Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study.
Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study.
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利格列汀与格列美脲对2型糖尿病患者认知功能的影响：随机双盲、活性药物对照的CAROLINA - COGNITION研究结果
DOI：
10.1007/s00125-021-05393-8
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发表时间：
2021-06
期刊：
影响因子：
8.2
通讯作者：
Johansen OE
中科院分区：
文献类型：
--
作者：
Biessels GJ;Verhagen C;Janssen J;van den Berg E;Wallenstein G;Zinman B;Espeland MA;Johansen OE
2型糖尿病，尤其是伴有心血管疾病（CVD）时，与认知障碍风险增加相关。我们评估了二肽基肽酶 - 4（DPP - 4）抑制剂利格列汀与磺酰脲类药物格列美脲对2型糖尿病患者加速认知衰退（ACD）的影响。
卡罗琳娜 - 认知研究是随机、双盲、活性对照的卡罗琳娜试验的一部分，该试验评估了利格列汀与格列美脲在年龄≥40岁且≤85岁、糖化血红蛋白（HbA1c）为48 - 69 mmol/mol（6.5 - 8.5%）且接受标准治疗（不包括胰岛素治疗）的个体中的心血管安全性。参与者使用交互式电话和网络系统按1:1随机分组，治疗分配由计算机生成的随机序列确定，并按中心分层。主要认知结局是随访结束时ACD的发生情况，在基线简易精神状态检查表（MMSE）评分≥24的参与者中，ACD定义为在MMSE或注意力与执行功能综合测量中基于回归的指数得分≤第16百分位数。预先指定的其他分析包括在第160周对ACD的影响、在亚组（性别、年龄、种族、民族、抑郁症状、心血管风险、2型糖尿病病程、蛋白尿）中的影响以及认知表现的绝对变化。参与者、照顾者以及参与测量、检查或判定的人员都不知道治疗分配情况。
从医院和初级医疗站点招募的6033名参与者中，3163名（38.0%为女性，平均年龄/糖尿病病程为64岁/7.6年，MMSE评分28.5，HbA1c为54 mmol/mol [7.1%]）构成了卡罗琳娜 - 认知队列。在中位6.1年的时间里，利格列汀组有27.8%（449/1618）发生ACD，格列美脲组有27.6%（426/1545）发生ACD，优势比（OR）为1.01（95%置信区间为0.86 - 1.18）。此外，在第160周时未观察到ACD的差异（OR为1.07 [0.91 - 1.25]），各亚组间的治疗差异以及认知的绝对变化也无差异。
在一项针对心血管风险较高的相对早期2型糖尿病患者的大型国际结局试验中，在6.1年的时间里，利格列汀和格列美脲在ACD风险方面未观察到差异。
本研究由勃林格殷格翰公司赞助。
临床试验注册号为NCT01243424。
在线版本包含经同行评审但未编辑的补充材料，可在10.1007/s00125 - 021 - 05393 - 8获取。
Type 2 diabetes, particularly with concomitant CVD, is associated with an increased risk of cognitive impairment. We assessed the effect on accelerated cognitive decline (ACD) of the DPP-4 inhibitor linagliptin vs the sulfonylurea glimepiride in individuals with type 2 diabetes. The CAROLINA-COGNITION study was part of the randomised, double-blind, active-controlled CAROLINA trial that evaluated the cardiovascular safety of linagliptin vs glimepiride in individuals with age ≥40 and ≤85 years and HbA1c 48–69 mmol/mol (6.5–8.5%) receiving standard care, excluding insulin therapy. Participants were randomised 1:1 using an interactive telephone- and web-based system and treatment assignment was determined by a computer-generated random sequence with stratification by center. The primary cognitive outcome was occurrence of ACD at end of follow-up, defined as a regression-based index score ≤16th percentile on either the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning, in participants with a baseline MMSE score ≥24. Prespecified additional analyses included effects on ACD at week 160, in subgroups (sex, age, race, ethnicity, depressive symptoms, cardiovascular risk, duration of type 2 diabetes, albuminuria), and absolute changes in cognitive performance. Participants, caregivers, and people involved in measurements, examinations or adjudication, were all masked to treatment assignment. Of 6033 participants recruited from hospital and primary care sites, 3163 (38.0% female, mean age/diabetes duration 64/7.6 years, MMSE score 28.5, HbA1c 54 mmol/mol [7.1%]) represent the CAROLINA-COGNITION cohort. Over median 6.1 years, ACD occurred in 27.8% (449/1618, linagliptin) vs 27.6% (426/1545, glimepiride), OR 1.01 (95% CI 0.86, 1.18). Also, no differences in ACD were observed at week 160 (OR 1.07 [0.91, 1.25]), between treatments across subgroups, or for absolute cognitive changes. In a large, international outcome trial in people with relatively early type 2 diabetes at elevated cardiovascular risk, no difference in risk for ACD was observed between linagliptin and glimepiride over 6.1 years. This study was sponsored by Boehringer Ingelheim. ClinicalTrials.gov NCT01243424. The online version contains peer-reviewed but unedited supplementary material available at 10.1007/s00125-021-05393-8.
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DOI：
10.1016/s0140-6736(17)31585-4
发表时间：
2017-10-07
期刊：
Lancet (London, England)
影响因子：
--
作者：
Athauda D;Maclagan K;Skene SS;Bajwa-Joseph M;Letchford D;Chowdhury K;Hibbert S;Budnik N;Zampedri L;Dickson J;Li Y;Aviles-Olmos I;Warner TT;Limousin P;Lees AJ;Greig NH;Tebbs S;Foltynie T
通讯作者：
Foltynie T
预测2型糖尿病患者10年痴呆风险的风险评分：一项队列研究。
影响因子：
44.5
作者：
Exalto, Lieza G.;Biessels, Geert Jan;Karter, Andrew J.;Huang, Elbert S.;Katon, Wayne J.;Minkoff, Jerome R.;Whitmer, Rachel A.
通讯作者：
Whitmer, Rachel A.
影响因子：
48
作者：
Cukierman-Yaffe, Tali;Gerstein, Hertzel C.;Temelkova-Kurktschiev, Theodora
通讯作者：
Temelkova-Kurktschiev, Theodora
影响因子：
2.6
作者：
Biessels GJ;Janssen J;van den Berg E;Zinman B;Espeland MA;Mattheus M;Johansen OE;CAROLINA® investigators
通讯作者：
CAROLINA® investigators
影响因子：
8.2
作者：
Lee AK;Rawlings AM;Lee CJ;Gross AL;Huang ES;Sharrett AR;Coresh J;Selvin E
通讯作者：
Selvin E