兩個高劑量statins（司他汀）類藥方對冠狀動脈硬化病程的療效
Effect of Two Intensive Statin Regimens on Progression of Coronary
Disease
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1110874
背景Background：
降低膽固醇的藥物statins（司他汀）類藥物可降低心血管不良結果，並延緩冠狀動脈硬化病程，能降低低密度脂蛋白（LDL）膽固醇的作用。Statins reduce adverse cardiovascular outcomes and slow the progression of coronary atherosclerosis in proportion to their ability to reduce low-density lipoprotein (LDL) cholesterol. 然而，很少有做強化statins（司他汀）類藥物治療研究評估，以達到冠狀動脈硬化病程的消退或以服用最大劑量的statins（司他汀）類藥物的治療做替代方案比較。However, few studies have either assessed the ability of intensive statin treatments to achieve disease regression or compared alternative approaches to maximal statin administration.
方法Methods：
我們對1039例冠狀動脈疾病患者分成2組，每天以atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克)，或每天以rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 做分組治療104週後，進行一系列血管內超音波檢查，We performed serial intravascular ultrasonography in 1039 patients with coronary disease, at baseline and after 104 weeks of treatment with either atorvastatin, 80 mg daily, or rosuvastatin, 40 mg daily, 來比較這兩個高劑量的statins（司他汀）類藥方對冠狀動脈粥樣硬化病程的療效，以及評估其藥物的安全性和副作用。 to compare the effect of these two intensive statin regimens on the progression of coronary atherosclerosis, as well as to assess their safety and side-effect profiles.
結果Results：
分組治療104週後， 每天服用rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 這一組的低密度脂蛋白（LDL）膽固醇比每天服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組還要低（62.6比70.2毫克每分升[1.62 - 1.82每公升毫摩爾]，P <0.001），但高密度脂蛋白（LDL）膽固醇比每天服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組還要高（50.4比48.6毫克每分升1.30與每升1.26毫摩爾]，P = 0.01）。
After 104 weeks of therapy,the rosuvastatin group had lower levels of LDL cholesterol than the atorvastatin group (62.6 vs. 70.2 mg per deciliter [1.62 vs. 1.82 mmol per liter], P<0.001), and higher levels of high-density lipoprotein (HDL) cholesterol (50.4 vs. 48.6 mg per deciliter [1.30 vs. 1.26 mmol per liter], P = 0.01). 主要療效終點，冠狀動脈粥狀瘤體積百分比（PAV）：服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組降低0.99％（95％信賴區間 [CI]，-1.19到-0.63）服用rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 這一組降低1.22％（95％信賴區間 [CI]，-1.52到-0.90）。
The primary efficacy end point, percent atheroma volume (PAV), decreased by 0.99% (95% confidence interval [CI], −1.19 to −0.63) with atorvastatin and by 1.22% (95% CI, −1.52 to −0.90) with rosuvastatin (P = 0.17).
次要療效終點，正常化的總冠狀動脈粥狀瘤體積（TAV），服用rosuvastatin, 40 mg/天組比服用atorvastatin, 80 mg/天組更有療效：−6.39 mm3 (95%信賴區間CI, −7.52 to −5.12), 比較 −4.42 mm3 (95%信賴區間CI, −5.98 to −3.26) (P = 0.01).
The effect on the secondary efficacy end point, normalized total atheroma volume (TAV), was more favorable with rosuvastatin than with atorvastatin: −6.39 mm3 (95% CI, −7.52 to −5.12), as compared with −4.42 mm3 (95% CI, −5.98 to −3.26) (P = 0.01). 這兩組藥物對大多數受試患者冠狀動脈硬化病程消退的療效：服用atorvastatin 組為63.2％和服用rosuvastatin 組為68.5％，冠狀動脈粥狀瘤體積百分比（PAV）：（P = 0.07）分別為64.7％和71.3％，正常化的總冠狀動脈粥狀瘤體積TAV（P = 0.02）。Both agents induced regression in the majority of patients: 63.2% with atorvastatin and 68.5% with rosuvastatin for PAV (P = 0.07) and 64.7% and 71.3%, respectively, for TAV (P = 0.02). 這兩組藥物的副作用都在可接受範圍，其在實驗室發生異常和心血管疾病的發生率均較低。 Both agents had acceptable side-effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events.
結論Conclusions：
最大劑量的rosuvastatin(商品名：CRESTOR冠脂妥膜衣錠40毫克/天)和atorvastatin(商品名：Lipitor立普妥膜衣錠80毫克/天)對冠狀動脈硬化病程消退有顯著的療效。Maximal doses of rosuvastatin and atorvastatin resulted in significant regression of coronary atherosclerosis. 儘管在rosuvastatin組的治療可降低低密度脂蛋白膽固醇濃度和提高高密度脂蛋白膽固醇濃度，觀察2組藥物對冠狀動脈粥狀瘤體積百分比（PAV）的消退有類似程度的療效。 （由AstraZeneca製藥公司的資助研究； ClinicalTrials.gov臨床試驗編號：NCT000620542）Despite the lower level of LDL cholesterol and the higher level of HDL cholesterol achieved with rosuvastatin, a similar degree of regression of PAV was observed in the two treatment groups. (Funded by AstraZeneca Pharmaceuticals; ClinicalTrials.gov number, NCT000620542.)
Effect of Two Intensive Statin Regimens on Progression of Coronary
Diseasehttp://www.nejm.org/doi/pdf/10.1056/NEJMoa1110874
背景Background：
降低膽固醇的藥物statins（司他汀）類藥物可降低心血管不良結果，並延緩冠狀動脈硬化病程，能降低低密度脂蛋白（LDL）膽固醇的作用。Statins reduce adverse cardiovascular outcomes and slow the progression of coronary atherosclerosis in proportion to their ability to reduce low-density lipoprotein (LDL) cholesterol. 然而，很少有做強化statins（司他汀）類藥物治療研究評估，以達到冠狀動脈硬化病程的消退或以服用最大劑量的statins（司他汀）類藥物的治療做替代方案比較。However, few studies have either assessed the ability of intensive statin treatments to achieve disease regression or compared alternative approaches to maximal statin administration.
方法Methods：
我們對1039例冠狀動脈疾病患者分成2組，每天以atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克)，或每天以rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 做分組治療104週後，進行一系列血管內超音波檢查，We performed serial intravascular ultrasonography in 1039 patients with coronary disease, at baseline and after 104 weeks of treatment with either atorvastatin, 80 mg daily, or rosuvastatin, 40 mg daily, 來比較這兩個高劑量的statins（司他汀）類藥方對冠狀動脈粥樣硬化病程的療效，以及評估其藥物的安全性和副作用。 to compare the effect of these two intensive statin regimens on the progression of coronary atherosclerosis, as well as to assess their safety and side-effect profiles.
結果Results：
分組治療104週後， 每天服用rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 這一組的低密度脂蛋白（LDL）膽固醇比每天服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組還要低（62.6比70.2毫克每分升[1.62 - 1.82每公升毫摩爾]，P <0.001），但高密度脂蛋白（LDL）膽固醇比每天服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組還要高（50.4比48.6毫克每分升1.30與每升1.26毫摩爾]，P = 0.01）。
After 104 weeks of therapy,the rosuvastatin group had lower levels of LDL cholesterol than the atorvastatin group (62.6 vs. 70.2 mg per deciliter [1.62 vs. 1.82 mmol per liter], P<0.001), and higher levels of high-density lipoprotein (HDL) cholesterol (50.4 vs. 48.6 mg per deciliter [1.30 vs. 1.26 mmol per liter], P = 0.01). 主要療效終點，冠狀動脈粥狀瘤體積百分比（PAV）：服用atorvastatin, 80 mg(商品名：Lipitor立普妥膜衣錠80毫克) 的一組降低0.99％（95％信賴區間 [CI]，-1.19到-0.63）服用rosuvastatin, 40 mg(商品名：CRESTOR冠脂妥膜衣錠40毫克) 這一組降低1.22％（95％信賴區間 [CI]，-1.52到-0.90）。
The primary efficacy end point, percent atheroma volume (PAV), decreased by 0.99% (95% confidence interval [CI], −1.19 to −0.63) with atorvastatin and by 1.22% (95% CI, −1.52 to −0.90) with rosuvastatin (P = 0.17).
次要療效終點，正常化的總冠狀動脈粥狀瘤體積（TAV），服用rosuvastatin, 40 mg/天組比服用atorvastatin, 80 mg/天組更有療效：−6.39 mm3 (95%信賴區間CI, −7.52 to −5.12), 比較 −4.42 mm3 (95%信賴區間CI, −5.98 to −3.26) (P = 0.01).
The effect on the secondary efficacy end point, normalized total atheroma volume (TAV), was more favorable with rosuvastatin than with atorvastatin: −6.39 mm3 (95% CI, −7.52 to −5.12), as compared with −4.42 mm3 (95% CI, −5.98 to −3.26) (P = 0.01). 這兩組藥物對大多數受試患者冠狀動脈硬化病程消退的療效：服用atorvastatin 組為63.2％和服用rosuvastatin 組為68.5％，冠狀動脈粥狀瘤體積百分比（PAV）：（P = 0.07）分別為64.7％和71.3％，正常化的總冠狀動脈粥狀瘤體積TAV（P = 0.02）。Both agents induced regression in the majority of patients: 63.2% with atorvastatin and 68.5% with rosuvastatin for PAV (P = 0.07) and 64.7% and 71.3%, respectively, for TAV (P = 0.02). 這兩組藥物的副作用都在可接受範圍，其在實驗室發生異常和心血管疾病的發生率均較低。 Both agents had acceptable side-effect profiles, with a low incidence of laboratory abnormalities and cardiovascular events.
結論Conclusions：
最大劑量的rosuvastatin(商品名：CRESTOR冠脂妥膜衣錠40毫克/天)和atorvastatin(商品名：Lipitor立普妥膜衣錠80毫克/天)對冠狀動脈硬化病程消退有顯著的療效。Maximal doses of rosuvastatin and atorvastatin resulted in significant regression of coronary atherosclerosis. 儘管在rosuvastatin組的治療可降低低密度脂蛋白膽固醇濃度和提高高密度脂蛋白膽固醇濃度，觀察2組藥物對冠狀動脈粥狀瘤體積百分比（PAV）的消退有類似程度的療效。 （由AstraZeneca製藥公司的資助研究； ClinicalTrials.gov臨床試驗編號：NCT000620542）Despite the lower level of LDL cholesterol and the higher level of HDL cholesterol achieved with rosuvastatin, a similar degree of regression of PAV was observed in the two treatment groups. (Funded by AstraZeneca Pharmaceuticals; ClinicalTrials.gov number, NCT000620542.)
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