Global Health Economics and Outcomes Research, Takeda Pharmaceuticals International, Inc., 1 Takeda Parkway, Deerfield, IL 60015, USA.
Curr Med Res Opin. 2011 Jan;27(1):189-95. doi: 10.1185/03007995.2010.536755. Epub 2010 Dec 9.
To compare glycemic goal achievement (HbA(1c) < 7%) in type 2 diabetes patients receiving initial metformin plus pioglitazone combination therapy and initial metformin monotherapy augmented with pioglitazone in a cohort follow-up study.
Adult patients were identified from the Ingenix Impact database (01/01/99-03/31/07). Qualified patients had a baseline HbA(1c) ≥ 7%; a second laboratory value within 9 months; no other anti-diabetic prescriptions 6 months before or 30 days after treatment initiation; and continuous enrollment during baseline. The index date was the date on which the second medication was initiated. Goal achievement was compared independently at 6, 12 and 18 months using a chi-square test. Logistic regression was used to control for baseline differences. Last observation carried forward was used to impute missing HbA(1c) values. Sub-group analysis was conducted on patients with baseline HbA(1c) values between 7% and 9%, and >9%.
The proportion of patients achieving glycemic goal at each specified time point.
A total of 179 patients received initial combination therapy and 347 patients received sequential therapy. A greater proportion of initial combination patients achieved the glycemic goal compared to sequential patients at months 6, 12 and 18 (66.5 vs. 49.6%; 65.9 vs. 48.1%; 65.9 vs. 48.4%, respectively; p < 0.001 for all). Logistic regression confirmed these findings (odds ratios [OR]: 3.18-3.31). Sub-group analysis showed a more pronounced advantage for aggressive initial combination treatment among patients with HbA(1c) > 9% (OR: 5.39-6.04) than among patients with HbA(1c) between 7% and 9% (OR: 2.28-2.79).
Initial combination therapy patients are more likely to achieve glycemic control than sequential therapy patients, especially for patients with baseline HbA(1c) > 9%. This study is limited by the relatively small sample size and the frequency of HbA(1c) reporting. Future research could examine goal achievement using a larger sample and more complete laboratory data to confirm these findings.
在一项队列随访研究中，比较初始接受二甲双胍加吡格列酮联合治疗的 2 型糖尿病患者和初始接受二甲双胍单药加吡格列酮治疗的患者的血糖控制达标率（HbA1c＜7%）。
从 Ingenix Impact 数据库（1999 年 1 月 1 日至 2007 年 3 月 31 日）中确定成年患者。合格患者的基线 HbA1c≥7%；在 9 个月内有第二次实验室值；治疗开始前 6 个月和治疗开始后 30 天内没有其他抗糖尿病处方；并且在基线期间连续入组。索引日期是第二次用药开始的日期。使用卡方检验分别在 6、12 和 18 个月时独立比较达标情况。使用逻辑回归控制基线差异。使用最后观察值结转法来推断缺失的 HbA1c 值。在基线 HbA1c 值在 7%至 9%和＞9%之间的患者中进行亚组分析。
在每个指定时间点达到血糖控制目标的患者比例。
共有 179 名患者接受初始联合治疗，347 名患者接受序贯治疗。与序贯治疗患者相比，初始联合治疗患者在 6、12 和 18 个月时达到血糖控制目标的比例更高（66.5%比 49.6%；65.9%比 48.1%；65.9%比 48.4%；所有 P＜0.001）。逻辑回归证实了这些发现（比值比[OR]：3.18-3.31）。亚组分析显示，在基线 HbA1c＞9%的患者中，初始联合治疗的强化治疗具有更显著的优势（OR：5.39-6.04），而在基线 HbA1c 在 7%至 9%之间的患者中（OR：2.28-2.79）。
与序贯治疗患者相比，初始联合治疗患者更有可能达到血糖控制，尤其是基线 HbA1c＞9%的患者。本研究受到相对较小的样本量和 HbA1c 报告频率的限制。未来的研究可以使用更大的样本量和更完整的实验室数据来检查目标的实现，以证实这些发现。
