The differences of the effects on lipid-lowering actions

and glucose metabolisms

between Rosuvastatin and Atorvastatin
in Japanese diabetic patients with hyperlipidemia.

- LIpid lowering with highly potent Statins in hyperlipidemia

with Type 2 diabetes patiENts
Hisao Ogawa, Yoshihiko Saito, Hideaki Jinnouchi, Masahiro Sugawara, Seigo Sugiyama,
Izuru. Masuda, Kunihiko Matsui, Hisao Mori, Masako Waki, Hirotaka Watada,
Minoru Yoshiyama on behalf of the LISTEN Study investigators

ESC Congress 2014

August 31, 2014
Barcelona Spain

Conflict of interest disclosure

LISTEN study was funded by the Non-Profit Organization, Hokkaido
Kenkoukagaku Institute and the Investigator Sponsored Study
Program of AstraZeneca K.K.

Hisao Ogawa, MD, PhD has received research supports or honoraria

or both from Astellas Pharma Inc., AstraZeneca K.K., Bayer Yakuhin,
Ltd., Boehringer Ingelheim Japan, Inc., Bristol-Myers Squibb
Company, Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo Company,
Limited, Dainippon Sumitomo Pharma Co., Ltd., Kowa Company, Ltd.,
MSD K.K., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd.,
Pfizer Japan Inc., Sanofi K.K., and Takeda Pharmaceutical Company
Limited.

Study design
Target population
1. Type 2 diabetes
2. HbA1c 7.4%
3. Hyper-LDLcholesterolemia

Randomized

Rosuvastatin 5 mg/day as starting dose (n=500)

(LDL-C 120 mg/dL

without ASCVD
[atherosclerotic
cardiovascular disease],
100 mg/dL with ASCVD)

Atorvastatin 10 mg/day as starting dose (n=500)

4. 20 years of age

Informed consent
/eligibility

Primary endpoints

0M

3M

6M

Multicenter, open-label, randomized, parallel-group study

: Percent Change in non-HDL-C level

Change of HbA1c level
Number of study sites : 132 sites in Japan

12M

Lipid parameters
Non-HDL-C

Percent change (%)

-30

Overall: P = 0.0922
P = 0.0475

P = 0.5374

P = 0.0780
113.6

-30
109.6
-35

111.0

111.3

110.2

LDL-C
Overall: P = 0.0399

90.6

87.7

85.9

-35

88.1
85.8
-40

Value (mg/dL)

82.0

Value (mg/dL)

106.8
-40

Rosuvastatin

Percent change (%)

-25

Atorvastatin

P = 0.0106

P = 0.3205

P = 0.0896

-45

12 (months)

No. of
participants

0 month

3 months

6 months

12 months

Atorvastatin

504

494

482

472

Rosuvastatin

514

493

485

468

12 (months)

Glucose metabolism parameters

Atorvastatin
Rosuvastatin

Blood glucose

HbA1c
P = 0.1661
Change (%)

15.0

Overall: P = 0.0846

0.2

0.1

P = 0.6695

P = 0.0104
6.52

6.50

6.44
6.50

0.0

Overall: P = 0.0683

P = 0.1492
Change (mg/dL)

0.3

10.0

122.8

121.4

5.0

122.9
120.1

118.8

Value(%)

6.40

126.0

0.0

6.44

P = 0.1882

P = 0.1259

Value(mg/dL)

-5.0

-0.1
6

12 (months)

12 (months)

No. of
participants

0
month

3
months

6
months

12
months

No. of
participants

0
month

3
months

6
months

12
months

Atorvastatin

504

494

482

472

Atorvastatin

503

493

481

471

Rosuvastatin

514

493

485

468

Rosuvastatin

514

492

485

468

The cumulative incidence of diabetes

treatment intensification
Intensification of diabetes treatment (%)

20

Hazard ratio: 1.46 (95%CI, 1.00-2.14)

P = 0.05
15

10

0
No. at Risk
Atorvastatin
Rosuvastatin

504
514

471
480

451
466

12 (months)
182
190

Conclusions
Rosuvastatin did not reduce non-HDL-C
compared with Atorvastatin, but overall did
reduce LDL-C significantly.
The intensification of diabetic treatments was
significantly less frequent in the Rosuvastatin
group than in the Atorvastatin group.
Further prospective studies are required to
confirm the differences in the effects on diabetes
among statins.