Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study
Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no...
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| Veröffentlicht in: | Diabetes care 2018-06, Vol.41 (6), p.1275-1284 |
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| container_title | Diabetes care |
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| creator | Itoh, Hiroshi Komuro, Issei Takeuchi, Masahiro Akasaka, Takashi Daida, Hiroyuki Egashira, Yoshiki Fujita, Hideo Higaki, Jitsuo Hirata, Ken-Ichi Ishibashi, Shun Isshiki, Takaaki Ito, Sadayoshi Kashiwagi, Atsunori Kato, Satoshi Kitagawa, Kazuo Kitakaze, Masafumi Kitazono, Takanari Kurabayashi, Masahiko Miyauchi, Katsumi Murakami, Tomoaki Murohara, Toyoaki Node, Koichi Ogawa, Susumu Saito, Yoshihiko Seino, Yoshihiko Shigeeda, Takashi Shindo, Shunya Sugawara, Masahiro Sugiyama, Seigo Terauchi, Yasuo Tsutsui, Hiroyuki Ueshima, Kenji Utsunomiya, Kazunori Yamagishi, Masakazu Yamazaki, Tsutomu Yo, Shoei Yokote, Koutaro Yoshida, Kiyoshi Yoshimura, Michihiro Yoshimura, Nagahisa Nakao, Kazuwa Nagai, Ryozo |
| description | Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no history of coronary artery disease (treat-to-target approach).
In this multicenter, prospective, randomized, open-label, blinded end point study, eligible patients were randomly assigned (1:1) to intensive statin therapy targeting LDL cholesterol (LDL-C) |
| doi_str_mv | 10.2337/dc17-2224 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2022982439</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2022982439</sourcerecordid><originalsourceid>FETCH-LOGICAL-c348t-dbec537abadefa1f8ba2fb24ad70476a1bd4294310262866639226f1fd69028b3</originalsourceid><addsrcrecordid>eNpd0c1u1DAQB3ALgei2cOAFkCUu9BDwV5yYW1U-tqgSaFnEMZrEk8ZlEwfbQQpPwuPiVQsHLh5b-mk8oz8hzzh7JaSsXtuOV4UQQj0gG25kWZSlqh-SDePKFKUx4oScxnjLGFOqrh-TE2G00KxSG_L7ako4RfcT6T4gpCL5Yg_hBhP9kiC5ie4HDDCvNF-37mYodi5-px9hhgkj0s_Z4JQi_ebSQLfrjKEb_AFjwpDL6IDCZOlbBy0m19FdPic_QxrWN_kx-5Co7ynQXWZ-dL_Q5o8Xuz4hj3o4RHx6X8_I1_fv9pfb4vrTh6vLi-uik6pOhW2xK2UFLVjsgfd1C6JvhQJbMVVp4K1VwijJmdCi1lpLI4TueW-1YaJu5Rl5edd3Dv7HkuduRhc7PBzyfn6JjWBCmFooaTJ98R-99UuY8nRZGVZqLiuZ1fmd6oKPMWDfzMGNENaGs-YYV3OMqznGle3z-45LO6L9J__mI_8As7qRSg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2090561373</pqid></control><display><type>article</type><title>Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><creator>Itoh, Hiroshi ; Komuro, Issei ; Takeuchi, Masahiro ; Akasaka, Takashi ; Daida, Hiroyuki ; Egashira, Yoshiki ; Fujita, Hideo ; Higaki, Jitsuo ; Hirata, Ken-Ichi ; Ishibashi, Shun ; Isshiki, Takaaki ; Ito, Sadayoshi ; Kashiwagi, Atsunori ; Kato, Satoshi ; Kitagawa, Kazuo ; Kitakaze, Masafumi ; Kitazono, Takanari ; Kurabayashi, Masahiko ; Miyauchi, Katsumi ; Murakami, Tomoaki ; Murohara, Toyoaki ; Node, Koichi ; Ogawa, Susumu ; Saito, Yoshihiko ; Seino, Yoshihiko ; Shigeeda, Takashi ; Shindo, Shunya ; Sugawara, Masahiro ; Sugiyama, Seigo ; Terauchi, Yasuo ; Tsutsui, Hiroyuki ; Ueshima, Kenji ; Utsunomiya, Kazunori ; Yamagishi, Masakazu ; Yamazaki, Tsutomu ; Yo, Shoei ; Yokote, Koutaro ; Yoshida, Kiyoshi ; Yoshimura, Michihiro ; Yoshimura, Nagahisa ; Nakao, Kazuwa ; Nagai, Ryozo</creator><creatorcontrib>Itoh, Hiroshi ; Komuro, Issei ; Takeuchi, Masahiro ; Akasaka, Takashi ; Daida, Hiroyuki ; Egashira, Yoshiki ; Fujita, Hideo ; Higaki, Jitsuo ; Hirata, Ken-Ichi ; Ishibashi, Shun ; Isshiki, Takaaki ; Ito, Sadayoshi ; Kashiwagi, Atsunori ; Kato, Satoshi ; Kitagawa, Kazuo ; Kitakaze, Masafumi ; Kitazono, Takanari ; Kurabayashi, Masahiko ; Miyauchi, Katsumi ; Murakami, Tomoaki ; Murohara, Toyoaki ; Node, Koichi ; Ogawa, Susumu ; Saito, Yoshihiko ; Seino, Yoshihiko ; Shigeeda, Takashi ; Shindo, Shunya ; Sugawara, Masahiro ; Sugiyama, Seigo ; Terauchi, Yasuo ; Tsutsui, Hiroyuki ; Ueshima, Kenji ; Utsunomiya, Kazunori ; Yamagishi, Masakazu ; Yamazaki, Tsutomu ; Yo, Shoei ; Yokote, Koutaro ; Yoshida, Kiyoshi ; Yoshimura, Michihiro ; Yoshimura, Nagahisa ; Nakao, Kazuwa ; Nagai, Ryozo ; EMPATHY Investigators</creatorcontrib><description>Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no history of coronary artery disease (treat-to-target approach).
In this multicenter, prospective, randomized, open-label, blinded end point study, eligible patients were randomly assigned (1:1) to intensive statin therapy targeting LDL cholesterol (LDL-C) <70 mg/dL (
= 2,518) or standard statin therapy targeting LDL-C 100-120 mg/dL (
= 2,524).
Mean follow-up was 37 ± 13 months. LDL-C at 36 months was 76.5 ± 21.6 mg/dL in the intensive group and 104.1 ± 22.1 mg/dL in the standard group (
< 0.001). The primary end point events occurred in 129 intensive group patients and 153 standard group patients (hazard ratio [HR] 0.84 [95% CI 0.67-1.07];
= 0.15). The relationship between the LDL-C difference in the two groups and the event reduction rate was consistent with primary prevention studies in patients with diabetes. Exploratory findings showed significantly fewer cerebral events in the intensive group (HR 0.52 [95% CI 0.31-0.88];
= 0.01). Safety did not differ significantly between the two groups.
We found no significant decrease in CV events or CV-associated deaths with intensive therapy, possibly because our between-group difference of LDL-C was lower than expected (27.7 mg/dL at 36 months of treatment). The potential benefit of achieving LDL-C <70 mg/dL in a treat-to-target strategy in high-risk patients deserves further investigation.</description><identifier>ISSN: 0149-5992</identifier><identifier>EISSN: 1935-5548</identifier><identifier>DOI: 10.2337/dc17-2224</identifier><identifier>PMID: 29626074</identifier><language>eng</language><publisher>United States: American Diabetes Association</publisher><subject>Aged ; Cardiovascular disease ; Cardiovascular diseases ; Cardiovascular Diseases - blood ; Cardiovascular Diseases - epidemiology ; Cholesterol ; Cholesterol, LDL - blood ; Comorbidity ; Complications ; Coronary artery ; Coronary artery disease ; Diabetes ; Diabetes mellitus ; Diabetic retinopathy ; Diabetic Retinopathy - blood ; Diabetic Retinopathy - complications ; Diabetic Retinopathy - epidemiology ; Drug therapy ; Dyslipidemia ; Female ; Health risks ; Heart diseases ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood ; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use ; Hypercholesterolemia ; Hypercholesterolemia - blood ; Hypercholesterolemia - drug therapy ; Hypercholesterolemia - epidemiology ; Incidence ; Japan - epidemiology ; Low density lipoprotein ; Male ; Middle Aged ; Patients ; Prospective Studies ; Randomization ; Research design ; Retinopathy ; Risk ; Risk groups ; Statins ; Therapy</subject><ispartof>Diabetes care, 2018-06, Vol.41 (6), p.1275-1284</ispartof><rights>2018 by the American Diabetes Association.</rights><rights>Copyright American Diabetes Association Jun 1, 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c348t-dbec537abadefa1f8ba2fb24ad70476a1bd4294310262866639226f1fd69028b3</citedby><cites>FETCH-LOGICAL-c348t-dbec537abadefa1f8ba2fb24ad70476a1bd4294310262866639226f1fd69028b3</cites><orcidid>0000-0002-0314-8807 ; 0000-0002-8872-3697 ; 0000-0002-2534-0939 ; 0000-0001-5489-9259 ; 0000-0001-5574-3571 ; 0000-0003-2514-4919</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29626074$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Itoh, Hiroshi</creatorcontrib><creatorcontrib>Komuro, Issei</creatorcontrib><creatorcontrib>Takeuchi, Masahiro</creatorcontrib><creatorcontrib>Akasaka, Takashi</creatorcontrib><creatorcontrib>Daida, Hiroyuki</creatorcontrib><creatorcontrib>Egashira, Yoshiki</creatorcontrib><creatorcontrib>Fujita, Hideo</creatorcontrib><creatorcontrib>Higaki, Jitsuo</creatorcontrib><creatorcontrib>Hirata, Ken-Ichi</creatorcontrib><creatorcontrib>Ishibashi, Shun</creatorcontrib><creatorcontrib>Isshiki, Takaaki</creatorcontrib><creatorcontrib>Ito, Sadayoshi</creatorcontrib><creatorcontrib>Kashiwagi, Atsunori</creatorcontrib><creatorcontrib>Kato, Satoshi</creatorcontrib><creatorcontrib>Kitagawa, Kazuo</creatorcontrib><creatorcontrib>Kitakaze, Masafumi</creatorcontrib><creatorcontrib>Kitazono, Takanari</creatorcontrib><creatorcontrib>Kurabayashi, Masahiko</creatorcontrib><creatorcontrib>Miyauchi, Katsumi</creatorcontrib><creatorcontrib>Murakami, Tomoaki</creatorcontrib><creatorcontrib>Murohara, Toyoaki</creatorcontrib><creatorcontrib>Node, Koichi</creatorcontrib><creatorcontrib>Ogawa, Susumu</creatorcontrib><creatorcontrib>Saito, Yoshihiko</creatorcontrib><creatorcontrib>Seino, Yoshihiko</creatorcontrib><creatorcontrib>Shigeeda, Takashi</creatorcontrib><creatorcontrib>Shindo, Shunya</creatorcontrib><creatorcontrib>Sugawara, Masahiro</creatorcontrib><creatorcontrib>Sugiyama, Seigo</creatorcontrib><creatorcontrib>Terauchi, Yasuo</creatorcontrib><creatorcontrib>Tsutsui, Hiroyuki</creatorcontrib><creatorcontrib>Ueshima, Kenji</creatorcontrib><creatorcontrib>Utsunomiya, Kazunori</creatorcontrib><creatorcontrib>Yamagishi, Masakazu</creatorcontrib><creatorcontrib>Yamazaki, Tsutomu</creatorcontrib><creatorcontrib>Yo, Shoei</creatorcontrib><creatorcontrib>Yokote, Koutaro</creatorcontrib><creatorcontrib>Yoshida, Kiyoshi</creatorcontrib><creatorcontrib>Yoshimura, Michihiro</creatorcontrib><creatorcontrib>Yoshimura, Nagahisa</creatorcontrib><creatorcontrib>Nakao, Kazuwa</creatorcontrib><creatorcontrib>Nagai, Ryozo</creatorcontrib><creatorcontrib>EMPATHY Investigators</creatorcontrib><title>Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study</title><title>Diabetes care</title><addtitle>Diabetes Care</addtitle><description>Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no history of coronary artery disease (treat-to-target approach).
In this multicenter, prospective, randomized, open-label, blinded end point study, eligible patients were randomly assigned (1:1) to intensive statin therapy targeting LDL cholesterol (LDL-C) <70 mg/dL (
= 2,518) or standard statin therapy targeting LDL-C 100-120 mg/dL (
= 2,524).
Mean follow-up was 37 ± 13 months. LDL-C at 36 months was 76.5 ± 21.6 mg/dL in the intensive group and 104.1 ± 22.1 mg/dL in the standard group (
< 0.001). The primary end point events occurred in 129 intensive group patients and 153 standard group patients (hazard ratio [HR] 0.84 [95% CI 0.67-1.07];
= 0.15). The relationship between the LDL-C difference in the two groups and the event reduction rate was consistent with primary prevention studies in patients with diabetes. Exploratory findings showed significantly fewer cerebral events in the intensive group (HR 0.52 [95% CI 0.31-0.88];
= 0.01). Safety did not differ significantly between the two groups.
We found no significant decrease in CV events or CV-associated deaths with intensive therapy, possibly because our between-group difference of LDL-C was lower than expected (27.7 mg/dL at 36 months of treatment). The potential benefit of achieving LDL-C <70 mg/dL in a treat-to-target strategy in high-risk patients deserves further investigation.</description><subject>Aged</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular Diseases - blood</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Cholesterol</subject><subject>Cholesterol, LDL - blood</subject><subject>Comorbidity</subject><subject>Complications</subject><subject>Coronary artery</subject><subject>Coronary artery disease</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetic retinopathy</subject><subject>Diabetic Retinopathy - blood</subject><subject>Diabetic Retinopathy - complications</subject><subject>Diabetic Retinopathy - epidemiology</subject><subject>Drug therapy</subject><subject>Dyslipidemia</subject><subject>Female</subject><subject>Health risks</subject><subject>Heart diseases</subject><subject>Humans</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood</subject><subject>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</subject><subject>Hypercholesterolemia</subject><subject>Hypercholesterolemia - blood</subject><subject>Hypercholesterolemia - drug therapy</subject><subject>Hypercholesterolemia - epidemiology</subject><subject>Incidence</subject><subject>Japan - epidemiology</subject><subject>Low density lipoprotein</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Randomization</subject><subject>Research design</subject><subject>Retinopathy</subject><subject>Risk</subject><subject>Risk groups</subject><subject>Statins</subject><subject>Therapy</subject><issn>0149-5992</issn><issn>1935-5548</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpd0c1u1DAQB3ALgei2cOAFkCUu9BDwV5yYW1U-tqgSaFnEMZrEk8ZlEwfbQQpPwuPiVQsHLh5b-mk8oz8hzzh7JaSsXtuOV4UQQj0gG25kWZSlqh-SDePKFKUx4oScxnjLGFOqrh-TE2G00KxSG_L7ako4RfcT6T4gpCL5Yg_hBhP9kiC5ie4HDDCvNF-37mYodi5-px9hhgkj0s_Z4JQi_ebSQLfrjKEb_AFjwpDL6IDCZOlbBy0m19FdPic_QxrWN_kx-5Co7ynQXWZ-dL_Q5o8Xuz4hj3o4RHx6X8_I1_fv9pfb4vrTh6vLi-uik6pOhW2xK2UFLVjsgfd1C6JvhQJbMVVp4K1VwijJmdCi1lpLI4TueW-1YaJu5Rl5edd3Dv7HkuduRhc7PBzyfn6JjWBCmFooaTJ98R-99UuY8nRZGVZqLiuZ1fmd6oKPMWDfzMGNENaGs-YYV3OMqznGle3z-45LO6L9J__mI_8As7qRSg</recordid><startdate>201806</startdate><enddate>201806</enddate><creator>Itoh, Hiroshi</creator><creator>Komuro, Issei</creator><creator>Takeuchi, Masahiro</creator><creator>Akasaka, Takashi</creator><creator>Daida, Hiroyuki</creator><creator>Egashira, Yoshiki</creator><creator>Fujita, Hideo</creator><creator>Higaki, Jitsuo</creator><creator>Hirata, Ken-Ichi</creator><creator>Ishibashi, Shun</creator><creator>Isshiki, Takaaki</creator><creator>Ito, Sadayoshi</creator><creator>Kashiwagi, Atsunori</creator><creator>Kato, Satoshi</creator><creator>Kitagawa, Kazuo</creator><creator>Kitakaze, Masafumi</creator><creator>Kitazono, Takanari</creator><creator>Kurabayashi, Masahiko</creator><creator>Miyauchi, Katsumi</creator><creator>Murakami, Tomoaki</creator><creator>Murohara, Toyoaki</creator><creator>Node, Koichi</creator><creator>Ogawa, Susumu</creator><creator>Saito, Yoshihiko</creator><creator>Seino, Yoshihiko</creator><creator>Shigeeda, Takashi</creator><creator>Shindo, Shunya</creator><creator>Sugawara, Masahiro</creator><creator>Sugiyama, Seigo</creator><creator>Terauchi, Yasuo</creator><creator>Tsutsui, Hiroyuki</creator><creator>Ueshima, Kenji</creator><creator>Utsunomiya, Kazunori</creator><creator>Yamagishi, Masakazu</creator><creator>Yamazaki, Tsutomu</creator><creator>Yo, Shoei</creator><creator>Yokote, Koutaro</creator><creator>Yoshida, Kiyoshi</creator><creator>Yoshimura, Michihiro</creator><creator>Yoshimura, Nagahisa</creator><creator>Nakao, Kazuwa</creator><creator>Nagai, Ryozo</creator><general>American Diabetes Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0314-8807</orcidid><orcidid>https://orcid.org/0000-0002-8872-3697</orcidid><orcidid>https://orcid.org/0000-0002-2534-0939</orcidid><orcidid>https://orcid.org/0000-0001-5489-9259</orcidid><orcidid>https://orcid.org/0000-0001-5574-3571</orcidid><orcidid>https://orcid.org/0000-0003-2514-4919</orcidid></search><sort><creationdate>201806</creationdate><title>Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study</title><author>Itoh, Hiroshi ; Komuro, Issei ; Takeuchi, Masahiro ; Akasaka, Takashi ; Daida, Hiroyuki ; Egashira, Yoshiki ; Fujita, Hideo ; Higaki, Jitsuo ; Hirata, Ken-Ichi ; Ishibashi, Shun ; Isshiki, Takaaki ; Ito, Sadayoshi ; Kashiwagi, Atsunori ; Kato, Satoshi ; Kitagawa, Kazuo ; Kitakaze, Masafumi ; Kitazono, Takanari ; Kurabayashi, Masahiko ; Miyauchi, Katsumi ; Murakami, Tomoaki ; Murohara, Toyoaki ; Node, Koichi ; Ogawa, Susumu ; Saito, Yoshihiko ; Seino, Yoshihiko ; Shigeeda, Takashi ; Shindo, Shunya ; Sugawara, Masahiro ; Sugiyama, Seigo ; Terauchi, Yasuo ; Tsutsui, Hiroyuki ; Ueshima, Kenji ; Utsunomiya, Kazunori ; Yamagishi, Masakazu ; Yamazaki, Tsutomu ; Yo, Shoei ; Yokote, Koutaro ; Yoshida, Kiyoshi ; Yoshimura, Michihiro ; Yoshimura, Nagahisa ; Nakao, Kazuwa ; Nagai, Ryozo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c348t-dbec537abadefa1f8ba2fb24ad70476a1bd4294310262866639226f1fd69028b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Cardiovascular disease</topic><topic>Cardiovascular diseases</topic><topic>Cardiovascular Diseases - blood</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Cholesterol</topic><topic>Cholesterol, LDL - blood</topic><topic>Comorbidity</topic><topic>Complications</topic><topic>Coronary artery</topic><topic>Coronary artery disease</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetic retinopathy</topic><topic>Diabetic Retinopathy - blood</topic><topic>Diabetic Retinopathy - complications</topic><topic>Diabetic Retinopathy - epidemiology</topic><topic>Drug therapy</topic><topic>Dyslipidemia</topic><topic>Female</topic><topic>Health risks</topic><topic>Heart diseases</topic><topic>Humans</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood</topic><topic>Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use</topic><topic>Hypercholesterolemia</topic><topic>Hypercholesterolemia - blood</topic><topic>Hypercholesterolemia - drug therapy</topic><topic>Hypercholesterolemia - epidemiology</topic><topic>Incidence</topic><topic>Japan - epidemiology</topic><topic>Low density lipoprotein</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Randomization</topic><topic>Research design</topic><topic>Retinopathy</topic><topic>Risk</topic><topic>Risk groups</topic><topic>Statins</topic><topic>Therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Itoh, Hiroshi</creatorcontrib><creatorcontrib>Komuro, Issei</creatorcontrib><creatorcontrib>Takeuchi, Masahiro</creatorcontrib><creatorcontrib>Akasaka, Takashi</creatorcontrib><creatorcontrib>Daida, Hiroyuki</creatorcontrib><creatorcontrib>Egashira, Yoshiki</creatorcontrib><creatorcontrib>Fujita, Hideo</creatorcontrib><creatorcontrib>Higaki, Jitsuo</creatorcontrib><creatorcontrib>Hirata, Ken-Ichi</creatorcontrib><creatorcontrib>Ishibashi, Shun</creatorcontrib><creatorcontrib>Isshiki, Takaaki</creatorcontrib><creatorcontrib>Ito, Sadayoshi</creatorcontrib><creatorcontrib>Kashiwagi, Atsunori</creatorcontrib><creatorcontrib>Kato, Satoshi</creatorcontrib><creatorcontrib>Kitagawa, Kazuo</creatorcontrib><creatorcontrib>Kitakaze, Masafumi</creatorcontrib><creatorcontrib>Kitazono, Takanari</creatorcontrib><creatorcontrib>Kurabayashi, Masahiko</creatorcontrib><creatorcontrib>Miyauchi, Katsumi</creatorcontrib><creatorcontrib>Murakami, Tomoaki</creatorcontrib><creatorcontrib>Murohara, Toyoaki</creatorcontrib><creatorcontrib>Node, Koichi</creatorcontrib><creatorcontrib>Ogawa, Susumu</creatorcontrib><creatorcontrib>Saito, Yoshihiko</creatorcontrib><creatorcontrib>Seino, Yoshihiko</creatorcontrib><creatorcontrib>Shigeeda, Takashi</creatorcontrib><creatorcontrib>Shindo, Shunya</creatorcontrib><creatorcontrib>Sugawara, Masahiro</creatorcontrib><creatorcontrib>Sugiyama, Seigo</creatorcontrib><creatorcontrib>Terauchi, Yasuo</creatorcontrib><creatorcontrib>Tsutsui, Hiroyuki</creatorcontrib><creatorcontrib>Ueshima, Kenji</creatorcontrib><creatorcontrib>Utsunomiya, Kazunori</creatorcontrib><creatorcontrib>Yamagishi, Masakazu</creatorcontrib><creatorcontrib>Yamazaki, Tsutomu</creatorcontrib><creatorcontrib>Yo, Shoei</creatorcontrib><creatorcontrib>Yokote, Koutaro</creatorcontrib><creatorcontrib>Yoshida, Kiyoshi</creatorcontrib><creatorcontrib>Yoshimura, Michihiro</creatorcontrib><creatorcontrib>Yoshimura, Nagahisa</creatorcontrib><creatorcontrib>Nakao, Kazuwa</creatorcontrib><creatorcontrib>Nagai, Ryozo</creatorcontrib><creatorcontrib>EMPATHY Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Diabetes care</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Itoh, Hiroshi</au><au>Komuro, Issei</au><au>Takeuchi, Masahiro</au><au>Akasaka, Takashi</au><au>Daida, Hiroyuki</au><au>Egashira, Yoshiki</au><au>Fujita, Hideo</au><au>Higaki, Jitsuo</au><au>Hirata, Ken-Ichi</au><au>Ishibashi, Shun</au><au>Isshiki, Takaaki</au><au>Ito, Sadayoshi</au><au>Kashiwagi, Atsunori</au><au>Kato, Satoshi</au><au>Kitagawa, Kazuo</au><au>Kitakaze, Masafumi</au><au>Kitazono, Takanari</au><au>Kurabayashi, Masahiko</au><au>Miyauchi, Katsumi</au><au>Murakami, Tomoaki</au><au>Murohara, Toyoaki</au><au>Node, Koichi</au><au>Ogawa, Susumu</au><au>Saito, Yoshihiko</au><au>Seino, Yoshihiko</au><au>Shigeeda, Takashi</au><au>Shindo, Shunya</au><au>Sugawara, Masahiro</au><au>Sugiyama, Seigo</au><au>Terauchi, Yasuo</au><au>Tsutsui, Hiroyuki</au><au>Ueshima, Kenji</au><au>Utsunomiya, Kazunori</au><au>Yamagishi, Masakazu</au><au>Yamazaki, Tsutomu</au><au>Yo, Shoei</au><au>Yokote, Koutaro</au><au>Yoshida, Kiyoshi</au><au>Yoshimura, Michihiro</au><au>Yoshimura, Nagahisa</au><au>Nakao, Kazuwa</au><au>Nagai, Ryozo</au><aucorp>EMPATHY Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study</atitle><jtitle>Diabetes care</jtitle><addtitle>Diabetes Care</addtitle><date>2018-06</date><risdate>2018</risdate><volume>41</volume><issue>6</issue><spage>1275</spage><epage>1284</epage><pages>1275-1284</pages><issn>0149-5992</issn><eissn>1935-5548</eissn><abstract>Diabetes is associated with high risk of cardiovascular (CV) events, particularly in patients with dyslipidemia and diabetic complications. We investigated the incidence of CV events with intensive or standard lipid-lowering therapy in patients with hypercholesterolemia, diabetic retinopathy, and no history of coronary artery disease (treat-to-target approach).
In this multicenter, prospective, randomized, open-label, blinded end point study, eligible patients were randomly assigned (1:1) to intensive statin therapy targeting LDL cholesterol (LDL-C) <70 mg/dL (
= 2,518) or standard statin therapy targeting LDL-C 100-120 mg/dL (
= 2,524).
Mean follow-up was 37 ± 13 months. LDL-C at 36 months was 76.5 ± 21.6 mg/dL in the intensive group and 104.1 ± 22.1 mg/dL in the standard group (
< 0.001). The primary end point events occurred in 129 intensive group patients and 153 standard group patients (hazard ratio [HR] 0.84 [95% CI 0.67-1.07];
= 0.15). The relationship between the LDL-C difference in the two groups and the event reduction rate was consistent with primary prevention studies in patients with diabetes. Exploratory findings showed significantly fewer cerebral events in the intensive group (HR 0.52 [95% CI 0.31-0.88];
= 0.01). Safety did not differ significantly between the two groups.
We found no significant decrease in CV events or CV-associated deaths with intensive therapy, possibly because our between-group difference of LDL-C was lower than expected (27.7 mg/dL at 36 months of treatment). The potential benefit of achieving LDL-C <70 mg/dL in a treat-to-target strategy in high-risk patients deserves further investigation.</abstract><cop>United States</cop><pub>American Diabetes Association</pub><pmid>29626074</pmid><doi>10.2337/dc17-2224</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-0314-8807</orcidid><orcidid>https://orcid.org/0000-0002-8872-3697</orcidid><orcidid>https://orcid.org/0000-0002-2534-0939</orcidid><orcidid>https://orcid.org/0000-0001-5489-9259</orcidid><orcidid>https://orcid.org/0000-0001-5574-3571</orcidid><orcidid>https://orcid.org/0000-0003-2514-4919</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-5992 |
| ispartof | Diabetes care, 2018-06, Vol.41 (6), p.1275-1284 |
| issn | 0149-5992 1935-5548 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2022982439 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals |
| subjects | Aged Cardiovascular disease Cardiovascular diseases Cardiovascular Diseases - blood Cardiovascular Diseases - epidemiology Cholesterol Cholesterol, LDL - blood Comorbidity Complications Coronary artery Coronary artery disease Diabetes Diabetes mellitus Diabetic retinopathy Diabetic Retinopathy - blood Diabetic Retinopathy - complications Diabetic Retinopathy - epidemiology Drug therapy Dyslipidemia Female Health risks Heart diseases Humans Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use Hypercholesterolemia Hypercholesterolemia - blood Hypercholesterolemia - drug therapy Hypercholesterolemia - epidemiology Incidence Japan - epidemiology Low density lipoprotein Male Middle Aged Patients Prospective Studies Randomization Research design Retinopathy Risk Risk groups Statins Therapy |
| title | Intensive Treat-to-Target Statin Therapy in High-Risk Japanese Patients With Hypercholesterolemia and Diabetic Retinopathy: Report of a Randomized Study |
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