Increasing awareness of hypoglycaemia in patients with Type 2 diabetes treated with oral agents

Abstract

Hypoglycaemia is the most common acute complication of type 2 diabetes and can limit therapeutic efforts to improve glycaemic control in order to protect against long-term complications. It is a potential side effect of the drugs used to treat diabetes, specifically exogenous insulin or insulin secretagogues. As many people are prescribed these agents, hypoglycaemia is frequent in clinical practice, although patients commonly do not inform their healthcare professional of the problems spontaneously. The impact of hypoglycaemia on the patient and to the healthcare system is significant through reduced treatment satisfaction and adherence, reduced quality of life and serious health consequences. This has financial implications and costs for the patient, the public and the economy at large.

The single most important risk factor for hypoglycaemia is previous hypoglycaemia. Prevention depends on appropriate education regarding diabetes management and selfcare, self-monitoring of blood glucose, awareness of factors that may precipitate hypoglycaemia, and an individualized approach to therapy and glycaemic control targets.

The purpose of this review is to increase understanding of the impact and consequences of hypoglycaemia, in particular that associated with sulphonylurea therapy, and to highlight areas requiring more attention in order to improve the overall management of people with type 2 diabetes.     

Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966-2004)

OBJECTIVE: To determine if therapeutic management programs that include self-monitoring of blood glucose result in greater HbA1c reduction in non-insulin-requiring type 2 diabetes patients compared to programs without blood glucose self-monitoring. RESEARCH DESIGN AND METHODS: Electronic databases including MEDLINE (1966-2004), Cochrane Database of Systematic Reviews, EMBASE (1950-2004), Centre for Reviews and Dissemination (CRD) and the Online Index Journals of the American Diabetes Association (ADA 1978-2004) were searched. Personal collections of investigators were also explored. Randomized controlled trials comparing HbA1c reduction in therapies with and without blood glucose self-monitoring among adult, non-insulin-treated type 2 diabetes patients were selected. Studies on patients who are pregnant, taking insulin, troglitazone or experimental drugs were excluded. Out of 14 potentially useful randomized controlled trials on self-monitoring of blood glucose in non-insulin treated type 2 diabetes patients, eight studies with a total of 1307 subjects were included in the analysis. Two independent reviewers assessed the quality of studies. MAIN OUTCOME MEASURE: The effect of SMBG was assessed by means of meta-analysis of the difference in HbA1c reduction between self-monitoring and non-self-monitoring groups. RESULTS: Antidiabetic therapies that included blood glucose self-monitoring as part of a multi-component management strategy produced a mean additional HbA(1c) reduction of -0.39% (95%CI: -0.54%, -0.23%) under the fixed effects model and -0.42% (95%CI: -0.63%, -0.21%) under the random effects model, when compared to therapies that did not. Heterogeneity among studies was not statistically significant. CONCLUSION: Multi-component diabetes management programs with self-monitoring of blood glucose result in better glycemic control among non-insulin-using type 2 diabetes patients.     

糖尿病患者的自我血糖监测和社区管理的效果评价

目的探讨对糖尿病患者予自我血糖监测和社区管理后对其血糖控制的效果。方法将64例在我社区中心就诊的2型糖尿病患者随机分为SMBG组和对照组各32例,2组均进行常规药物治疗和定期复诊,SMBG组在此基础上予自我血糖监测和社区管理措施,持续1年。观察2组患者的症状性低血糖事件及心脑血管事件的发生率及血糖控制情况。结果 SMBG组的空腹血糖、餐后2h血糖及糖化血红蛋白均明显低于对照组（P〈0.01）,SMBG组的症状性低血糖事件的发生率也低于对照组（P〈0.01）。结论自我血糖监测和社区管理可有效控制糖尿病患者的血糖,减少并发症,提高患者的生活质量。     

Influence of intensive versus conventional glucose control on microvascular and macrovascular complications in type 1 and 2 diabetes mellitus

In type 1 and 2 diabetes mellitus patients, hyperglycaemia is independently related to the development of microvascular and macrovascular complications. Glycaemic targets and the benefits of intensive versus conventional glucose control are under debate. The purpose of this review is to provide an overview of the randomized controlled trials and meta-analyses comparing the effects of intensive versus conventional glucose control on microvascular and macrovascular complications in type 1 and 2 diabetes. MEDLINE and Cochrane database searches were performed with a limit on randomized controlled trials or meta-analysis and keywords related to glucose control and diabetes. In addition, related articles and reference lists of relevant articles and guidelines were reviewed. Nine randomized controlled trials, three in type 1 and six in type 2 diabetes, and four meta-analyses in type 2 diabetes were reviewed. These studies included more than 30,000 patients. On the basis of these trials and meta-analyses, it can be concluded that intensive glucose control has a beneficial effect on microvascular complications (retinopathy, nephropathy, neuropathy) in both type 1 and type 2 diabetes patients. The risk reduction of developing a microvascular complication varied between 25% and 76%. Particularly in patients with type 2 diabetes, there was a 10-15% decrease in nonfatal myocardial infarction with intensive glucose control, but no effect on stroke, cardiovascular death or all-cause mortality was observed. There was a beneficial effect of intensive glucose control on cardiovascular disease in patients with type 1 diabetes in only one trial. In all studies, intensive glucose control was associated with at least twice the risk for serious hypoglycaemia than the conventional-control group. In conclusion, compared with conventional glucose control, intensive glucose control is associated with fewer microvascular complications in both type 1 and type 2 diabetes, a decrease in coronary events, especially in type 2 diabetes, and more serious hypoglycaemia.     

心理辅助治疗2型糖尿病患者150例分析

目的了解心理辅助治疗对伴有抑郁、焦虑症状的2型糖尿病患者血糖控制的作用。方法对照组采用包括饮食疗法、运动疗法、药物治疗和自我监测等常规方法治疗;观察组在常规方法治疗基础上给予心理辅助治疗,心理治疗前和治疗后常规治疗方案相同。结果通过心理辅助治疗2型糖尿病患者血糖控制有明显改善,观察组空腹血液(FPG)降至7.0 mmol/L以下例数明显高于对照组,差异有统计学意义(P<0.01)。结论心理辅助治疗对2型糖尿病患者血糖控制有效。     

Insulin detemir: a review of its use in the management of type 1 and 2 diabetes mellitus

Insulin detemir (Levemir) is a soluble long-acting human insulin analogue acylated with a 14-carbon fatty acid. The fatty acid modification allows insulin detemir to reversibly bind to albumin, thereby providing slow absorption and a prolonged and consistent metabolic effect of up to 24 hours in patients with type 1 or type 2 diabetes mellitus. Insulin detemir has a more predictable, protracted and consistent effect on blood glucose than neutral protamine Hagedorn (NPH) insulin, with less intrapatient variability in glycaemic control, compared with NPH insulin or insulin glargine. Insulin detemir, administered once or twice daily, is at least as effective as NPH insulin in maintaining overall glycaemic control, with a similar or lower risk of hypoglycaemia, especially nocturnal hypoglycaemia, compared with NPH insulin in patients with type 1 or type 2 diabetes. Insulin detemir also provides the added clinical benefit of no appreciable bodyweight gain in patients with type 1 diabetes and less bodyweight gain than NPH insulin in patients with type 2 diabetes. Insulin detemir is, therefore, a promising new option for basal insulin therapy in patients with type 1 or 2 diabetes.     

格列美脲联合胰岛素治疗2型糖尿病的临床观察

目的评价格列美脲联合胰岛素对2型糖尿病（T2DM）的临床疗效。方法 T2DM患者64例,均为单用胰岛素血糖控制欠佳者,随机分为观察组和对照组,观察组加用格列美脲2~4 mg/d,根据血糖调整胰岛素用量;对照组继续应用胰岛素治疗,并根据血糖加大剂量。12周后观察治疗前后空腹血糖（FBG）、餐后2 h血糖（2 hBG）、糖化血红蛋白（HbA1c）、体重指数（BMI）、每日胰岛素用量变化以及药物不良反应。结果治疗后观察组FBG、2 hBG、HbA1c较对照组明显降低,胰岛素用量减少（P〈0.05）;所有入选者共发生低血糖6例,其中观察组2例,对照组4例。结论 T2DM单用胰岛素血糖控制不佳者,加用格列美脲可显著改善血糖控制,低血糖发生率低,并可减少胰岛素用量。     

Repaglinide: a review of its therapeutic use in type 2 diabetes mellitus

Repaglinide, a carbamoylmethyl benzoic acid derivative, is the first of a new class of oral antidiabetic agents designed to normalise postprandial glucose excursions in patients with type 2 diabetes mellitus. Like the sulphonylureas, repaglinide reduces blood glucose by stimulating insulin release from pancreatic beta-cells, but differs from these and other antidiabetic agents in its structure, binding profile, duration of action and mode of excretion. In clinical trials of up to 1-year's duration, repaglinide maintained or improved glycaemic control in patients with type 2 diabetes mellitus. In comparative, 1-year, double-blind, randomised trials (n = 256 to 544), patients receiving repaglinide (0.5 to 4mg before 3 daily meals) achieved similar glycaemic control to that in patients receiving glibenclamide (glyburide) < or = 15 mg/day and greater control than patients receiving glipizide < or = 15 mg/day. Changes from baseline in glycosylated haemoglobin and fasting blood glucose levels were similar between patients receiving repaglinide and glibenclamide in all studies; however, repaglinide was slightly better than glibenclamide in reducing postprandial blood glucose in I short term study (n = 192). Patients can vary their meal timetable with repaglinide: the glucose-lowering efficacy of repaglinide was similar for patients consuming 2, 3 or 4 meals a day. Repaglinide showed additive effects when used in combination with other oral antidiabetic agents including metformin, troglitazone, rosiglitazone and pioglitazone, and intermediate-acting insulin (NPH) given at bedtime. In 1-year trials, the most common adverse events reported in repaglinide recipients (n = 1,228) were hypoglycaemia (16%), upper respiratory tract infection (10%), rhinitis (7%), bronchitis (6%) and headache (9%). The overall incidence of hypoglycaemia was similar to that recorded in patients receiving glibenclamide, glipizide or gliclazide (n = 597) [18%]; however, the incidence of serious hypoglycaemia appears to be slightly higher in sulphonylurea recipients. Unlike glibenclamide, the risk of hypoglycaemia in patients receiving repaglinide was not increased when a meal was missed in 1 trial. In conclusion, repaglinide is a useful addition to the other currently available treatments for type 2 diabetes mellitus. Preprandial repaglinide has displayed antihyperglycaemic efficacy at least equal to that of various sulphonylureas and is associated with a reduced risk of serious hypoglycaemia. It is well tolerated in a wide range of patients, including the elderly, even if a meal is missed. Furthermore, glycaemic control is improved when repaglinide is used in combination with metformin. Thus, repaglinide should be considered for use in any patient with type 2 diabetes mellitus whose blood glucose cannot be controlled by diet or exercise alone, or as an adjunct in patients whose glucose levels are inadequately controlled on metformin alone.     

Empagliflozin/metformin fixed-dose combination: a review in patients with type 2 diabetes

Introduction: Most patients with type 2 diabetes, who receive monotherapy, are unable to maintain glucose levels with the progress of disease. Therefore, combination therapy with two or more anti-diabetic agents of different classes is highly desired. Sodium glucose co-transporter 2 (SGLT2) inhibitors improve glycemic control through increasing urinary glucose excretion, which is independent of β-cell function. In addition, they are generally well tolerated and associated with a low risk of hypoglycaemia. SGLT2 inhibitors as add-on therapy to metformin have an additive effect on glycemic control in patients with type 2 diabetes, and fixed-dose tablet is likely to reduce pill burden and then improve patients’ adherence.

Areas covered: This article reviews empagliflozin/metformin combination therapy for the treatment of type 2 diabetes. The clinical efficacy and tolerability of empagliflozin/metformin in patients with type 2 diabetes are discussed based on the available literature.

Expert opinion: It was found that empagliflozin/metformin combination therapy could significantly improve glycemic control, body weight and blood pressure with a low risk of hypoglycaemia. In addition, the empagliflozin/metformin fixed-dose tablets, supported by bioequivalence studies, could reduce pill burden to further achieve the improved patients’ adherence, better glycemic control and optimized cost-effectiveness.     

Self-monitoring of glucose in type 2 diabetes mellitus: a Bayesian meta-analysis of direct and indirect comparisons

OBJECTIVE: To evaluate the relative effectiveness of interventions with self-monitoring blood glucose and self-monitoring of urine glucose, versus interventions without self-monitoring, in terms of HbA(1c) reductions in type 2 diabetes mellitus. METHODS: Thirteen published full reports on randomised controlled trials investigating the effects of self-monitoring glucose were identified by a systematic search of Medline, Embase, the Cochrane Library (1966-Nov 2005) and previous reviews. Three types of studies were included: self-monitoring of blood glucose versus no self-monitoring, self-monitoring of blood glucose versus self-monitoring of urine glucose and self-monitoring of blood glucose with regular feedback versus monitoring without feedback. The internal validity of studies was assessed systematically by two reviewers, using 13 criteria of a validated list. Results from the three types of studies were analysed simultaneously with a Bayesian metaanalysis of direct and indirect comparisons. RESULTS: Adjusted for baseline HbA(1c) level and internal validity, interventions with self-monitoring of blood glucose showed a reduction in HbA(1c) of 0.40 percentage-points (%) (95% credible interval [CrI] 0.07 to 0.70%) in comparison to interventions without self-monitoring. Regular feedback more than doubled the HbA(1c) reduction. Self-monitoring of urine glucose showed comparable results to interventions without self-monitoring (0.02% decrease in HbA(1c); 95% CrI -0.62 to 0.70%). There is a 88% probability that interventions with self-monitoring blood glucose are more effective than interventions with urine glucose monitoring (relative reduction in HbA(1c) is 0.38%, 95% CrI -0.30 to 1.00%). CONCLUSION: The randomized clinical trials performed to date provided positive results on the effectiveness of interventions with self-monitoring of blood glucose in type 2 diabetes mellitus. Regular medical feedback of the monitored HbA(1c) levels is important. Furthermore, self-monitoring of blood glucose is likely to be more effective than self-monitoring of urine glucose.     

Insulin glulisine

Insulin glulisine is a rapid-acting human insulin analogue that has a faster onset of action and shorter duration of action than regular human insulin (RHI) in patients with type 1 or 2 diabetes mellitus and is efficacious in controlling prandial blood glucose levels in these patients. In large, well designed trials in patients with type 1 diabetes, insulin glulisine demonstrated a similar degree of glycaemic control, as measured by glycosylated haemoglobin (HbA(1c)) levels, to RHI after 12 weeks and insulin lispro after 26 weeks. Pre-meal insulin glulisine was also more effective than RHI at controlling 2-hour post-prandial glucose excursions in patients with type 1 or 2 diabetes over a period of 12 weeks. In patients with type 2 diabetes, insulin glulisine induced significantly greater reductions in HbA(1c) levels and 2-hour post-breakfast and post-dinner blood glucose levels than RHI over a period of 26 weeks. Insulin glulisine was generally well tolerated by patients with type 1 or 2 diabetes and had a similar safety profile to insulin lispro or RHI. Severe hypoglycaemia was experienced by similar proportions of insulin glulisine or comparator insulin (insulin lispro or RHI) recipients with type 1 or type 2 diabetes.     

血糖自我监测在老年糖尿病患者中的应用研究

目的研究老年糖尿病患者自我血糖监测相关知识的认知情况,为开展老年糖尿病健康教育提供依据。方法通过问卷调查法对到我院特约门诊就医的老年糖尿病患者进行认知情况调查,发放问卷150份,收回有效问卷136份。结果 136例被调查的老年糖尿病患者中,32.35%不了解血糖控制目标,仅有67.65%进行自我血糖监测,其中有60%以上的患者对血糖监测的时间、频率及记录方法了解不够。结论老年糖尿病患者缺乏自我血糖监测的相关知识,应加强对老年糖尿病患者自我血糖监测知识的健康宣教及技术上的指导,努力提高自我管理能力。     

胰岛素泵强化治疗初发2型糖尿病的临床研究

目的 比较胰岛素泵持续皮下输注胰岛素(CSⅡ)与诺和锐R 加诺和灵N (MSⅡ)治疗初发2 型糖尿病的临床对比分析,探讨胰岛素泵持续皮下输注胰岛素在初发2 型糖尿病中的应用价值.方法 选择已确诊为初发2 型糖尿病的患200例,随机分为胰岛素泵持续皮下输注胰岛素(CSⅡ) 组和诺和锐R 加诺和灵N (MSⅡ) 组.记录治疗前后血糖、并比较血糖达标所需要的时间、胰岛素用量、低血糖发生等情况.结果 两种方法均可使血糖达标,而CSⅡ组治疗后稳定期血糖明显低于MSⅡ组,差异有统计学意义(P<0.05);且CSⅡ组的达标时间、胰岛素用量及低血糖发生率均明显小于MSⅡ组,差异有统计学意义(P<0.05).结论 胰岛素泵强化治疗初诊2型糖尿病在临床上是值得推广应用.     

社区2型糖尿病患者实施健康教育干预效果观察

目的：观察社区2型糖尿病患者实施健康教育干预效果。方法100例社区2型糖尿病患者随机分为观察组和对照组,每组50例。对照组予药物治疗。干预组患者在此基础上着重实施健康教育干预措施,其内容包括饮食、运动、用药指导、心理干预、血糖自我监测。观察并比较两组治疗前后血糖的变化情况。结果两组空腹血糖、餐后2h血糖较治疗前显著降低（P＜0.05）,且干预组较对照组降低更显著（P＜0.05）。干预组干预后遵医嘱用药、按时用药、合理饮食、适量运动、血糖监测情况明显优于对照组,差异有统计学意义（x2=4.48、6.32、7.13、5.13、7.97,P＜0.05）。结论对社区2型糖尿病患者实施健康教育干预措施,可以有效控制血糖水平,从而进一步提高患者的生活质量。     

Defining the role of insulin detemir in Basal insulin therapy

Insulin detemir is a novel long-acting insulin analogue with a unique mechanism underlying its prolonged duration of action. Unlike neutral protamine Hagedorn (NPH) insulin (insulin suspension isophane) and insulin glargine, which precipitate after administration, insulin detemir remains soluble after it is injected. The prolonged duration of action of insulin detemir is a result of the ability to self-associate into hexamers and dihexamers, and to bind reversibly to albumin. This mechanism of protraction provides a more prolonged, consistent and predictable glycaemic effect in patients with type 1 or type 2 diabetes mellitus compared with NPH insulin. Clinical studies have demonstrated that insulin detemir administered once or twice daily is at least as effective as NPH insulin and insulin glargine in achieving glycaemic control. Most trials have also shown that insulin detemir exhibits less intrapatient variability in glycaemic control compared with NPH insulin and insulin glargine. One of the benefits of insulin detemir is its favourable effect on bodyweight. Insulin detemir has shown weight neutrality in patients with type 1 diabetes and is associated with less weight gain than NPH insulin in clinical studies. Patients with type 2 diabetes using insulin detemir gain less weight than patients using NPH insulin and insulin glargine. In addition, a reduced risk of hypoglycaemia, particularly nocturnal hypoglycaemia, has been reported with insulin detemir compared with NPH insulin in patients with type 1 and type 2 diabetes. A reduced risk of major and nocturnal hypoglycaemia compared with insulin glargine in patients with type 1 diabetes has also been observed. Together, these data indicate that insulin detemir is a valuable new option for basal insulin therapy in patients with type 1 or type 2 diabetes.     

Improvement of diabetes indices of care by a short pharmaceutical care program

Objective Diabetes mellitus is a serious health problem associated with an increased mortality and morbidity. The association of improved glycemic control with sustained decrease in the rate of complications has been shown in randomized clinical trials. Pharmaceutical care is a relatively new concept in Turkey; yet, there are no recorded routine pharmaceutical care programs. Therefore, we aimed to assess the impact of a short pharmaceutical care program conducted in the community pharmacy setting, on the indices of diabetes care of type 2 diabetic patients, particularly those regarding glycemic control and high blood pressure management. Setting The study was carried out at eight community pharmacies in Pendik district of Istanbul. Method All patients who visited any of the eight pharmacies through the pre-determined 1-week period were questioned for the presence of type 2 diabetes. Patients who reported to be type 2 diabetic (n = 67) were informed about the study and invited to involve. During this prospective longitudinal study, pharmaceutical care was provided to the patients by the same clinical pharmacist. The 3 month pharmaceutical care period consisted of six pharmacy visits. Main outcome measure: The main outcome measures were the improvement in glycemic control and blood pressure control; while, weight control, self-monitoring of blood glucose, compliance and being under physician-control were also assessed. Results The study was conducted on 43 patients who accepted to involve. Fasting blood glucose was lowered by a mean of 23% over 3-months from an initial value of 167.2 mg/dl. Number of patients reaching the desired blood glucose goals increased from 16.3% to 39.5%. Systolic and diastolic blood pressures also significantly fell over 3 months (mean reductions were 10.9 mmHg for the systolic and 9.3 mmHg for the diastolic blood pressure). Number of patients reaching the desired blood pressure goal increased from 30.2% to 51.2%. Conclusion Our short-course pharmaceutical care program yielded measurable improvements in clinical indicators of diabetes and comorbidity management. The results suggest that the pharmacist is a beneficial key component of integrated care for patients with type 2 diabetes. We think that the positive results observed in this first reported pharmaceutical care program on diabetes in Turkey can be motivating and encouraging for all community pharmacists.     

Insulin glargine: a review of its therapeutic use as a long-acting agent for the management of type 1 and 2 diabetes mellitus

Insulin glargine is a recombinant human insulin analogue produced by DNA technology using a nonpathogenic strain of Escherichia coli. Two modifications of human insulin result in a stable molecule which is soluble in slightly acidic conditions (pH 4.0) and precipitates in the neutral pH of subcutaneous tissue. Because of these properties, absorption of insulin glargine is delayed and the analogue provides a fairly constant, basal insulin supply without peaks in plasma insulin levels for approximately 24 hours, similar to that achieved by a continuous subcutaneous insulin infusion. Insulin glargine is indicated as a once daily subcutaneous injection to provide basal glycaemic control in adults and children aged >6 years with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Fasting plasma glucose and fasting blood glucose levels generally improved to a greater extent in patients with type 1 diabetes mellitus receiving insulin glargine than patients who administered Neutral Protamine Hagedorn (NPH) insulin. In patients with type 1 or 2 disease, glycosylated haemoglobin levels were slightly reduced and to a similar extent with insulin glargine and NPH insulin. Most clinical trials in patients with type 1 or 2 diabetes mellitus demonstrated a lower incidence of hypoglycaemia, especially nocturnal hypoglycaemia, compared with NPH insulin. One of the most common adverse events with insulin glargine treatment was injection site pain which, in some studies, occurred more frequently than in patients receiving NPH insulin. In all cases the symptoms were mild and treatment discontinuation was not required. Otherwise, the drug is well tolerated and does not appear to be immunogenic. CONCLUSIONS: Insulin glargine once a day provides basal control of glycaemia for approximately 24 hours without inducing peaks in plasma insulin levels in patients with type 1 or 2 diabetes mellitus. In long term, well designed trials insulin glargine once daily improved glycaemic control at least as effectively as NPH insulin given once or twice daily. The drug was well tolerated and in most studies the incidence of nocturnal hypoglycaemia was significantly less in patients treated with insulin glargine compared with patients receiving NPH insulin. Therefore, insulin glargine is likely to be a useful addition to the armamentarium of insulin therapy by establishing basal glycaemic control with once daily administration and a reduced risk of nocturnal hypoglycaemia.     

血糖控制对急性心肌梗死患者C反应蛋白及近期预后的影响

目的探讨伴2型糖尿病的急性心肌梗死患者血糖控制情况对高敏c反应蛋白（hs—CRP）水平及住院期间不良心血管事件产生的影响。方法110例急性心肌梗死患者分为3组,I组为不伴糖尿病组,Ⅱ组为伴2型糖尿病且血糖控制良好组,Ⅲ组为伴2型糖尿病且血糖控制不良组。观察3组患者既往糖化血红蛋白水平、入院后hs—CRP水平及不良心血管事件发生。结果Ⅱ组和Ⅲ组患者hs-CRP水平分别为（7．21±1．37）mg／L、（9．48±1．10）mg／L,明显高于I组（3．56±1．72）mg／L,差异有统计学意义（均P〈0．01）。I组、Ⅱ组和Ⅲ组不良心血管事件发生概率分别为13．5％（7／52）、31．6％（12／38）和60．0％（12／20）,Ⅱ组与I组比较P〈0．05,Ⅲ组与Ⅰ组比较P〈0．01。结论血糖控制不良可抬高伴2型糖尿病的心肌梗死患者hs—CRP水平,伴2型糖尿病的冠心病患者控制血糖可改善发生心肌梗死后的近期预后。     

Modelling cost effectiveness of insulin glargine for the treatment of type 1 and 2 diabetes in Canada

BACKGROUND AND OBJECTIVE: Intensive insulin therapy improves glycosylated haemoglobin (Hb(A1C)) levels and delays the onset of long-term diabetes-related complications. Current treatment guidelines recommend maintaining a glycosylated haemoglobin (Hb(A1C)) of < or = 7% in patients with type 1 and 2 diabetes mellitus. However, the risk of hypoglycaemia increases with lower Hb(A1C) levels. As such, patients often choose to settle for suboptimal glucose control in order to prevent hypoglycaemic events. At a given Hb(A1C) level, treatment with insulin glargine results in a lower risk of hypoglycaemia in type 1 and 2 diabetes compared with NPH insulin. It has been proposed that the lower hypoglycaemic risk will allow more patients to achieve target Hb(A1C) levels with insulin glargine compared with NPH insulin. The objective of this study was to assess the cost effectiveness of insulin glargine compared with NPH insulin in patients with type 1 or 2 diabetes who had inadequate glycaemic control. METHODS: A long-term, state-transition model was developed to simulate the natural history of type 1 and 2 diabetes. Risks of diabetes-related macro- and microvascular complications and mortality by Hb(A1C) levels were estimated based on the UKPDS (United Kingdom Prospective Diabetes Study). Outcome measures included complication rates and associated costs, insulin costs, life years (LYs) and QALYs. The baseline analysis was conducted for patients with type 1 and 2 diabetes (aged 27 and 53 years, respectively) with Hb(A1C) levels >7%, using a 36-year time horizon and a Canadian public payer perspective. Costs and effects were discounted at 5% per annum. Univariate sensitivity analyses were performed on key model inputs. All costs were reported in $Can (2005 values). RESULTS: The NPH insulin group had lower total costs than the insulin glargine group for patients with inadequately controlled diabetes (Hb(A1C) >7%; lifetime difference 1398 Can dollars and 1992 Can dollars, respectively, in type 1 and 2 diabetes). However, patients treated with insulin glargine had greater total and quality-adjusted life expectancy than those who received NPH insulin (incremental LY = 0.08 and QALYs = 0.07 in type 1 diabetes and incremental LY = 0.25 and QALYs = 0.23 in type 2 diabetes). The weighted incremental cost per LY gained and QALY gained were 18,661 Can dollars and 20,799 Can dollars, respectively, in type 1 diabetes and 8041 Can dollars and 8618 Can dollars, respectively, in type 2 diabetes (discounted results). CONCLUSIONS: The cost-effectiveness ratios for insulin glargine use for type 1 and 2 diabetes provide evidence for its adoption from a Canadian healthcare payer perspective.