Kawamori Ryuzo, Daida Hiroyuki, Tanaka Yasushi, Miyauchi Katsumi, Kitagawa Akira, Hayashi Dobun, Kishimoto Junji, Ikeda Shunya, Imai Yutaka, Yamazaki Tsutomu
Metabolism and Endocrinology, Department of Medicine, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
BMC Cardiovasc Disord. 2006 Oct 9;6:39. doi: 10.1186/1471-2261-6-39.
The coexistence of type 2 diabetes mellitus and hypertension increases the risk of cardiovascular diseases. The U.K. Prospective Diabetes Study has shown that blood pressure control as well as blood glucose control is efficient for prevention of complications in hypertensive patients with diabetes mellitus. However, some reports have shown that it is difficult to control the blood pressure and the concomitant use of a plurality of drugs is needed in hypertensive patients with diabetes mellitus. In recent years renin-angiotensin system depressants are increasingly used for the blood pressure control in diabetic patients. Particularly in Japan, angiotensin II (A II) antagonists are increasingly used. However, there is no definite evidence of the point of which is efficient for the control, the increase in dose of A II antagonist or the concomitant use of another drug, in hypertensive patients whose blood pressure levels are inadequately controlled with A II antagonist.
METHODS/DESIGN: Hypertensive patients of age 20 years or over with type 2 diabetes mellitus who have been treated by the single use of AII antagonist at usual doses for at least 8 weeks or patients who have been treated by the concomitant use of AII antagonist and an antihypertensive drug other than calcium channel blockers and ACE inhibitors at usual doses for at least 8 weeks are included.
We designed a multi-center, prospective, randomized, open label, blinded-endpoint trial, ADVANCED-J, to compare the increases in dose of A II antagonist and the concomitant use of a Ca-channel blocker (amlodipine) and A II antagonist in hypertensive patients with diabetes mellitus, whose blood pressure levels were inadequately controlled with A II antagonist. This study is different from the usual previous studies in that home blood pressures are assessed as indicators of evaluation of blood pressure. The ADVANCED-J study may have much influence on selection of antihypertensive drugs for treatment in hypertensive patients with diabetes mellitus. It is expected to give an important hint for considering the validity of selection of antihypertensive drugs from the aspects not only of the antihypertensive effect but medical cost-effectiveness.
2型糖尿病与高血压并存会增加心血管疾病的风险。英国前瞻性糖尿病研究表明，血压控制以及血糖控制对于预防糖尿病高血压患者的并发症是有效的。然而，一些报告显示，糖尿病高血压患者难以控制血压，需要联合使用多种药物。近年来，肾素-血管紧张素系统抑制剂越来越多地用于糖尿病患者的血压控制。特别是在日本，血管紧张素II（A II）拮抗剂的使用越来越多。然而，对于血压水平未用A II拮抗剂充分控制的高血压患者，增加A II拮抗剂剂量或联合使用另一种药物哪个对控制有效，尚无明确证据。
方法/设计：纳入年龄20岁及以上的2型糖尿病高血压患者，这些患者单用常规剂量AII拮抗剂治疗至少8周，或联合使用常规剂量AII拮抗剂与除钙通道阻滞剂和ACE抑制剂以外的抗高血压药物治疗至少8周。
我们设计了一项多中心、前瞻性、随机、开放标签、盲终点试验ADVANCED-J，以比较血压水平未用A II拮抗剂充分控制的糖尿病高血压患者增加A II拮抗剂剂量与联合使用钙通道阻滞剂（氨氯地平）和A II拮抗剂的效果。本研究与以往常规研究的不同之处在于，将家庭血压作为血压评估指标。ADVANCED-J研究可能会对糖尿病高血压患者治疗用抗高血压药物的选择产生很大影响。预计它将从不仅抗高血压作用而且医疗成本效益方面为考虑抗高血压药物选择的有效性提供重要提示。
