FDA批准雷萨吉兰片剂（Rasagiline/Azilect）治疗帕金森病
日前，美国食品药品管理局（FDA）批准了以色列梯瓦制药工业公司开发的雷萨吉兰（Rasagiline/Azilect）片剂，用于1日1次单药治疗早期帕金森病和作为中、晚期帕金森病左旋多巴（Levodoba）疗法的附加用药。

3项总计包括1600多例各阶段帕金森病患者的大型、多中心、国际性、双盲、随机、安慰剂对照临床试验证实，雷萨吉兰治疗有益、安全，且能被很好耐受。该药目前还在进行一项大型研究，以考察其能否减缓帕金森病患者的疾病进展。

雷萨吉兰单药治疗的副反应有关节痛和消化不良等；用作附加用药的副反应包括运动障碍、意外伤害、体重下降、体位性低血压、呕吐、关节痛、恶心、便秘、口干、皮疹和嗜睡等。
雷萨吉兰先前已于2005年在欧盟和以色列获准上市。

【原产地英文商品名】AZILECT 1mg/Tablet 30Tablets/bottle
【原产地英文药品名】RASAGILINE MESYLATE
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
·阿齐莱 1毫克/片，30片/瓶
·阿齐莱 0.5毫克/片，30片/瓶
【中文参考药品译名】雷萨吉兰
【曾用名】雷沙吉兰，雷沙吉林
【生产厂家中文参考译名】以色列梯瓦制药工业公司
【生产厂家英文名】Teva Pharmaceutical Industries Ltd

Azilect – Parkinson’s Disease Treatment

Posted on May 25, 2011 with Comments 0

【通 用 名】雷萨吉兰

【别    名】雷沙吉兰 雷沙吉林

【适 应 症】用于1日1次单药治疗早期帕金森病和作为中、晚期帕金森病左旋多巴（Levodoba）疗法的附加用药。

【用法用量】Azilect每天只需要服用一次，医生不需要改变患者的用药剂量和习惯

【副 作 用】单药治疗的副反应有关节痛和消化不良等；用作附加用药的副反应包括运动障碍、意外伤害、体重下降、体位性低血压、呕吐、关节痛、恶心、便秘、口干、皮疹和嗜睡等。

【生产厂家】以色列梯瓦制药工业公司

雷萨吉兰片剂（Rasagiline/Azilect）治疗帕金森病 

根据科学家于本周五公布的最新研究结果，Teva制药公司研制生产的药物Azilect（雷沙吉兰，rasagiline）能够降低晚期帕金森综合症患者的废用症状。

来自法国Toulouse大学附属医院的Olivier Rascol介绍说，在这项临床研究中，共有687名患者，受试者每天一次服用雷沙吉兰治疗，同时还服用左旋多巴来改善患者的运动功能。Rascol说： “在服用左旋多巴治疗的同时服用雷沙吉兰取得了两方面的效果，既减少了患者的残疾症状，又降低了患者运动功能的波动。这些治疗作用提示，雷沙吉兰应该成为治疗帕金森综合症的常规药物之一。”

根据科学家在最近一期《柳叶刀》杂志上发表的研究结果，Azilect能够缩短左旋多巴无效期的时间，使其缩短至每天平均1.2小时。对于那些多年接受药物治疗，疗效已经逐渐减弱的退行性脑病患者，Azilect还能够加强左旋多巴的治疗作用。

来自英国Birmingham大学医院的Carl Clarke说，Azilect每天只需要服用一次，医生不需要改变患者的用药剂量和习惯，这使得患者的用药更加方便。

Azilect是在上个月在欧洲获得批准，其作用机制是阻断多巴胺的分解，多巴胺的主要作用是促进患者的运动功能。来自以色列的Teva制药公司和丹麦H. Lundbeck A/S制药公司将合作在欧洲地区生产该药物。在美国，这种药物仍在等待美国国家食品与药品管理局的批准。

雷萨吉兰（Rasagiline/Azilect）片剂，用于1日1次单药治疗早期帕金森病和作为中、晚期帕金森病左旋多巴（Levodoba）疗法的附加用药。

3项总计包括1600多例各阶段帕金森病患者的大型、多中心、国际性、双盲、随机、安慰剂对照临床试验证实，雷萨吉兰治疗有益、安全，且能被很好耐受。该药目前还在进行一项大型研究，以考察其能否减缓帕金森病患者的疾病进展。

雷萨吉兰单药治疗的副反应有关节痛和消化不良等；用作附加用药的副反应包括运动障碍、意外伤害、体重下降、体位性低血压、呕吐、关节痛、恶心、便秘、口干、皮疹和嗜睡等。

Efficacy of Azilect® in early Parkinson's disease
Effective once-daily monotherapy in early PD

Total UPDRS score (6 month change) TEMPO study (ref. 1)

**** p<0.0001 vs. placebo)
Azilect® monotherapy significantly improves Parkinson's disease symptoms compared to placebo (ref. 1)
Following 2 years of treatment, 46% of patients were adequately controlled on Azilect® monotherapy (ref. 2)
Efficacy in moderate to advanced Parkinson's disease
Azilect significantly increases daily "ON" time.

Increase in daily 'ON' time and decrease in 'OFF' time (18-week change) LARGO study (ref. 1)

 ****p<=0.0001 vs. placebo ***p<0.001 vs. placebo

Azilect effect on daily "ON" and "OFF" time is similar to that seen with multi-dose entacapone therapy (ref. 1)
Azilect significantly increases "ON" time without increasing the incidence of troublesome dyskinesia (ref. 1)
 
Increase in daily total 'ON' time and decrease in 'OFF' time (6 month change) PRESTO study (ref. 1, ref. 2)
 

****p<0.0001 vs placebo

Azilect significantly increases daily "On" time when added to levodopa in PD patients (ref. 1, ref. 2)
Azilect offers significantly additional therapeutic benefits in PD patients already optimised on levodopa and other concomitant PD therapies, including dopamine agonists and entacapone (ref. 1, ref. 2)  
Safe and well tolerated
Azilect – safe and well tolerated in early and advanced Parkinson’s disease patients

Adverse events occurring with an incidence of >5% in the Azilect 1 mg/day group and with a frequency of >2% over placebo (ref.1)

No greater incidence of hallucinations, confusion and fatigue compared to placebo (ref.1)
Low discontinuation rates due to adverse events - comparable to placebo in monotherapy (ref.2) and adjunct treatment trials (ref.3, ref.4)
Equally well tolerated in younger and elderly patients(>70 years) (ref.4)
When to prescribe Azilect
Azilect is indicated for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa), or as an adjunct therapy (with levodopa) in patients with end of dose fluctuations. Azilect is safe and well tolerated even when used in addition to other PD medications, including dopamine agonists, entacapone and levodopa (ref.1).

Azilect is a treatment that can be used as initial therapy for the early stages of mild Parkinson's disease, in newly diagnosed patients, and throughout the course of the disease as an adjunct to levodopa therapy in moderate to severe Parkinson's disease.

The use of Azilect can be considered as:

Initial treatment (monotherapy) upon diagnosis, i.e., new patients
Initiation of combination therapy (adjunct therapy) at the time of levodopa wearing-off and motor complications, when the need for adjunct therapy becomes evident.
Is Azilect right for your Parkinson's disease patient?

If your patient is experiencing the early symptoms of Parkinson's disease, taking Azilect alone may provide the following benefits:

Relief of tremor, slowness and stiffness
Improvement in simple, everyday activities such as getting dressed in the morning, walking, enjoying a meal and writing
Improved quality of life
While almost everyone with Parkinson's disease will use levodopa at some point, as the disease progresses, the medication may lose its effectiveness and motor complications will eventually appear, worsening the patient's condition. Because of this, you might choose to hold off on levodopa therapy and consider other treatment options for your patient, such as Azilect, to control the early symptoms of Parkinson's disease.

Adding Azilect to your patient's Parkinson's disease treatment plan.
If the current medication is not working as well as it used to, Azilect may help. Because Parkinson's disease is progressive, a treatment regimen that has been effective for months or years may not work as well over time.

For instance, after several years of taking levodopa, the benefits of the drug may wear off more quickly in between doses, resulting in fluctuations between ON and OFF state.

Another challenge is dyskinesia (uncontrolled, sudden or jerky movements) soon after taking a levodopa dose.

If your patient is experiencing such problems, you may consider adding Azilect to the therapy and in parallel adjusting the levodopa dose. Adding Azilect may provide the following benefits:

More ON time
Less OFF time
Further decrease of symptoms like tremor, slowness and stiffness
Decreased severity in OFF state. Decrease gait disturbances, including freezing