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Erschienen in: Heart and Vessels 5/2015

01.09.2015 | Original Article

Impact of combined lipid lowering with blood pressure control on coronary plaque regression: rationale and design of MILLION study

verfasst von: Masa-aki Kawashiri, Kenji Sakata, Tadatsugu Gamou, Honin Kanaya, Kenji Miwa, Kosei Ueda, Toshinori Higashikata, Sumio Mizuno, Ichiro Michishita, Masanobu Namura, Yutaka Nitta, Shoji Katsuda, Kazuyasu Okeie, Hiroaki Hirase, Hayato Tada, Katsuharu Uchiyama, Tetsuo Konno, Kenshi Hayashi, Hidekazu Ino, Keisuke Nagase, Mitsuyasu Terashima, Masakazu Yamagishi

Erschienen in: Heart and Vessels | Ausgabe 5/2015

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Abstract

A line of epidemiological studies suggests that the accumulation of coronary risk factors promotes the progression of coronary atherosclerosis. Recent clinical studies showed that aggressive low-density lipoprotein (LDL) cholesterol-lowering therapy using statins could regress coronary atheroma and reduce major cardiovascular events. Additionally, therapy that controlled amlodipine-based blood pressure reduced major cardiovascular events in patients with hypertension compared with an atenolol-based regimen. An open-label randomized multicenter study is primarily planned to evaluate the changes in coronary atheroma volume using intravascular ultrasonography 18–24 months after intensive lowering of LDL-cholesterol and blood pressure compared with a standard therapy indicated by current guidelines in Japanese patients with coronary artery disease (CAD). The secondary endpoints include changes in serum lipid levels, inflammatory markers, glucose markers and blood pressure. In total, 100 subjects with CAD who are undergoing percutaneous coronary intervention will be tested. The MILLION study will provide new evidence and therapeutic standards for the prevention of CAD in Japanese patients by controlling both LDL-C levels and blood pressure.
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Literatur
1.
Zurück zum Zitat Kannel WB, McGee D, Gordon T (1976) A general cardiovascular risk profile: the Framingham Study. Am J Cardiol 38:46–51CrossRefPubMed Kannel WB, McGee D, Gordon T (1976) A general cardiovascular risk profile: the Framingham Study. Am J Cardiol 38:46–51CrossRefPubMed
2.
Zurück zum Zitat The multiple risk factor intervention trial (MRFIT) (1976) A national study of primary prevention of coronary heart disease. JAMA 235:825–827CrossRef The multiple risk factor intervention trial (MRFIT) (1976) A national study of primary prevention of coronary heart disease. JAMA 235:825–827CrossRef
3.
Zurück zum Zitat Nozue T, Yamamoto S, Tohyama S, Fukui K, Umezawa S, Onishi Y, Kunishima T, Sato A, Nozato T, Miyake S, Takeyama Y, Morino Y, Yamauchi T, Muramatsu T, Hirano T, Hibi K, Terashima M, Michishita I (2013) Impacts of age on coronary atherosclerosis and vascular response to statin therapy. Heart Vessels. doi:10.1007/s00380-013-0387-1 Nozue T, Yamamoto S, Tohyama S, Fukui K, Umezawa S, Onishi Y, Kunishima T, Sato A, Nozato T, Miyake S, Takeyama Y, Morino Y, Yamauchi T, Muramatsu T, Hirano T, Hibi K, Terashima M, Michishita I (2013) Impacts of age on coronary atherosclerosis and vascular response to statin therapy. Heart Vessels. doi:10.​1007/​s00380-013-0387-1
4.
Zurück zum Zitat Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E, Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators (2005) C-reactive protein levels and outcomes after statin therapy. N Engl J Med 352:20–28CrossRefPubMed Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E, Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators (2005) C-reactive protein levels and outcomes after statin therapy. N Engl J Med 352:20–28CrossRefPubMed
5.
Zurück zum Zitat LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK, Treating to New Targets (TNT) Investigators (2005) Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 352:1425–1435CrossRefPubMed LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK, Treating to New Targets (TNT) Investigators (2005) Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 352:1425–1435CrossRefPubMed
6.
Zurück zum Zitat Dahlöf B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O’Brien E, Ostergren J, ASCOT Investigators (2005) Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 366:895–906CrossRefPubMed Dahlöf B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O’Brien E, Ostergren J, ASCOT Investigators (2005) Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 366:895–906CrossRefPubMed
7.
Zurück zum Zitat Nissen SE, Tuzcu EM, Libby P, Thompson PD, Ghali M, Garza D, Berman L, Shi H, Buebendorf E, Topol EJ, CAMELOT Investigators (2004) Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA 292:2217–2225CrossRefPubMed Nissen SE, Tuzcu EM, Libby P, Thompson PD, Ghali M, Garza D, Berman L, Shi H, Buebendorf E, Topol EJ, CAMELOT Investigators (2004) Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA 292:2217–2225CrossRefPubMed
8.
Zurück zum Zitat Kohro T, Yamazaki T, Izumi T, Daida H, Kurabayashi M, Miyauchi K, Tojo T, Nagai R, JCADII Investigators (2011) Intensively lowering both low-density lipoprotein cholesterol and blood pressure does not reduce cardiovascular risk in Japanese coronary artery disease patients. Circ J 75:2062–2070CrossRefPubMed Kohro T, Yamazaki T, Izumi T, Daida H, Kurabayashi M, Miyauchi K, Tojo T, Nagai R, JCADII Investigators (2011) Intensively lowering both low-density lipoprotein cholesterol and blood pressure does not reduce cardiovascular risk in Japanese coronary artery disease patients. Circ J 75:2062–2070CrossRefPubMed
9.
Zurück zum Zitat Nissen SE, Tuzcu EM, Schoenhagen P, Brown BG, Ganz P, Vogel RA, Crowe T, Howard G, Cooper CJ, Brodie B, Grines CL, DeMaria AN, REVERSAL Investigators (2004) Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 291:1071–1080CrossRefPubMed Nissen SE, Tuzcu EM, Schoenhagen P, Brown BG, Ganz P, Vogel RA, Crowe T, Howard G, Cooper CJ, Brodie B, Grines CL, DeMaria AN, REVERSAL Investigators (2004) Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 291:1071–1080CrossRefPubMed
10.
Zurück zum Zitat Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM, ASTEROID Investigators (2006) Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 295:1556–1565CrossRefPubMed Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM, ASTEROID Investigators (2006) Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA 295:1556–1565CrossRefPubMed
11.
Zurück zum Zitat Okazaki S, Yokoyama T, Miyauchi K, Shimada K, Kurata T, Sato H, Daida H (2004) Early statin treatment in patients with acute coronary syndrome: demonstration of the beneficial effect on atherosclerotic lesions by serial volumetric intravascular ultrasound analysis during half a year after coronary event: the ESTABLISH Study. Circulation 110:1061–1068CrossRefPubMed Okazaki S, Yokoyama T, Miyauchi K, Shimada K, Kurata T, Sato H, Daida H (2004) Early statin treatment in patients with acute coronary syndrome: demonstration of the beneficial effect on atherosclerotic lesions by serial volumetric intravascular ultrasound analysis during half a year after coronary event: the ESTABLISH Study. Circulation 110:1061–1068CrossRefPubMed
12.
Zurück zum Zitat Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M, JAPAN-ACS Investigators (2009) Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol 54:293–302CrossRefPubMed Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M, JAPAN-ACS Investigators (2009) Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol 54:293–302CrossRefPubMed
13.
Zurück zum Zitat Takayama T, Hiro T, Yamagishi M, Daida H, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M, COSMOS Investigators (2009) Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J 73:2110–2117CrossRefPubMed Takayama T, Hiro T, Yamagishi M, Daida H, Hirayama A, Saito S, Yamaguchi T, Matsuzaki M, COSMOS Investigators (2009) Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Circ J 73:2110–2117CrossRefPubMed
14.
Zurück zum Zitat Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, Egusa G, Hiro T, Hirobe K, Iida M, Kihara S, Kinoshita M, Maruyama C, Ohta T, Okamura T, Yamashita S, Yokode M, Yokote K (2012) Executive summary of the Japan Atherosclerosis Society (JAS) guideline for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan—2012 version. J Atheroscler Thromb 20:517–523CrossRef Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, Egusa G, Hiro T, Hirobe K, Iida M, Kihara S, Kinoshita M, Maruyama C, Ohta T, Okamura T, Yamashita S, Yokode M, Yokote K (2012) Executive summary of the Japan Atherosclerosis Society (JAS) guideline for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan—2012 version. J Atheroscler Thromb 20:517–523CrossRef
15.
Zurück zum Zitat Ogihara T, Kikuchi K, Matsuoka H, Fujita T, Higaki J, Horiuchi M, Imai Y, Imaizumi T, Ito S, Iwao H, Kario K, Kawano Y, Kim-Mitsuyama S, Kimura G, Matsubara H, Matsuura H, Naruse M, Saito I, Shimada K, Shimamoto K, Suzuki H, Takishita S, Tanahashi N, Tsuchihashi T, Uchiyama M, Ueda S, Ueshima H, Umemura S, Ishimitsu T, Rakugi H, Japanese Society of Hypertension Committee (2009) The Japanese Society of Hypertension Guidelines for the management of hypertension (JSH 2009). Hypertens Res 32:3–107CrossRefPubMed Ogihara T, Kikuchi K, Matsuoka H, Fujita T, Higaki J, Horiuchi M, Imai Y, Imaizumi T, Ito S, Iwao H, Kario K, Kawano Y, Kim-Mitsuyama S, Kimura G, Matsubara H, Matsuura H, Naruse M, Saito I, Shimada K, Shimamoto K, Suzuki H, Takishita S, Tanahashi N, Tsuchihashi T, Uchiyama M, Ueda S, Ueshima H, Umemura S, Ishimitsu T, Rakugi H, Japanese Society of Hypertension Committee (2009) The Japanese Society of Hypertension Guidelines for the management of hypertension (JSH 2009). Hypertens Res 32:3–107CrossRefPubMed
16.
Zurück zum Zitat Ge CJ, Lu SZ, Chen YD, Wu XF, Hu SJ, Ji Y (2008) Synergistic effect of amlodipine and atorvastatin on blood pressure, left ventricular remodeling, and C-reactive protein in hypertensive patients with primary hypercholesterolemia. Heart Vessels 23:91–95CrossRefPubMed Ge CJ, Lu SZ, Chen YD, Wu XF, Hu SJ, Ji Y (2008) Synergistic effect of amlodipine and atorvastatin on blood pressure, left ventricular remodeling, and C-reactive protein in hypertensive patients with primary hypercholesterolemia. Heart Vessels 23:91–95CrossRefPubMed
17.
Zurück zum Zitat Nakajima K, Saito T, Tamura A, Suzuki M, Nakano T, Adachi M, Tanaka A, Tada N, Nakamura H, Campos E (1993) Cholesterol in remnant-like lipoproteins in human serum using monoclonal anti apo B-100 and anti apo A-I immunoaffinity mixed gels. Clin Chim Acta 223:53–71CrossRefPubMed Nakajima K, Saito T, Tamura A, Suzuki M, Nakano T, Adachi M, Tanaka A, Tada N, Nakamura H, Campos E (1993) Cholesterol in remnant-like lipoproteins in human serum using monoclonal anti apo B-100 and anti apo A-I immunoaffinity mixed gels. Clin Chim Acta 223:53–71CrossRefPubMed
18.
Zurück zum Zitat Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H (2011) Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J 75:1071–1079CrossRefPubMed Kojima T, Miyauchi K, Yokoyama T, Yokoyama K, Kurata T, Suwa S, Kawamura M, Tamura H, Okazaki S, Inoue K, Fujiwara Y, Sumiyoshi M, Tanimoto K, Nakazato Y, Yamagami S, Hiro T, Komiyama N, Daida H (2011) Azelnidipine and amlodipine anti-coronary atherosclerosis trial in hypertensive patients undergoing coronary intervention by serial volumetric intravascular ultrasound analysis in Juntendo University (ALPS-J). Circ J 75:1071–1079CrossRefPubMed
Metadaten
Titel
Impact of combined lipid lowering with blood pressure control on coronary plaque regression: rationale and design of MILLION study
verfasst von
Masa-aki Kawashiri
Kenji Sakata
Tadatsugu Gamou
Honin Kanaya
Kenji Miwa
Kosei Ueda
Toshinori Higashikata
Sumio Mizuno
Ichiro Michishita
Masanobu Namura
Yutaka Nitta
Shoji Katsuda
Kazuyasu Okeie
Hiroaki Hirase
Hayato Tada
Katsuharu Uchiyama
Tetsuo Konno
Kenshi Hayashi
Hidekazu Ino
Keisuke Nagase
Mitsuyasu Terashima
Masakazu Yamagishi
Publikationsdatum
01.09.2015
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 5/2015
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-014-0522-7

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