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诺德诺德减肥药Saxenda控制血糖效果明显,或有望预防糖尿病

2015年3月11日讯/生物谷BIOON/--近日一项临床研究结果表明,服用诺和诺德减肥药Saxenda的患者,其血糖和血压水平也获得很大改善。

此外,这项研究的一个重要目的是验证长期服用Saxenda是否有助于延迟2型糖尿病的发生,尽管目前的数据还不能很好地说明这一点。

然而,目前的临床试验结果已经足够鼓舞人心了。数据表明,在服用56周Saxenda并且辅助以体育锻炼之后,63%的超重患者的体重都减轻了至少5%,而节食锻炼并服用安慰剂的对照组只有27%的人数达到了同样的效果。

此外据调查显示,服用Saxenda的患者的空腹血糖、腰围、收缩压水平都下降了,生活质量也得到了很大的改善。

IIIa期临床试验的受试者是3731名超重患者,尽管他们没有患糖尿病,但是都伴随肥胖相关的问题,例如高血压或高胆固醇。该药物对糖尿病发病进展的影响将会于随访病人160周后加以评估。该结果日前发表于圣地亚哥举办的内分泌学会上。

南卡罗来纳医科大学的首席研究员Patrick O'Neil表示,许多肥胖人群还没能认识到肥胖对健康造成的危害。肥胖这种疾病的本质非常复杂,这就导致单纯依靠减肥极富挑战性,需要多种治疗方法联合介入,从而帮助患者控制体重以及维持身体健康。

尽管Saxenda在控制血糖和血压方面具有积极的优势,但是在该药物的注册临床试验中还是重点强调了减肥的功效。据统计,共有三分之一的患者在服药后体重至少减轻了10%,而安慰剂组只有10%的人数达到了同样的效果。诺和诺德的另外一种减肥药Victoza去年获得了FDA的批准,并且也在欧洲被推荐批准。

有分析师认为,尽管目前美国市场上推出了三款减肥新药(Belviq、Qsymia和Contrave),但是Saxenda只要获批推向市场,还是能够为诺和诺德每年至少创造10亿美金的收益。

诺和诺德近期希望Saxenda能在2015年上半年推向美国市场,在15年年底之前在几个欧洲国家上市。诺和诺德将会在美国设置500个销售代表,目的就是在“相对狭窄”的体重控制领域斩获相当的市场份额。(生物谷Bioon.com)

原文 Positive data in Saxenda diabetes prevention study

Patients who lose weight when treated with Novo Nordisk's obesity drug Saxenda also show improvements in blood glucose and blood pressure levels, according to a clinical trial.

One of the main goals of the trial is to see if long-term treatment with Saxenda (liraglutide) will help delay the onset of type 2 diabetes, although data on this outcome will not be ready until later.

The initial results from the SCALE trial are however encouraging. 63% of patients treated with a once-daily Saxenda shot on top of calorie restriction and physical activity achieved a 5% or more weight reduction after 56 weeks, compared to 27% of those who were treated with placebo plus diet and exercise.

Moreover, those who responded to treatment with Novo's drug showed reductions in fasting plasma glucose, waist circumference, systolic blood pressure and quality of life as measured by the Short Form Health Survey (SF-36).

The phase IIIa trial involved 3,731 overweight or obese adults who were not diabetic, but had other weight-related problems such as high blood pressure or elevated cholesterol levels. The drugs impact on the development of diabetes will be assessed after patients have been followed up for 160 weeks.

The results were presented at the annual meeting of the Endocrine Society (ENDO) in San Diego.

"Many people with obesity are unaware of its severity and its implications for their health," said lead investigator Patrick O'Neil of the Medical University of South Carolina in Charleston, US."

"The nature of this disease is complex and maintaining weight loss can be challenging [and] multiple treatment options are needed to help people with obesity lose weight, keep it off, and improve their health."

The positive effects of Saxenda on blood pressure and blood glucose are encouraging, but SCALE also reinforces the positive effect on weight seen in registration trials for the drug. All told, a third of patients on Saxenda lost 10% or more of their body weight, compared to 10% of the placebo group.

Saxenda - which is a low-dose formulation of the same drug used in Novo's big-selling diabetes therapy Victoza - was approved for obesity in the US towards the end of last year and has also been recommended for approval in Europe.

Analysts have suggested that the product could achieve sales of $1bn or more, succeeding in revitalising the market for weight-loss drugs which remains fairly static despite the recent launches in the US of three other drugs; Eisai and Arena's Belviq (lorcaserin), Vivus' Qsymia (phentermine/topiramate) and Orexigen's Contrave (naltrexone and bupropion).

None of these has made significant headway since their US launches, and of the three only Orexigen's drug (branded as Mysimba) has been backed in Europe, with both Belviq and Qsymia turned down by the European Medicines Agency (EMA) on safety concerns.

Novo said recently it expects to launch Saxenda in the US in the first half of 2015 and in several EU markets before the end of the year, with "modest" sales contribution in the early months. The company will put 500 sales reps behind the product in the US, targeting what it describes as a "relatively narrow" group of weight management specialists.

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