LISTEN: LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts

• Sponsor: Listen Trial Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01544309
• Collaborator: (none)
• Enrollment: 1,049
• Locations: 133
• Arms: 2
• Patients Per Site: 7.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia With Concomitant Type 2 Diabetes	Drug: Atorvastatin; Drug: Rosuvastatin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1049 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin administration group	Drug: Atorvastatin; Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.); Other Names: Lipitor
Experimental: Rosuvastatin administration group	Drug: Rosuvastatin; Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.); Other Names: Crestor

Outcome Measures

Primary Outcome Measures

1. Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level [Baseline, and 12 months after administration]

2. Change in HbA1c Level [Baseline, 12 months after administration]

Secondary Outcome Measures

1. Occurrence of Deterioration of Diabetic Treatment Status [Baseline, 12 months after administration]

   "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.

2. Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status [Baseline, 3, 6, 12 months after administration]

   "Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.

3. Percent Change in 1,5-AG Level [Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）]

   An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa

4. Change in HbA1c Level [Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）]

5. Percent Change in Blood Glucose Level (Fasting) [Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）]

6. Change in Blood Glucose Level (Fasting) [Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）]

7. Percent Change in Insulin Level [Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）]

   An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.

8. Change From Baseline in Insulin Level [Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）]

   An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa

9. Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) [From the start of the treatment to the end of study treatment]

10. Frequency of Serious Adverse Events (SAE) [Up to 12 months]

11. Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) [Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment]

12. Percent Change in Non-HDL-C Level [Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment]

13. Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation [Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment]

    Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)

14. Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 [3 months after administration, the end of starting dose and the end of study treatment]

    Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.

15. Change From Baseline in 1,5-AG Level [Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）]

    An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Hypercholesterolemia patients

• Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007"

1. Type 2 diabetes patients

• Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication

• Patients who received constant therapy for three months before registration and have no plan for therapy change

• Patients with kept HbA1c level (Japan Diabetes Society [JDS] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program [NGSP] level of less than 7.4%) within three months before registration

• Patients receiving or not receiving medication at present

1. Patients giving voluntary written consent to participate in the study

2. Male or female patients at 20 years or older

Exclusion Criteria:

1. Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration

2. Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg)

3. Patients with type 1 diabetes

4. Patients judged to have familial hypercholesterolemia

5. Patients with a serum triglyceride level of ≥ 400 mg/dL

6. Patients who had the onset of cardiovascular or cerebrovascular disease within three months

7. Patients with serious heart failure (NYHA classification III - IV)

8. Patients with a history of hypersensitivity to statins

9. Patients with a history of drug-induced myopathy

10. Patients with severe complication of diabetes

11. Patients receiving insulin

12. Patients with serious liver or kidney disease

13. Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan

14. Patients who are or may be pregnant

15. Patients judged by the investigators to be ineligible for participation in the study for any other reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hiramitsu Heart Clinic	Nagoya city	Aichi pref.	Japan
2	Honjo Daiichi Hospital	Yurihonjo city	Akita pref.	Japan
3	Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin	Matsudo city	Chiba pref.	Japan
4	Matsuno Medical Clinic	Iyo gun	Ehime pref.	Japan
5	Ishite Matsumoto Naika Junkanki Clinic	Matsuyama city	Ehime pref.	Japan
6	Ehime Medical CO OP Izumigawa Clinic	Niihama city	Ehime pref.	Japan
7	Fukui Chuoh Clinic	Fukui city	Fukui pref.	Japan
8	Fukuoka City Medical Association Hospital	Fukuoka city	Fukuoka pref.	Japan
9	Matsumoto Clinic	Fukuoka city	Fukuoka pref.	Japan
10	Saku Hospital	Fukuoka city	Fukuoka pref.	Japan
11	Soejima Medical Clinic	Fukuoka city	Fukuoka pref.	Japan
12	Takei's Clinic Internal Medicine	Fukuoka city	Fukuoka pref.	Japan
13	Nakamura Cardiovascular Clinic	Itoshima city	Fukuoka pref.	Japan
14	Morizono Naika	Kitakyushu city	Fukuoka pref.	Japan
15	Seino Internal Medicine Clinic	Koriyama city	Fukushima pref.	Japan
16	Kawade Iin	Gifu city	Gifu pref.	Japan	Japan
17	Hashimoto Naika Clinic	Gifu city	Gifu pref.	Japan
18	Iinuma Iin	Gifu city	Gifu pref.	Japan
19	Ishimura Clinic	Gifu city	Gifu pref.	Japan
20	Kawai Clinic	Gifu city	Gifu pref.	Japan
21	Niimi Clinic	Gifu city	Gifu pref.	Japan
22	Takai Clinic	Gifu city	Gifu pref.	Japan
23	Kobayashi Internal Medicine	Kakamigahara city	Gifu pref.	Japan
24	Horibe Clinic	Motosu city	Gifu pref.	Japan
25	Kondo Cardiovascular Clinic	Ogaki	Gifu pref.	Japan
26	Yoshida Naika	Ogaki	Gifu pref.	Japan
27	Kogure Clinic	Maebashi city	Gunma pref.	Japan
28	Nakano Clinic	Shibukawa city	Gunma pref.	Japan
29	Yoshii Central Clinic	Takasaki city	Gunma pref.	Japan
30	Shigenobu Clinic	Miyoshi city	Hiroshima pref.	Japan
31	Takahashi Kiyohito Clinic	Hakodate city	Hokkaido pref.	Japan
32	Hokuto Internal Medicine Clinic	Sapporo city	Hokkaido pref.	Japan
33	Katsuya Clinic	Amagasaki city	Hyogo pref.	Japan
34	Nakatani Hospital	Himeji city	Hyogo pref.	Japan
35	Kosumo Clinic	Kako gun	Hyogo pref.	Japan
36	Harima Clinic	Kakogawa	Hyogo pref.	Japan
37	Kusunose Clinic	Kobe city	Hyogo pref.	Japan
38	Yanagi Medical Clinic	Hakusan city	Ishikawa pref.	Japan
39	Okyozuka Clinic	Ishikawa gun	Ishikawa pref.	Japan
40	Doniwa Clinic	Kanazawa city	Ishikawa pref.	Japan
41	Wakasa Medical Clinic	Kanazawa city	Ishikawa pref.	Japan
42	Association Medical Corporation Neurology Internal Medicine Kanamori Clinic	Iwate gun	Iwate pref.	Japan
43	Medical Corporation Kuon-kai Kamata Medical Clinic	Morioka city	Iwate pref.	Japan
44	Kagawa Clinic	Marugame city	Kagawa pref.	Japan
45	Hasegawa Outpatients Clinic for Cardiovascular Disease	Takamatsu city	Kagawa pref.	Japan
46	Tempozan Naika Clinic	Kagoshima city	Kagoshima pref.	Japan
47	Kashiwagi Clinic	Ayase city	Kanagawa pref.	Japan
48	Hayashi Diabetes Clinic	Chigasaki city	Kanagawa pref.	Japan
49	Takada Internal Medicine Clinic	Hiratsuka city	Kanagawa pref.	Japan
50	Iroden Clinic	Kamakura city	Kanagawa pref.	Japan
51	Nagasu Clinic	Kamakura city	Kanagawa pref.	Japan
52	Kobayashi Hospital	Odawara city	Kanagawa pref.	Japan
53	Hakuai Iin	Sagamihara city	Kanagawa pref.	Japan
54	Yamamoto Clinic	Sagamihara city	Kanagawa pref.	Japan
55	Arima Clinic	Yokohama city	Kanagawa pref.	Japan
56	Kikuchi Clinic	Yokohama city	Kanagawa pref.	Japan
57	Miho cho Cardiovascular Medical Clinic	Yokohama city	Kanagawa pref.	Japan
58	Minamisawa Clinic	Yokohama city	Kanagawa pref.	Japan
59	Shimokurata Heart Clinic	Yokohama city	Kanagawa pref.	Japan
60	Yokohama Sotetsu Bldg. Clinic of Internal Medicine	Yokohama city	Kanagawa pref.	Japan
61	Jinnouchi Clinic Diabetes Care Center	Kumamoto city	Kumamoto pref.	Japan
62	Maki Cardiovascular Clinic	Kumamoto city	Kumamoto pref.	Japan
63	Munakata Clinic	Kumamoto city	Kumamoto pref.	Japan
64	Terao Hospital	Kumamoto city	Kumamoto pref.	Japan
65	Higashi Diabetes and Cardiovascular Clinic	Tamana city	Kumamoto pref.	Japan
66	Matsuo Clinic	Tamana city	Kumamoto pref.	Japan
67	Miyagi Clinic Cardiovascular Medicine	Yatsushiro city	Kumamoto pref.	Japan
68	Sawai Naika Iin	Kyotanabe city	Kyoto pref.	Japan
69	Asamoto Internal Medical Clinic	Kyoto city	Kyoto pref.	Japan
70	Ijinkai Takeda General Hospital	Kyoto city	Kyoto pref.	Japan
71	Koseikai Clinic	Kyoto city	Kyoto pref.	Japan
72	Sakabe International Clinic	Kyoto city	Kyoto pref.	Japan
73	Takenaka Clinic	Kyoto city	Kyoto pref.	Japan
74	Tegoshi Clinic	Kyoto city	Kyoto pref.	Japan
75	Iwasaki Hospital	Tsu city	Mie pref.	Japan
76	Ishikawa Clinic	Miyazaki city	Miyazaki pref.	Japan
77	Yokota Naika	Miyazaki city	Miyazaki pref.	Japan
78	Etou Clinic	Nichinan city	Miyazaki pref.	Japan
79	Kawano Clinic	Nichinan city	Miyazaki pref.	Japan
80	Yamaguchi Clinic	Nichinan city	Miyazaki pref.	Japan
81	Hasegawa Clinic	Nakano city	Nagano pref.	Japan
82	Nara Prefectural Gojo Hospital	Gojo city	Nara pref.	Japan
83	Fujii Internal Medicine Clinic	Kashihara city	Nara pref.	Japan
84	Matsuoka Clinic	Kita katsuragi gun	Nara pref.	Japan
85	Ote Clinic of Internal	Sakurai city	Nara pref.	Japan
86	Uchiyama Clinic	Joetsu city	Niigata pref.	Japan
87	Inoue Clinic	Niigata city	Niigata pref.	Japan
88	Maeda Medical Clinic	Niigata city	Niigata pref.	Japan
89	Nishimura Clinic	Fujiidera city	Osaka pref.	Japan
90	Shoseikai Matsuda Iin	Fujiidera city	Osaka pref.	Japan
91	Ikeda Clinic	Higashiosaka city	Osaka pref.	Japan
92	Kanazawa Clinic	Izumi city	Osaka pref.	Japan
93	Fukuda Clinic	Osaka city	Osaka pref.	Japan
94	Jikuhara Clinic	Osaka city	Osaka pref.	Japan
95	Kawagishi-naika Clinic	Osaka city	Osaka pref.	Japan
96	Kinugawa Cardiology Clinic	Osaka city	Osaka pref.	Japan
97	Kubota Clinic	Osaka city	Osaka pref.	Japan
98	Masaki Clinic	Osaka city	Osaka pref.	Japan
99	Nanko Clinic	Osaka city	Osaka pref.	Japan
100	Osaka Ekisaikai Hospital	Osaka city	Osaka pref.	Japan
101	Tamatani Clinic	Osaka city	Osaka pref.	Japan
102	Hayashi Clinic	Sakai city	Osaka pref.	Japan
103	Nakao Medical Clinic	Sakai city	Osaka pref.	Japan
104	Saga Memorial Clinic	Saga city	Saga pref.	Japan
105	Enomoto Clinic	Ageo city	Saitama pref.	Japan
106	Asano Internal Medicine Clinic	Kawagoe city	Saitama pref.	Japan
107	Iryohojin Hogi Sinryojyo	Kawaguchi city	Saitama pref.	Japan
108	Tokutake Iin	Kawaguchi city	Saitama pref.	Japan
109	Medical Corporation Shibuya Clinic	Kumagaya city	Saitama pref.	Japan
110	Tanaka Medical Clinic	Saitama city	Saitama pref.	Japan
111	Yoshimura Eye&Internal Medical Clinic	Mishima city	Shizuoka pref.	Japan
112	Shizuoka Municipal Hospital	Shizuoka city	Shizuoka pref.	Japan
113	Takada Clinic	Tochigi city	Tochigi pref.	Japan
114	Murakami Clinic	Anan city	Tokushima pref.	Japan
115	Ota Clinic	Awa city	Tokushima pref.	Japan
116	Arizumi Clinic	Itano gun	Tokushima pref.	Japan
117	Yuki National Health Insurance Hospital of Minami Town	Kaifu gun	Tokushima pref.	Japan
118	Sekishinkan Hospital	Komatsushima city	Tokushima pref.	Japan
119	Iryohojin Tokujikai Tanaka Iin	Myozai gun	Tokushima pref.	Japan
120	Kensei Uchimachi Clinic	Tokushima city	Tokushima pref.	Japan
121	Yata Clinic	Yoshinogawa city	Tokushima pref.	Japan
122	Tokyo Center Clinic	Chuo ku	Tokyo	Japan
123	Okudo Poly Clinic	Katsushika ku	Tokyo	Japan
124	Nakano Sunbright Clinic	Nakano ku	Tokyo	Japan
125	Sugawara Clinic	Nerima ku	Tokyo	Japan
126	Tsurumachi Clinic	Setagaya ku	Tokyo	Japan
127	Oda Clinic	Shinjuku ku	Tokyo	Japan
128	Ishii Clinic	Tachikawa city	Tokyo	Japan
129	Ayame Medical Clinic	Shimonoseki city	Yamaguchi pref.	Japan
130	Matsuda Medical Clinic	Shimonoseki city	Yamaguchi pref.	Japan
131	Mizumachi Medical Clinic	Shimonoseki city	Yamaguchi pref.	Japan
132	Kuroda Iin	Otsuki city	Yamanashi pref.	Japan
133	Yasue Naika	Gifu city		Japan

Sponsors and Collaborators

• Listen Trial Group

Investigators

• Study Chair: Hisao Ogawa, Ph.D, Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Listen Trial Group
• ClinicalTrials.gov Identifier: NCT01544309
• Other Study ID Numbers: 0059
• First Posted: Mar 5, 2012
• Last Update Posted: Mar 17, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia; Atorvastatin; Rosuvastatin Calcium

Study Results

Participant Flow

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)
Period Title: Overall Study
STARTED	524	525
COMPLETED	504	514
NOT COMPLETED	20	11

Baseline Characteristics

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group	Total
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)	Total of all reporting groups
Overall Participants	504	514	1018
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.6 (10.6)	66.3 (11.6)	66.4 (11.1)
Sex/Gender, Customized (participants) [Number]
Male	504 100%	514 100%	1018 100%
Statin administration before entry (participants) [Number]
Administered	120 23.8%	121 23.5%	241 23.7%
Not administered	384 76.2%	393 76.5%	777 76.3%
Cardiovascular and Cerebrovascular events before entry (participants) [Number]
With events	103 20.4%	103 20%	206 20.2%
Without events	401 79.6%	411 80%	812 79.8%
Myocardial infarction (participants) [Number]
With events	7 1.4%	7 1.4%	14 1.4%
Without events	497 98.6%	507 98.6%	1004 98.6%
Angina pectoris (participants) [Number]
With events	31 6.2%	31 6%	62 6.1%
Without events	473 93.8%	483 94%	956 93.9%
Heart failure (participants) [Number]
With events	10 2%	8 1.6%	18 1.8%
Without events	494 98%	506 98.4%	1000 98.2%
Revascularization (participants) [Number]
With events	3 0.6%	9 1.8%	12 1.2%
Without events	501 99.4%	505 98.2%	1006 98.8%
Cardiac arrhythmias (participants) [Number]
With events	31 6.2%	26 5.1%	57 5.6%
Without events	473 93.8%	488 94.9%	961 94.4%
Cerebral haemorrhage (participants) [Number]
With events	3 0.6%	6 1.2%	9 0.9%
Without events	501 99.4%	508 98.8%	1009 99.1%
Cerebral infarction (participants) [Number]
With events	21 4.2%	30 5.8%	51 5%
Without events	483 95.8%	484 94.2%	967 95%
Transient ischaemic attack (participants) [Number]
With events	5 1%	4 0.8%	9 0.9%
Without events	499 99%	510 99.2%	1009 99.1%
Complications related to diabetes (participants) [Number]
With diabetic complications	49 9.7%	67 13%	116 11.4%
Without diabetic complications	455 90.3%	447 87%	902 88.6%
Diabetic retinopathy (participants) [Number]
With diabetic retinopathy	4 0.8%	9 1.8%	13 1.3%
Without diabetic retinopathy	500 99.2%	505 98.2%	1005 98.7%
Diabetic nephropathy (participants) [Number]
With diabetic nephropathy	13 2.6%	21 4.1%	34 3.3%
Without diabetic nephropathy	491 97.4%	493 95.9%	984 96.7%
Diabetic neuropathy (participants) [Number]
With diabetic neuropathy	23 4.6%	23 4.5%	46 4.5%
Without diabetic neuropathy	481 95.4%	491 95.5%	972 95.5%
Diabetic foot (participants) [Number]
With diabetic foot	0 0%	1 0.2%	1 0.1%
Without diabetic foot	504 100%	513 99.8%	1017 99.9%
Hypertension (participants) [Number]
With hypertension	307 60.9%	338 65.8%	645 63.4%
Without hypertension	197 39.1%	176 34.2%	373 36.6%
Non-high-density lipoprotein cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	169.0 (30.6)	168.9 (35.8)	168.9 (33.3)
Low-density lipoprotein cholesterol (LDL-C) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	139.6 (27.9)	139.2 (31.9)	139.4 (30.0)
HDL-C (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	55.8 (14.6)	54.1 (13.6)	54.9 (14.1)
Total cholesterol (TC) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	224.8 (31.8)	223.0 (36.0)	223.9 (34.0)
Triglyceride (TG) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	149.6 (89.1)	154.5 (137.1)	152.1 (115.8)
Non-HDL-C/HDL-C ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	3.25 (1.07)	3.36 (1.31)	3.30 (1.20)
LDL-C/HDL-C ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	2.66 (0.81)	2.73 (0.91)	2.69 (0.86)
Free fatty acids (FFA) (mEq/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mEq/L]	0.585 (0.297)	0.584 (0.299)	0.584 (0.298)
HbA1c (% (NGSP value)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% (NGSP value)]	6.38 (0.59)	6.40 (0.66)	6.39 (0.63)
Blood glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	118.8 (27.0)	119.1 (31.2)	118.9 (29.2)
Insulin (μU/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μU/mL]	10.95 (18.66)	12.57 (20.07)	11.77 (19.39)
1,5-anhydro-D-glucitol (1,5-AG) (μg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μg/mL]	15.40 (7.91)	15.39 (8.10)	15.40 (8.01)

Outcome Measures

1. Primary Outcome

Title	Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
Time Frame	Baseline, and 12 months after administration

Outcome Measure Data

Analysis Population Description

Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	472	468
Mean (Standard Deviation) [Percent change]	-31.3 (19.1)	-32.8 (18.1)

2. Primary Outcome

Title	Change in HbA1c Level
Time Frame	Baseline, 12 months after administration

Outcome Measure Data

Analysis Population Description

Participants in FAS except the ones who had no HbA1c data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	472	468
Mean (Standard Deviation) [Amount of change (%)]	0.120 (0.65)	0.10 (0.67)

3. Secondary Outcome

Title	Occurrence of Deterioration of Diabetic Treatment Status
Description	"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.
Time Frame	Baseline, 12 months after administration

Outcome Measure Data

Analysis Population Description

Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
Therapy intensification	64 12.7%	45 8.8%
Deterioration in HbA1c of > 0.5%	177 35.1%	162 31.5%

4. Secondary Outcome

Title	Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status
Description	"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.
Time Frame	Baseline, 3, 6, 12 months after administration

Outcome Measure Data

Analysis Population Description

Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
Therapy intensification: 0-3 months	20 4%	14 2.7%
Therapy intensification: 3-6 months	12 2.4%	8 1.6%
Therapy intensification: 6-12 months	32 6.3%	23 4.5%
Other: 0-3 months	6 1.2%	5 1%
Other: 3-6 months	5 1%	5 1%
Other: 6-12 months	8 1.6%	6 1.2%
No deterioration	421 83.5%	453 88.1%

5. Secondary Outcome

Title	Percent Change in 1,5-AG Level
Description	An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

Participants in FAS except the ones who had no 1,5-AG data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	-1.6 (30.8)	5.5 (72.6)
At 6 months	-6.5 (35.8)	2.6 (83.7)
At 12 months	-3.8 (35.1)	3.5 (98.0)

6. Secondary Outcome

Title	Change in HbA1c Level
Time Frame	Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

Full analysis set - All participants who received at least 1 dose of open-label study drug.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
At 3 months	0.05 (0.42)	0.00 (0.50)
At 6 months	0.13 (0.57)	0.12 (0.65)

7. Secondary Outcome

Title	Percent Change in Blood Glucose Level (Fasting)
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

Participants in FAS except the ones who had no blood glucose level data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	3.3 (19.3)	2.7 (25.0)
At 6 months	7.0 (24.1)	5.9 (25.7)
At 12 months	4.6 (24.3)	3.7 (26.1)

8. Secondary Outcome

Title	Change in Blood Glucose Level (Fasting)
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	2.6 (24.5)	0.1 (31.2)
At 6 months	6.8 (30.2)	4.3 (31.5)
At 12 months	3.6 (30.7)	1.5 (35.0)

9. Secondary Outcome

Title	Percent Change in Insulin Level
Description	An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

Full analysis set - All participants who received at least 1 dose of open-label study drug

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	40.7 (211.2)	31.3 (166.4)
At 6 months	45.1 (193.9)	35.5 (142.8)
At 12 months	17.4 (132.9)	13.8 (148.1)

10. Secondary Outcome

Title	Change From Baseline in Insulin Level
Description	An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

Full analysis set - All participants who received at least 1 dose of open-label study drug.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	-0.10 (20.26)	-0.54 (18.56)
At 6 months	0.66 (18.63)	-0.44 (19.86)
At 12 months	-1.50 (18.69)	-2.91 (19.02)
Baseline Insulin level	10.95 (18.66)	12.57 (20.07)

11. Secondary Outcome

Title	Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)
Time Frame	From the start of the treatment to the end of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
Number [Number of patients with any events]	5	9

12. Secondary Outcome

Title	Frequency of Serious Adverse Events (SAE)
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	506	516
Number [Number of patients with SAE]	14	19

13. Secondary Outcome

Title	Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)
Time Frame	Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

Outcome Measure Data

Analysis Population Description

Participants in FAS except the ones who had no lipids level data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
LDL-C: at 3 months	-36.6 (19.2)	-39.2 (21.3)
LDL-C: at 6 months	-35.6 (19.4)	-36.4 (21.8)
LDL-C: at 12 months	-33.2 (21.5)	-34.7 (21.0)
HDL-C: at 3 months	4.1 (14.3)	5.6 (13.9)
HDL-C: at 6 months	7.1 (15.1)	8.2 (15.2)
HDL-C: at 12 months	4.9 (14.7)	7.7 (15.9)
TC: at 3 months	-24.7 (13.3)	-25.9 (14.3)
TC: at 6 months	-23.5 (13.0)	-23.8 (14.9)
TC: at 12 months	-22.7 (14.3)	-23.5 (14.0)
TG at 3 months	-12.7 (38.0)	-11.0 (42.2)
TG: at 6 months	-12.4 (45.9)	-11.9 (38.0)
TG: at 12 months	-12.6 (62.2)	-15.9 (35.4)
Non-HDL-C/HDL-C ratio: at 3 months	-34.8 (22.6)	-37.7 (20.2)
Non-HDL-C/HDL-C ratio: at 6 months	-36.1 (19.4)	-37.2 (20.8)
Non-HDL-C/HDL-C ratio: at 12 months	-33.1 (22.7)	-36.0 (20.7)
FFA: at 3 months	19.9 (87.8)	25.9 (111.3)
FFA: at 6 months	13.8 (80.5)	15.9 (88.9)
FFA: at 12 months	37.2 (125.3)	34.8 (111.0)

14. Secondary Outcome

Title	Percent Change in Non-HDL-C Level
Time Frame	Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment

Outcome Measure Data

Analysis Population Description

Participants in FAS except the ones who had no non-HDL-C level data at 12 months.

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	504	514
At 3 months	-33.8 (17.6)	-35.5 (18.4)
At 6 months	-33.2 (16.6)	-33.5 (18.8)

15. Secondary Outcome

Title	Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation
Description	Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)
Time Frame	Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007
Description	Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.
Time Frame	3 months after administration, the end of starting dose and the end of study treatment

Outcome Measure Data

Analysis Population Description

Full analysis set except participants who have reached the target LDL-C level specified at the treatment start

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	383	366
At 3 months	89.0 17.7%	89.9 17.5%
At the end of study treatment	86.3 17.1%	87.5 17%

17. Secondary Outcome

Title	Change From Baseline in 1,5-AG Level
Description	An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa
Time Frame	Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin Administration Group	Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)	Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
Measure Participants	503	514
At 3 months	-0.51 (3.48)	-0.21 (3.77)
At 6 months	-1.28 (4.23)	-0.94 (4.64)
At 12 months	-0.88 (4.33)	-1.09 (4.66)
Baseline 1,5-AG level	15.40 (7.91)	15.39 (8.10)

Adverse Events

Time Frame	At the start of the treatment, 3, 6, and 12 months after administration
Adverse Event Reporting Description	Analyzed: Safety analysis set - all participants who received at least 1 dose of open-label study drug.
Arm/Group Title	Atorvastatin Administration Group		Rosuvastatin Administration Group
Arm/Group Description	Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)		Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)
All Cause Mortality
	Atorvastatin Administration Group		Rosuvastatin Administration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin Administration Group		Rosuvastatin Administration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/506 (2.8%)		19/516 (3.7%)
Cardiac disorders
Cardiac failure	0/506 (0%)		1/516 (0.2%)
Acute myocardial infarction	0/506 (0%)		1/516 (0.2%)
Angina unstable	0/506 (0%)		1/516 (0.2%)
Coronary artery stenosis	0/506 (0%)		1/516 (0.2%)
Ventricular fibrillation	0/506 (0%)		1/516 (0.2%)
Gastrointestinal disorders
Colonic polyp	1/506 (0.2%)		0/516 (0%)
Gastric ulcer	1/506 (0.2%)		0/516 (0%)
Gastrointestinal haemorrhage	0/506 (0%)		1/516 (0.2%)
Inguinal hernia	0/506 (0%)		1/516 (0.2%)
General disorders
Thrombosis in device	0/506 (0%)		1/516 (0.2%)
Hepatobiliary disorders
Cholangitis	0/506 (0%)		1/516 (0.2%)
Infections and infestations
Pneumonia	1/506 (0.2%)	1	2/516 (0.4%)	1
Diverticulitis	0/506 (0%)		1/516 (0.2%)
Nocardiosis	1/506 (0.2%)		0/516 (0%)
Keratitis fungal	1/506 (0.2%)		0/516 (0%)
Injury, poisoning and procedural complications
Clavicle fracture	0/506 (0%)		1/516 (0.2%)
Compression fracture	0/506 (0%)		1/516 (0.2%)
Spinal cord injury	1/506 (0.2%)		0/516 (0%)
Subdural haematoma	1/506 (0.2%)		0/516 (0%)
Brain contusion	1/506 (0.2%)		0/516 (0%)
Meniscus lesion	1/506 (0.2%)		0/516 (0%)
Skull fracture	1/506 (0.2%)		0/516 (0%)
Upper limb fracture	1/506 (0.2%)		0/516 (0%)
In-stent coronary artery restenosis	0/506 (0%)		1/516 (0.2%)
Musculoskeletal and connective tissue disorders
Large intestine carcinoma	1/506 (0.2%)		1/516 (0.2%)
Myalgia	1/506 (0.2%)		0/516 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma	0/506 (0%)		1/516 (0.2%)
Cholesteatoma	0/506 (0%)		1/516 (0.2%)
Chronic myeloid leukaemia	0/506 (0%)		1/516 (0.2%)
Colon cancer	0/506 (0%)		1/516 (0.2%)
Lung neoplasm malignant	1/506 (0.2%)		0/516 (0%)
Metastasis	0/506 (0%)		1/516 (0.2%)
Nervous system disorders
Cerebral infarction	0/506 (0%)		1/516 (0.2%)
Altered state of consciousness	1/506 (0.2%)		0/516 (0%)
Cerebellar infarction	0/506 (0%)		1/516 (0.2%)
Cerebrovascular disorder	1/506 (0.2%)		0/516 (0%)
Psychiatric disorders
Completed suicide	1/506 (0.2%)		0/516 (0%)
Mental disorder	0/506 (0%)		1/516 (0.2%)
Respiratory, thoracic and mediastinal disorders
Emphysema	1/506 (0.2%)		0/516 (0%)
Vascular disorders
Aortic dissection	0/506 (0%)		1/516 (0.2%)
Other (Not Including Serious) Adverse Events
	Atorvastatin Administration Group		Rosuvastatin Administration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/506 (17.2%)		88/516 (17.1%)
Blood and lymphatic system disorders
Anaemia	0/506 (0%)		1/516 (0.2%)
Leukocytosis	0/506 (0%)		1/516 (0.2%)
Cardiac disorders
Cardiac failure	2/506 (0.4%)		1/516 (0.2%)
Palpitations	3/506 (0.6%)		1/516 (0.2%)
Angina pectoris	0/506 (0%)		1/516 (0.2%)
Cardiac failure congestive	0/506 (0%)		1/516 (0.2%)
Extrasystoles	0/506 (0%)		1/516 (0.2%)
Ventricular arrhythmia	0/506 (0%)		1/516 (0.2%)
Ventricular extrasystoles	1/506 (0.2%)		0/516 (0%)
Ear and labyrinth disorders
Tinnitus	0/506 (0%)		2/516 (0.4%)
Ear pain	1/506 (0.2%)		0/516 (0%)
Endocrine disorders
Goitre	0/506 (0%)		1/516 (0.2%)
Hyperthyroidism	1/506 (0.2%)		0/516 (0%)
Eye disorders
Blepharitis	0/506 (0%)		1/516 (0.2%)
Blepharospasm	1/506 (0.2%)		0/516 (0%)
Conjunctivitis	0/506 (0%)		1/516 (0.2%)
Corneal erosion	1/506 (0.2%)		0/516 (0%)
Posterior capsule opacification	0/506 (0%)		1/516 (0.2%)
Retinal detachment	1/506 (0.2%)		0/516 (0%)
Gastrointestinal disorders
Constipation	5/506 (1%)		2/516 (0.4%)
Diarrhoea	2/506 (0.4%)		3/516 (0.6%)
Abdominal discomfort	1/506 (0.2%)		3/516 (0.6%)
Nausea	3/506 (0.6%)		1/516 (0.2%)
Gastritis	2/506 (0.4%)		1/516 (0.2%)
Abdominal pain	0/506 (0%)		2/516 (0.4%)
Abdominal pain upper	1/506 (0.2%)		1/516 (0.2%)
Gastrooesophageal reflux disease	1/506 (0.2%)		1/516 (0.2%)
Aphthous stomatitis	0/506 (0%)		1/516 (0.2%)
Dyspepsia	1/506 (0.2%)		0/516 (0%)
Enterocolitis	1/506 (0.2%)		0/516 (0%)
Gastritis erosive	1/506 (0.2%)		0/516 (0%)
Periodontal disease	0/506 (0%)		1/516 (0.2%)
Proctitis	1/506 (0.2%)		0/516 (0%)
Stomatitis	0/506 (0%)		1/516 (0.2%)
Toothache	0/506 (0%)		1/516 (0.2%)
Vomiting	0/506 (0%)		1/516 (0.2%)
Epigastric discomfort	1/506 (0.2%)		0/516 (0%)
Paraesthesia oral	0/506 (0%)		1/516 (0.2%)
General disorders
Chest discomfort	1/506 (0.2%)		3/516 (0.6%)
Malaise	1/506 (0.2%)		1/516 (0.2%)
Oedema	0/506 (0%)		2/516 (0.4%)
Oedema peripheral	1/506 (0.2%)		1/516 (0.2%)
Chest pain	1/506 (0.2%)		0/516 (0%)
Cyst	0/506 (0%)		1/516 (0.2%)
Face oedema	1/506 (0.2%)		0/516 (0%)
Feeling cold	1/506 (0.2%)		0/516 (0%)
Pain	1/506 (0.2%)		0/516 (0%)
Thirst	0/506 (0%)		1/516 (0.2%)
Hepatobiliary disorders
Hepatic function abnormal	5/506 (1%)		2/516 (0.4%)
Cholangitis	1/506 (0.2%)		0/516 (0%)
Immune system disorders
Seasonal allergy	1/506 (0.2%)		3/516 (0.6%)
Infections and infestations
Nasopharyngitis	13/506 (2.6%)		15/516 (2.9%)
Bronchitis	3/506 (0.6%)		3/516 (0.6%)
Cystitis	1/506 (0.2%)		5/516 (1%)
Pneumonia	0/506 (0%)		2/516 (0.4%)
Influenza	2/506 (0.4%)		2/516 (0.4%)
Pharyngitis	1/506 (0.2%)		2/516 (0.4%)
Rhinitis	0/506 (0%)		2/516 (0.4%)
Oral herpes	1/506 (0.2%)		1/516 (0.2%)
Body tinea	0/506 (0%)		1/516 (0.2%)
Gastroenteritis	0/506 (0%)		1/516 (0.2%)
Gastroenteritis viral	1/506 (0.2%)		0/516 (0%)
Herpes zoster	1/506 (0.2%)		0/516 (0%)
Onychomycosis	0/506 (0%)		1/516 (0.2%)
Pertussis	1/506 (0.2%)		0/516 (0%)
Skin infection	1/506 (0.2%)		0/516 (0%)
Purulence	1/506 (0.2%)		0/516 (0%)
Injury, poisoning and procedural complications
Foot fracture	1/506 (0.2%)		1/516 (0.2%)
Rib fracture	2/506 (0.4%)		0/516 (0%)
Contusion	2/506 (0.4%)		0/516 (0%)
Arthropod sting	0/506 (0%)		1/516 (0.2%)
Hand fracture	1/506 (0.2%)		0/516 (0%)
Periorbital haematoma	1/506 (0.2%)		0/516 (0%)
Rectal polypectomy	0/506 (0%)		1/516 (0.2%)
Investigations
Blood creatine phosphokinase increased	4/506 (0.8%)		5/516 (1%)
Gamma-glutamyltransferase increased	3/506 (0.6%)		1/516 (0.2%)
Alanine aminotransferase increased	2/506 (0.4%)		1/516 (0.2%)
Aspartate aminotransferase increased	2/506 (0.4%)		1/516 (0.2%)
Blood triglycerides increased	3/506 (0.6%)		0/516 (0%)
Blood pressure decreased	1/506 (0.2%)		0/516 (0%)
Blood pressure increased	0/506 (0%)		1/516 (0.2%)
Intraocular pressure increased	0/506 (0%)		1/516 (0.2%)
Lipids increased	0/506 (0%)		1/516 (0.2%)
Metabolism and nutrition disorders
Hypoglycaemia	1/506 (0.2%)		1/516 (0.2%)
Gout	1/506 (0.2%)		0/516 (0%)
Hyperuricaemia	1/506 (0.2%)		0/516 (0%)
Hypocholesterolaemia	0/506 (0%)		1/516 (0.2%)
Musculoskeletal and connective tissue disorders
Back pain	5/506 (1%)		4/516 (0.8%)
Muscle spasms	5/506 (1%)		3/516 (0.6%)
Arthralgia	2/506 (0.4%)		3/516 (0.6%)
Myalgia	2/506 (0.4%)		2/516 (0.4%)
Musculoskeletal pain	0/506 (0%)		2/516 (0.4%)
Osteoarthritis	0/506 (0%)		2/516 (0.4%)
Muscular weakness	0/506 (0%)		1/516 (0.2%)
Neck pain	0/506 (0%)		1/516 (0.2%)
Osteoporosis	0/506 (0%)		1/516 (0.2%)
Pain in extremity	0/506 (0%)		1/516 (0.2%)
Periarthritis	0/506 (0%)		1/516 (0.2%)
Spinal osteoarthritis	0/506 (0%)		1/516 (0.2%)
Intervertebral disc protrusion	0/506 (0%)		1/516 (0.2%)
Limb discomfort	0/506 (0%)		1/516 (0.2%)
Muscle contracture	0/506 (0%)		1/516 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic	0/506 (0%)		1/516 (0.2%)
Nervous system disorders
Dizziness	5/506 (1%)		6/516 (1.2%)
Hypoaesthesia	2/506 (0.4%)		2/516 (0.4%)
Dizziness postural	1/506 (0.2%)		2/516 (0.4%)
Cerebral infarction	0/506 (0%)		1/516 (0.2%)
Cervicobrachial syndrome	2/506 (0.4%)		0/516 (0%)
Headache	1/506 (0.2%)		1/516 (0.2%)
Carotid artery stenosis	1/506 (0.2%)		0/516 (0%)
Dementia	0/506 (0%)		1/516 (0.2%)
Dementia Alzheimer's type	0/506 (0%)		1/516 (0.2%)
Diabetic neuropathy	0/506 (0%)		1/516 (0.2%)
Dizziness exertional	0/506 (0%)		1/516 (0.2%)
Dysgeusia	0/506 (0%)		1/516 (0.2%)
Sciatica	1/506 (0.2%)		0/516 (0%)
Somnolence	0/506 (0%)		1/516 (0.2%)
Transient ischaemic attack	1/506 (0.2%)		0/516 (0%)
Cubital tunnel syndrome	0/506 (0%)		1/516 (0.2%)
Parkinson's disease	1/506 (0.2%)		0/516 (0%)
Psychiatric disorders
Insomnia	3/506 (0.6%)		2/516 (0.4%)
Depression	1/506 (0.2%)		1/516 (0.2%)
Hallucination	1/506 (0.2%)		0/516 (0%)
Illusion	0/506 (0%)		1/516 (0.2%)
Sleep disorder	0/506 (0%)		1/516 (0.2%)
Renal and urinary disorders
Atonic urinary bladder	3/506 (0.6%)		1/516 (0.2%)
Pollakiuria	0/506 (0%)		2/516 (0.4%)
Renal impairment	2/506 (0.4%)		0/516 (0%)
Calculus ureteric	0/506 (0%)		1/516 (0.2%)
Haematuria	1/506 (0.2%)		0/516 (0%)
Nephrotic syndrome	1/506 (0.2%)		0/516 (0%)
Nocturia	1/506 (0.2%)		0/516 (0%)
Proteinuria	1/506 (0.2%)		0/516 (0%)
Reproductive system and breast disorders
Prostatitis	0/506 (0%)		1/516 (0.2%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	4/506 (0.8%)		14/516 (2.7%)
Asthma	1/506 (0.2%)		2/516 (0.4%)
Rhinitis allergic	1/506 (0.2%)		2/516 (0.4%)
Chronic obstructive pulmonary disease	1/506 (0.2%)		0/516 (0%)
Oropharyngeal pain	0/506 (0%)		1/516 (0.2%)
Skin and subcutaneous tissue disorders
Eczema	4/506 (0.8%)		3/516 (0.6%)
Pruritus	2/506 (0.4%)		3/516 (0.6%)
Rash	2/506 (0.4%)		1/516 (0.2%)
Cold sweat	1/506 (0.2%)		1/516 (0.2%)
Dermatitis	0/506 (0%)		1/516 (0.2%)
Dermatitis allergic	1/506 (0.2%)		0/516 (0%)
Hyperkeratosis	1/506 (0.2%)		0/516 (0%)
Urticaria	0/506 (0%)		1/516 (0.2%)
Vascular disorders
Hypertension	2/506 (0.4%)		1/516 (0.2%)
Essential hypertension	0/506 (0%)		1/516 (0.2%)
Hypotension	0/506 (0%)		1/516 (0.2%)
Peripheral arterial occlusive disease	0/506 (0%)		1/516 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.