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Background <p>There is limited information about the pleiotropic effects of statin on cerebrovascular diseases. The authors aimed to investigate the effect of pravastatin on non-hemorrhagic vertebral artery dissection (VAD) in a clinical setting.</p> Methods <p>An exploratory randomized and controlled study was designed for the non-hemorrhage VAD (CRIS, KCT00035970). Primary outcomes were 1- and 6-month radiologic changes on vessel wall magnetic resonance imaging (VW-MRI), with secondary outcomes related to the clinical and laboratory parameters, and safety outcomes of the pravastatin use.</p> Results <p>Finally, 23 patients were enrolled, consisting of 12 in the pravastatin group and 11 in the control with similar baseline characteristics except the age (55.0 versus 45.5 years, <i>P</i> = .01). Morphologic changes in the early period (0–1 month) were more improved or resolved in the pravastatin group with a borderline significance (crude odds ratio: 7.500 [95% confidence interval: 0.921-64.047], <i>P</i> = .06). However, age-adjusted analysis showed no difference in morphologic changes between the groups (adjusted odds ratio: 0.853 [95% confidence interval: 0.033-22.020], <i>P</i> = .92). The serum level of high-sensitivity C-reactive protein (hs-CRP) in the pravastatin group showed a descending tendency in the early period (Z-score: -1.843, <i>P</i> = .07), whereas it significantly increased in the control (Z-score: -2.371, <i>P</i> = .02). There were no safety issues at all.</p> Conclusion <p>Pravastatin had a borderline significant effect on the recovery of non-hemorrhage VAD with no additional adverse effects. A further study with a larger scale is expected to make more concrete evidences about the pleiotropic effects of statin on the non-hemorrhagic VAD.</p> Trial registration <p>The present study registered in a clinical research information service approved by World Health Organization (CRIS, KCT00035970, Registered on 7 March 2019; available at: <a href="https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25234%26status=5%26seq_group=12949%26search_page=M">https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25234%26status=5%26seq_group=12949%26search_page=M</a>).</p>

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Preliminary results of pravastatin on non-hemorrhagic vertebral artery dissection: an exploratory randomized and controlled study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月3日

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  • Hyun Jin Han,
  • Keun Young Park,
  • Chang Ki Jang,
  • Joonho Chung,
  • Yong Bae Kim,
  • Sung Ho Lee,
  • Kangmin Kim,
  • Hyun-Seung Kang,
  • Jeong Eun Kim,
  • Won-Sang Cho

摘要

Background

There is limited information about the pleiotropic effects of statin on cerebrovascular diseases. The authors aimed to investigate the effect of pravastatin on non-hemorrhagic vertebral artery dissection (VAD) in a clinical setting.

Methods

An exploratory randomized and controlled study was designed for the non-hemorrhage VAD (CRIS, KCT00035970). Primary outcomes were 1- and 6-month radiologic changes on vessel wall magnetic resonance imaging (VW-MRI), with secondary outcomes related to the clinical and laboratory parameters, and safety outcomes of the pravastatin use.

Results

Finally, 23 patients were enrolled, consisting of 12 in the pravastatin group and 11 in the control with similar baseline characteristics except the age (55.0 versus 45.5 years, P = .01). Morphologic changes in the early period (0–1 month) were more improved or resolved in the pravastatin group with a borderline significance (crude odds ratio: 7.500 [95% confidence interval: 0.921-64.047], P = .06). However, age-adjusted analysis showed no difference in morphologic changes between the groups (adjusted odds ratio: 0.853 [95% confidence interval: 0.033-22.020], P = .92). The serum level of high-sensitivity C-reactive protein (hs-CRP) in the pravastatin group showed a descending tendency in the early period (Z-score: -1.843, P = .07), whereas it significantly increased in the control (Z-score: -2.371, P = .02). There were no safety issues at all.

Conclusion

Pravastatin had a borderline significant effect on the recovery of non-hemorrhage VAD with no additional adverse effects. A further study with a larger scale is expected to make more concrete evidences about the pleiotropic effects of statin on the non-hemorrhagic VAD.

Trial registration

The present study registered in a clinical research information service approved by World Health Organization (CRIS, KCT00035970, Registered on 7 March 2019; available at: https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25234%26status=5%26seq_group=12949%26search_page=M).