Fish Oil Drug Recommended for Wider Use

2023-07-12 17:33:4405:48 443
声音简介

Government advisors have suggested that people use a prescription version of fish oil to fight heart health problems.
政府顾问建议人们使用处方版鱼油来对抗心脏健康问题。


Currently, the drug Vascepa is approved for use in a fairly narrow group of patients. It is given to people who have very high levels of triglycerides --- fats in the blood that are linked to heart disease.

目前,Vascepa药物被批准用于相当狭窄的患者群体。甘油三酯(血液中与心脏病有关的脂肪)含量很高的人服用。


The drug maker Amarin wants the Food and Drug Administration to approve Vascepa for other problems linked to heart health. 

制药商Amarin希望食品和药物管理局批准Vascepa治疗与心脏健康相关的其他问题。


For example, doctors might prescribe the drug to patients with lower fat levels, but who are still at risk of heart problems and who take drugs for high cholesterol.

例如,医生可能会给脂肪含量较低的病人开这种药,但这些病人仍有心脏病的风险,而且他们服用的药物是治疗高胆固醇的。


A group of advisers to the Food and Drug Administration, or FDA, all agreed to support the expansion based on a recent study result.

美国食品和药物管理局(FDA)的一组顾问都同意根据最近的一项研究结果支持这一扩展。


The study suggested that the drug can reduce rates of life-threatening heart problems in high-risk patients.

这项研究表明,这种药物可以降低高危患者的危及生命的心脏病发病率。


Doctor Jack Yanovski is a member of the advisory group and a hormone specialist from the National Institutes of Health. He said, "There is no doubt this drug could benefit" a large number of people.

杰克·亚诺夫斯基博士是咨询小组的成员,也是美国国立卫生研究院的激素专家。他说,“毫无疑问,这种药物可以造福”一大批人。


The advisory group noted several side effects of the drug. They include uneven heartbeat and bleeding inside the body. But the members agreed the good results outweighed those risks when a patient is under a doctor's care.

咨询小组注意到该药的几种副作用。包括心跳不均和体内出血。但成员们一致认为,当病人在医生的照顾下时,好的结果超过了这些风险。


FDA approval could mean wider use

FDA的批准可能意味着更广泛的应用


The FDA is not required to follow the advice of the group. The agency is expected to make a decision by the end of this year.

食品和药物管理局不需要遵循集团的建议。该机构预计将在今年年底作出决定。


One member of the advisory group urged that the drug labeling should target patients who need it.

咨询小组的一名成员敦促药品标签应针对需要的患者。


The representative, Philip Posner, said, "I do not want to see this become what I call cardio candy."

代表菲利普·波斯纳说:“我不想看到这成为我所谓的有氧运动糖果。”


The FDA writes labels for drugs to guide doctors who prescribe them. The labels also are used by health insurance companies to decide which uses of drugs they are willing to pay for.

FDA为药品贴上标签,指导开药的医生。这些标签也被医疗保险公司用来决定他们愿意为哪种药物付费。


A new label would make Vascepa the first fat-lowering drug approved by the FDA to reduce heart problems.

一个新的标签将使Vascepa成为FDA批准的第一个减少心脏问题的降脂药物。


The advisory group based its decision on a study that was supported by the manufacturer. The study found that Vascepa reduced the risk of heart attack, blocked arteries and other problems by about 25 percent compared to an inactive treatment.

咨询小组的决定是基于一项得到制造商支持的研究。研究发现,与不积极的治疗方法相比,血管紧张素A能将心脏病发作、动脉阻塞和其他问题的风险降低约25%。


Patients in the study had high triglyceride levels and other risks for heart problems, such as diabetes.

研究中的患者有高甘油三酯水平和其他心脏问题的风险,如糖尿病。


However, the results came as a surprise because recent research has suggested that fish oil supplements did not improve heart health.

然而,这一结果令人惊讶,因为最近的研究表明,鱼油补充剂并不能改善心脏健康。


Millions of Americans take fish oil supplements which they believe improve their health. Fish oils are rich in fats called omega-3 fatty acids which scientists agree reduce triglycerides. But several studies have failed to show that this directly produces good results in patients.

数以百万计的美国人服用鱼油补充剂,他们相信这些补充剂可以改善他们的健康。鱼油富含被称为omega-3脂肪酸的脂肪,科学家们一致认为这种脂肪酸可以降低甘油三酯。但几项研究未能表明,这直接对患者产生良好的效果。


Amarin, however, says that its prescription drug is different from fish oil supplements. It would take 10 to 40 fish oil supplements to have the same effect as Vascepa, the company said.

然而,Amarin说,它是不同于鱼油补充剂的药物。该公司说,这将需要10至40个鱼油补充剂,以产生与Vascepa相同的效果。


If the FDA does expand approved usage, financial experts say Amarin's sales could sharply rise to as much as $3 billion a year. A one month supply of Vascepa costs about $300.

金融专家说,如果FDA真的扩大了批准的使用范围,Amarin的销售额可能会急剧上升到每年30亿美元。一个月的瓦塞帕供应大约需要300美元。


The company's total sales for 2018 were about $228 million.

该公司2018年的总销售额约为2.28亿美元。



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