Hengstler 增量型编码器产品说明书[8]

1、FDAAnesthetic & Life Support DrugsAdvisory CommitteeSept. 10, 2003Art Van Zee,MDSt. Charles ClinicSt. Charles, Va.增量编码器 http:/ hydromorphone(Palladone)-Risks vs. benefits discussionBenefitsReview sustained release opioids vs.IR opioids IR oxycodone vs CR oxycodone Comparable Efficacy & Safet

2、y Hale Clin J Pain 9/99 BACK PAINKaplan R J Clin Oncol 10/98 CANCERStambauugh J.Clin Pharm 5/01 CANCER OxyContin-NDA-1995MEDICAL OFFICER REVIEW (MOR)Summary of Safety“ The best conclusion is that the efficacyof the CR (oxycodone) is equivalent to the IR, with an adverse event profile that is as good

3、 asthe IR. I would not allow a better claim”-Curtis Wright, MROOxyContin-NDA-1995Summary of Efficacy “CR oxycodone appears to be a BID alternativeto conventional QID oxycodone. Approval is recommended. Care should be taken to limit competitive promotion. This product has been shown to be as good as

4、current therapy, but has not been shown to have a significant advantage beyond reduction in frequency of dosing.”-Curtis Wright, MRO The Medical Letter9/17/01 “OxyContin is a q12h controlled-release formulation of oxycodone that can be used effectively in the treatment of pain due to cancer, and occ

5、asionally, other types of chronic pain. There is no evidence that oxycodone offers any advantage over appropriate doses of other opioids, and it appears to have the same potential for addiction as morphine.”CR morphine vs CR oxycodoneComparable inEfficacy and SafetyHeiskanen Pain 10/97 CANCERMucci-L

6、oRusso 98 CANCERBruera J. Clin Oncol 10/98 CANCER IR hydromorphone vs CR hydromorphone (Q12hr) Comparable Efficacy and Safety Hayes Cancer 9/94 CANCER Bruera J. Clin Oncol 5/96 CANCERCR oxycodone vs CR hydromorphone (Q12hrs)ComparableEfficacy & Safety Hagen Cancer 4/97 CANCERSummary1. IR opioids

7、 and SR opioids are comparable in efficacy & safety2. SR preparations appear comparable in efficacy & safetyBenefits:-CONVENIENCE of bid or qd dosing-Convenience of less pills-for patients intolerant to other opioid preparationsRisks of sustained releasehydromorphone1. of addiction when take

8、n as prescribed-Unknown2. of addictionwhen used non-medicallyrecreationally3. of overdose and deathhigh potency opioid dosing- one pill RISKS of CR hydromorphone1.Brief over-view of the promotion and marketing of OxyContin-”Aggressive” marketing for chronic non-malignant pain-Aggressive marketing to

9、 primarycare physiciansOxyContin marketing (cont)- Trivializing the risk of addiction for chronic non-cancer pain-Use of sophisticated marketingdata to target and influence high opioid prescribing docs 1998 2000Counties hydrocodone OxyContinTazewell,Va 545% 456% Perry, Ky 415% 559%Logan,WVa 397% 430% % above national averagePersonal thoughts:1.Replication of OxyContin problem if “Indications” for use of Pallado