skyblue 2009-12-11 12:06
FDA核准Ziprasidone用於躁鬱症的維持治療
作者：Yael Waknine
出處：WebMD醫學新聞
November 23, 2009 — 美國食品藥物管理局(FDA)核准非典型抗精神病藥物ziprasidone HCl (商品名為Geodon膠囊，Pfizer藥廠製造)擴大適應症，准許它輔助鋰鹽或valproate用於躁鬱症成人的維持治療。
德州大學健康科學中心精神科與藥理臨床教授Charles Bowden醫師在該公司的新聞稿中表示，FDA核准 Geodon，提供需要維持治療以控制病情之躁鬱症病患的另一種治療選擇；反覆情緒發作的盛行率超過90%，且與較高的失能率有關，對病患的生活可能有毀滅性的影響。
此次適應症核准是根據一個有24名穩定病患的雙盲、安慰劑控制試驗，資料顯示，將ziprasidone加入情緒穩定劑處方，可顯著延遲情緒發作的復發時間。在6個月期間，接受併用治療的病患只有19.7%需要情緒發作的介入，單用鋰鹽或valproate者則有32.4%需要。
在這項研究中，加入ziprasidone治療一般耐受良好；相較於單用鋰鹽或valproate者，只有震顫這項副作用的發生率較頻繁(6.3%相較於vs3.6%)。其他ziprasidone相關副作用，包括困倦、錐體外症候群、頭昏眼花、靜坐不能、視力異常。
Ziprasidone之前核准用於躁症/混合型躁鬱發作和精神分裂症的急性治療。
FDA Approves Ziprasidone for Maintenance Treatment of Bipolar Disorder
By Yael Waknine
Medscape Medical News
November 23, 2009 — The US Food and Drug Administration (FDA) has approved an expanded indication for the atypical antipsychotic ziprasidone HCl (Geodon capsules, Pfizer, Inc), allowing its use as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder in adults.
"The FDA approval of Geodon provides an additional treatment option for patients with bipolar disorder, who require maintenance therapy to keep the symptoms of the disease under control," said Charles Bowden, MD, clinical professor of psychiatry and pharmacology at University of Texas Health Science Center, San Antonio, in a company news release. With a prevalence of more than 90%, recurrent mood episodes are linked to a high rate of disability that can have a devastating effect on patients' lives.
Approval of the indication was based on data from a double-blind, placebo-controlled trial of 240 stabilized patients showing that the addition of ziprasidone to mood stabilizers significantly delayed time to recurrence of a mood episode. Only 19.7% of patients receiving combination therapy required intervention for a mood episode during the 6-month period compared with 32.4% of those receiving lithium or valproate alone.
Add-on ziprasidone therapy was generally well-tolerated in the study; tremor was the only adverse event occurring more frequently than with lithium or valproate alone (6.3% vs 3.6%). Other ziprasidone-related effects may include somnolence, extrapyramidal symptoms, dizziness, akithisia, and abnormal vision.
Ziprasidone was previously approved for the acute treatment of manic/mixed bipolar episodes and schizophrenia.