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The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M, J-STARS collaborato - EBioMedicine (2015)

Bottom Line: No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan.After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

ABSTRACT

Background: Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.

Methods: This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.

Finding: Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.

Interpretation: Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.

Funding: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

No MeSH data available.


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f0005: Trial profile.

Mentions: The 1589 patients were randomly allocated to the pravastatin or control group (Fig. 1). However, due to ineligibility found after randomization or overlapped registration, 4 patients in the pravastatin group and 7 patients in the control group were excluded, resulting in 1578 patients (793 in pravastatin group, 785 in control group) for intention-to-treat analysis. Also, in the pravastatin group, 13 patients (1.6%) did not take pravastatin and 11 patients (1.4%) had no evaluation of primary endpoint. In the control group, 7 patients (0.9%) had no evaluation of primary endpoint. Also, 143 patients (18.0%) in pravastatin group took less than 1/4 of prescribed drug, and 104 patients (13.2%) in control group received certain kinds of statins during the follow-up (Supplementary Table S1). Final follow-up rates were 79.3% in the pravastatin group and 80.4% in the control group.


The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

Hosomi N, Nagai Y, Kohriyama T, Ohtsuki T, Aoki S, Nezu T, Maruyama H, Sunami N, Yokota C, Kitagawa K, Terayama Y, Takagi M, Ibayashi S, Nakamura M, Origasa H, Fukushima M, Mori E, Minematsu K, Uchiyama S, Shinohara Y, Yamaguchi T, Matsumoto M, J-STARS collaborato - EBioMedicine (2015)

Trial profile.
© Copyright Policy - CC BY
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4588424&req=5

f0005: Trial profile.
Mentions: The 1589 patients were randomly allocated to the pravastatin or control group (Fig. 1). However, due to ineligibility found after randomization or overlapped registration, 4 patients in the pravastatin group and 7 patients in the control group were excluded, resulting in 1578 patients (793 in pravastatin group, 785 in control group) for intention-to-treat analysis. Also, in the pravastatin group, 13 patients (1.6%) did not take pravastatin and 11 patients (1.4%) had no evaluation of primary endpoint. In the control group, 7 patients (0.9%) had no evaluation of primary endpoint. Also, 143 patients (18.0%) in pravastatin group took less than 1/4 of prescribed drug, and 104 patients (13.2%) in control group received certain kinds of statins during the follow-up (Supplementary Table S1). Final follow-up rates were 79.3% in the pravastatin group and 80.4% in the control group.

Bottom Line: No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan.After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.

ABSTRACT

Background: Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.

Methods: This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.

Finding: Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.

Interpretation: Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.

Funding: This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

No MeSH data available.


Related in: MedlinePlus