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ディオバンとアムロジンの比較試験


Hypertens Res(Official Journal of the Japanese Society of Hypertension:日本高血圧学会の英文雑誌). 2011 Jan;34(1):62-9. doi: 10.1038/hr.2010.186. Epub 2010 Oct 7.
Effects of valsartan and amlodipine on cardiorenal protection in Japanese hypertensive patients: the Valsartan Amlodipine Randomized Trial.
Narumi H, Takano H, Shindo S, Fujita M, Mizuma H, Kuwabara Y, Komuro I; Valsartan Amlodipine Randomized Trial Investigators.
Collaborators (125):Komuro I, Takano H, Kuwabara Y, Shindo S, Nakayama K, Fujita M, Narumi H, Mizuma H, Himi T, Aouda A, Takami T, Takahashi O, Niwayama H, Kohno Y, Shirahashi N, Asakawa M, Daimon M, Doi K, Fujimoto Y, Fujita M, Furukawa T, Furuya M, Hasegawa R, Hashimoto N, Hattori T, Hijikata Y, Hibiya K, Himi T, Higaki S, Hirai A, Hosaka Y, Hoshino T, Ichikawa T, Iijima Y, Ikegami T, Imai H, Imai H, Isoyama K, Ito K, Iwama Y, Iwabe K, Kabe T, Kajikawa T, Kasaya T, Kataoka M, Kiuchi N, Kodama Y, Koizumi H, Koizumi T, Koshibu Y, Kozu M, Kozai Y, Kuroda A, Kurono T, Kuribayashi S, Kuwabara Y, Maeda F, Matsudo Y, Matsuishi T, Matsunaga H, Mikami Y, Minato A, Mitsuhashi O, Miura M, Mizuguchi K, Mizuma H, Mizuno K, Mizuno T, Murayama H, Mitsunaga S, Nagai T, Nagashima M, Nakajima K, Nakamura M, Nakazato T, Nakayama K, Narita S, Ogura K, Ohie K, Ohkubo S, Ohkubo T, Okuyama K, Pearce Y, Sakakibara M, Sakaguchi T, Saigusa N, Sakamoto F, Sato H, Sato I, Sekiya T, Seko M, Shikama N, Shikama T, Shimada I, Shina M, Shindo S, Shinozaki H, Shiraishi H, Sugibayashi T, Sugiyama T, Takahashi M, Takano H, Takahashi N, Takeda K, Takizawa T, Tanaka M, Teramoto K, Terashima M, Tomita Y, Toyoda T, Toyozaki T, Tsukamoto Y, Umimura T, Wagai F, Wakisaka K, Watanabe S, Yajima T, Yamanouchi M, Yamada K, Yamada M, Yamada Z, Yamamoto M, Yokosuka T, Yoshida H, Yoshida K.
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.
Erratum in
Hypertens Res. 2011 Jan;34(1):152.(152ページに訂正あり、という意味?)

Abstract

The Valsartan Amlodipine Randomized Trial, a multicenter, prospective, randomized, open-labeled, blinded-end point trial, was designed to compare the beneficial effects of the angiotensin II receptor blocker valsartan and the calcium channel blocker amlodipine on cardiovascular events in Japanese essential hypertensive patients.
The primary end point was a composite of all-cause death, sudden death, cerebrovascular death, cardiac events, vascular events and renal events.
The secondary endpoints were effects on left ventricular hypertrophy, cardiac sympathetic nerve activity and renal function.

PROBE法(何を飲んでいるかは患者も主治医も知っているが、統計をまとめる研究者は知らない)で、ディオバンとアムロジンの比較試験を行った。
主として比較したのは、死亡率、突然死、心臓血管死、心臓発作、腎不全の頻度。
ついでに比較したのが、左心室肥大、心臓の交感神経活動(?、今度娘に聞こう)、腎機能検査。

A total of 1021 patients were enrolled in the present trial. The mean follow-up period was 3.4 years.
There were no significant differences in blood pressure (BP) levels between the valsartan group and the amlodipine group throughout the trial.
There was no significant difference in the primary endpoint between the two groups (hazard ratio: 1.0, P = 0.843).
No difference in any event category of the primary endpoint was noted for either group.

1021人を平均3.4年観察。
血圧は全観察期間を通じて、両群間で有意差なし。
主として比較した項目にも、有意差なし。

However, we observed a significant reduction of left ventricular mass index, as determined by echocardiography, in the valsartan group compared with the amlodipine group.
We also observed a significant decrease in cardiac sympathetic nerve activity in the valsartan group but not in the amlodipine group.
Moreover, there was a significant reduction in the urinary albumin to creatinine ratio in the valsartan group but not in the amlodipine group.

心エコーで評価した左心室肥大はディオバンで軽かった。
心臓の交感神経活動(?)もディオバンで低かった。
尿たんぱくもディオバンで低かった。

Therefore, although BP levels were well controlled and remained equal in the two groups, valsartan had more protective effects on the heart and kidney than amlodipine in Japanese hypertensive patients.

両群で降圧効果に差はなかったが、ディオバンはアムロジンより、心臓・腎臓を守る作用がある。

2013年5月19日の院長ブログ原稿


[横浜市都筑区センター南駅木村泌尿器皮膚科院長日記一覧]