Thrasher James, Daniels Kristen, Patel Sanjay, Whetteckey Jacqueline, Woerle Hans-Juergen
Medical Investigations Inc., Little Rock, Arkansas.
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut.
Endocr Pract. 2014 May;20(5):412-20. doi: 10.4158/EP13365.OR.
Although black/African American individuals are disproportionately affected by type 2 diabetes, there is scant clinical trial information available on antidiabetes therapies in this group. We compared linagliptin with placebo in black/African American adults who were treatment-naïve or receiving one oral antidiabetes drug.
Of 226 patients randomized to 24 weeks' linagliptin 5 mg/day or placebo, 208 had baseline and at least one on-treatment glycated hemoglobin (HbA1c) measurement. Mean baseline HbA1c was 8.6% in the linagliptin group (n = 98) and 8.68% in the placebo group (n = 110). The primary outcome was change in HbA1c from baseline to week 24.
By week 24, mean HbA1c changes were -0.84% with linagliptin and -0.25% with placebo (treatment difference, -0.58%; P<.001), and more patients in the linagliptin group achieved HbA1c <7.0% (26.8% vs. 8.3%; P = .001) or an HbA1c reduction ≥0.5% (54.1% vs. 30.0%; P<.001). Mean weight loss was -1.1 kg in both groups. During the treatment period, 8 of 98 linagliptin-group patients and 17 of 110 placebo-group patients required rescue therapy (odds ratio, 0.5; P = .14). For postprandial glucose, values were available for few patients (11 placebo, 10 linagliptin), and thus the between-group difference was associated with wide confidence intervals (CIs) (difference, -1.97 mg/dL; 95% CI, -53.80 to 49.86; P = .94). In the overall study population, a similar proportion of patients in both groups had adverse events (58.5% vs. 61.7%); most events were mild or moderate and considered unrelated to study drug. Investigator-defined hypoglycemia was rare (3 linagliptin-group patients and 1 placebo-group patient), with no severe events (requiring external assistance).
This study confirms that linagliptin is efficacious and well tolerated in black/African American patients with type 2 diabetes.
尽管黑人/非裔美国人受2型糖尿病的影响尤为严重，但关于该群体抗糖尿病治疗的临床试验信息却很少。我们比较了利格列汀与安慰剂在未接受过治疗或正在接受一种口服抗糖尿病药物治疗的黑人/非裔美国成年人中的疗效。
226例患者被随机分为接受为期24周的每日5毫克利格列汀治疗组或安慰剂组，其中208例患者有基线糖化血红蛋白（HbA1c）测量值且至少有一次治疗期间的测量值。利格列汀组（n = 98）的平均基线HbA1c为8.6%，安慰剂组（n = 110）为8.68%。主要结局是从基线到第24周HbA1c的变化。
到第24周时，利格列汀组的平均HbA1c变化为-0.84%，安慰剂组为-0.25%（治疗差异为-0.58%；P<0.001），利格列汀组更多患者的HbA1c<7.0%（26.8%对8.3%；P = 0.001）或HbA1c降低≥0.5%（54.1%对30.0%；P<0.001）。两组的平均体重减轻均为-1.1千克。在治疗期间，98名利格列汀组患者中有8例、110名安慰剂组患者中有17例需要抢救治疗（优势比为0.5；P = 0.14）。对于餐后血糖，只有少数患者（11例安慰剂组、10例利格列汀组）有测量值，因此组间差异的置信区间（CI）较宽（差异为-1.97毫克/分升；95%CI为-53.80至49.86；P = 0.94）。在整个研究人群中，两组发生不良事件的患者比例相似（58.5%对61.7%）；大多数事件为轻度或中度，且被认为与研究药物无关。研究者定义的低血糖很少见（3名利格列汀组患者和1名安慰剂组患者），无严重事件（需要外部协助）。
本研究证实利格列汀在患有2型糖尿病的黑人/非裔美国患者中有效且耐受性良好。
