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美国食品药物管理局（FDA）日前在一项更新的初期通讯中表示，一项大型、为期4年、由厂商赞助、收纳了将近6,000位病患的研究结果显示，相较于安慰剂，使用吸入性的长效抗胆碱激性药物 tiotropium bromide（Spiriva Handihaler，百龄佳药厂赞助）并不会增加中风风险。
根据FDA的药物安全性资讯与不良反应通报系统MedWatch发出的警讯，这项称为UPLIFT（the Potential Long-Term Impacts on Function with Tiotropium）的研究预计将在2008年11月发表；届时，这些资料将被送交官署审查，这可能需要花上好几个月的时间。
然而，这项研究结果与最近的两项研究相反，另外两项研究报导使用tiotropium以及其他抗胆碱激性药物治疗慢性肺阻塞疾病（COPD）的病患，死亡风险以及/或是心脏血管事件风险上升。
这项研究是系统性回顾与综合分析，总共收纳了17项临床研究，研究中使用抗胆碱激性药物（共14,783位），而其他则是使用抗胆碱激性药物的病例控制研究，包括使用吸入性抗胆碱激性药物（共32,130位）与控制组病患（共320,501位）。
在2008年3月，百灵佳药厂报导来自一项收纳28篇安慰剂控制临床研究的综合分析，这项分析结果发现年度风险每1,000位病患大约上升2例。在那个时候，FDA建议这些研究结果应该谨慎判读。
Tiotropium适用于长期、每天一次、与COPD有关的支气管收缩治疗，包括慢性支气管炎与肺气肿。
有关于使用吸入性tiotropium的不良反应都应该通报到FDA的MedWatch通报系统，可以拨打电话1-800-FDA-1088，或传真1-800-FDA-0178，或线上通报至http://www.fda.gov/medwatch，也可以邮寄到5600 Fishers Lane, Rockville, MD 20852-9787。
Preliminary Data Suggest Spiriva Not Linked to Increased Stroke Risk
By Yael Waknine
Medscape Medical News
October 8, 2008 — Preliminary data from a large, 4-year, company-sponsored study of about 6000 patients suggest that the inhaled, long-acting anticholinergic agent tiotropium bromide (Spiriva HandiHaler, Boehringer Ingelheim Pharmaceuticals, Inc) is not linked to an increased risk for stroke relative to placebo, the US Food and Drug Administration (FDA) announced yesterday in an updated early communication.
Complete results of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study are expected to be available in November 2008, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. At that time, they will be subjected to an agency review that may take several months.
Thus far, however, the findings contradict those of 2 recent publications, which have reported an increased risk for mortality and/or cardiovascular events in patients receiving tiotropium and other inhaled anticholinergic agents for the treatment of chronic obstructive pulmonary disease (COPD).
One study was a systematic review and meta-analysis of 17 clinical trials involving inhaled anticholinergic agents (n = 14,783), and the other was a case-control study of inhaled medications that included an anticholinergic (n = 32,130 case patients and 320,501 control patients).
In March 2008, Boehringer Ingelheim had also reported findings from a meta-analysis of 28 placebo-controlled studies that suggested an annual excess risk for stroke of about 2 cases per 1000 patients. At that time, the FDA advised that these results be interpreted with caution.
Tiotropium is indicated for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.
Adverse events related to use of inhaled tiotropium should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.