University of Birmingham, Birmingham, UK.
Curr Med Res Opin. 2013 Jul;29(7):807-11. doi: 10.1185/03007995.2013.803054. Epub 2013 May 31.
To assess treatment adherence to dipeptidyl peptidase-4 inhibitor vildagliptin compared with sulphonylureas (SU) in Muslim patients with type 2 diabetes mellitus who were fasting during Ramadan in the UK.
This prospective, observational cohort study was conducted in four UK centres. Patients already taking vildagliptin (50 mg twice a day) or an SU as add-on therapy to metformin were followed up for ≤16 weeks. They were asked to record all missed doses of anti-diabetes medications.
Of the 72 patients enrolled (vildagliptin, n = 30; SU, n = 41; not allocated to treatment, n = 1), 59 (81.9%) completed the study (vildagliptin, n = 23; SU, n = 36), including one patient in the SU arm who completed but failed to provide information on missed doses; all patients in the SU arm were taking gliclazide. In the vildagliptin arm one patient (4.3%) missed a total of four doses while in the SU arm 10 patients (27.8%) missed a total of 266 doses (mean [SD] number of doses missed per patient: 26.6 [16.5]). The mean (SD) proportions of doses missed during fasting were 0.2% (0.9) and 10.4% (21.7) in the vildagliptin and SU arms, respectively, with a significant mean between-group difference of -10.2% (95% CI: -19.3%, -1.1%; p = 0.0292). There were no patients in the vildagliptin arm who missed more than 20% of OAD doses compared with 19.4% in the SU arm (p = 0.0358). Of the patients receiving an SU, 15 (42%) collectively reported 34 hypoglycaemic events (HEs) and one grade 2 HE; of these, fewer were non-adherent (n = 6, 40%) than adherent (n = 9, 60%). No patients reported HEs in the vildagliptin arm.
During Ramadan fasting, treatment with vildagliptin resulted in better treatment adherence compared with SU in Muslim patients with type 2 diabetes mellitus. Study limitations are the sample size and the lack of diet and exercise data.
评估在英国的穆斯林 2 型糖尿病患者在斋月期间禁食时,与磺酰脲类药物(SU)相比,二肽基肽酶-4 抑制剂维格列汀的治疗依从性。
这是一项在英国四家中心进行的前瞻性观察性队列研究。已经服用维格列汀(50mg,每日两次)或 SU 作为二甲双胍附加疗法的患者接受了最长 16 周的随访。他们被要求记录所有漏服的抗糖尿病药物。
共纳入 72 名患者(维格列汀组 n=30,SU 组 n=41,未分配治疗组 n=1),59 名(81.9%)完成了研究(维格列汀组 n=23,SU 组 n=36),其中 SU 组有 1 名患者完成但未能提供漏服剂量的信息;SU 组所有患者均服用格列齐特。在维格列汀组,1 名患者(4.3%)共漏服了 4 剂,而在 SU 组,10 名患者(27.8%)共漏服了 266 剂(每名患者漏服的平均剂量:26.6[16.5])。在维格列汀组和 SU 组,禁食期间漏服的平均(SD)剂量比例分别为 0.2%(0.9)和 10.4%(21.7),两组之间存在显著的平均差异-10.2%(95%CI:-19.3%,-1.1%;p=0.0292)。在维格列汀组没有患者漏服超过 20%的 OAD 剂量,而 SU 组有 19.4%(p=0.0358)。在接受 SU 的患者中,15 名(42%)共报告了 34 例低血糖事件(HE)和 1 例 2 级 HE;其中,不依从者(n=6,40%)比依从者(n=9,60%)少。在维格列汀组没有患者报告 HE。
在斋月禁食期间,与 SU 相比,维格列汀治疗可提高穆斯林 2 型糖尿病患者的治疗依从性。研究局限性是样本量和缺乏饮食和运动数据。