妊娠末期糖尿病患者应用格列本脲联合胰岛素治疗的效果及对妊娠结局与新生儿指标的影响

目的探讨妊娠末期糖尿病患者应用格列本脲联合胰岛素治疗的效果及对妊娠结局与新生儿指标的影响。方法选取盘锦辽油宝石花医院2017年1月至2019年6月收治的妊娠末期糖尿病患者150例作为研究对象,将其遵照双盲随机法分为对照组(75例,采用单纯胰岛素治疗方式)与试验组(75例,采用格列本脲联合胰岛素治疗方式)。比较两组基本资料、空腹血糖(FPG)、餐后2 h血糖水平(2 hPBG)、糖化血红蛋白(HbA1C)、妊娠结局与新生儿指标。结果与对照组比较,试验组患者FPG、2hPBG、HbA1C水平更低,差异有统计学意义(P<0.05);与对照组比较,试验组新生儿体重、体长、头围、肩周更佳,差异有统计学意义(P<0.05);与对照组比较,试验组新生儿早产率、低血糖发生率、黄疸发生率更低,差异有统计学意义(P<0.05)。结论将格列本脲联合胰岛素治疗应用于末期糖尿病患者中,有利于控制患者血糖水平,改善患者妊娠结局及新生儿指标,疗效显著。     

地特胰岛素注射液的临床效果和经济学评价研究综述

采用文献综述法,系统地分析国外已发表的地特胰岛素注射液（IDet）的临床研究和经济学评价结果,以评估地特胰岛素治疗1型和2型糖尿病患者的临床疗效和经济学价值。研究结果表明,在临床效果方面,患者从应用口服降糖药、中性鱼精蛋白锌胰岛素（NPH）或甘精胰岛素注射液（IGlar）,转换使用IDet后,均有助于进一步降低患者的血糖水平。许多国家的经济学研究显示,与NPH或IGlar相比,IDet是成本节约或具有成本-效果的治疗方案。     

Comparison of utilization,cost, adherence,and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe

Abstract

Background:

Studies examining outcomes of different insulin delivery systems are limited. The objective of this study was to compare healthcare utilization, costs, adherence, and hypoglycemia rates in patients with type 2 diabetes mellitus (T2DM) initiating rapid-acting insulin analog (RAIA) using prefilled pen versus vial/syringe.

Methods:

A retrospective analysis was conducted using a US claims database (1/1/2007 to 12/31/2008). Inclusion criteria were: ≥18 years old, with T2DM, ≥12 months of continuous eligibility, and new to RAIA. Difference-in-difference analyses after propensity score matching were conducted to compare changes in outcomes from 6 months prior to and 6 months after initiating RAIA with a prefilled pen versus vial/syringe (Wilcoxon rank-sum test for costs and t-test for other outcomes). Categories of utilization and costs (2009 USD) included total and diabetes-related inpatient, outpatient, and emergency room. Adherence was measured by proportion of days covered (PDC). Hypoglycemia was identified using ICD-9-CM codes.

Results:

Baseline characteristics were similar between the prefilled pen (n?=?239) and vial/syringe (n?=?590) cohorts after matching. Adherence to RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (PDC: 54.6 vs. 45.2%, p?<?0.001). While the increase in diabetes-related pharmacy costs from before to after initiating RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (+$900 vs. +$607, p?<?0.001), the prefilled pen cohort was associated with greater reductions in the total diabetes-related costs (–$235 vs. +$61, p?=?0.006) and the utilization of oral anti-hyperglycemic agents (–1.3 vs. –0.7, p?=?0.016). There were no significant differences in other outcomes.

Limitations:

Claims databases do not provide optimal measures for adherence or T2DM severity, and only capture hypoglycemia events requiring clinical intervention.

Conclusion:

Initiating RAIA with a prefilled pen was associated with better adherence and greater reduction in total diabetes-related costs than a vial/syringe. There was no significant difference in total healthcare costs.     

Cost-effectiveness of insulin detemir compared with NPH insulin in people with type 2 diabetes in Denmark,Finland, Norway,and Sweden

Abstract

Objective:

To assess the cost-effectiveness of insulin detemir compared with Neutral Protamine Hagedorn (NPH) insulin when initiating insulin treatment in people with type 2 diabetes mellitus (T2DM) in Denmark, Finland, Norway, and Sweden.

Methods:

Efficacy and safety data were derived from a 20-week multi-centre randomized controlled head-to-head clinical trial comparing insulin detemir and NPH insulin in insulin naïve people with T2DM, and short-term (1-year) cost effectiveness analyses were performed. As no significant differences in HbA_1c were observed between the two treatment arms, the model was based on significant differences in favour of insulin detemir in frequency of hypoglycaemia (Rate-Ratio?=?0.52; CI?=?0.44–0.61) and weight gain (Δ?=?0.9?kg). Model outcomes were measured in Quality Adjusted Life Years (QALYs) using published utility estimates. Acquisition costs for insulin and direct healthcare costs associated with non-severe hypoglycaemic events were obtained from National Health Service public sources. One-way and probabilistic sensitivity analyses were performed.

Results:

Based on lower incidence of non-severe hypoglycaemic events and less weight gain, the QALY gain from initiating treatment with insulin detemir compared with NPH insulin was 0.01 per patient per year. Incremental cost-effectiveness ratios for the individual countries were: Denmark, Danish Kroner 170,852 (€22,933); Finland, €28,349; Norway, Norwegian Kroner 169,789 (€21,768); and Sweden, Swedish Krona 226,622 (€25,097) per QALY gained. Possible limitations of the study are that data on hypoglycaemia and relative weight benefits from a clinical trial were combined with hypoglycaemia incidence data from observational studies. These populations may have slightly different patient characteristics.

Conclusions:

The lower risk of non-severe hypoglycaemia and less weight gain associated with using insulin detemir compared with NPH insulin when initiating insulin treatment in insulin naïve patients with type 2 diabetes provide economic benefits in the short-term. Based on cost/QALY threshold values, this represents good value for money in the Nordic countries. Using a short-term modelling approach may be conservative, as reduced frequency of hypoglycaemia and less weight gain may also have positive long-term health-related implications.     

胰岛素撤退对血浆FGF-21及FFAs的影响

目的评估1型糖尿病胰岛素撤退试验对血成纤维细胞生长因子-21（FGF-21）及游离脂肪酸（FFAs）的影响。方法测定1型糖尿病患者胰岛素撤退试验前后血胰岛素、FGF-21、FFAs及其它代谢因子的变化情况,并进行统计学分析。结果试验组血糖、血酮、血FFAs显著增高（P〈0.001）,血FGF-21显著增高（P=0.02）。对照组血酮显著增高（P=0.04）。试验组胰岛素变化与血FFAs及FGF-21变化无显著相关性。而血FFAs变化与FGF-21变化呈显著正相关（r=0.63,P=0.03）。结论 1型糖尿病FFAs精细调控FGF-21,而且具有相对独立性。胰岛素对1型糖尿病FFAs调控FGF-21不产生实质性影响。     

The cost-effectiveness and budget impact of stepwise addition of bolus insulin in the treatment of type 2 diabetes: evaluation of the FullSTEP trial

Background and aims:

Intensification of basal insulin-only therapy in type 2 diabetes is often achieved through addition of bolus insulin 3-times daily. The FullSTEP trial demonstrated that stepwise addition (SWA) of bolus insulin aspart was non-inferior to full basal-bolus (FBB) therapy and reduced the rate of hypoglycemia. Here the cost-effectiveness and budget impact of SWA is evaluated.

Methods:

Cost-effectiveness and budget impact models were developed to assess the cost and quality-of-life (QoL) implications of intensification using SWA compared with FBB in the US setting. At assessment, SWA patients added one bolus dose to their current regimen if the HbA1c target was not met. SWA patients reaching three bolus doses used FBB event rates. Outcomes were evaluated at trial end and projected annually up to 5 years. Models captured hypoglycemic events, the proportion meeting HbA1c target, and self-measured blood glucose. Event rates and QoL utilities were taken from trial data and published literature. Costs were evaluated from a healthcare-payer perspective, reported in 2013 USD, and discounted (like clinical outcomes) at 3.5% annually. This analysis applies to patients with HbA1c 7.0–9.0% and body mass index <40?kg/m².

Results:

SWA was associated with improved QoL and reduced costs compared with FBB. Improvement in QoL and cost reduction were driven by lower rates of hypoglycemia. Sensitivity analyses showed that outcomes were most influenced by the cost of bolus insulin and QoL impact of symptomatic hypoglycemia. Budget impact analysis estimated that, by moving from FBB to SWA, a health plan with 77,000 patients with type 2 diabetes, of whom 7.8% annually intensified to basal-bolus therapy, would save USD 1304 per intensifying patient over the trial period.

Conclusions:

SWA of bolus insulin should be considered a beneficial and cost-saving alternative to FBB therapy for the intensification of treatment in type 2 diabetes.     

Cost-effectiveness of insulin detemir versus insulin glargine for Thai type 2 diabetes from a payer’s perspective

Aims: An economic evidence is a vital tool that can inform the decision to use costly insulin analogs. This study aimed to evaluate long-term cost-effectiveness of insulin detemir (IDet) compared with insulin glargine (IGlar) in type 2 diabetes (T2DM) from the Thai payer’s perspective.

Methods: Long-term costs and outcomes were projected using a validated IMS CORE Diabetes Model, version 8.5. Cohort characteristics, baseline risk factors, and costs of diabetes complications were derived from Thai data sources. Relative risk was derived from a systematic review and meta-analysis study. Costs and outcomes were discounted at 3% per annum. Incremental cost-effectiveness ratio (ICER) was presented in 2015?US Dollars (USD). A series of one-way and probabilistic sensitivity analyses were performed.

Results: IDet yielded slightly greater quality-adjusted life years (QALYs) (8.921 vs 8.908), but incurred higher costs than IGlar (90,417.63 USD vs 66,674.03 USD), resulting in an ICER of ～1.7 million USD per QALY. The findings were very sensitive to the cost of IDet. With a 34% reduction in the IDet cost, treatment with IDet would become cost-effective according to the Thai threshold of 4,434.59 USD per QALY.

Conclusions: Treatment with IDet in patients with T2DM who had uncontrolled blood glucose with oral anti-diabetic agents was not a cost-effective strategy compared with IGlar treatment in the Thai context. These findings could be generalized to other countries with a similar socioeconomics level and healthcare systems.     

甘精胰岛素联合二甲双胍治疗2型糖尿病的临床疗效

目的探讨甘精胰岛素联合二甲双胍治疗2型糖尿病的临床疗效。方法选取2型糖尿病患者66例,将其随机分为观察组和对照组各33例,观察组患者服用二甲双胍+甘精胰岛素皮下注射治疗;对照组患者仅服用二甲双胍进行治疗,两组患者治疗16周后,检测空腹血糖(FBG)、餐后2 h血糖(2 h BG)、C肽水平及糖化血红蛋白(Hb A1c)。结果两组患者经治疗后FBG、2 h BG、Hb A1c均明显下降,与治疗前比较差异有统计学意义(P<0.05),同时观察组较对照组下降明显(P<0.05)。观察组患者C肽水平明显高于对照组(P<0.05)。结论甘精胰岛素联合二甲双胍具有良好的降糖效果,同时能改善胰岛功能,减少低血糖发生,安全有效。     

Modeling the lifetime costs of insulin glargine and insulin detemir in type 1 and type 2 diabetes patients in Canada: a meta-analysis and a cost-minimization analysis

Abstract

Background:

Two basal insulin analogues, insulin glargine once daily and insulin detemir once or twice daily, are marketed in Canada.

Objective:

To estimate the long-term costs of insulin glargine once daily (QD) versus insulin detemir once or twice daily (QD or BID) for type 1 (T1DM) and type 2 (T2DM) diabetes mellitus from a Canadian provincial government’s perspective.

Methods:

A cost-minimization analysis comparing insulin glargine (IGlarg) to insulin detemir (IDet) was conducted using a validated computer simulation model, the CORE Diabetes Model. Lifetime direct medical costs including costs of insulin treatment and diabetes complications were projected. T1DM and T2DM patients’ daily insulin dose (T1DM: IGlarg QD 26.2?IU; IDet BID 33.6?IU; T2DM: IGlarg QD 47.2?IU; IDet QD 65.7?IU or IDet BID 80.4?IU) was derived from a meta-analysis of randomized trials. All patients were assumed to stay on the same treatment for life. Costs were discounted at 5% per annum and reported in 2010 Canadian Dollars.

Results:

The meta-analysis showed T1DM and T2DM patients had similar HbA_1c change from baseline when receiving IGlarg compared to IDet (T1DM: 0.002%-points; p?=?0.97; T2DM: ?0.05%-points; p?=?0.28). Treatment of T1DM patients with IGlarg versus IDet BID resulted in lifetime cost savings of $4231 per patient. Treatment of T2DM patients with IGlarg resulted in lifetime cost savings of $4659 per patient versus IDet QD and cost savings of $8709 per patient versus IDet BID.

Conclusions:

Similar HbA_1c change from baseline can be achieved with a lower IGlarg than IDet dose. From the perspective of a Canadian provincial government, treatment of T1DM and T2DM patients with IGlarg instead of IDet can generate long-term cost savings. Main limitations include trial data were derived from multi-country studies rather than the Canadian population and self-monitoring blood glucose costs were not included.