双时相门冬胰岛素30每日1次对2型糖尿病患者的疗效和安全性

目的 评价2型糖尿病患者每日1次应用双时相门冬胰岛素30治疗的有效性和安全性.方法 本研究为多中心、开放性、自身对照的临床观察性研究.2008年9月至2009年6月选取未接受降糖治疗或既往口服降糖药治疗血糖控制效果欠佳的2型糖尿病患者621例,平均年龄（56±11）岁,平均糖尿病病程（4.4±4.2）年（0～30年）,平均体重指数（25.5±2.9）kg/m2,平均糖化血红蛋白（HbA1c）8.5%±1.2%.使用每日1次双时相门冬胰岛素30,起始剂量和最终剂量分别为（0.16±0.05）U/kg、（0.20±0.07）U/kg.联合口服药治疗12周后评价其有效性和安全性,并探索不同基线因素对于疗效的影响.结果 治疗12周后,HbA1c下降了1.8%±1.1%.HbA1c＜6.5%的患者占30.8%,HbA1c＜7%的患者占65.5%.空腹血糖和餐后血糖均显著下降,8时点血糖平均值下降了（3.8±2.3）mmol/L.分别按基线糖尿病病程、HbA1c、注射时间和体重指数分层的分析结果显示,HbA1c达标率随着糖尿病病程的延长和HbA1c的升高而降低.在双时相门冬胰岛索30治疗中,非重度低血糖事件每年每例患者的发生率为1.83次.仅有1例（0.2%）患者发生1次重度（夜间）低血糖事件.患者治疗后体重较治疗前显著降低（P=0.0053）.结论 在未使用降糖治疗或已用口服降糖药但血糖控制不佳的2型糖尿病患者中,双时相门冬胰岛素30每日1次治疗作为胰岛素起始方案,可安全有效地降低血糖水平,尤其适用于HbA1c水平轻至中度升高,病程相对较短的患者.     

诺和锐30治疗控制不良老年2型糖尿病临床体会

目的探讨预混胰岛素类似物双相门冬胰岛素（诺和锐30）对口服降糖药血糖控制不良的老年2型糖尿病的疗效和不良反应。方法：40例口服降糖药血糖控制不良的老年2型糖尿病使用诺和锐30治疗16周,观察治疗前后空腹血糖（FBG）、餐后血糖（PBG）、糖化血红蛋白（HbA1c）,并记录低血糖等不良反应。结果：FBG、PBG、HbA1c均明显下降,无严重低血糖及其它不良事件。结论：诺和锐30治疗口服降糖药血糖控制不良的老年2型糖尿病安全、有效。     

瑞格列奈联合二甲双胍治疗口服降糖药控制不良的2型糖尿病患者的有效性和安全性

目的 评价瑞格列奈和二甲双胍联合治疗对已经使用口服降糖药但血糖控制不佳的2型糖尿病患者的有效性和安全性.方法 5个临床研究中心的187例2型糖尿病患者入选本研究,其中44.4%的病例以往使用一种口服降糖药,55.6%的病例以往使用两种或两种以上口服降糖药,平均HbA1C(8.60 ±0.67)%.试验为多中心、单组、开放性研究,由筛选期、剂量调整期和剂量维持期组成,根据瑞格列奈治疗剂量将治疗分为Ⅰ级、Ⅱ级和Ⅲ级3组.观察瑞格列奈和二甲双胍联合治疗20周的有效性和安全性.结果 与基线数据比较,使用瑞格列奈和二甲双胍联合治疗后,总体HbA1C、空腹血糖(FPG)、餐后2 h血糖(PPG)水平均显著降低,分别下降(0.96±0.88)%、(1.75±2.03)mmol/L、(2.89 ± 3.67)mmol/L(均P＜0.01).不同剂量级各组HbA1C、FPG、PPG下降情况分别为:剂量Ⅰ级(1.39±0.79)%、(1.49 ±1.53)mmol/L、(3.35 ±3.21)mmol/L;剂量Ⅱ级(0.97 ±0.92)%、(1.80 ±2.35)mmol/L、(2.58 ±4.71)mmol/L;剂量Ⅲ级(0.76 ± 0.86)%、(1.87±2.10)mmol/L、(2.90±3.36)mmol/L.试验期间共发生轻度和重度低血糖事件各1例,其余均仅有症状表现.低血糖事件的发生与药物剂量无关.治疗结束后患者体重略有下降.结论 瑞格列奈联合二甲双胍治疗可有效降低使用口服降糖药疗效不佳的2型糖尿病患者的HbA1C、FPG、PPG水平,有利于帮助和促进患者实现HbA1C达标     

诺和锐30特充治疗50例2型糖尿病临床观察

本文观察50例2型糖尿病患者,治疗前后自身对照.结果诺和锐30特充治疗一个月后空腹血糖(PBG),餐后血糖(FBG)均明显下降(P＜0.05),低血糖发生率低.结论诺和锐30特充能很好模拟人胰岛素生理分泌模式,实现更佳降糖,且低血糖发生率低.     

诺和锐30R和诺和灵30R对老年糖尿病患者降糖治疗的有效性和安全性比较

目的 为探寻对老年糖尿病有效、安全及依从性好的胰岛素制剂.方法 40例老年糖尿病患者随机分为使用诺和锐30R组和使用诺和灵30R组各20例,进行为期26w的临床治疗观察,比较两组治疗前与治疗后13、26w 7个时间点的血糖和糖化血红蛋白(HbAlc)下降程度,并对一般临床资料、胰岛素用量、药物不良反应及患者的满意度、依从性进行了分析比较.结果 两组患者7个时间点的血糖治疗前与治疗后13、26w比较及同组治疗前后比较血糖均显著下降(均P＜0.01),尤其是使用诺和锐30R组餐后血糖下降更为突出.HbAlc在治疗前与治疗后13、26w均明显下降(P＜0.05),使用诺和锐30R组低血糖发生率(为10%)较使用诺和灵30R组低血糖发生率(40%)显著降低(P＜0.05);且诺和锐30R组胰岛素用量少于诺和灵30R组,患者的满意度和依从性诺和锐30R组较诺和灵30R组显著增高(P＜0.01和P＜0.05).结论 对血糖控制不佳的老年糖尿病患者,尽早使用诺和锐30R,能使血糖控制更好,HbAlc更早达标.且低血糖发生率低.     

甘精胰岛素联合诺和锐30治疗2型糖尿病临床观察

30例诺和锐30血糖控制不满意患者,改为甘精胰岛素联合诺和锐30。结果12周后所有患者空腹血糖(治疗前9.34±2.15,治疗后5.37±1.26 mmol/L),接近正常上限,血糖波动小,糖血红蛋白HbA1c下降(治疗前8.19,1.38,治疗后7.21±0.72)症状性低血糖事件发生率明显减少。结论一部分应用诺和锐30治疗血糖控制不佳的患者,更改为甘精胰岛素联合诺和锐30治疗后可以获得良好的血糖控制。     

双时相门冬胰岛素30联合二甲双胍治疗基础胰岛素控制不佳的2型糖尿病患者:疗效及安全性评价

目的 评价既往基础胰岛素联合口服降糖药物(OAD)治疗血糖控制不佳的2型糖尿病患者转用双时相门冬胰岛素30(BIAsp30)联合二甲双胍治疗的疗效及安全性.方法 本试验为多中心、非随机、开放、单组治疗达标研究,包括2周筛选期、4周导入期和16周治疗期.既往使用基础胰岛素联合OAD治疗血糖控制不佳的2型糖尿病患者转用每日两次BIAsp30注射联合口服二甲双胍治疗.收集疗效及安全性数据进行统计学分析.结果 共293例患者(男154,女139)入选,平均年龄(54.0±9.6)岁,平均糖尿病病程(8.54±5.49)年,平均体重指数(24.89±3.28)kg/m2,HbA1c 8.16%±0.89%,122例既往使用基础胰岛素类似物,169例使用人中效胰岛素.经16周的治疗,平均HbA1C降幅达1.30%±0.96%(P＜0.01);HbA1C达到＜7.0%和≤6.5%的患者比例分别为60.4%和38.9%.患者8点血糖谱各点血糖值均有显著降低(P＜0.01),8点血糖均值由基线时的(10.53±2.58)mmol/L降至(7.79±1.58)mmol/L(P＜0.01),降幅为2.76 mmol/L.早餐和晚餐后血糖增幅显著下降,分别下降了1.73 mmol/L(P＜0.01)和1.28 mmol/L(P＜0.01),而午餐后的血糖增幅未发现显著性降低(-0.09 mmol/L,P=0.734 5).研究治疗中无严重不良事件和重度低血糖事件报告,总体低血糖发生率为2.68例/患者年;患者体重平均增加(0.76±0.14)kg(P＜0.01).结论 BIAsp30联合二甲双胍可显著改善基础胰岛素联合OAD血糖控制不佳的2型糖尿病患者的血糖控制,并具有良好的安全性.     

诺和锐30R强化治疗对2型糖尿病患者血糖控制的临床价值探讨

目的对诺和锐30R强化治疗对2型糖尿病患者血糖控制的临床价值进行深入分析和研究。方法收集该院2015年1月—2016年12月收治的40例2型糖尿病患者作为研究对象,随机分为A组(使用诺和灵30R进行治疗)和B组(使用诺和锐30R进行治疗),每组20例。对比两组患者的血糖控制效果以及低血糖事件的发生情况。结果A、B两组患者在治疗之后的空腹血糖、餐后2 h血糖、糖化血红蛋白水平明显低于治疗前;B组患者在治疗之后的空腹血糖、餐后2 h血糖、糖化血红蛋白水平低于A组患者治疗后,差异有统计学意义(P0.05)。B组患者低血糖事件发生率5.00%明显低于A组患者的20.00%,差异有统计学意义(P0.05)。结论诺和锐30R强化治疗对2型糖尿病患者血糖控制有着比较好的临床价值,通过诺和锐30R强化治疗能够有效控制患者的血糖水平,减少低血糖事件的发生,对于促进患者的恢复十分有利,因此可进行临床推广应用。     

诺和锐30治疗老年初诊2型糖尿病16例

目的探讨预混胰岛素类似物双相门冬胰岛素（诺和锐30）对老年初诊2型糖尿病（T2DM）的疗效和不良反应. 方法 16例初诊的老年T2DM使用诺和锐30治疗8周,观察空腹血糖（FBG）、餐后2h血糖（2 hPG）、糖化血红蛋白（HbA1c）的变化及低血糖等不良反应. 结果治疗8周后FBG平均下降3.44 mmol/L,2hPG平均下降8.52 mmol/L,HbA1c平均下降2.65%.未发生严重低血糖事件以及其他严重不良反应. 结论诺和锐30治疗老年初诊T2DM具有疗效确切、患者易于接受、低血糖反应少等特点,值得尝试推广使用.     

来得时联合拜唐苹和诺和锐30治疗口服降糖药疗效不佳的高龄2型糖尿病患者的临床观察

目的探讨来得时联合拜唐苹和诺和锐30治疗高龄（80岁以上）2型糖尿病（T2DM）患者血糖、糖化血红蛋白（HbA1c）变化,低血糖事件发生率及临床意义。方法将120例口服降糖药物疗效较差的高龄T2DM患者随机分为来得时联合拜唐苹组和诺和锐30组（每组60例）。来得时联合拜唐苹组每日早餐前注射1次来得时加三餐中口服拜唐苹,诺和锐30组早晚餐前各皮下注射1次,共16周,比较两组患者空腹血糖（FBG）及餐后2小时血糖（2hPBG）、甘油三酯（TG）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）,高密度脂蛋白胆固醇（HDL-C）、HbA1c的下降情况,低血糖事件发生率。结果两组治疗前后血糖、TG、TC、LDL-C、HbA1c下降明显,其中来得时联合拜唐苹组HbA1c从（8.8%±2.0%）下降至（7.1%±1.2%）;诺和锐30组HbA1c从（8.9%±2.4%）下降到（7.0%±1.2%）;治疗后两组之间差异无统计学意义（P＞0.05）;来得时联合拜唐苹组低血糖事件发生率明显低于诺和锐30组（3.3%vs 13.3%,P＜0.01）。结论来得时联合拜唐苹组和诺和锐30组都具有明显降低FBG、2hPBG、TG、TC、LDL-C、HbA1c的作用,来得时联合拜唐苹组低血糖事件发生率明显低于诺和锐30组。     

Lessons in initiating insulin in clinical practice

Insulin therapy in type 2 diabetes (T2DM) can produce greater improvements in fasting plasma glucose (FPG) and glycated haemoglobin (HbA1c) than oral antidiabetic drugs (OADs). There is a growing trend to recommend initiation of insulin in T2DM patients sooner in the course of the disease, and good results have been achieved in insulin-na?ve patients during randomised, controlled trials, often using aggressive dose titration algorithms. The Physicians' Routine Evaluation of Safety & Efficacy NovoMix((R)) 30 Therapy (PRESENT) study was a 6-month observational study of the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) as monotherapy or in combination with OADs in inadequately controlled patients with T2DM. This review article compares results from those patients who entered the study insulin-na?ve (either with or without previous OAD treatment), with results from randomised, controlled trials of BIAsp 30 in insulin-na?ve T2DM patients. It aims to provide guidance on the initiation of insulin in patients with T2DM, focusing on the efficacy of BIAsp 30 when used for this purpose, and highlighting both the low risk of hypoglycaemia associated with therapy, and the availability of delivery devices that can minimise injection site discomfort and help to overcome psychological insulin resistance.     

Study design and baseline characteristics of patients in the PRESENT study

PRESENT (Physicians' Routine Evaluation of Safety & Efficacy of NovoMix 30 Therapy) is a 6-month observational study of safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in 31,044 type 2 diabetes patients from 15 countries. The aim of this article is to describe the study protocol and assess baseline characteristics of patients in various countries according to diabetes duration (<5 years, 5 to or=20 years), to improve treatment decisions in clinical practice. Glycaemic control was similar across all groups: HbA1c 9.3-9.4%; fasting plasma glucose 11.3-11.6 mmol/L; postprandial glucose 15.9-16.3 mmol/L. Major hypoglycaemia was reported by 5% of all patients, minor hypoglycaemia increased with diabetes duration (25.4-30.3%); overall hypoglycaemia rate was 6.7 events/patient/year. Complications increased with diabetes duration; the most reported were hypertension (40.6-71.0%) and hyperlipidaemia (39.4-56.6%). Of patients 38% previously received OADs only, 28% insulin only, 19% insulin with OADs, and 13% received no therapy. Glycaemic control appeared independent of diabetes duration. HbA1c was well above targets and the clinical inertia was quite apparent; even patients with diabetes for <5 years had high HbA1c levels. Patients suffered high rates of complications and hypoglycaemia before starting BIAsp 30 therapy.     

Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes

AIM: To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy. METHODS: This 26-week, multi-centre, open-labelled, randomized, two-arm parallel trial consisted of a 2-week screening period, followed by 24 weeks of treatment. Subjects randomized to BIAsp30 treatment (n = 129) received BIAsp30 once daily (o.d.) at dinnertime between Week 2 and Week 14, and those not reaching treatment targets were switched to twice daily (b.i.d.) BIAsp30 at Week 14 (n = 50). Subjects randomized to the OAD-only arm (n = 63) continued with their previous OAD treatment and, in an attempt to reach treatment goals, the dose was optimized (but OAD unchanged) in accordance to local treatment practice and labelling. RESULTS: Significantly greater reductions in HbA(1c) over Weeks 0-13 with BIAsp30 (o.d.) vs. OAD-only treatment (1.16 vs. 0.58%; p < 0.001), and over Weeks 0-26, with BIAsp30 (o.d.) and BIAsp30 (b.i.d.) treatments vs. OAD-only treatment (1.24 vs. 1.34 vs. 0.67%; p < 0.01). Hypoglycaemic episodes were reported in 54% of the patients in BIAsp30 (o.d. and b.i.d. pooled) and 30% of the patients in OAD-only group. All episodes were minor or symptomatic, except for one in each treatment group, which was major. CONCLUSIONS: Initiating BIAsp30 treatment is a safe and more effective way to improve glycaemic control in Western Pacific patients with type 2 diabetes inadequately controlled with oral monotherapy or oral combination therapy compared with optimizing oral combination therapy alone. In patients not reaching treatment target on BIAsp30 (o.d.), treatment with BIAsp30 (b.i.d.) should be considered.     

加用甘精胰岛素或中效胰岛素的2型糖尿病患者血糖波动的比较

目的 比较空腹血糖控制不佳的2型糖尿病患者加用甘精胰岛素(glargine)或中效胰岛素治疗对血糖波动的影响.方法 30例口服抗糖尿病药治疗的2型糖尿病患者(空腹血糖>9.0 mmoL/L,HbA1C> 8.5%),按1:1随机分成两组,分别加用甘精胰岛素(来得时(R))或中效胰岛素(诺和灵(R)N)联合治疗.以空腹指尖毛细血管血糖<6.0 mmol/L为目标,用动态血糖检测仪监测患者血糖水平,计算全天血糖水平的标准差(SDBG)、最大血糖波动幅度(LAGE)以及空腹血糖变异系数(CV-FPG)作为反映lffL糖波动的指数.结果 加用甘精胰岛素组上述三个指标均低于加用中效胰岛素组(SDBG:1.49±0.35 vs 1.73±0.46;LAGE:3.23±0.76 vs 3.73±1.00;CV-FPG 17.26±2.24 vs 3520.33±3.21,均P<0.05),同时甘精胰岛素组低血糖发生人次数也低于中效胰岛素组,但差异无统计学意义(P>0.05).结论 空腹血糖控制不佳的2型糖尿病患者加用甘精胰岛素比加用中效胰岛素治疗更有利于血糖的平稳,且不增加低血糖的风险.     

双时相门冬胰岛素30在中国人群中的临床应用——A1chieve观察性研究结果

目的在A1chieve国际多中心、前瞻性、开放标签的观察性研究中,提供双时相门冬胰岛素30（以下简称门冬胰岛素30）在中国常规2型糖尿病临床治疗中有关安全性和疗效方面的数据。方法于2008年11月至2011年3月,在全国130家研究中心入组曾用或未用药治疗但血糖控制不佳、经医师判断需要并起始门冬胰岛素30的2型糖尿病患者,分为总体研究人群（包括8578例接受门冬胰岛素30治疗的中国2型糖尿病患者）、亚组研究人群（包括1191例由预混人胰岛素转为门冬胰岛素30治疗的患者）。医师根据临床经验决定治疗方案并进行剂量调整,随访24周。采用配对t检验、Fisher精确概率检验等进行统计学分析。结果经过24周治疗,总体研究人群的所有低血糖事件、重度低血糖事件、夜间低血糖事件发生率（次／人年）分别从基线时2．32、0．15、0．58下降至1．54、0．00、0．28（Fisher精确概率检验P〈0．05,P〈0．01,P〈0．01）。基线时,总体研究人群的糖化血红蛋白为（9．5±2．3）％,治疗24周后下降至（7．0±l.0）％（P〈0．01）;空腹和餐后2h血糖后分别下降（3．5±3．6）mmo]／L和（5．5±5．0）mmol／L（均P〈0．01）。亚组患者的所有低血糖事件、重度低血糖事件、夜间低血糖事件发生率（次／人年）分别从基线时7．20、0．51、2．15下降至2．37、0．00、0．43（均P〈0．01）。治疗24周后,亚组患者的糖化血红蛋白由基线时（8．7±2．1）％下降至（7．0±1．1）％（P〈0．01）。结论血糖控制不佳的中国2型糖尿病患者,无论既往是否接受过口服降糖药或胰岛素治疗,接受门冬胰岛素30治疗24周后耐受性和安全性良好,显著改善血糖控制。     

使用口服降糖药血糖控制欠佳的中国2型糖尿病患者起始胰岛素治疗现状

目的 在口服降糖药（OADs）血糖控制欠佳的中国T2DM患者中,了解起始胰岛素治疗的安全性和疗效。方法OADs血糖控制欠佳的中国T2DM患者按临床常规起始胰岛素治疗,于基线和治疗16周后分别收集患者的临床数据,主要安全性指标有低血糖事件和药物不良反应的发生情况,主要疗效指标包括HbA1c的变化和达标率、平均FBG和2hBG的变化。结果共观察4847例T2DM患者,女性患者有2327例（48．0％）。完成研究的患者共4364例（90．0%）。基线年龄（59．7±12．2）岁,HbA1c（9．65±2．12）％,糖尿病病程（7．94士6．13）年。起始胰岛素使用比例最高为预混人胰岛素（38．1%）,其次为预混胰岛素类似物（31．3％）。重度低血糖事件的发生率（事件／人年）在基础人胰岛素和类似物组最低（均为o．02）。夜间低血糖发生率在基础-餐时胰岛素类似物组最低（0．27）。治疗后HbA1c降幅为2．3％（P〈O．001）,基础-餐时胰岛素类似物组降幅最大（3．02±1．94）％,预混胰岛素类似物组次之（2．61±1．97）％。HbA1c〈7．0％的达标率为43．2％。胰岛素治疗后平均FBG和2hBG的降幅分别为3．21mmol／L和5．21mmol／L（P＜0．001）,均在基础一餐时胰岛素类似物组降幅最大。结论起始胰岛素治疗后T2DM患者整体血糖控制均有显著的改善。基础胰岛素的安全性较好;基础一餐时胰岛素HbA1c、空腹和餐后血糖的改善情况最佳;预混胰岛素是目前我国T2DM人群最常用的起始治疗胰岛素,其疗效和安全性介于上述两种治疗方案之间,预混胰岛素类似物的无低血糖事件达标率优于其他的常用胰岛素治疗方案。     

Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study)

AIM: This observational study in patients with type 2 diabetes failing oral agent therapy with or without basal insulin was conducted to assess whether addition and self-titration of biphasic insulin aspart 70/30 (BIAsp 30) could achieve American Association of Clinical Endocrinologists (AACE)/International Diabetes Federation (IDF) and American Diabetes Association (ADA) glycemic targets (HbA(1c)< or =6.5 and <7%). METHODS: Enrolled patients (n = 100, HbA(1c)> or =7.5 and < or =10%) were > or =18 years of age, had diabetes > or =12 months and had received a stable antidiabetic regimen for at least 3 months [minimum of two oral antidiabetic drugs (OADs) or at least one OAD plus once-daily basal insulin < or =60 U]. Patients discontinued prior basal insulin and added one injection of BIAsp 30 (12 U or 70-100% of prior basal insulin dose within 15 min of dinner initiation). Patients self-titrated their BIAsp 30 dose with investigator guidance every 3 or 4 days to achieve pre-breakfast fasting blood glucose (FBG) of 80-110 mg/dl. At 16 weeks, a pre-breakfast injection of 6 U of BIAsp 30 was added if week 15 HbA(1c) exceeded 6.5%; the added dose was titrated to achieve pre-dinner BG of 80-110 mg/dl. After an additional 16 weeks, 3 U of pre-lunch BIAsp 30 was added if HbA(1c) exceeded 6.5%. This added dose was adjusted based on 2-h post-lunch BG to achieve postprandial glucose of 100-140 mg/dl. Subjects achieving an HbA(1c)< or =6.5% at 15 and 31 weeks completed the study at weeks 16 and 32 respectively. RESULTS: Addition of once-daily BIAsp 30 before dinner enabled 21% of the patients to achieve AACE and IDF targets (HbA(1c)< or =6.5%) and 41% to achieve ADA targets (HbA(1c) <7%). With two daily injections of BIAsp 30, these glycaemic goals were achieved by 52 and 70% of subjects. With three daily BIAsp 30 injections, 60% of patients achieved HbA(1c)< or =6.5%, and 77% achieved HbA(1c) <7.0%. CONCLUSIONS: This clinical trial demonstrates that initiation of once-daily BIAsp 30 to type 2 diabetes patients poorly controlled on various OAD regimens was an effective treatment approach for achieving glycaemic goals. Additional patients safely achieved these goals by increasing the number of BIAsp 30 injections from one to two, and then, if uncontrolled, from two to three doses per day. Eventually, most patients previously uncontrolled on OADs with or without basal insulin were controlled by the addition and vigorous titration of BIAsp 30 to oral agent therapy.     

Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US

OBJECTIVES: To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30% soluble and 70% protaminated insulin aspart) vs. insulin glargine in insulin-na?ve type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs). METHODS: Baseline patient characteristics and treatment effect data from the recent 'INITIATE' clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (-0.43%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0% per annum. Sensitivity analyses were performed. RESULTS: Improvements in glycaemic control were projected to lead to gains in LE (0.19 +/- 0.24 years) and QALE (0.19 +/- 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was $46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c >/= 8.5%, it was $34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0% and 相似文献