Komajda Michel, Curtis Paula, Hanefeld Markolf, Beck-Nielsen Henning, Pocock Stuart J, Zambanini Andrew, Jones Nigel P, Gomis Ramon, Home Philip D
Université Pierre et Marie Curie Paris 6; Assistance Publique Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Paris, France.
Cardiovasc Diabetol. 2008 Apr 24;7:10. doi: 10.1186/1475-2840-7-10.
Hypertension and type 2 diabetes are common co-morbidities. Preliminary studies suggest that thiazolidinediones reduce blood pressure (BP). We therefore used ambulatory BP to quantify BP lowering at 6-12 months with rosiglitazone used in combination with metformin or sulfonylureas compared to metformin and sulfonylureas in people with type 2 diabetes.
Participants (n = 759) in the multicentre RECORD study were studied. Those taking metformin were randomized (open label) to add-on rosiglitazone or sulfonylureas, and those on sulfonylurea to add-on rosiglitazone or metformin.
24-Hour ambulatory BP was measured at baseline, 6 months and 12 months. At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin (difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [95% CI 0.2-4.8] mmHg, p = 0.031). Corresponding changes for ambulatory diastolic BP (dBP) were comparable (6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [95% CI 1.8-4.5] mmHg, p < 0.001). Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049). Changes in BP were not accompanied by compensatory increases in heart rate, did not correlate with basal insulin sensitivity estimates and were not explained by changes in antihypertensive therapy between the various strata.
When added to metformin or a sulfonylurea, 12-month treatment with rosiglitazone reduces ambulatory BP to a greater extent than when metformin and a sulfonylurea are combined.
NCT00379769 http://clinicaltrials.gov/
高血压和2型糖尿病是常见的合并症。初步研究表明，噻唑烷二酮类药物可降低血压（BP）。因此，我们采用动态血压监测来量化在2型糖尿病患者中，罗格列酮与二甲双胍或磺脲类药物联合使用6至12个月时的血压降低情况，并与单独使用二甲双胍和磺脲类药物进行比较。
对多中心RECORD研究中的参与者（n = 759）进行了研究。服用二甲双胍的患者被随机（开放标签）分配加用罗格列酮或磺脲类药物，服用磺脲类药物的患者则加用罗格列酮或二甲双胍。
在基线、6个月和12个月时测量24小时动态血压。在6个月和12个月时，罗格列酮组24小时动态收缩压（sBP）的降低幅度大于二甲双胍组（6个月时差异为2.7 [95% CI 0.5 - 4.9] mmHg，p = 0.015；12个月时差异为2.5 [95% CI 0.2 - 4.8] mmHg，p = 0.031）。动态舒张压（dBP）的相应变化具有可比性（6个月时差异为2.7 [95% CI 1.4 - 4.0] mmHg，p < 0.001；12个月时差异为3.1 [95% CI 1.8 - 4.5] mmHg，p < 0.001）。在12个月时，罗格列酮组与磺脲类药物组之间也观察到类似差异（sBP 2.7 [95% CI 0.5 - 4.9] mmHg，p = 0.016；dBP 2.1 [95% CI 0.7 - 3.4] mmHg，p = 0.003），但在6个月时差异较小且/或无统计学意义（sBP 1.5 [95% CI -0.6至3.6] mmHg，p = 无显著性差异；dBP 1.3 [95% CI 0.0 - 2.5] mmHg，p = 0.049）。血压变化并未伴随心率的代偿性增加，与基础胰岛素敏感性估计值无关，也无法用各亚组间降压治疗的变化来解释。
与二甲双胍和磺脲类药物联合使用相比，罗格列酮联合二甲双胍或磺脲类药物治疗12个月能更大程度地降低动态血压。
NCT00379769 http://clinicaltrials.gov/
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