Bariatric surgery for patients with type 2 diabetes mellitus requiring insulin: Clinical outcome and cost-effectiveness analyses.
Bariatric surgery for patients with type 2 diabetes mellitus requiring insulin: Clinical outcome and cost-effectiveness analyses.
复制标题
DOI：
10.1371/journal.pmed.1003228
复制
发表时间：
2020-12
期刊：
影响因子：
15.8
通讯作者：
Khan OA
中科院分区：
文献类型：
--
作者：
McGlone ER;Carey I;Veličković V;Chana P;Mahawar K;Batterham RL;Hopkins J;Walton P;Kinsman R;Byrne J;Somers S;Kerrigan D;Menon V;Borg C;Ahmed A;Sgromo B;Cheruvu C;Bano G;Leonard C;Thom H;le Roux CW;Reddy M;Welbourn R;Small P;Khan OA
虽然减肥手术作为一种有效的治疗肥胖和2型糖尿病（T2DM）的方法已经得到了很好的证实，但对于严重T2DM患者来说，仍不太愿意增加其可用性。本研究的目的是利用来自国家数据库的数据，研究减肥手术对肥胖和需要胰岛素治疗的T2DM患者（T2DM- ins）的T2DM缓解的影响，并建立一个健康经济模型，以评估与最佳药物治疗（BMT）相比，该队列中手术的成本效益。从英国减肥手术综合数据库国家减肥手术登记处（NBSR）提取临床数据，分析2009年至2017年期间接受原发性减肥手术的肥胖和T2DM-Ins患者的结局。该组的结果与来自全面文献综述的数据相结合，以建立一个状态转变微观模拟模型，以评估5年内减肥手术与BMT对患者的成本效益。临床研究的主要结局指标是手术后1年的胰岛素停止：确定总结预测因素的相对风险（RR），未经调整，并在调整变量包括年龄、初始体重指数（BMI）、T2DM持续时间和体重减轻后。经济评价的主要结果指标为总成本、总质量调整生命年（QALYs）和在2万英镑支付意愿阈值下的增量成本-效果比（ICER）。共有2484例患者符合纳入条件，其中1847例患者有1年随访数据（平均年龄51岁，平均初始BMI为47.2 kg/m2，女性占64%）。67%的患者术后1年不再需要胰岛素：这些比率持续了4年。Roux-en-Y胃旁路（RYGB）与胰岛素停止率（71.7%）的相关性高于袖胃切除术（SG; 64.5%; RR 0.92，可信区间（CI） 0.86-0.99）和可调节胃带（AGB; 33.6%; RR 0.45, CI 0.34-0.60; p < 0.001）。在调整总体重减轻百分比和人口统计学变量后，RYGB和SG的手术后胰岛素停止率相当（RR 0.97, CI 0.90-1.04）， AGB的戒烟率最低（RR 0.55, CI 0.40-0.74; p < 0.001）。在5年的时间里，减肥手术与BMT相比节省了成本（总成本分别为22,057英镑和26,286英镑，增量差异为4,229英镑）。这是由于较低的治疗费用以及减少糖尿病相关并发症的费用和增加的健康益处。本研究的局限性包括NBSR数据集中患者随访缺失，以及经济分析的时间范围限制为5年。此外，该研究反映了该队列患者当前的药物和手术治疗方案，这些方案可能会发生变化。在这项研究中，我们观察到，在肥胖和T2DM-Ins患者中，减肥手术与术后胰岛素治疗停止率高相关，这反过来又成为直接医疗成本总体降低的主要驱动因素。我们的研究结果表明，在5年的时间范围内，对肥胖和T2DM-Ins患者进行减肥手术的策略可以为国家医疗保健提供者（国民健康服务体系）节省成本。Emma Rose McGlone和同事报告了2型糖尿病患者减肥手术的临床和成本效益。减肥或减肥手术可以显著改善肥胖患者的2型糖尿病（T2DM），使许多患者完全停用治疗T2DM的药物。不幸的是，进行减肥手术的资源有限。需要每日注射胰岛素的严重T2DM患者被认为优先级低于使用片剂治疗的T2DM患者。这是因为一些小型研究表明，需要胰岛素的T2DM （T2DM- ins）进展太迟，无法通过手术逆转。本研究的目的是观察减肥手术对肥胖和t2dm - in患者的效果，以及确定在5年内对这组患者进行手术是否具有成本效益。我们使用了英国全国范围内接受减肥手术的患者登记数据，以检查手术对需要胰岛素治疗T2DM的患者的影响。我们发现某些类型的手术（Roux en Y胃旁路术（RYGB）和袖胃切除术（SG））与极好的胰岛素停药率相关（大约三分之二的患者）。然后，我们设计了一个经济模型来比较这种手术的成本与使用最佳药物治疗2型糖尿病患者的成本。我们发现，在5年的时间里，对国家医疗保健提供者（国民健康服务体系（NHS））来说，进行手术的成本更低，效果更有效。这些发现很重要，因为它们表明肥胖和t2dm - in患者是减肥手术的良好候选者。为这些患者提供减肥手术可以改善他们的健康状况，并为国家医疗保健支付者节省成本。
Although bariatric surgery is well established as an effective treatment for patients with obesity and type 2 diabetes mellitus (T2DM), there exists reluctance to increase its availability for patients with severe T2DM. The aims of this study were to examine the impact of bariatric surgery on T2DM resolution in patients with obesity and T2DM requiring insulin (T2DM-Ins) using data from a national database and to develop a health economic model to evaluate the cost-effectiveness of surgery in this cohort when compared to best medical treatment (BMT). Clinical data from the National Bariatric Surgical Registry (NBSR), a comprehensive database of bariatric surgery in the United Kingdom, were extracted to analyse outcomes of patients with obesity and T2DM-Ins who underwent primary bariatric surgery between 2009 and 2017. Outcomes for this group were combined with data sourced from a comprehensive literature review in order to develop a state-transition microsimulation model to evaluate cost-effectiveness of bariatric surgery versus BMT for patients over a 5-year time horizon. The main outcome measure for the clinical study was insulin cessation at 1-year post-surgery: relative risks (RR) summarising predictive factors were determined, unadjusted, and after adjusting for variables including age, initial body mass index (BMI), duration of T2DM, and weight loss. Main outcome measures for the economic evaluation were total costs, total quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) at willingness-to-pay threshold of GBP£20,000. A total of 2,484 patients were eligible for inclusion, of which 1,847 had 1-year follow-up data (mean age of 51 years, mean initial BMI 47.2 kg/m2, and 64% female). 67% of patients no longer required insulin at 1-year postoperatively: these rates persisted for 4 years. Roux-en-Y gastric bypass (RYGB) was associated with a higher rate of insulin cessation (71.7%) than sleeve gastrectomy (SG; 64.5%; RR 0.92, confidence interval (CI) 0.86–0.99) and adjustable gastric band (AGB; 33.6%; RR 0.45, CI 0.34–0.60; p < 0.001). When adjusted for percentage total weight loss and demographic variables, insulin cessation following surgery was comparable for RYGB and SG (RR 0.97, CI 0.90–1.04), with AGB having the lowest cessation rates (RR 0.55, CI 0.40–0.74; p < 0.001). Over 5 years, bariatric surgery was cost saving compared to BMT (total cost GBP£22,057 versus GBP£26,286 respectively, incremental difference GBP£4,229). This was due to lower treatment costs as well as reduced diabetes-related complications costs and increased health benefits. Limitations of this study include loss to follow-up of patients within the NBSR dataset and that the time horizon for the economic analysis is limited to 5 years. In addition, the study reflects current medical and surgical treatment regimens for this cohort of patients, which may change. In this study, we observed that in patients with obesity and T2DM-Ins, bariatric surgery was associated with high rates of postoperative cessation of insulin therapy, which is, in turn, a major driver of overall reductions in direct healthcare cost. Our findings suggest that a strategy utilising bariatric surgery for patients with obesity and T2DM-Ins is cost saving to the national healthcare provider (National Health Service (NHS)) over a 5-year time horizon. Emma Rose McGlone and colleagues report the clinical and cost- effectiveness of bariatric surgery for patients with Type 2 diabetes. Bariatric or weight loss surgery can dramatically improve type 2 diabetes mellitus (T2DM) in patients with obesity, allowing many patients to stop medicines for T2DM completely. Unfortunately, there are limited resources for performing bariatric surgery. Patients with severe T2DM, who require daily insulin injections, are at risk of being considered lower priority than those with T2DM managed by tablet medications. This is because some small studies have suggested that T2DM requiring insulin (T2DM-Ins) is too advanced to be reversed by surgery. The aims of this study were to see how effective bariatric surgery is in patients with obesity and T2DM-Ins, as well as to determine if performing surgery in this group is cost-effective over a 5-year period. We used data from a nationwide registry of patients undergoing bariatric surgery in the UK to examine the effect of surgery on patients that require insulin for T2DM. We found that certain types of procedure (Roux en Y gastric bypass (RYGB) and sleeve gastrectomy (SG)) were associated with excellent rates of stopping insulin (approximately two-thirds of patients). We then devised an economic model to compare the costs of this type of surgery with the costs of treating patients using optimal medicines for T2DM. We found that performing surgery was less costly and more effective for the national healthcare provider (National Health Service (NHS)), over a 5-year timeline. These findings are important because they suggest that patients with obesity and T2DM-Ins are good candidates for bariatric surgery. Offering bariatric surgery to such patients could improve their health and provide cost savings to national healthcare payers.
登录
查看更多内容
影响因子：
16.2
作者：
Batterham, Rachel L.;Cummings, David E.
通讯作者：
Cummings, David E.
影响因子：
8.2
作者：
Davies, Melanie J.;D'Alessio, David A.;Buse, John B.
通讯作者：
Buse, John B.
影响因子：
3.1
作者：
Khan, Omar A.;McGlone, Emma Rose;Welbourn, Richard
通讯作者：
Welbourn, Richard
影响因子：
--
作者：
Prasad-Reddy, Lalita;Isaacs, Diana
通讯作者：
Isaacs, Diana
影响因子：
8.2
作者：
Aron-Wisnewsky, Judith;Sokolovska, Nataliya;Clement, Karine
通讯作者：
Clement, Karine