FDA顾问委员会正在审查治疗COPD的药物
2013-01-27 20:56:48   来源：37度医学网   作者：  评论：0 点击：

1.WASHINGTON -- A once-daily treatment for chronic obstructive pulmonary disease (COPD) appeared to modestly improve lung capacity in patients, but its effects might have been blunted by other drugs, the FDA said Friday.
华盛顿----FDA在周五表示，一种用于慢性阻塞性肺病（COPD）的每日一次的治疗措施显示能适度改善患者的肺功能，但它的疗效可能会被其他药物减弱。

2.Patients taking olodaterol inhalation solution (Striverdi Respimat) showed improvement in pulmonary function in three of four 48-week COPD trials, the FDA said in briefing documents released before an advisory committee meeting on Tuesday.
在周四的咨询委员会会议前公开的简报中FDA说，在四组为期48周的COPD临床试验中有三组显示患者在使用茚达特罗吸入溶液（Striverdi Respimat）后出现肺功能的改善。

3.The long-acting beta-agonist (LABA) improved FEV1 on average by 0.164L, 0.134L, 0.151L, and 0.129L (P<0.0001) in the three trials within 3 hours after taking olodaterol via inhaler, the agency said.
该机构表示，在这三组试验中，经气道摄入茚达特罗3小时后，这种长效β受体激动剂（LABA）使患者的平均
FEV1分别提高了0.164L, 0.134L, 0.151L, 和 0.129L (P<0.0001)。

4.The trough FEV1 response rates were less dramatic, with differences over placebo of 0.084L (p=0.0002), 0.033L (p>0.05), 0.078L (p=0.0002), and 0.053L (p=0.006) in the four 48-week trials.
低谷FEV1反应速度的变化并不明显，在四组48周试验中该项数值与安慰剂组之间的差异分别为0.084L (p=0.0002), 0.033L (p>0.05), 0.078L (p=0.0002), 和0.053L (p=0.006)。

5."Based on these results, the effect size was relatively modest with respect to trough FEV1," the FDA said. "However, this may have been in part related to concomitant medications, as patients were allowed to continue on all maintenance COPD medications, except for LABAs."
“基于这些结果，对于低谷FEV1的影响是相对温和的，”FDA说，“但是，除了LABA外，病人们获准继续服用其他治疗COPD的药物，合并用药这也许是造成这一结果的部分原因。”

6.Patients involved in the studies were allowed to continue their usual care with the exception of LABAs. Anticholinergics, short-acting beta agonists, inhaled corticosteroids, and xanthines were permitted.
参与研究的患者获准继续他们的除LABA外的常规治疗。抗胆碱能药物，短效β受体激动剂，吸入糖皮质激素，和黄嘌呤都在被允许范围之内。

7.The agency's Pulmonary-Allergy Drugs Advisory Committee will meet Tuesday to discuss the results and vote on recommending approval. Boehringer Ingelheim is seeking approval for a 5 mcg, once-daily, inhaled solution of olodaterol as a bronchodilator to treat COPD, including chronic bronchitis and emphysema.
该机构的肺过敏药物咨询委员会将在星期二开会讨论这些结果并对推荐能否获准进行投票表决。勃林格殷格翰公司正在寻求批准一种用法为5毫克每次，一日一次的茚达特罗吸入溶液作为气管扩张剂用于治疗包括慢性支气管炎和肺气肿在内的COPD。

8.The German drugmaker is also seeking approval of claims for increased exercise tolerance, increased inspiratory capacity at rest and during exercise, and reduced lung hyperinflation. In the U.S., no products for COPD have claims related to exercise tolerance, inspiratory capacity, or hyperinflation.
这个来自德国的制药商同时也在寻求批准他们所认为的增加运动耐受，在静息状态和运动时增加吸气量，以及降低肺的膨胀过度。在美国，还没有一项针对COPD的产品拥有与运动耐受，吸气量或者膨胀过度相关的声明。

9.If the compounding effect of other drugs is a question, the FDA pointed to other non-pivotal trials.
其他药物的复合效应是否是一个问题，FDA求证于其他的非关键性试验。

10.In two 6-week trials where long-acting muscarinic antagonists (LAMAs) were prohibited, olodaterol's effect on trough FEV1 at the end of treatment was higher, at 0.133L and 0.134L (P<0.0001), the FDA found. Also, 5 mcg of olodaterol was similar to the active comparator formoterol ( Symbicort).
FDA发现，在两项为期六周的禁止使用长效β受体激动剂（LABAs）的试验中，茚达特罗在治疗后对低谷FEV1的作用更加明显，分别为0.133L 和 0.134L (P<0.0001)。而且，5mcg茚达特罗与有效对照物福莫特罗（信必可）作用类似。

11.Boehringer Ingelheim is also studying olodaterol in combination with tiotropium for once-daily use via its Respimat inhaler for treating COPD. Almost a quarter of the patients in those 48-week trials took tiotropium, the FDA said.
勃林格殷格翰公司同时正在进行一项研究，通过他们研发的 Respimat吸入器每日一次联合使用茚达特罗和噻托溴铵用于治疗COPD。FDA说，在那些48周的试验中大约有四分之一的患者使用了噻托溴铵。

12.The manufacturer also studied exercise tolerance in two 6-week trials and found that 5 mcg of olodaterol improved patients' tolerance by 12% to 14%, or 40 seconds to 50 seconds, in each trial. Inspiratory capacity also increased at trough and 1 hour after dose when compared with placebo.
该制药商同时也在两项六周的试验中研究了运动耐量，发现在两项试验中5mcg茚达特罗分别提高了患者的耐量12%和14%，或者40秒和50秒。与安慰剂组相比，低谷和服药一小时后的深吸气量也提高了。

13."The issues for discussion are whether the relatively modest bronchodilator effect observed in the setting of background therapy is clinically meaningful, and whether the improvement in exercise tolerance at 6 weeks represents a clinically meaningful exercise improvement," the FDA wrote to committee members.
FDA在写给委员会成员的信中说：“需要讨论的问题是，在这种治疗背景的设置下观察到的相对温和的支气管扩张作用是否具有临床意义？以及六周的运动耐量的改善是否表现为具有临床意义的运动提高？”

14.However, there were no major identified safety concerns with olodaterol, the FDA said. Also, there were no asthma-related deaths or increases in asthma-related adverse events in patients -- a concern in other LABA drugs, the agency noted. Other drugs in olodaterol's class include salmeterol (Serevent), budesonide/formoterol ( Symbicort), and arformoterol (Brovana).
FDA说，目前缺乏与茚达特罗相关的重要安全验证。该机构指出，同样缺乏关于使用其他LABA药物的患者哮喘相关死亡及不良事件数据。其他的与茚达特罗同一类别的药物包括舒利迭（沙美特罗），布地奈德/福莫特罗（吸必扩），和福莫特罗（brovana）。

15.While there were 53 deaths in patients receiving olodaterol, they were spread among treatment arms, the FDA said. Serious adverse events also were spread among treatment groups.
FDA说，尽管接受茚达特罗治疗的患者中有53例死亡病例，但他们散布于各个治疗组。同样，严重的不良事件也散布于各个治疗组。

16.More than 4,900 patients were involved in Phase III studies, the manufacturer said.
该制药商说，有超过4900个患者接受了三期临床研究。

17.Boehringer Ingelheim, a privately held company, declined to disclose a date by which an FDA decision is due. The FDA doesn't have to follow the advice of its advisory committees, but often does.
作为一家私企，勃林格殷格翰公司拒绝透露FDA作出决定的截止日期。FDA不必完全听命于他的咨询委员会，但他往往会这样做。