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Assessing Blood Pressure Responses to Noncardiovascular Drugs: The Beneficial Role of Ambulatory Blood Pressure Monitoring

机译:评估对非心血管药物的血压反应:动态血压监测的有益作用

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It has become apparent that noncardiovascular drugs can affect blood pressure (BP) in an off-target manner, either by raising or lowering pressure or by negating the beneficial hypotensive effect of concomitantly prescribed antihypertensives. This paper presents compelling evidence that ambulatory blood pressure monitoring (ABPM) should be used to detect BP effects during the development of noncardiovascular drugs. The requirements for standardizing ABPM to obtain the most information from the least number of participants and the many advantages of obtaining a 24-hour BP profile are discussed. The use of ABPM in trials of antihypertensive agents, though differing in purpose (the demonstration of BP-lowering efficacy) from the use of ABPM in trials of noncardiovascular drugs (the demonstration of any off-target effect on BP) nonetheless provides methodological similarities that can be applied in both contexts with advantage. The paper also considers whether there are lessons to be learned from a regulatory science approach that is designed to prospectively identify unacceptable off-target cardiac effects of noncardiac drugs and offers some thoughts on how a future paradigm of standardized use of ABPM to assess off-target BP effects during the development of noncardiovascular drugs might benefit patient safety.
机译:显而易见的是,非心血管药物可以通过升高或降低压力或通过否定同时使用的降压药的有益降压作用以脱靶的方式影响血压(BP)。本文提供了令人信服的证据,即在非心血管药物开发过程中应使用动态血压监测(ABPM)来检测BP的影响。讨论了标准化ABPM以从最少数量的参与者获得最多信息的要求,以及获得24小时BP曲线的许多优点。在抗高血压药的试验中使用ABPM,尽管其目的(证明BP降低功效)与在非心血管药物试验中使用ABPM(证明对BP有脱靶作用)有所不同,但仍提供了方法上的相似之处,可以有利地应用于两种情况。本文还考虑了是否有必要从监管科学方法中汲取经验教训,该方法旨在前瞻性地确定非心脏药物的脱靶心脏效应,并就未来标准化使用ABPM评估脱靶的范式提供一些想法。非心血管药物开发过程中的BP效应可能有益于患者安全。

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