Des Moines University Department of Public Health Des Moines IA USA.
Leslie Dan Faculty of Pharmacy University of Toronto Ontario Canada.
J Am Heart Assoc. 2024 Jan 2;13(1):e032266. doi: 10.1161/JAHA.123.032266. Epub 2023 Dec 29.
Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors.
We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations/emergency department visits/urgent care visits for stroke/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall.
The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.
2018 年 7 月，美国食品和药物管理局召回缬沙坦，因其存在致癌杂质，导致缬沙坦短缺，给缬沙坦使用者带来了管理挑战。缬沙坦召回对临床结局的影响尚不清楚。我们比较了使用缬沙坦的高血压患者和使用未召回血管紧张素受体阻滞剂和血管紧张素转换酶抑制剂的倾向评分匹配组之间不良事件的风险。
我们使用 Optum 的匿名 Clinformatics Datamart（2017 年 7 月至 2019 年 1 月）。比较在召回日期之前和召回日期当天接受缬沙坦或未召回血管紧张素受体阻滞剂/血管紧张素转换酶抑制剂治疗 1 年的高血压患者。主要结局在召回后 6 个月内测量，包括：（1）全因住院、全因急诊就诊和全因紧急护理就诊的综合指标，以及（2）因急性心肌梗死住院和因中风/短暂性脑缺血发作、心力衰竭或高血压住院/急诊就诊/紧急护理就诊的综合心脏事件指标。我们使用 Cox 比例风险模型比较治疗组之间的结局风险。在高血压患者中，76934 人接受缬沙坦治疗，509472 人接受未召回血管紧张素受体阻滞剂/血管紧张素转换酶抑制剂治疗。在召回时使用缬沙坦与全因住院、急诊就诊或紧急护理就诊的风险增加相关（风险比 [HR]，1.02[95%CI，1.00-1.04]）和召回后 6 个月内的心脏事件综合指标（HR，1.22[95%CI，1.15-1.29]）。
缬沙坦召回和短缺影响了高血压患者。需要加强地方和国家层面的系统，通过提供安全可靠的替代药物来保护患者免受药物短缺的影响。
