Related Experiment Video
Updated: May 24, 2025
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Current usage of inclisiran for cardiovascular diseases: overview of current clinical trials
1Pharmacology and Toxicology Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
Insights
Inclisiran effectively lowers LDL-C and PCSK9 in cardiovascular disease patients. However, more real-world data is needed on long-term cardiovascular outcomes and combination therapy effectiveness.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Cardiovascular diseases represent a global health burden.
- Inclisiran, a small interfering RNA (siRNA), targets PCSK9 to reduce LDL-C.
- The precise role of Inclisiran in managing cardiovascular diseases requires further elucidation.
Purpose of the Study:
- To review the current utilization of Inclisiran in the context of cardiovascular diseases.
- To analyze clinical trial data on Inclisiran's efficacy and safety for cardiovascular conditions.
Main Methods:
- A comprehensive search of Clinicaltrials.gov was performed for studies involving Inclisiran and cardiovascular diseases.
- Data extraction focused on study design, participant numbers, intervention specifics, and outcomes.
- Eleven relevant clinical trials were analyzed.
Main Results:
- Analysis of 11 trials (214,176 participants) showed Inclisiran's favorable safety profile and effective LDL-C and PCSK9 reduction.
- Twice-yearly dosing after a loading dose was a common regimen.
- Most studies primarily assessed LDL-C reduction, with limited focus on direct cardiovascular outcomes.
Conclusions:
- Inclisiran demonstrates significant LDL-C lowering capabilities.
- Limited evidence currently exists regarding its impact on long-term cardiovascular outcomes.
- Further real-world studies are necessary to evaluate long-term safety, adherence, cost-effectiveness, and combination therapy benefits.
Background:
Cardiovascular diseases are predominant health conditions across the world due to their rising prevalence and association with several disorders. Inclisiran, a small interfering RNA (siRNA) therapy, lowers low density lipoproteins cholesterol (LDL-C) by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). Its exact role in cardiovascular diseases is not fully understood.
Aim:
This review examines current usage of Inclisran for cardiovascular diseases.
Method:
A detailed search of Clinicaltrials.gov was conducted to identify relevant studies that investigated heart diseases using Inclisran. Data on study design, sample size, intervention details, and outcomes related to Inclisran were extracted and analyzed.
Results:
As of 30 December 2024, there were 92 clinical trials on involving inclisiran found at clinicaltrials.gov. The investigation focused on studies that used inclisiran for cardiovascular diseases and found that limited clinical trials were identified with limited interventional measures. The final number of analyzed trials was 11. The follow-up duration ranged from 270 to 1,695 days with a total of 214,176 participants with a favorable safety profile and twice-yearly dosing after initial loading dose. The collective findings from these trials demonstrated effective LDL-C and PCSK9 lowering compared to baseline measurements. Most studies focused on LDL-C lowering rather than measuring cardiovascular outcomes.
Conclusion:
Although the studies showed inclisiran to lower LDL-C effectively, the evidence is still limited with regards to cardiovascular outcomes data. There is a need for real world studies addressing long-term safety, adherence and cost-effectiveness and therapeutic outcomes of combination therapy.
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