Efficacy and safety of idebenone tablets in patients with post-stroke cognitive impairment: a real-world study

With your 5 lost years of brain cognition due to your stroke,

 will your doctor guarantee this will recover all that? Why not?

 Efficacy and safety of idebenone tablets in patients with post-stroke cognitive impairment: a real-world study

Yanqi Shao¹Xinyu Zhao²Zunchun Xie³You Xie⁴Shunyuan Guo^1*

• ¹Department of Neurology, Zhejiang Provincial People’s Hospital, Hangzhou, China
• ²Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
• ³Department of Neurology, The First Affiliated Hospital of Nanchang University, Nanchang, China
• ⁴Department of Neurology, Xiangxi Tujia and Miao Autonomous Prefecture People’s Hospital, Jishou, China

Objective: To evaluate the efficacy, safety, and adherence of idebenone tablets in improving cognitive function among patients with post-stroke cognitive impairment in a real-world setting.

Methods: This single-arm, multicenter, real-world observational study enrolled 3,755 patients with post-stroke cognitive impairment from 342 hospitals across China between January 2020 and December 2024. Patients received idebenone (30 mg three times daily) for 3 months. Cognitive function was assessed using MoCA and MMSE at baseline and months 1, 2, and 3. Treatment effectiveness was categorized as markedly effective (≥80% improvement), effective (30–79% improvement), or ineffective (<30% improvement).

Results: Of the 3,755 patients (mean age 60.7 ± 10.4 years; 58.5% male), 61.8% had hypertension and 48.4% had ischemic stroke. The total effectiveness rate increased progressively from 10.9–13.0% at month 1 to 37.4–38.2% at month 3 for both MoCA and MMSE scores (p < 0.001). MoCA scores improved from 14.6 ± 5.1 at baseline to 17.6 ± 6.2 at month 3, while MMSE scores increased from 14.2 ± 4.6 to 17.5 ± 6.2. High medication adherence (≥80%) was achieved by 96.9% of patients. Only mild adverse events were reported in less than 2% of patients, with no severe adverse events documented.

Conclusion: This real-world study suggests that three-month idebenone therapy provides meaningful improvements in cognitive function among patients with post-stroke cognitive impairment, with excellent safety and adherence profiles. However, the observational, single-arm design without a control group means that observed improvements cannot be definitively attributed to the intervention alone. Further randomized controlled trials are warranted to confirm these findings and optimize treatment protocols.

What is the Risk of Poststroke Epilepsy?

 You're that incompetent and out-of-date, not reading previous research? Which is why we need a complete database of all stroke research and rehab protocols so survivors can train their medical staff in what needs to be done to recover.

Wasted research dollars that should have used to prevent post-stroke epilepsy

• 10% seizures post stroke (19 posts to April 2017)

• 5% epileptic seizures after stroke (10 posts to April 2021)

• epileptic seizures (6 posts to December 2015)

• post-stroke epilepsy (9 posts to December 2016)

The latest here:

What is the Risk of Poststroke Epilepsy?

• Bastien Rioux , MD, MSc , @B_Rioux
• 
  

Ebbesen MQB, Dreier JW, Andersen G, Johnsen SP, Christensen J. Stroke and Risk of Epilepsy: A Danish Nationwide Register-Based Study. Stroke. 2024.

Stroke is a major cause of new-onset epilepsy in adults,¹ especially in people aged 60 years and older.² Published estimates of poststroke epilepsy risk, however, are heterogeneous, likely reflecting variable stroke and epilepsy classification accuracies in population-based cohorts, variable follow-up duration and attrition rates, and different statistical methods used to derive risk estimates. For example, crude incidences obtained from Kaplan-Meier estimates of the survival function tend to inflate risks in the presence of competing events such as death.³ This study, therefore, aimed to determine the short- and long-term risk of poststroke epilepsy while accounting for death as a competing risk.

The authors defined a population-based cohort from Danish nationwide registries. Strokes occurring between 2004-2018 were identified from the Danish Stroke Registry, which captures all acute strokes treated in hospital departments, whereas strokes occurring before 2004 and epilepsy cases were identified from the Danish National Patient Register, which contains International Classification of Diseases (ICD) codes from inpatient hospital discharge diagnoses (since 1977) and diagnoses from outpatient and emergency department visits (since 1995). The stroke group was defined from individuals who experienced a first-ever stroke between April 2004 and December 2018, without prior epilepsy. Individuals in the stroke group were matched with up to 10 reference people without prior epilepsy or stroke (i.e., the control group) on age, sex, and calendar time. Poststroke epilepsy was defined from ICD codes for epilepsy recorded at least 14 days after stroke to distinguish it from early seizures. The authors included 101,034 people in the stroke group and 1,010,333 people in the control group.

At two years, the cumulative incidence of epilepsy reached 3.5% (95% confidence interval [CI]: 3.4, 3.7%) in the stroke group vs 0.2% (95% CI: 0.1, 0.2%) in the control group, which at 10 years increased to 5.8% (95% CI: 5.6, 5.9%) in the stroke group vs 0.7% (95% CI: 0.7, 0.7%) in the control group. Poststroke epilepsy risk was higher in people with intracerebral haemorrhage as compared to those with ischemic stroke (12.5% [95% CI: 11.7, 13.2%] vs 5.1% [95% CI: 4.9, 5.3%] at 10 years). Poststroke epilepsy risk also increased with higher stroke severity and cortical involvement. Seizures within 14 days of stroke occurred in 0.6% of people with ischemic stroke and 2.2% of people with intracerebral haemorrhage, and early seizures increased the risk of poststroke epilepsy. As expected, risk estimates were higher when derived from the Kaplan-Meier estimates as compared to cumulative incidence functions that accounted for competing death risk.

This study is interesting and relevant to clinicians and researchers in stroke medicine for two main reasons. First, the authors report results which elegantly replicate prior studies that suggested not all strokes are equal when it comes to seizure risk. The first externally validated prognostic model of late (>7 days) seizures after ischemic stroke (the SeLECT score) was published in 2018⁴ and included five clinical predictors: stroke severity, cortical involvement, early seizures, large artery atherosclerotic aetiology, and territory of middle cerebral artery involvement. In this study, the overall 5-year risk of late seizure after stroke was 8% (95% CI: 6, 9%), while people with the highest SeLECT score had a markedly high predicted 5-year risk of 83% (95% CI: 62, 93%). Both studies confirm that achieving accurate stratification of poststroke epilepsy risk is feasible.

Second, this study reports precise and reasonably accurate estimates of poststroke epilepsy risk in the general Danish population using a large prospective cohort. Producing valid estimates of poststroke epilepsy risk is a first step towards understanding the natural history of the disease, which can then be used for clinical decisions (e.g., offering closer follow-up), public health advocacy (e.g., campaigning for better resources to support people with poststroke epilepsy), research advocacy (e.g., influencing resources invested in poststroke epilepsy research), and future research questions (e.g., sample size calculation for clinical trials of interventions to prevent poststroke epilepsy). These estimates, however, may not be generalizable and need replication in other populations which might be subject to differences in factors known to influence poststroke epilepsy risk, like access to acute stroke care and stroke etiology.

Beyond stratifying and estimating risk, the optimal clinical management of people with higher poststroke epilepsy risk remains unclear. How can poststroke epilepsy risk stratification be designed and implemented? What could be the effect on routine care and patient-reported outcomes? Should stroke survivors undergo routine assessments (e.g., electroencephalogram) or monitoring (e.g., actigraphy)? Can patients with higher risk be included in trials of interventions to prevent epilepsy onset (e.g., the registered trial Exploring the Preventive Effect of Mitochondrial Protective Agent  on Post-stroke Epilepsy; clinicaltrials.gov ID: NCT05987397)? These are only a few of the persisting knowledge gaps that still need to be addressed in poststroke epilepsy research.