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Treatment Drug Therapy Journal of Atherosclerosis and Thrombosis Vol.15, No.4 167 Committee Report 8 Treatment─Drug Therapy Tamio Teramoto, Jun Sasaki, Hirotsugu Ueshima, Genshi Egusa, Makoto Kinoshita, Kazuaki Shimamoto, Hiroyuki Daida, Sadatoshi Biro, Kazuhiko Hirobe, Tohru Funahashi, Koutaro Yokote, and Masayuki Yokode Committee for Epidemiology and Clinical Management of Atherosclerosis J Atheroscler Thromb, 2008; 15:167-178. The basis of treatment either for primary or sec- menopausal female, they may be treated with lifestyle ondary prevention is through the modification of life- modification alone, even if target management lipid style such as correction of dietary habits, increase in levels are not attained. Drug therapy should be con- physical activities, maintenance of an appropriate body sidered only if management targets cannot be attained weight, and smoking cessation. Concerning primary even after the continuation of guidance aimed to prevention, in particular, it is necessary to perform improve lifestyle for 3-6 months depending on the treatments by accurately evaluating risk factors of ath- level of risk. erosclerosis and stratifying patients according to their On the basis of the results of many overseas risk. For this purpase, it is important to evaluate not large-scale clinical trials using statins, the effectiveness only the presence or absence of coronary artery disease of lipid-lowering therapy targeted to dyslipidemia, par- (CAD) and the LDL-C level, but also other coexisting ticularly high-LDL-cholesterolemia, for the primary2-7) major risk factors, i.e., atherosclerotic disorders other and secondary8-14) prevention of CAD has been dem- than CAD such as cerebrovascular diseases and arte- onstrated (Table 1). In HPS (partially including riosclerosis obliterans, and to perform risk stratifica- secondary prevention)4, 15), ASCOT-LLA6), CARDS7), tion and lipid management based on the guideline. and other studies, LDL-C-lowering therapy using However, for secondary prevention, stringent inter- statins showed significant preventive effects against vention is always required, and the necessity of drug stroke as well as CAD in high-risk groups. These trials therapy is greater than for primary prevention. have also demonstrated that lipid lowering therapy were equally effective regardless of age, gender, and the presence or absence of diabetes or hypertention. 1. Primary Prevention In Japan (Table 2), KLIS16) in males with hyer- 1) LDL-C Lowering cholesterolemia and PATE17) in elderly subjects (par- The relationship between the LDL-C level and tially including secondary prevention) were reported relative risk of CAD is similar among Japan and West- as studies using pravastatin for primary prevention. ern countries, but there was controversy regarding the While these studies suggested the effectiveness of LDL- effectiveness of LDL-C-lowering therapy for the pre- C-lowering therapy for primary prevention, problems vention, particularly primary prevention, of CAD in such as the inadequate randomization for KLIS and Japanese population, because their absolute risk was the insufficient size of the cohort for PATE have been lower than those in Western populations. However, raised. As mentioned earlier, MEGA1), a large-scale MEGA (Management of Elevated Cholesterol in the study on primary prevention, was also reported in Primary Prevention Group of Adult Japanese)1), a Japan, showing a 33% decrease in CAD though an large-scale clinical trial conducted in Japan, confirmed 18% reduction in the LDL-C level. In this study, 68% the significance of LDL-C-reducing therapy using of the subjects were female, but no significant gender statin for primary prevention in Japanese, as men- difference was noted in any endpoint concerning the tioned below. However, drug therapy for primary pre- therapeutic effect, and the statin treatment was con- vention should not be performed without adequate firmed to be effective in females as well as males. In risk evaluation. Drug therapy for LDL-C lowering addition, the data during the first 5 years indicated should be performed in those at high risk. Because the significant decreases in stroke morbidity and total mor- risk is low particularly in young patients and pre- tality rates. 168 Teramoto et al. Treatment ─ Drug Therapy 169 Table 1. Representative foreign large-scale clinical studies using statins Dose Number of subjects Mean age Females Diabetics History of myocardial Duration Study name Drug used (mg/day) (treated group/control group) (years) (%) (%) infarction (%) (years) WOSCOPS Pravastatin 40 3,302/3,293 55 0 1 0 4.9 AFCAPS/TexCAPS Lovastatin 20-40 3,304/3,301 58 15 2 0 5.2 ALLHAT-LLT Pravastatin 40 5,170/5,185 66 49 35 0 4.8 ASCOT-LLA Atorvastatin 10 5,168/5,137 63 19 25 0 3.3 CARDS Atorvastatin 10 1,428/1,410 61 32 100 0 3.9 HPS Simvastatin 40 10,269/10,267 (40-80) 25 29 41 5 PROSPER Pravastatin 40 2,891/2,913 75 52 11 13 3.2 4S Simvastatin 20-40 2,221/2,223 59 19 5 79 5.4 CARE Pravastatin 40 2,081/20,78 59 14 14 100 5 LIPID Pravastatin 40 4,512/4,502 62 17 9 64 6.1 CCLA 45,054/45,002 24 21 32 4.7 Table 2. Representative large-scale clinical studies in Japan Dose Number of subjects Mean age Females Diabetics History of myocardial Duration Study name Drug used (mg/day) (treated group/control group) (years) (%) (%) infarction (%) (years) KLIS Pravastatin 10-20 2,219/1,634 58 0 23 0 5 PATE Pravastatin 10-20 331/334＊ 73 79 30 3 3.9 MEGA Pravastatin 10-20 3,966/3,866 58 68 21 0 5.3 JELIS Ethyl icosapentate 1,800 9,326/9,319 61 68 16 20 4.6 ＊: A low-dose group at 5 mg/day Table 3. Representative foreign large-scale clinical studies using fibrates Dose Number of subjects Mean age Females Diabetics History of myocardial Duration Study name Drug used (mg/day) (treated group/control group) (years) (%) (%) infarction (%) (years) Helsinki Heart study Gemfibrozil 1,200 2,051/2,030 47 0 2.6 0 5 FIELD Fenofibrate 200 4,895/4,900 62 37 100 5 5 VA-HIT Gemfibrozil 1,200 1,264/1,267 64 0 24 61 5.1 BIP Bezafibrate 400 1,548/1,542 60 9 10 79 6.2 LDL-C-lowering therapy using statins has also of cerebral infarction in hyperlipidemic patients, was been suggested to have a primary preventive effect initiated in 2004 and is currently in progress. The Jap- against stroke similar to that against CAD15, 18-24). anese guidelines for the treatment of stroke27) recom- SPARCL25), intended to evaluate the preventive effect mend the administration of statins for the prevention of atorvastatin against stroke recurrence in patients of cerebral infarction in patients with CAD. with no history of CAD. It was shown to be effective for the prevention of cerebral infarction. However, 2) Treatment of Dyslipidemia other than High increase in cerebral hemorrhage indicated by the same LDL-C study warrants further evaluation in the future. Large-scale clinical studies trials in patients with In Japan, also, J-STARS26), aimed to evaluate the hypertriglyceridemia and low HDL-cholesterol not preventive effect of pravastatin against the recurrence accompanied by high LDL-cholesterolemia have not 168 Teramoto et al. Treatment ─ Drug Therapy 169 NS: not significant, NA: not available TC (mg/dL) LDL-C (mg/dL) Relative risk of CVD (% reduction) Year of Before After treatment Before After treatment Major cardiovascular Stroke Cardiovascular Total publication treatment (% decrease) treatment (% decrease) events (lethal/non-lethal) deaths deaths 272 218 (－20) 192 142 (－26) －32 NS －32 －22 1995 221 184 (－17) 150 115 (－25) －37 NA －32 NS 1998 224 184 (－17) 146 105 (－28) NS NS NS NS 2002 213 163 (－24) 131 90 (－31) －36 －27 NS NS 2003 207 159 (－23) 118 82 (－31) －37 －48 NA NS 2004 226 NA 130 89 (－32) －27 －25 －17 －13 2002 220 NA 147 98 (－33) －19 NS NS NS 2002 261 196 (－25) 188 123 (－35) －34 －30 －42 －30 1994 209 167 (－20) 139 97 (－32) －24 －31 NS NS 1996 218 179 (－18) 150 112 (－25) －24 －19 －34 －22 1998 －23 －17 －19 －12 2005 NS: not significant, NA: not available TC (mg/dL) LDL-C (mg/dL) Relative risk of CVD (% reduction) Year of Before After treatment Before After treatment Major cardiovascular Stroke Cardiovascular Total publication treatment (% decrease) treatment (% decrease) events (lethal/non-lethal) deaths deaths 254 215 (－15) 169 132 (－22) NS NS NS NS 2000 253 209 (－16) 166 125 (－25) NS NA NA NS 2001 243 215 (－12) 157 128 (－18) －33 NS NS NS 2005 275 182 －19 NS －24 NS 2005 NS: not significant, NA: not available TC (mg/dL) LDL-C (mg/dL) Relative risk of CVD (% reduction) Year of Before After treatment Before After treatment Major cardiovascular Stroke Cardiovascular Total publication treatment (% decrease) treatment (% decrease) events (lethal/non-lethal) deaths deaths 270 247 (－9) 189 173 (－9) －34 NA NS NS 1987 195 164 (－15) 119 94 (－21) NS NS NS NS 2005 175 170 (－4) 111 111 (0) －22 －29 NS NS 1999 212 202 (－5) 148 139 (－7) NS NS NS NS 2000 provided evidence as reliable as that supporting LDL- CAD, but it was effective for the prevention of non- C-lowering therapy (Table 3)28-32). As for fibrates, fatal cardiovascular events. which most effectively reduce the TG level as well as In JELIS35), performed in Japan to evaluate the increase the HDL-C level, the Helsinki Heart Study 83) effect of ethyl icosapentate (EPA), in which the sub- showed that Gemfibrozil (not approved in Japan) was jects were patients with high LDL-cholesterol (14,981 effective for the primary prevention of cardiovascu- primary prevention and 3,664 secondary prevention lar events.
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