新研究检验ADHD药物所带来的潜在心血管风险

　　September 19, 2007 — 美国食品药物管理局（FDA）以及健康照护研究与品质署（AHRQ）宣布他们将共同进行最具意义的研究，检验使用于治疗注意力缺损／过动异常（ADHD）处方药物的潜在心血管风险。

　　项研究将会针对大约50万名曾使用药物治疗ADHD之儿童与成人临床资料，检验其心血管风险，包括心肌梗塞（MI）与中风。

　　一项来自FDA的声明指出，因为ADHD的治疗药物会增加心率与血压，对于这些药物增加心脏风险仍有些疑虑，且成人与儿童的风险也可能有差异，因此需要多有关于ADHD药物使用的长期效应证据。

　　声明中表示，这项计划好的分析是一项FDA赞助之早期研究的后续，这项研究收集并分析来自大型健康照护资料库的资讯，包括处方药物使用、住院病患照护、门诊病患照护、以及包括死亡的健康预后；根据这项研究，研究者找出在2005年前使用ADHD药物超过7年的资料。

　　这项研究将会由泛德堡大学研究者团队、以及主要研究者William D. Cooper医师主导，透过与AHRQ的效率健康照护计划联系，而数据分析将在泛德堡、加州Kaiser Permanente、HMO研究网络、以及i3药物安全、还有FDA与AHRQ进行。

　　这项研究的分析将针对所有目前在市面上使用的ADHD药物，并以整体及不同分类进行检验，研究将耗时大约2年。

　　FDA的监视与流行病学办公室主任Gerald Dal Pan医师表示，已经有许多案例报告指出，有特定危险因子的成人与儿童病患使用ADHD药物治疗发生不良心血管事件，但这些事件是否与治疗有关仍不清楚，这项研究的目的就是希望找出有关这问题的更多资讯。

　　AHRQ主任Carolyn M. Clancy在这项声明中表示，这项研究突显出AHRQ一项重要的任务之一：收集并分析可以帮助病患、政策制定者、临床医师做出最好可能的决定。

　　【ADHD药物使用的增加】

　　根据国家精神健康机构，ADHD影响了大约3-5%的学龄儿童、以及大约4%的成人。

　　这项声明附带，使用ADHD药物，不论是成人还是儿童，在最近几年有增加的趋势；AHRQ最近一项针对药物使用的分析指出，3种ADHD药物，分别是Concerta（methylphenidate hydrochloride(ALZA/McNeil Pediatrics)）、Strattera（atomoxetine HCL(礼来药厂)）、以及Adderall（安非他命产物的混合盐类(Shire US)），分占17岁以前儿童用药排行榜的前五名，这项声明中表示，2004年间，使用这些药物的花费估计将近13亿美金，成人使用这些药物的频率普遍更高。

　　2007年2月，FDA要求所有被核准用于治疗ADHD药物的制造厂商必须制作病患用药须知，来提醒病患可能会有与治疗有关的心血管及精神事件；这样的行动是在FDA回顾严重心血管事件，包括本来就有心脏问题或缺损个体猝死、以及有特定危险因子个体发生中风与MI的案例报告之后。

　　他们也注意到药物相关精神不良反应，例如幻听、疑神疑鬼、或是变得疯狂，这样的风险有上升的情形（大约1000分之一），即使是过去没有精神疾病病史的患者。

　　New Study to Examine Potential Cardiovascular Risks of ADHD Drugs By Susan Jeffrey

　　Medscape Medical NewsSeptember 19, 2007 — The Food and Drug Administration (FDA) and the Agency for Healthcare Research and Quality (AHRQ) announced they will collaborate on "the most comprehensive study to date" of potential cardiovascular risks associated with the prescription medications used to treat attention deficit/hyperactivity disorder (ADHD).The study will examine clinical data on about 500,000 children and adults who have taken medications used in ADHD, looking specifically for cardiovascular risks, including myocardial infarction (MI) and stroke."Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks," a statement from the FDA notes. "It is also thought that these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications."The planned analysis follows an FDA-sponsored preliminary study that compiled information from large healthcare databases on prescription drug use, inpatient care, outpatient treatment, and health outcomes including death, the statement says. From this work, researchers identified people who took ADHD drugs over a 7-year period ending in 2005.The study will be coordinated by Vanderbilt University researchers, with principal investigator William D. Cooper, MD, on contract through AHRQ's Effective Health Care Program, and data analysis will be performed at Vanderbilt, Kaiser Permanente of California, the HMO Research Network, and i3 Drug Safety, as well as the FDA and AHRQ.The analysis will focus on all drugs currently marketed for ADHD and look at risks associated with the drugs as a whole and grouped by class. The results are expected in about 2 years."Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, MD, director of the FDA's Office of Surveillance and Epidemiology. "The goal of the study is to develop better information on this question.""This study highlights 1 of AHRQ's most important missions: to collect and analyze scientific evidence that will help patients, policymakers, and clinicians make the best possible decisions," said AHRQ director Carolyn M. Clancy in the statement.Increasing Use of ADHD DrugsAccording to the National Institute of Mental Health, ADHD affects approximately 3% to 5% of school-aged children and about 4% of adults.Use of ADHD drugs has increased in recent years among both children and adults, the statement added. "A recent AHRQ analysis of medication expenditures found 3 ADHD drugs — Concerta (methylphenidate hydrochloride [ALZA/McNeil Pediatrics]), Strattera (atomoxetine HCL [Eli Lilly]), and Adderall (mixed salts of a single-entity amphetamine product [Shire US]) — ranked among the top 5 drug prescribed for children ages 17 years and younger," the statement notes, with an estimated $1.3 billion spent in 2004. Adult use is also thought to be increasing.In February 2007, the FDA directed manufacturers of all drug products approved for ADHD to develop patient medication guides to alert patients to possible adverse cardiovascular and psychiatric events related to treatment. The move came after an FDA review of case reports of serious cardiovascular events including sudden death in subjects with underlying heart problems or defects and reports of stroke and MI in adults with certain risk factors.They also noted a slight increased risk (about 1 per 1000) of drug-related psychiatric adverse events such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients without a previous psychiatric history.