新研究檢驗ADHD藥物所帶來的潛在心血管風(fēng)險

September19,2007— 美國食品藥物管理局（FDA）以及健康照護研究與品質(zhì)署（AHRQ）宣布他們將共同進行最具意義的研究，檢驗使用于治療注意力缺損／過動異常（ADHD）處方藥物的潛在心血管風(fēng)險。

項研究將會針對大約50萬名曾使用藥物治療ADHD之兒童與成人臨床資料，檢驗其心血管風(fēng)險，包括心肌梗塞（MI）與中風(fēng)。

一項來自FDA的聲明指出，因為ADHD的治療藥物會增加心率與血壓，對于這些藥物增加心臟風(fēng)險仍有些疑慮，且成人與兒童的風(fēng)險也可能有差異，因此需要多有關(guān)于ADHD藥物使用的長期效應(yīng)證據(jù)。

聲明中表示，這項計劃好的分析是一項FDA贊助之早期研究的后續(xù)，這項研究收集并分析來自大型健康照護資料庫的資訊，包括處方藥物使用、住院病患照護、門診病患照護、以及包括死亡的健康預(yù)后；根據(jù)這項研究，研究者找出在2005年前使用ADHD藥物超過7年的資料。

這項研究將會由泛德堡大學(xué)研究者團隊、以及主要研究者William D.Cooper醫(yī)師主導(dǎo)，透過與AHRQ的效率健康照護計劃聯(lián)系，而數(shù)據(jù)分析將在泛德堡、加州Kaiser Permanente、HMO研究網(wǎng)絡(luò)、以及i3藥物安全、還有FDA與AHRQ進行。

這項研究的分析將針對所有目前在市面上使用的ADHD藥物，并以整體及不同分類進行檢驗，研究將耗時大約2年。

FDA的監(jiān)視與流行病學(xué)辦公室主任Gerald Dal Pan醫(yī)師表示，已經(jīng)有許多案例報告指出，有特定危險因子的成人與兒童病患使用ADHD藥物治療發(fā)生不良心血管事件，但這些事件是否與治療有關(guān)仍不清楚，這項研究的目的就是希望找出有關(guān)這問題的更多資訊。

AHRQ主任Carolyn M.Clancy在這項聲明中表示，這項研究突顯出AHRQ一項重要的任務(wù)之一：收集并分析可以幫助病患、政策制定者、臨床醫(yī)師做出最好可能的決定。

【ADHD藥物使用的增加】

根據(jù)國家精神健康機構(gòu)，ADHD影響了大約3-5%的學(xué)齡兒童、以及大約4%的成人。

這項聲明附帶，使用ADHD藥物，不論是成人還是兒童，在最近幾年有增加的趨勢；AHRQ最近一項針對藥物使用的分析指出，3種ADHD藥物，分別是Concerta（methylphenidate hydrochloride(ALZA/McNeil Pediatrics)）、Strattera（atomoxetine HCL(禮來藥廠)）、以及Adderall（安非他命產(chǎn)物的混合鹽類(Shire US)），分占17歲以前兒童用藥排行榜的前五名，這項聲明中表示，2004年間，使用這些藥物的花費估計將近13億美金，成人使用這些藥物的頻率普遍更高。

2007年2月，F(xiàn)DA要求所有被核準(zhǔn)用于治療ADHD藥物的制造廠商必須制作病患用藥須知，來提醒病患可能會有與治療有關(guān)的心血管及精神事件；這樣的行動是在FDA回顧嚴(yán)重心血管事件，包括本來就有心臟問題或缺損個體猝死、以及有特定危險因子個體發(fā)生中風(fēng)與MI的案例報告之后。

他們也注意到藥物相關(guān)精神不良反應(yīng)，例如幻聽、疑神疑鬼、或是變得瘋狂，這樣的風(fēng)險有上升的情形（大約1000分之一），即使是過去沒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 NewsSeptember19,2007— 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 about500,000children 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 a7-year period ending in2005.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 i3Drug 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 about2years."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 highlights1of 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 approximately3%to5%of school-aged children and about4%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 found3ADHD 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 top5drug prescribed for children ages17years and younger," the statement notes,with an estimated $1.3billion spent in2004.Adult use is also thought to be increasing.In February2007,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(about1per1000)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.