1%),p值=0.06),在回归分析中也是如此(OR(95%CI):0.08(0.001,0.76),p值=0.002)。另一方面,两组在大出血和小出血的几率上无统计学显著差异(OR(95%CI):0.39(0.07,2.03),p值=0.26;OR(95%CI):1.2