Abstract：
There is no refuting that America\'s population is growing older: for the first time in US history, by 2034 older adults (defined as >65 years of age) are projected to outnumber children under the age of 18, representing approximately 70 million people or almost 25% of the population (Lloyd-Jones et al., 2010). Described as the \"silver tsunami\", this flood of older adults is driven by the baby boomers (people born after World War II, from 1946 to 1964): they are now reaching old age, living longer due to significant advances in healthcare coupled with a record low birth rate, resulting in a skewed elderly population demographic. Unfortunately, older adults are also becoming increasingly unhealthy. Many often suffer from several chronic disorders requiring the use of multiple medications at a level higher than any other age group, resulting in an increased risk of drug-drug interactions (DDIs) and adverse drug reactions (ADRs). Indeed, because of age-related changes in pharmacokinetics (PK) and pharmacodynamics (PD), older adults are also more vulnerable to drug toxicity. Prescribed drugs certainly improve a range of health outcomes, but also often cause considerable ADRs, leading to devastating consequences for patients, clinicians, and manufacturers. Therefore, safe and effective pharmacotherapy remains one of the greatest growing challenges in geriatric medicine. In this review we examine the effects of aging and its impact on the increased risk of experiencing ADRs, resulting in devastating consequences for patients and manufacturers. We assess the current regulatory considerations related to the development of drugs for this population and highlight issues, concerns, and propose alternatives to the standard battery of tests focused on assessing cardiovascular (CV) safety in an attempt to develop safer and efficient new drugs for the growing elderly demographic.
摘要：
没有人反驳说美国的人口正在变老：这是美国历史上的第一次，到2034年，预计老年人（定义为>65岁）的数量将超过18岁以下的儿童，约占70万人或人口的近25％（Lloyd-Jones等人。,2010).被描述为“银色海啸”，这种老年人的洪水是由婴儿潮一代(二战后出生的人，从1946年到1964年)：他们现在已经到了老年，由于医疗保健的显着进步以及创纪录的低出生率，寿命更长，导致老年人口人口结构倾斜。不幸的是,老年人也变得越来越不健康。许多人经常患有几种慢性疾病，需要使用多种药物的水平高于任何其他年龄组。导致药物-药物相互作用（DDI）和药物不良反应（ADR）的风险增加。的确,由于年龄相关的药代动力学（PK）和药效学（PD）的变化，老年人也更容易受到药物毒性的影响。处方药物肯定会改善一系列健康结果，但也经常引起相当多的不良反应，给病人带来毁灭性的后果，临床医生,和制造商。因此,安全有效的药物治疗仍然是老年医学中最大的挑战之一。在这篇综述中，我们研究了衰老的影响及其对经历ADR的风险增加的影响，对患者和制造商造成毁灭性后果。我们评估了与针对该人群的药物开发相关的当前监管考虑因素，并强调了问题，关注,并提出了一系列标准测试的替代方案，重点是评估心血管（CV）安全性，以期为不断增长的老年人群开发更安全有效的新药。
