The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS): Protocol, patient characteristics, and blood pressure during the first 12 months

Yoshio Goto; Masao Ishii; Takao Saruta; Tadashi Kawakami; Kanemi Kawabe; Toshio Ogihara; Yuhei Kawano; Kenjiro Kikuchi; Kazuaki Shimamoto; Masayuki Sakurai; Makoto Sugahara; Sadayoshi Ito; Hiroaki Matsuoka; Yoshihiko Sato; Seishiro Ono; Satoshi Umemura; Yoshiro Shiota; Masaaki Miyagawa; Kenichi Doniwa; Genjiro Kimura; Yutaka Tada; Masayoshi Nakao; Takeshi Takami; Mikio Arita; Mitunori Okamoto; Kunio Hiwada; Masunori Matsuzaki; Akira Takeshita; Kozaburo Abe; Takashi Honda; Shinichi Minakoe; Masanori Fujishima; Akira Kitabatake; Koichi Hayashi; Junichi Yoshikawa; Kazuhiro Harada; Naokata Shimizu; Chihiro Hirotsu; Hiroe Tsubaki; Ryozo Nagai; Iwao Kuwajima; Machiko Adachi; Keiko Takeuchi; Hideo Shibagaki; Satoshi Iwakura; Yoshihiro Matsubara; Takenobu Tasaki; Yoshihide Tsuchiya; Hideaki Hida; Kenzo Mori; Yoshio Yazaki

doi:10.1291/hypres.28.513

The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS): Protocol, patient characteristics, and blood pressure during the first 12 months

Yoshio Goto, Masao Ishii, Takao Saruta, Tadashi Kawakami, Kanemi Kawabe, Toshio Ogihara, Yuhei Kawano, Kenjiro Kikuchi, Kazuaki Shimamoto, Masayuki Sakurai, Makoto Sugahara, Sadayoshi Ito, Hiroaki Matsuoka, Yoshihiko Sato, Seishiro Ono, Satoshi Umemura, Yoshiro Shiota, Masaaki Miyagawa, Kenichi Doniwa, Genjiro KimuraYutaka Tada, Masayoshi Nakao, Takeshi Takami, Mikio Arita, Mitunori Okamoto, Kunio Hiwada, Masunori Matsuzaki, Akira Takeshita, Kozaburo Abe, Takashi Honda, Shinichi Minakoe, Masanori Fujishima, Akira Kitabatake, Koichi Hayashi, Junichi Yoshikawa, Kazuhiro Harada, Naokata Shimizu, Chihiro Hirotsu, Hiroe Tsubaki, Ryozo Nagai, Iwao Kuwajima, Machiko Adachi, Keiko Takeuchi, Hideo Shibagaki, Satoshi Iwakura, Yoshihiro Matsubara, Takenobu Tasaki, Yoshihide Tsuchiya, Hideaki Hida, Kenzo Mori, Yoshio Yazaki

Research output: Contribution to journal › Article › peer-review

37 Citations (Scopus)

Abstract

The benefits of a systolic blood pressure (BP) below 150-160 mmHg are well established; whether a systolic BP of less than 140 mmHg provides additional benefits remains controversial. This study was designed to compare the 2-year effect of a strict treatment to maintain systolic BP below 140 mmHg (group A) and that of a mild treatment to maintain systolic BP at between 140 and below 160 mmHg (group B). The study design followed the Prospective Randomized Open Blinded, End-point (PROBE) study. The subjects were elderly patients (65-85 years old) who consistently had a systolic BP of 160 mmHg or higher. The baseline drug was efonidipine hydrochloride (efonidipine), a long-acting dihydropiridine calcium antagonist. The primary endpoints were stroke, cardiac disease, vascular disease, and renal failure. After a run-in period of 2 to 4 weeks, 2,165 patients were assigned to group A and 2,155 patients to group B. There were no significant differences between the groups in sex, age, baseline BP, or other cardiovascular risk factors. The systolic BP was 7.2 mmHg lower (p<0.0001) and the diastolic BP 2.4 mmHg lower (p<0.0001) in group A than in group B after 12 months of treatment. As of this interim analysis, primary endpoints have occurred in 87 patients (stroke in 58 patients, cardiac disease in 27 patients, occlusive arterial disease in 1 patient, and renal failure in 1 patient). Five patients have died of stroke and 2 patients of myocardial infarction. The primary-endpoint-related morbidity rate was 20.9/1,000 patient-years, and the mortality rate was 1.7/1,000 patient-years. Currently available results indicate that this study, one of the largest randomized trials of antihypertensive therapy in elderly patients in Japan, was conducted safely. The final results are expected to provide important and practical information for the management of hypertension in elderly patients.

Original language	English
Pages (from-to)	513-520
Number of pages	8
Journal	Hypertension Research
Volume	28
Issue number	6
DOIs	https://doi.org/10.1291/hypres.28.513
Publication status	Published - 2005 Jun
Externally published	Yes

Keywords

Calcium antagonists
Efonidipine hydrochloride
Essential hypertension
Systolic blood pressure

ASJC Scopus subject areas

Internal Medicine
Physiology
Cardiology and Cardiovascular Medicine

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10.1291/hypres.28.513

Cite this

Goto, Y., Ishii, M., Saruta, T., Kawakami, T., Kawabe, K., Ogihara, T., Kawano, Y., Kikuchi, K., Shimamoto, K., Sakurai, M., Sugahara, M., Ito, S., Matsuoka, H., Sato, Y., Ono, S., Umemura, S., Shiota, Y., Miyagawa, M., Doniwa, K., ... Yazaki, Y. (2005). The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS): Protocol, patient characteristics, and blood pressure during the first 12 months. Hypertension Research, 28(6), 513-520. https://doi.org/10.1291/hypres.28.513

Goto, Y, Ishii, M, Saruta, T, Kawakami, T, Kawabe, K, Ogihara, T, Kawano, Y, Kikuchi, K, Shimamoto, K, Sakurai, M, Sugahara, M, Ito, S, Matsuoka, H, Sato, Y, Ono, S, Umemura, S, Shiota, Y, Miyagawa, M, Doniwa, K, Kimura, G, Tada, Y, Nakao, M, Takami, T, Arita, M, Okamoto, M, Hiwada, K, Matsuzaki, M, Takeshita, A, Abe, K, Honda, T, Minakoe, S, Fujishima, M, Kitabatake, A, Hayashi, K, Yoshikawa, J, Harada, K, Shimizu, N, Hirotsu, C, Tsubaki, H, Nagai, R, Kuwajima, I, Adachi, M, Takeuchi, K, Shibagaki, H, Iwakura, S, Matsubara, Y, Tasaki, T, Tsuchiya, Y, Hida, H, Mori, K & Yazaki, Y 2005, 'The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS): Protocol, patient characteristics, and blood pressure during the first 12 months', Hypertension Research, vol. 28, no. 6, pp. 513-520. https://doi.org/10.1291/hypres.28.513

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abstract = "The benefits of a systolic blood pressure (BP) below 150-160 mmHg are well established; whether a systolic BP of less than 140 mmHg provides additional benefits remains controversial. This study was designed to compare the 2-year effect of a strict treatment to maintain systolic BP below 140 mmHg (group A) and that of a mild treatment to maintain systolic BP at between 140 and below 160 mmHg (group B). The study design followed the Prospective Randomized Open Blinded, End-point (PROBE) study. The subjects were elderly patients (65-85 years old) who consistently had a systolic BP of 160 mmHg or higher. The baseline drug was efonidipine hydrochloride (efonidipine), a long-acting dihydropiridine calcium antagonist. The primary endpoints were stroke, cardiac disease, vascular disease, and renal failure. After a run-in period of 2 to 4 weeks, 2,165 patients were assigned to group A and 2,155 patients to group B. There were no significant differences between the groups in sex, age, baseline BP, or other cardiovascular risk factors. The systolic BP was 7.2 mmHg lower (p<0.0001) and the diastolic BP 2.4 mmHg lower (p<0.0001) in group A than in group B after 12 months of treatment. As of this interim analysis, primary endpoints have occurred in 87 patients (stroke in 58 patients, cardiac disease in 27 patients, occlusive arterial disease in 1 patient, and renal failure in 1 patient). Five patients have died of stroke and 2 patients of myocardial infarction. The primary-endpoint-related morbidity rate was 20.9/1,000 patient-years, and the mortality rate was 1.7/1,000 patient-years. Currently available results indicate that this study, one of the largest randomized trials of antihypertensive therapy in elderly patients in Japan, was conducted safely. The final results are expected to provide important and practical information for the management of hypertension in elderly patients.",

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author = "Yoshio Goto and Masao Ishii and Takao Saruta and Tadashi Kawakami and Kanemi Kawabe and Toshio Ogihara and Yuhei Kawano and Kenjiro Kikuchi and Kazuaki Shimamoto and Masayuki Sakurai and Makoto Sugahara and Sadayoshi Ito and Hiroaki Matsuoka and Yoshihiko Sato and Seishiro Ono and Satoshi Umemura and Yoshiro Shiota and Masaaki Miyagawa and Kenichi Doniwa and Genjiro Kimura and Yutaka Tada and Masayoshi Nakao and Takeshi Takami and Mikio Arita and Mitunori Okamoto and Kunio Hiwada and Masunori Matsuzaki and Akira Takeshita and Kozaburo Abe and Takashi Honda and Shinichi Minakoe and Masanori Fujishima and Akira Kitabatake and Koichi Hayashi and Junichi Yoshikawa and Kazuhiro Harada and Naokata Shimizu and Chihiro Hirotsu and Hiroe Tsubaki and Ryozo Nagai and Iwao Kuwajima and Machiko Adachi and Keiko Takeuchi and Hideo Shibagaki and Satoshi Iwakura and Yoshihiro Matsubara and Takenobu Tasaki and Yoshihide Tsuchiya and Hideaki Hida and Kenzo Mori and Yoshio Yazaki",

year = "2005",

month = jun,

doi = "10.1291/hypres.28.513",

language = "English",

volume = "28",

pages = "513--520",

journal = "Hypertension Research",

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T1 - The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS)

T2 - Protocol, patient characteristics, and blood pressure during the first 12 months

AU - Goto, Yoshio

AU - Ishii, Masao

AU - Saruta, Takao

AU - Kawakami, Tadashi

AU - Kawabe, Kanemi

AU - Ogihara, Toshio

AU - Kawano, Yuhei

AU - Kikuchi, Kenjiro

AU - Shimamoto, Kazuaki

AU - Sakurai, Masayuki

AU - Sugahara, Makoto

AU - Ito, Sadayoshi

AU - Matsuoka, Hiroaki

AU - Sato, Yoshihiko

AU - Ono, Seishiro

AU - Umemura, Satoshi

AU - Shiota, Yoshiro

AU - Miyagawa, Masaaki

AU - Doniwa, Kenichi

AU - Kimura, Genjiro

AU - Tada, Yutaka

AU - Nakao, Masayoshi

AU - Takami, Takeshi

AU - Arita, Mikio

AU - Okamoto, Mitunori

AU - Hiwada, Kunio

AU - Matsuzaki, Masunori

AU - Takeshita, Akira

AU - Abe, Kozaburo

AU - Honda, Takashi

AU - Minakoe, Shinichi

AU - Fujishima, Masanori

AU - Kitabatake, Akira

AU - Hayashi, Koichi

AU - Yoshikawa, Junichi

AU - Harada, Kazuhiro

AU - Shimizu, Naokata

AU - Hirotsu, Chihiro

AU - Tsubaki, Hiroe

AU - Nagai, Ryozo

AU - Kuwajima, Iwao

AU - Adachi, Machiko

AU - Takeuchi, Keiko

AU - Shibagaki, Hideo

AU - Iwakura, Satoshi

AU - Matsubara, Yoshihiro

AU - Tasaki, Takenobu

AU - Tsuchiya, Yoshihide

AU - Hida, Hideaki

AU - Mori, Kenzo

AU - Yazaki, Yoshio

PY - 2005/6

Y1 - 2005/6

N2 - The benefits of a systolic blood pressure (BP) below 150-160 mmHg are well established; whether a systolic BP of less than 140 mmHg provides additional benefits remains controversial. This study was designed to compare the 2-year effect of a strict treatment to maintain systolic BP below 140 mmHg (group A) and that of a mild treatment to maintain systolic BP at between 140 and below 160 mmHg (group B). The study design followed the Prospective Randomized Open Blinded, End-point (PROBE) study. The subjects were elderly patients (65-85 years old) who consistently had a systolic BP of 160 mmHg or higher. The baseline drug was efonidipine hydrochloride (efonidipine), a long-acting dihydropiridine calcium antagonist. The primary endpoints were stroke, cardiac disease, vascular disease, and renal failure. After a run-in period of 2 to 4 weeks, 2,165 patients were assigned to group A and 2,155 patients to group B. There were no significant differences between the groups in sex, age, baseline BP, or other cardiovascular risk factors. The systolic BP was 7.2 mmHg lower (p<0.0001) and the diastolic BP 2.4 mmHg lower (p<0.0001) in group A than in group B after 12 months of treatment. As of this interim analysis, primary endpoints have occurred in 87 patients (stroke in 58 patients, cardiac disease in 27 patients, occlusive arterial disease in 1 patient, and renal failure in 1 patient). Five patients have died of stroke and 2 patients of myocardial infarction. The primary-endpoint-related morbidity rate was 20.9/1,000 patient-years, and the mortality rate was 1.7/1,000 patient-years. Currently available results indicate that this study, one of the largest randomized trials of antihypertensive therapy in elderly patients in Japan, was conducted safely. The final results are expected to provide important and practical information for the management of hypertension in elderly patients.

AB - The benefits of a systolic blood pressure (BP) below 150-160 mmHg are well established; whether a systolic BP of less than 140 mmHg provides additional benefits remains controversial. This study was designed to compare the 2-year effect of a strict treatment to maintain systolic BP below 140 mmHg (group A) and that of a mild treatment to maintain systolic BP at between 140 and below 160 mmHg (group B). The study design followed the Prospective Randomized Open Blinded, End-point (PROBE) study. The subjects were elderly patients (65-85 years old) who consistently had a systolic BP of 160 mmHg or higher. The baseline drug was efonidipine hydrochloride (efonidipine), a long-acting dihydropiridine calcium antagonist. The primary endpoints were stroke, cardiac disease, vascular disease, and renal failure. After a run-in period of 2 to 4 weeks, 2,165 patients were assigned to group A and 2,155 patients to group B. There were no significant differences between the groups in sex, age, baseline BP, or other cardiovascular risk factors. The systolic BP was 7.2 mmHg lower (p<0.0001) and the diastolic BP 2.4 mmHg lower (p<0.0001) in group A than in group B after 12 months of treatment. As of this interim analysis, primary endpoints have occurred in 87 patients (stroke in 58 patients, cardiac disease in 27 patients, occlusive arterial disease in 1 patient, and renal failure in 1 patient). Five patients have died of stroke and 2 patients of myocardial infarction. The primary-endpoint-related morbidity rate was 20.9/1,000 patient-years, and the mortality rate was 1.7/1,000 patient-years. Currently available results indicate that this study, one of the largest randomized trials of antihypertensive therapy in elderly patients in Japan, was conducted safely. The final results are expected to provide important and practical information for the management of hypertension in elderly patients.

KW - Calcium antagonists

KW - Efonidipine hydrochloride

KW - Essential hypertension

KW - Systolic blood pressure

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The Japanese trial to assess optimal systolic blood pressure in elderly hypertensive patients (JATOS): Protocol, patient characteristics, and blood pressure during the first 12 months

Abstract

Keywords

ASJC Scopus subject areas

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