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首页 » 强生 » 强生降糖药INVOKANA显著改善老年群体血糖及健康措施

强生降糖药INVOKANA显著改善老年群体血糖及健康措施

来源:生物谷 2014-06-19 09:20

2014年6月19讯 /生物谷BIOON/ --强生(JNJ)旗下杨森研发单元6月16日公布了一项为期2年(104周)的III期研究(DIA3010)的新数据。该研究在接受当前降糖疗法但仍控制不佳的55-80岁2型糖尿病(T2D)老年群体中开展,评估了INVOKANA(canagliflozin)的长期疗效。数据显示,100mg和300mg剂量INVOKANA相对于安慰剂使血糖水平(糖化血红蛋白,HA1c)取得了更大幅度的降低(-0.49%和-0.60%),并在数个关键次要终点相对于安慰剂也取得了更大幅度的降低,包括:实现HA1c<7的患者比例(15.6%和21.7%)、空腹血糖(-21.4和-23.4 mg/dL)、体重(-2.3%和-3.2%)、收缩压(-5.8和-7.5 mm Hg)、高密度脂蛋白胆固醇(HDL-C)水平升高(3.6%和4.8%)。此外,INVOKANA与安慰剂在甘油三酯和低密度脂蛋白胆固醇(LDL-C)水平无显著性变化。这些数据加强了INVOKANA对老年T2D患者关键健康措施方面的积极疗效。

研究中,100mg、300mg剂量INVOKANA、安慰剂不良事件(AE)整体发生率分别为88%、90%、86%,AE相关停药率分别为5%、7%、10%,严重AE在各组相似。发病率较高的AE事件包括尿路感染、生殖器真菌感染、渗透性利尿。AE属性与广泛的INVOKANA治疗群体中相一致。

有关该项研究的详细信息,请访问美国糖尿病协会科学会议网站,并检索摘要号268-OR。

在所有年龄组中,老年群体糖尿病患病率最高,在美国,65岁及以上老年人中,有25%罹患糖尿病。美国整体人口的老龄化已被公认是糖尿病大流行的驱动因素。在糖尿病群体中,2型糖尿病约占到了90-95%,如果不加控制,会导致严重的并发症。

INVOKANA(canagliflozin)于2013年获FDA和欧盟批准,该药为日服一次的口服糖尿病药物,属于选择性纳葡萄糖共转运体2(sodium glucose co-transporter 2,SGLT2)抑制剂的一类新药,通过阻断肾脏对血糖的重吸收及增加尿液中血糖的排泄,来降低机体血糖水平。

与非糖尿病人群相比,2型糖尿病患者的肾脏能够重吸收大量的葡萄糖进入血液,这可能会推高血糖水平。(生物谷Bioon.com)

英文原文:New Long-Term Data Show INVOKANA (canagliflozin) Lowers Blood Glucose in Older Patients with Type 2 Diabetes Inadequately Controlled on Other Therapies
Phase 3 Study Results Also Demonstrate INVOKANA? Reduces Secondary Endpoints of Body Weight and Systolic Blood Pressure

Note: This release corresponds to American Diabetes Association (ADA) abstract 268-OR

RARITAN, N.J., JUNE 16, 2014 – Janssen Research & Development, LLC (Janssen) today announced new results from a 104-week Phase 3 clinical study evaluating the long-term effects of INVOKANA? (canagliflozin) in patients aged 55 to 80 years with type 2 diabetes inadequately controlled on current antihyperglycemic therapies. The randomized double-blind study showed INVOKANA? 100 milligrams (mg) and 300 mg, compared to placebo, provided greater reductions in blood glucose (A1C), and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic blood pressure.

Older adults have the highest prevalence of diabetes of any age group, with more than 25 percent of U.S. adults aged 65 years and older living with diabetes.[1] The aging of the overall U.S. population is acknowledged as a driver of the diabetes epidemic.[2] Type 2 diabetes comprises 90 to 95 percent of people with diabetes and if left uncontrolled can lead to serious complications.[1]

"The results presented today reinforce the positive effects of INVOKANA? on key health measures for older people with type 2 diabetes," said Norman Rosenthal, MD, FACE, FACP, canagliflozin compound development team leader, Janssen. "As INVOKANA? continues its rapid uptake in the type 2 diabetes community, we remain committed to enhancing understanding of its full impact on different patient types and the healthcare system overall."

In the long-term study (DIA3010), after 104 weeks, levels of A1C, the primary endpoint, were significantly reduced with INVOKANA? 100 mg and 300 mg, respectively, relative to placebo: -0.49 percent (95 percent confidence interval [CI] -0.65, -0.32) and -0.60 percent (CI -0.77, -0.44). A1C, also called hemoglobin A1c, is the percent of red blood cell hemoglobin with glucose attached to it, and is an indicator of average blood glucose over the previous two to three months.[3]

INVOKANA? 100 mg and 300 mg, respectively, also resulted in significant improvements in a number of secondary endpoints relative to placebo:

The percent of patients reaching the A1C goal level of less than 7.0 percent: 15.6 percent (CI 7.2, 24.0) and 21.7 percent (CI 13.0, 30.3)
Body weight reduction: -2.3 percent (CI -3.1, -1.6) and -3.2 percent (CI -4.0, -2.4)
Fasting plasma glucose reduction: -21.4 mg/dL (CI -28.5, -14.2) and -23.4 mg/dL (CI -30.6, -16.2)
Systolic blood pressure reduction: -5.8 mm Hg (CI -8.0, -3.5 and -7.5 mm Hg (CI -9.8, -5.2)
Increased levels of HDL-C (high-density lipoprotein cholesterol): 3.6 percent (CI 0.4, 6.9) and 4.8 percent (CI 1.5, 8.1)
Treatment with INVOKANA? was also associated with non-significant changes, relative to placebo, in blood triglycerides and LDL-C (low-density lipoprotein cholesterol).

The overall incidence of adverse events (AEs) for INVOKANA? 100 mg, 300 mg and placebo, respectively, was 88 percent, 90 percent, and 86 percent. AE-related discontinuation rates were 5 percent, 10 percent and 7 percent, and serious AE rates were similar across groups. Higher incidences of urinary tract infections, genital mycotic infections, osmotic diuresis (increased urination)-related AEs, and volume depletion were seen with INVOKANA? compared to placebo. Hypoglycemia was more common with INVOKANA? than placebo, with few severe episodes across groups. The AE profile was consistent with that seen among a broad range of INVOKANA?-treated patients.

For more details about the study, visit the American Diabetes Association Scientific Sessions website and search online abstracts for presentation number 268-OR.

The results presented today are among a total of 15 presentations on INVOKANA? made at the American Diabetes Association 74th Scientific Sessions? in San Francisco.

About INVOKANA?

INVOKANA? is the first sodium glucose co‐transporter 2 (SGLT2) inhibitor available in the United States.

It is an oral medication that reduces the reabsorption of glucose by the kidney, thereby promoting the loss of glucose in the urine and lowering blood glucose levels in adults with type 2 diabetes. In clinical trials, INVOKANA? also has been shown to provide secondary endpoint reductions in body weight and systolic blood pressure.

In March 2013, the United States Food and Drug Administration (FDA) approved INVOKANA? as a single agent as an adjunct to diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA? has since been widely adopted and today it is the number-one branded therapy prescribed by U.S. endocrinologists when adding or switching non‐insulin type 2 diabetes medications. INVOKANA? also is approved in the European Union (31 countries), Australia, Canada, Chile, Mexico, Switzerland, Singapore, South Korea, Peru, Aruba, Kuwait, United Arab Emirates and Guatemala.

INVOKANA? has been studied as monotherapy and in combination with other type 2 diabetes therapies.

The comprehensive global Phase 3 clinical development program for INVOKANA? enrolled 10,285 patients in nine studies and was one of the largest clinical programs in type 2 diabetes submitted to health authorities to date. In two separate trials, INVOKANA? 300mg demonstrated greater reductions in A1C versus sitagliptin 100mg at 52 weeks, as well as greater reductions in body weight and systolic blood pressure. The recommended starting dose on INVOKANA? is 100mg. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.

The most common adverse events with INVOKANA? are genital mycotic (fungal) infections, urinary tract

infections and increased urination. These specific adverse events were generally mild to moderate in

intensity and infrequently led to discontinuation in Phase 3 studies.

About Type 2 Diabetes

An estimated 371 million worldwide are living with diabetes[4] and approximately 25.8 million people have diabetes in the United States.[5] Type 2 diabetes comprises 90 percent of people with diabetes,[6] which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.

Nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, and if left uncontrolled, type 2 diabetes can lead to serious complications.[7],[8],[9] Improved glycemic control has been demonstrated to reduce the onset and progression of these complications. [10]

INDICATION STATEMENT
WHAT IS INVOKANA??

INVOKANA? is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
INVOKANA? is not for people with type 1 diabetes.
INVOKANA? is not for people with diabetic ketoacidosis (increased ketones in blood or urine).
It is not known if INVOKANA? is safe and effective in children under 18 years of age.

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