Kagolanu Deepthi, Sayedy Najia, Haseeb Syed, Shah Shivani, Lam Paul, Munnangi Swapna, Viswanathan Prakash, Stephenson Kent
Department of Internal Medicine, Nassau University Medical Center, East Meadow, USA.
Department of Internal Medicine, Nassau University Medical Center, East Meadow, USA.
Am J Cardiol. 2017 Oct 1;120(7):1118-1121. doi: 10.1016/j.amjcard.2017.06.052. Epub 2017 Jul 14.
Aspirin has been the mainstay for secondary prevention of coronary artery disease to decrease early recurrence and severity of recurrent cardiovascular events. However, an increase in gastrointestinal bleeding due to aspirin is preventing many patients from adhering to this daily regimen. PA32540, a combination pill with aspirin and omeprazole, is a newly emerging intervention that has the potential to reinforce patient compliance with the aspirin regimen due to fewer gastrointestinal adverse effects. This systematic review assessed three recent phase 3 clinical trials investigating the safety and efficacy of PA32540. Clinical trials were chosen based on inclusion criteria such as phase 3, randomized, open-label or blinded studies, utilization of enteric-coated aspirin 325 mg dose, and measured GI adverse effects and major adverse cardiac events (MACE) as primary outcomes. Study A, a 6-month phase-3 study by Whellan et al., used two identically designed, randomized, double-blind trials to compare the GI adverse events and MACE after the use of PA32540 to 325mg of enteric coated Aspirin (EC-ASA) in subjects at risk for aspirin-associated gastric ulcers. Results showed fewer upper GI symptoms, decreased size of ulcers, and improved heartburn symptoms in subjects receiving PA32540 compared to EC-ASA. Study B, a 12-month phase-3 study by Hatoum et al., assessed secondary cardiovascular event prevention in a study population that was treated with PA32540 in comparison to a community setting (CS) group that was started on a standard antiplatelet treatment. Results indicated a 28% reduction of CV events in subjects treated with PA32540 compared to the CS group. Study C, a phase-3 open-label study by Goldstein et al., evaluating secondary prevention of cardiovascular/cerebrovascular events with the use of PA32450 for 12 months found that none of the 12-month completers were reported to have new-onset gastric ulcers. In conclusion, PA32540 could be an effective therapy for secondary prevention of coronary artery disease as studies are showing similar efficacy in preventing MACE with reduced GI side effects.
阿司匹林一直是冠状动脉疾病二级预防的主要药物，用于降低心血管事件早期复发率和复发的严重程度。然而，阿司匹林导致的胃肠道出血增加，使得许多患者无法坚持每日服用该药物。PA32540是一种含有阿司匹林和奥美拉唑的复方药丸，作为一种新出现的干预措施，因其胃肠道不良反应较少，有可能增强患者对阿司匹林治疗方案的依从性。本系统评价评估了三项近期的3期临床试验，这些试验研究了PA32540的安全性和有效性。临床试验是根据纳入标准选择的，如3期、随机、开放标签或盲法研究，使用325毫克肠溶阿司匹林剂量，以及将胃肠道不良反应和主要不良心脏事件（MACE）作为主要结局指标进行测量。研究A是Whellan等人进行的一项为期6个月的3期研究，该研究采用了两项设计相同的随机双盲试验，比较了PA32540与325毫克肠溶阿司匹林（EC-ASA）在有阿司匹林相关性胃溃疡风险的受试者中使用后的胃肠道不良事件和MACE。结果显示，与EC-ASA相比，接受PA32540的受试者上消化道症状更少，溃疡面积减小，烧心症状改善。研究B是Hatoum等人进行的一项为期12个月的3期研究，该研究评估了PA32540治疗人群中继发性心血管事件的预防情况，并与开始接受标准抗血小板治疗的社区环境（CS）组进行了比较。结果表明，与CS组相比，接受PA32540治疗的受试者心血管事件减少了28%。研究C是Goldstein等人进行的一项3期开放标签研究，该研究使用PA32450评估心血管/脑血管事件的二级预防，为期12个月，结果发现，在12个月完成研究的受试者中，没有报告有新发胃溃疡。总之，PA32540可能是冠状动脉疾病二级预防的有效疗法，因为研究表明，它在预防MACE方面具有相似的疗效，同时胃肠道副作用减少。
