??????????????????
??????????????????????cardiovascular risks???????????????????????????????
?JAMA ???????????????????????????????????????????????????????????????17??14783???????????????????????????????????????????????????????1.58??????????1.80???????????1.53?????????????stroke?1.46???????????????????????????????????????
?????6????????????????????????????????????1.73???????????
Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease
???JAMA. 2008;300(12):1439-1450?
???http://jama.ama-assn.org/cgi/content/abstract/300/12/1439
???Ann Intern Med ??????????????????COPD?????????????????????????????
Risk for Death Associated with Medications for Recently Diagnosed Chronic Obstructive Pulmonary Disease
???Ann Intern Med 2008; 149: 380-390?
??http://www.annals.org/cgi/content/full/149/6/380
?????????????????Nested case-control study???????????????????????????????????????????????????????????????????
????????????????????????????????????????????????????1.34??????????
??????????????????????????????????????????????????COPD?????????????????????????????????????????????????????????????????????
???????????????????????????Boehringer Ingelheim??23??37??5993?????????UPLIFT (Understanding Potential Long-term Impacts on Function with Tiotropium)???30??????????????19545????????????????????? ????????????????????????????????????????????????????????????????
Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials and the Landmark Trial UPLIFT
???Boehringer Ingelheim????????2008.9.23?
???http://us.boehringer-ingelheim.com/newsroom/2008/09-23-08_spiriva_safety.html
?????????????????????????????????????????????�Early Coumunication�???3?18?????????????FDA????????10?7??Update?????????????FDA??????????????????
????????Vol.6?No.9?Update????????
???http://www.nihs.go.jp/dig/sireport/weekly6/09080502.pdf
Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)(FDA 2008.10.7)
???????????????????Vol.6?No.22?????????
??http://www.nihs.go.jp/dig/sireport/weekly6/22081030.pdf
???????????????????????????????????????????????????????????
???COPD Medicines: Risky or Safe??WebMD 2008.9.23?
??http://www.webmd.com/news/20080923/copd-medicines-risky-safe
????Leading COPD Drugs Tied to Stroke, Heart Attack
??????Healthday 2008.9.24)
??http://www.healthday.com/Article.asp?AID=619626
2010?1?15????????
FDA?2010?1?14?????????????????????????????????
FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
Current data do not support increased risks for stroke, heart attack, or death
(FDA 2010.1.14)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197649.htm
Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler) ?FDA 2010.1.14?
投稿者 by ???????? — 2010年1月15日(金)17:13
????????
?????????????FDA??????????????1?15??
?http://intmed.exblog.jp/9667301/
??????????????11?19???????�Pulmonary-Allergy Drugs Advisory Committee Meeting�??????????????????
November 19, 2009: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
?FDA?
?http://www.fda.gov/AdvisoryCommittees/Calendar/ucm183398.htm
??????????
投稿者 by ???????? — 2010年1月15日(金)21:50