Specific birth defects and asthma medications in pregnancy: Demonstration project

妊娠期特定出生缺陷和哮喘药物：示范项目

• 批准号: 8105480
• 负责人: ALLEN A MITCHELL
• 金额: $ 49.15万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8105480
• 关键词: Specific; birth; defects; asthma; medications

DESCRIPTION (provided by applicant): Recognition of the comparative effectiveness of medications has profound implications for both rational and cost-effective therapeutics, but without knowing the comparative risks of medications, benefit-risk estimates are necessarily incomplete. Unique among any other treated population, risks among pregnant women relate not just to the patient (the pregnant woman), but also to the fetus. Because premarketing studies don't and can't provide meaningful risk data, this task falls to the post marketing setting. Though the debacle of thalidomide in the early 1960s identified the devastating potential of medications to cause birth defects, more than four decades later there is no system in place to comprehensively assess the pregnancy safety of even relatively commonly used medications. Asthma is the most common chronic condition requiring medication treatment in pregnancy, yet we know little about the risks to the fetus of current and newly introduced asthma medications. Using an established case control surveillance study of specific drug exposures in relation to specific birth defects (the Slone Epidemiology Center Birth Defects Study, BDS), we seek to demonstrate its ability to assess, in a systematic, efficient, and valid manner, the risks and safety of various asthma medications in relation to specific birth defects. In addition to capturing information on actual use of medications (including prescription, over-the counter, and herbals) and validating birth defects through medical record review, this study will use a validated questionnaire to assess asthma control and capture information on important confounders-such as smoking and periconceptional folate consumption-that are critical to the consideration of birth defects. Further, the project will work closely with the OTIS Pregnancy Registries and the American Academy of Asthma, Allergy, and Immunology (AAAAI) to demonstrate the feasibility and value of the Asthma and Allergy Medications in Pregnancy Safety Surveillance (AAMPSS) approach, a collaborative system involving two complementary data collection methods (BDS case-control surveillance and OTIS pregnancy registries) combined into a common infrastructure that includes an Independent Advisory Committee (to be coordinated by the AAAAI). The success of this demonstration project will lead to an ongoing, comprehensive, and valid system to assess the fetal risks associated with the wide range of medications (beyond asthma), and will permit comparative effectiveness measures to finally include critically important information on the risks and safety of medications taken by pregnant women.

描述（由申请人提供）：认识到药物的比较有效性对合理和具有成本效益的治疗具有深远的意义，但在不知道药物的比较风险的情况下，获益-风险估计必然是不完整的。在任何其他接受治疗的人群中，孕妇的风险都是独一无二的，不仅与患者（孕妇）有关，还与胎儿有关。由于上市前研究不能提供有意义的风险数据，因此该任务福尔斯落在上市后环境中。虽然20世纪60年代初沙利度胺的崩溃确定了药物导致出生缺陷的破坏性潜力，但四十多年后，即使是相对常用的药物，也没有系统来全面评估妊娠安全性。哮喘是妊娠期最常见的需要药物治疗的慢性疾病，但我们对目前和新引入的哮喘药物对胎儿的风险知之甚少。使用一项已建立的病例对照监测研究，研究与特定出生缺陷相关的特定药物暴露（斯隆流行病学中心出生缺陷研究，BDS），我们试图证明其能够以系统、有效和有效的方式评估与特定出生缺陷相关的各种哮喘药物的风险和安全性。除了获取实际使用药物（包括处方药、非处方药和草药）的信息和通过病历审查确认出生缺陷外，本研究还将使用经过验证的问卷来评估哮喘控制和获取重要混淆因素（如吸烟和围受孕期叶酸摄入量）的信息，这些因素对考虑出生缺陷至关重要。此外，该项目将与奥蒂斯妊娠登记处和美国哮喘、过敏和免疫学学会（AAAAI）密切合作，以证明哮喘和过敏药物在妊娠安全监测（AAMPSS）方法中的可行性和价值，涉及两种互补数据收集方法的协作系统（BDS病例对照监测和奥蒂斯妊娠登记）合并为一个共同的基础设施，包括一个独立的咨询委员会（由AAAAI协调）。该示范项目的成功将导致一个持续的，全面的，有效的系统来评估与广泛的药物（哮喘以外）相关的胎儿风险，并将允许比较有效性措施，最终包括孕妇服用药物的风险和安全性的重要信息。