Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel Disease Article Swipe
Joanna M. Wardlaw
,
Lisa J Woodhouse
,
Iris Mhlanga
,
Katherine Oatey
,
Anna K. Heye
,
John Bamford
,
Vera Cvoro
,
Fergus Doubal
,
Timothy J. England
,
Ahamad Hassan
,
Alan Montgomery
,
John T. O’Brien
,
Christine Roffe
,
Nikola Sprigg
,
David J. Werring
,
Philip M. Bath
,
Colin Baigent
,
Gary A. Ford
,
Jonathan Emberson
,
Alison D. Murray
,
A. Ross Naylor
,
Kailash Krishnan
,
Jesse Dawson
,
Chris Patterson
,
German Guzman Gutierrez
,
Stephen Makin
,
Usman Khan
,
L. Sztriha
,
Tom Booth
,
Amanathan Kirthivasan
,
Anwar Ijaz
,
Kirsty Harkness
,
Sevasti Ispoglou
,
Nigel Smyth
,
Aravinth Sivagnanaratnam
,
David Cohen
,
Lakshmanan Sekaran
,
Dinesh Chadha
,
Nasar Ahmad
,
Pratap Rana
,
Malik Azhar Hussain
,
Nic Weir
,
Thomas S. Harrison
,
Salim Elyas
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1001/jamaneurol.2023.1526
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1001/jamaneurol.2023.1526
Importance Cerebral small vessel disease (cSVD) is a common cause of stroke (lacunar stroke), is the most common cause of vascular cognitive impairment, and impairs mobility and mood but has no specific treatment. Objective To test the feasibility, drug tolerability, safety, and effects of 1-year isosorbide mononitrate (ISMN) and cilostazol treatment on vascular, functional, and cognitive outcomes in patients with lacunar stroke. Design, Setting, and Participants The Lacunar Intervention Trial-2 (LACI-2) was an investigator-initiated, open-label, blinded end-point, randomized clinical trial with a 2 × 2 factorial design. The trial aimed to recruit 400 participants from 26 UK hospital stroke centers between February 5, 2018, and May 31, 2021, with 12-month follow-up. Included participants had clinical lacunar ischemic stroke, were independent, were aged older than 30 years, had compatible brain imaging findings, had capacity to consent, and had no contraindications to (or indications for) the study drugs. Data analysis was performed on August 12, 2022. Interventions All patients received guideline stroke prevention treatment and were randomized to ISMN (40-60 mg/d), cilostazol (200 mg/d), ISMN-cilostazol (40-60 and 200 mg/d, respectively), or no study drug. Main Outcomes The primary outcome was recruitment feasibility, including retention at 12 months. Secondary outcomes were safety (death), efficacy (composite of vascular events, dependence, cognition, and death), drug adherence, tolerability, recurrent stroke, dependence, cognitive impairment, quality of life (QOL), and hemorrhage. Results Of the 400 participants planned for this trial, 363 (90.8%) were recruited. Their median age was 64 (IQR, 56.0-72.0) years; 251 (69.1%) were men. The median time between stroke and randomization was 79 (IQR, 27.0-244.0) days. A total of 358 patients (98.6%) were retained in the study at 12 months, with 257 of 272 (94.5%) taking 50% or more of the allocated drug. Compared with those participants not receiving that particular drug, neither ISMN (adjusted hazard ratio [aHR], 0.80 [95% CI, 0.59 to 1.09]; P = .16) nor cilostazol (aHR, 0.77 [95% CI, 0.57 to 1.05]; P = .10) alone reduced the composite outcome in 297 patients. Isosorbide mononitrate reduced recurrent stroke in 353 patients (adjusted odds ratio [aOR], 0.23 [95% CI, 0.07 to 0.74]; P = .01) and cognitive impairment in 308 patients (aOR, 0.55 [95% CI, 0.36 to 0.86]; P = .008). Cilostazol reduced dependence in 320 patients (aHR, 0.31 [95% CI, 0.14 to 0.72]; P = .006). Combination ISMN-cilostazol reduced the composite (aHR, 0.58 [95% CI, 0.36 to 0.92]; P = .02), dependence (aOR, 0.14 [95% CI, 0.03 to 0.59]; P = .008), and any cognitive impairment (aOR, 0.44 [95% CI, 0.23 to 0.85]; P = .02) and improved QOL (adjusted mean difference, 0.10 [95% CI, 0.03 to 0.17]; P = .005) in 153 patients. There were no safety concerns. Conclusions and Relevance These results show that the LACI-2 trial was feasible and ISMN and cilostazol were well tolerated and safe. These agents may reduce recurrent stroke, dependence, and cognitive impairment after lacunar stroke, and they could prevent other adverse outcomes in cSVD. Therefore, both agents should be tested in large phase 3 trials. Trial Registration ClinicalTrials.gov Identifier: NCT03451591
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Metadata
- Type
- article
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- en
- Landing Page
- https://doi.org/10.1001/jamaneurol.2023.1526
- https://jamanetwork.com/journals/jamaneurology/articlepdf/2805321/jamaneurology_wardlaw_2023_oi_230032_1684339623.44286.pdf
- OA Status
- hybrid
- Cited By
- 101
- References
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- Related Works
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- OpenAlex ID
- https://openalex.org/W4377940039
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4377940039Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1001/jamaneurol.2023.1526Digital Object Identifier
- Title
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Isosorbide Mononitrate and Cilostazol Treatment in Patients With Symptomatic Cerebral Small Vessel DiseaseWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-05-24Full publication date if available
- Authors
-
Joanna M. Wardlaw, Lisa J Woodhouse, Iris Mhlanga, Katherine Oatey, Anna K. Heye, John Bamford, Vera Cvoro, Fergus Doubal, Timothy J. England, Ahamad Hassan, Alan Montgomery, John T. O’Brien, Christine Roffe, Nikola Sprigg, David J. Werring, Philip M. Bath, Colin Baigent, Gary A. Ford, Jonathan Emberson, Alison D. Murray, A. Ross Naylor, Kailash Krishnan, Jesse Dawson, Chris Patterson, German Guzman Gutierrez, Stephen Makin, Usman Khan, L. Sztriha, Tom Booth, Amanathan Kirthivasan, Anwar Ijaz, Kirsty Harkness, Sevasti Ispoglou, Nigel Smyth, Aravinth Sivagnanaratnam, David Cohen, Lakshmanan Sekaran, Dinesh Chadha, Nasar Ahmad, Pratap Rana, Malik Azhar Hussain, Nic Weir, Thomas S. Harrison, Salim ElyasList of authors in order
- Landing page
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https://doi.org/10.1001/jamaneurol.2023.1526Publisher landing page
- PDF URL
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https://jamanetwork.com/journals/jamaneurology/articlepdf/2805321/jamaneurology_wardlaw_2023_oi_230032_1684339623.44286.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
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https://jamanetwork.com/journals/jamaneurology/articlepdf/2805321/jamaneurology_wardlaw_2023_oi_230032_1684339623.44286.pdfDirect OA link when available
- Concepts
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Cilostazol, Medicine, Tolerability, Lacunar stroke, Stroke (engine), Randomized controlled trial, Internal medicine, Isosorbide mononitrate, Physical therapy, Adverse effect, Aspirin, Ischemic stroke, Ischemia, Engineering, Mechanical engineeringTop concepts (fields/topics) attached by OpenAlex
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101Total citation count in OpenAlex
- Citations by year (recent)
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2025: 38, 2024: 46, 2023: 17Per-year citation counts (last 5 years)
- References (count)
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30Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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