厄贝沙坦治疗2型糖尿病伴尿白蛋白患者有效性和安全性:多中心随机双盲对照研究

该文评估厄贝沙坦治疗2型糖尿病伴白蛋白尿患者的疗效与安全性。方法:采用随机、双盲、安慰剂对照、多中心临床研究方法,8个医院326例受试者随机分配到厄贝沙坦(300 mg/d)组(160例)或安慰剂组     

厄贝沙坦治疗2型糖尿病伴尿白蛋白患者有效性和安全性：多中心随机双盲对照研究

该文评估厄贝沙坦治疗2型糖尿病伴白蛋白尿患者的疗效与安全性。方法：采用随机、双盲、安慰剂对照、多中心临床研究方法，8个医院326例受试者随机分配到厄贝沙坦（300mg／d）组（160例）或安慰剂组（166例），治疗24周。检测尿白蛋白排泄率（UAER）、收缩压、舒张压、三酰甘油、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇（LDL-C）和糖化血红蛋白（HbA1c）水平。     

达格列净联合厄贝沙坦治疗2型糖尿病合并糖尿病肾病的有效性及安全性

目的 探讨达格列净联合厄贝沙坦治疗2型糖尿病合并糖尿病肾病(diabetic kidney disease, DKD)的疗效和安全性。方法 选取2021年1月—2021年12月绵阳市第三人民医院收治的120例2型糖尿病合并DKD患者为研究对象,随机分为观察组及对照组,每组60例。在常规治疗的基础上,对照组给予厄贝沙坦治疗,观察组给予达格列净联合厄贝沙坦治疗。对比治疗前后糖代谢指标、血压水平、肾功能指标水平及不良反应发生情况。结果 治疗后,观察组空腹血糖(6.81±1.01)mmol/L,糖化血红蛋白(7.07±0.56)%均低于对照组,差异有统计学意义(P<0.05)。治疗后,观察组收缩压(122±8)mmHg,舒张压(74±3)mmHg均低于对照组,差异有统计学意义(P<0.05)。治疗后,观察组UACR、24 h尿蛋白定量、肌酐均低于对照组,观察组UACR、24 h尿蛋白定量治疗前后差值均高于对照组,差异有统计学意义(P<0.05)。两组不良反应发生率对比,差异无统计学意义(χ²=0.209,P>0.05)。结论 达格列净联合厄贝沙坦可...     

厄贝沙坦联合氨氯地平治疗老年高血压伴2型糖尿病的疗效

目的探讨厄贝沙坦联合氨氯地平治疗老年高血压伴2型糖尿病(T2DM)的临床疗效及安全性。方法将2013年6月至2014年6月该院收治的60岁高血压伴T2DM患者120例,按照随机数字法随机分为观察组和对照组A及对照组B,每组40例,对照组A口服厄贝沙坦;对照组B口服氨氯地平;观察组联合口服厄贝沙坦和氨氯地平,每组患者给予12 w治疗,对比分析三组的临床疗效和安全性。结果三组治疗12 w后,收缩压(SBP)、舒张压(DBP)均低于治疗前(均P0.05);观察组SBP、DBP均低于对照组A及对照组B(均P0.05);观察组降压有效率均高于对照组A及对照组B(P0.05)。观察组治疗后空腹血糖(FPG)、空腹胰岛素(FINS)均低于治疗前和对照组A及对照组B(均P0.05);三组患者均未出现严重不良反应,三组不良反应比较差异无统计学意义(P0.05)。结论厄贝沙坦联合氨氯地平治疗老年高血压伴T2DM,临床疗效好,安全性高,值得临床推广。     

硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压的疗效

目的探讨硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压的临床疗效。方法选取本院2011年7月—2013年7月收治的2型糖尿病合并高血压患者68例,将其随机分为对照组和治疗组,各34例。对照组采用常规治疗,治疗组在常规治疗的基础上给予硝苯地平联合厄贝沙坦治疗,均以8周为1个疗程,治疗1个疗程后,比较两组患者的疗效及不良反应发生情况。结果治疗前两组患者收缩压(SBP)、舒张压(DBP)、空腹血糖、餐后血糖比较,差异均无统计学意义(P0.05);治疗后治疗组患者SBP、DBP、空腹血糖、餐后血糖低于对照组(P0.05)。治疗组患者总有效率为91.2%(31/34),高于对照组的64.7%(22/34)(P0.05)。治疗组低血糖发生率为2.9%(1/34),低于对照组的14.7%(5/34)(P0.05)。结论硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压疗效显著,且不良反应少。     

氨氯地平联合厄贝沙坦片治疗2型糖尿病患者脑出血急性期的安全性分析

目的 探究2型糖尿病患者脑出血急性期应用氨氯地平联合厄贝沙坦片的临床效果.方法 抽取92例在该院2018年2月—2020年9月期间进行诊治的2型糖尿病合并脑出血急性期患者,利用抽签法分为两组,参照组予以患者甘露醇,实验组予以患者氨氯地平联合厄贝沙坦,比较两组患者临床治疗效果.结果 实验组患者NIHSS评分、空腹血糖以及...     

恩格列净联合厄贝沙坦治疗2型糖尿病肾病患者疗效及安全性评价

目的 分析恩格列净联合厄贝沙坦治疗2型糖尿病肾病患者的疗效及安全性。方法 选取2020年1月—2021年12月上海市松江区泗泾医院收治的98例2型糖尿病肾病患者,采用分层随机法将其分为对照组和研究组,对照组（n=49）给予厄贝沙坦治疗,研究组（n=49）给予恩格列净联合厄贝沙坦治疗。对比两组血糖指标、血脂指标、肾功能指标、不良反应总发生率。结果 治疗后,研究组FPG、2 hPG、TC、TG、LDL-C、UA、UACR水平均较对照组更低,HDL-C均较对照组更高,差异有统计学意义（P<0.05）;两组低血糖、酮症酸重度、泌尿系感染、生殖系感染等不良反应总发生率比较,差异无统计学意义（P>0.05）。结论 2型糖尿病肾病给予恩格列净联合厄贝沙坦治疗可改善血糖、血脂水平,减缓肾功能恶化,且安全性良好。     

硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压的疗效

目的研究探讨硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压的有效性以及安全性。方法选择在该院2012年2月—2014年2月收治的160例2型糖尿病合并高血压患者,收集汇总患者的临床资料,其中研究组的80例患者采用硝苯地平联合厄贝沙坦进行相关治疗,对照组80例患者则采用硝苯地平进行相关治疗,比较两组患者的治疗效果。结果经过治疗后研究组患者总体的治疗有效率为100%,明显高于对照组的患者,并且存在统计学差异(P<0.05),且通过比较研究组患者的收缩压和舒张压等相关指标均明显低于对照组,差异有统计学意义。(P<0.05)。结论硝苯地平联合厄贝沙坦治疗2型糖尿病合并高血压疗效较为显著,对患者的血糖影响尚不明显,值得在临床中进行推广应用。     

2型糖尿病合并高血压采用厄贝沙坦和氨氯地平治疗的临床价值探析

目的探讨对应用氨氯地平与厄贝沙坦联合对合并患有高血压疾病的2型糖尿病患者实施治疗的临床效果进行研究。方法将该院2011年4月—2014年4月收治的72例合并患有高血压疾病的2型糖尿病患者随机分为对照组和治疗组,平均每组36例。采用厄贝沙坦对对照组患者实施治疗;采用氨氯地平与厄贝沙坦联合对治疗组患者实施治疗。结果治疗组患者2型糖尿病合并高血压疾病治疗效果明显优于对照组;血糖和血压水平复常时间、住院治疗总时间明显短于对照组;药物不良反应明显少于对照组。结论应用氨氯地平与厄贝沙坦联合对合并患有高血压疾病的2型糖尿病患者实施治疗的临床效果非常明显。     

大剂量厄贝沙坦治疗慢性肾脏病患者临床蛋白尿的疗效及安全性

目的 评估大剂量厄贝沙坦治疗慢性肾脏病(CKD)患者轻、中度蛋白尿的疗效与安全性.方法 采用单中心前瞻观察性研究,将96例受试者先行厄贝沙坦150 mg/d治疗4周,疗效达好转标准者作为厄贝沙坦单倍剂量组( 150 mg/d)(26例);若单倍剂量治疗无效,逐渐加大厄贝沙坦治疗剂量作为大剂量组( 300～ 600 mg...     

Efficacy and safety of pioglitazone versus metformin in patients with type 2 diabetes mellitus: a double-blind, randomized trial

Pioglitazone increases the insulin sensitivity of peripheral tissues and may provide an alternative first-line treatment for type 2 diabetes. This study compared metabolic control in drug-naive type 2 diabetes patients given either pioglitazone or metformin. Eleven hundred and ninety-nine patients with poorly controlled type 2 diabetes mellitus [glycosylated hemoglobin (HbA1c), 7.5-11%; normal, 4.3-6.1%] were randomized to receive either pioglitazone (< or =45 mg/d) or metformin (< or =850 mg, three times daily). HbA1c, fasting plasma glucose (FPG), insulin levels, total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol, triglycerides, free fatty acids, and urinary albumin/creatinine ratio were measured. Mean HbA1c decreased in both treatment groups from baseline to wk 52 (-1.4% and -1.5%). Significantly greater mean reductions in FPG were observed in the pioglitazone group (-45.0 mg/dl; -2.5 mmol/liter) than in the metformin (-39.6 mg/dl; -2.2 mmol/liter) group (P = 0.016). Favorable changes in triglycerides and HDL-C were more pronounced with pioglitazone. Although low density lipoprotein cholesterol and TC levels increased with pioglitazone, TC/HDL-C ratios decreased similarly with both treatments. The urinary albumin/creatinine ratio was reduced by 19% with pioglitazone treatment, but remained unchanged with metformin therapy (-1%; P = 0.002). There was an increase in body weight of 1.9 kg in the pioglitazone group and a decrease of 2.5 kg in the metformin group. The overall frequency of adverse events was similar between treatment groups, but adverse event profiles were different between treatment groups. HbA1c reduction is similar after pioglitazone and metformin monotherapies, but differences in FPG, plasma lipids, and adverse effects between the two compounds may influence decision-making in individual prescribers.     

Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial

Aim

To assess efficacy and safety of saxagliptin added to metformin versus placebo plus metformin in Asian patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin alone.

Methods

Adults (HbA_1c 7.0-10.0%, on stable metformin ≥1500 mg/day) were randomized 1:1 to saxagliptin 5 mg daily plus metformin (n = 283) or placebo plus metformin (n = 287). The primary end point was HbA_1c change from baseline to Week 24.

Results

Saxagliptin plus metformin provided significant adjusted mean decreases versus placebo plus metformin (p ≤ 0.0052) in HbA_1c (−0.78% versus −0.37%), fasting plasma glucose (−1.14 mmol/L versus −0.58 mmol/L), and postprandial glucose area under the curve from 0 to 180 min (−315 mmol min/L versus −160 mmol min/L). Significantly more saxagliptin-treated patients achieved a therapeutic glycemic response (HbA_1c < 7.0%) (46.5% versus 30.5%; p = 0.0001). The proportion of patients experiencing adverse events (excluding hypoglycemia) was similar for saxagliptin plus metformin (42.8%) versus placebo plus metformin (40.8%). Hypoglycemic events were reported in 1.4% of patients in each group.

Conclusion

Saxagliptin added to metformin significantly improved glycemic control and was well tolerated in Asian patients with T2DM who had inadequate glycemic control with metformin and diet and lifestyle modification.     

Efficacy and safety of treatment with sitagliptin or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy: a randomized, double-blind, non-inferiority trial

Aim: To evaluate the efficacy and safety of adding sitagliptin or glimepiride to the treatment regimen of patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin monotherapy. Methods: Patients with type 2 diabetes and an HbA_1c of 6.5–9.0% while on a stable dose of metformin (≥1500 mg/day) combined with diet and exercise for at least 12 weeks were randomized in a double‐blind manner to receive either sitagliptin 100 mg daily (N = 516) or glimepiride (starting dose 1 mg/day and up‐titrated, based upon patient's self‐monitoring of blood glucose results, to a maximum dose of up to 6 mg/day) (N = 519) for 30 weeks. The primary analysis assessed whether sitagliptin is non‐inferior to glimepiride in reducing HbA_1c at week 30 (based on the criterion of having an upper bound of the 95% CI less than the prespecified non‐inferiority bound of 0.4%). Results: The mean baseline HbA_1c was 7.5% in both the sitagliptin group (n = 443) and the glimepiride group (n = 436). After 30 weeks, the least squares (LS) mean change in HbA_1c from baseline was ?0.47% with sitagliptin and ?0.54% with glimepiride, with a between‐group difference (95% CI) of 0.07% (?0.03, 0.16). This result met the prespecified criterion for declaring non‐inferiority. The percentages of patients with an HbA_1c < 7.0% at week 30 were 52 and 60% in the sitagliptin and glimepiride groups, respectively. The LS mean change in fasting plasma glucose from baseline (95% CI) was ?0.8 mmol/l (?1.0, ?0.6) with sitagliptin and ?1.0 mmol/l (?1.2, ?0.8) with glimepiride, for a between‐group difference (95% CI) of 0.2 mmol/l (?0.1, 0.4). The percentages of patients for whom hypoglycaemia was reported were 7% in the sitagliptin group and 22% in the glimepiride group (percentage‐point difference = ?15, p < 0.001). Relative to baseline, sitagliptin was associated with a mean weight loss (?0.8 kg), whereas glimepiride was associated with a mean weight gain (1.2 kg), yielding a between‐group difference of ?2.0 kg (p < 0.001). Conclusions: In patients with type 2 diabetes and inadequate glycaemic control on metformin monotherapy, the addition of sitagliptin or glimepiride led to similar improvement in glycaemic control after 30 weeks. Sitagliptin was generally well tolerated. Compared to treatment with glimepiride, treatment with sitagliptin was associated with a lower risk of hypoglycaemia and with weight loss versus weight gain ( ClinicalTrials.gov : NCT00701090).     

Efficacy and safety of linagliptin as add-on therapy to insulin in Chinese patients with type 2 diabetes mellitus: A randomized,double-blind,placebo-controlled trial

This 24-week, double-blind, placebo-controlled, phase III trial evaluated the efficacy and safety of linagliptin in 206 Chinese patients with inadequately controlled (glycated haemoglobin [HbA1c] 7.5%–10.0%) type 2 diabetes mellitus (T2DM) receiving insulin (basal or premixed) ± metformin. Patients were randomized (1:1) to receive linagliptin 5 mg/d or placebo. The decrease from baseline in HbA1c (primary endpoint) was greater with linagliptin than with placebo (−0.61% vs. −0.20%, adjusted mean difference −0.40%; P = 0.0016). Linagliptin demonstrated significantly greater improvement in 2-hour postprandial glucose (−1.77 mmol/L [−31.95 mg/dL]; P < 0.001), and a numerical reduction in fasting plasma glucose (−0.34 mmol/L [−6.2 mg/dL]; P = 0.2241) versus placebo. Proportionally more patients on linagliptin achieved a HbA1c reduction of ≥0.5% versus those on placebo (odds ratio 2.293, P < 0.01). Adverse events in both groups were similar, with no new safety findings or clinically relevant changes in body weight. Among investigator-defined hypoglycaemic events (linagliptin: 17.3%; placebo: 12.7%; odds ratio 1.48, P = 0.337), none were severe. In Chinese patients with T2DM, linagliptin add-on to insulin improved glycaemic control and was well tolerated, without increased risk of hypoglycaemia or weight gain.     

Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12-week,multicentre, randomized,double-blind,placebo-controlled,phase 2 trial

Aims

The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium-glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 diabetes mellitus.

Materials and Methods

Patients with glycated haemoglobin (HbA1c) of 7.0-10.0%, entered a 2-week placebo run-in period, and were randomized to receive once-daily enavogliflozin (0.1, 0.3 or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12.

Results

Overall, 194 patients were included in the full analysis set [placebo, n = 46; enavogliflozin (0.1 mg, n = 49; 0.3 mg, n = 50; 0.5 mg, n = 49)]. Patients receiving 0.1, 0.3 and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (−0.79%, −0.89%, −0.92% and −0.08%, respectively; p < .001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were −30.5, −31.1, −35.0 and 4.9 mg/dl in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2% and 17.4%, respectively). A higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3% and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycaemia and genital infection between the groups.

Conclusions

Once-daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well-tolerated treatment for Korean patients with type 2 diabetes mellitus.