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諾德諾德減肥藥Saxenda控制血糖效果明顯,或有望預防糖尿病

2015年3月11日訊/生物谷BIOON/--近日一項臨床研究結果表明,服用諾和諾德減肥藥Saxenda的患者,其血糖和血壓水平也獲得很大改善。

此外,這項研究的一個重要目的是驗證長期服用Saxenda是否有助于延遲2型糖尿病的發生,盡管目前的數據還不能很好地說明這一點。

然而,目前的臨床試驗結果已經足夠鼓舞人心了。數據表明,在服用56周Saxenda并且輔助以體育鍛煉之后,63%的超重患者的體重都減輕了至少5%,而節食鍛煉并服用安慰劑的對照組只有27%的人數達到了同樣的效果。

此外據調查顯示,服用Saxenda的患者的空腹血糖、腰圍、收縮壓水平都下降了,生活質量也得到了很大的改善。

IIIa期臨床試驗的受試者是3731名超重患者,盡管他們沒有患糖尿病,但是都伴隨肥胖相關的問題,例如高血壓或高膽固醇。該藥物對糖尿病發病進展的影響將會于隨訪病人160周后加以評估。該結果日前發表于圣地亞哥舉辦的內分泌學會上。

南卡羅來納醫科大學的首席研究員Patrick O'Neil表示,許多肥胖人群還沒能認識到肥胖對健康造成的危害。肥胖這種疾病的本質非常復雜,這就導致單純依靠減肥極富挑戰性,需要多種治療方法聯合介入,從而幫助患者控制體重以及維持身體健康。

盡管Saxenda在控制血糖和血壓方面具有積極的優勢,但是在該藥物的注冊臨床試驗中還是重點強調了減肥的功效。據統計,共有三分之一的患者在服藥后體重至少減輕了10%,而安慰劑組只有10%的人數達到了同樣的效果。諾和諾德的另外一種減肥藥Victoza去年獲得了FDA的批準,并且也在歐洲被推薦批準。

有分析師認為,盡管目前美國市場上推出了三款減肥新藥(Belviq、Qsymia和Contrave),但是Saxenda只要獲批推向市場,還是能夠為諾和諾德每年至少創造10億美金的收益。

諾和諾德近期希望Saxenda能在2015年上半年推向美國市場,在15年年底之前在幾個歐洲國家上市。諾和諾德將會在美國設置500個銷售代表,目的就是在“相對狹窄”的體重控制領域斬獲相當的市場份額。(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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