“BREAKTHROUGHS IN

MEDICINE”
RESEARCH EVIDENCE-BASED MEDICINE & MEDICAL INFORMATICS
(REBMMI-2)
Rutuja Dilip Gade
20-2-01638
DM 1-2
TITLE OF BREAKTHROUGHS
Inclisiran in Patients at High Cardiovascular Risk
01 with Elevated LDL Cholesterol

Brain–computer interfaces: communication and

02 restoration of movement in paralysis

03 mRNA vaccines — a new era in vaccinology

01
Inclisiran in Patients at
High Cardiovascular
Risk
with Elevated LDL
Cholesterol
 Discovery and Development
● According to this study, inclisiran, a small interfering RNA, can lower low-density
lipoprotein (LDL) cholesterol levels in high-risk patients with higher LDL cholesterol.

● Patients were randomly randomized to receive a single dosage or two doses in the
phase 2 multicenter, double-blind, placebo-controlled, multiple-ascending-dose
experiment.

● The change in LDL cholesterol levels after 180 days was the primary outcome.
 Practical Implications

● The statin drug Inclisiran has shown promise as a treatment for high-risk patients
with higher LDL cholesterol levels.

● The two-dose 300-mg inclisiran regimen reduced LDL cholesterol levels the most,
with 48% of patients having LDL levels less than 50 mg per deciliter.

● More research is needed to evaluate its effects on people of non-European origin.

 Limitations
● One limitation of this paper is that the majority of patients in the trial were of
European descent, so further study is warranted to determine whether inclisiran
has the same effects in persons of non-European ancestry.

● Another limitation is that the trial was of a relatively short duration, and larger
studies are needed to determine the long-term safety and efficacy of inclisiran.

● Additionally, the trial cannot rule out infrequent serious side effects or side effects
that might emerge after a longer period of observation.
02
Brain–computer
interfaces:
communication and
restoration of
movement in paralysis
 Discovery and Development

● The study examines brain-computer interface research, with a particular emphasis

on non-invasive BCIs for communication in paralysis and stroke.

● It demonstrates the disconnect between invasive animal and human BCI

preparations and clinical reality, implying a lack of dependencies between goal-
directed thoughts and intentions.

● Invasive BMIs are suggested in severe cases of stroke and spinal cord paralysis,
according to the report. Brain metabolism and blood flow modulation should be
investigated more in the future.
 Practical Implications

● The research examines the potential of non-invasive brain-computer interfaces

(BCIs) for direct communication in individuals with paralysis and stroke.

● Clinical trials and commercial manufacture of BCIs based on

electroencephalographic potentials or oscillations are underway.

● Brain metabolism, blood flow, and stimulation should be the focus of future
research.
 Limitations
• The paper discusses non-invasive brain-computer interfaces (BCIs) and their
clinical utility in paralysis and motor restoration in stroke.

• It highlights the gap between invasive animal and human BCI preparations and
clinical reality, suggesting a lack of contingencies between goal-directed
thoughts and intentions.

• The paper suggests future directions for BCI research should include regulating
brain metabolism, blood flow, and electrical and magnetic stimulation of the
human brain, but does not provide a detailed roadmap for achieving these
goals.

• Additionally, the paper lacks a detailed analysis of the ethical and social
implications of BCIs.
03
mRNA vaccines — a
new era in vaccinology
 Discovery and Development

● The research investigates the potential of mRNA vaccines as a new vaccine development
strategy, emphasizing the obstacles as well as the necessity for quick development and
large-scale deployment.

● It emphasizes the viability of mRNA vaccines in the fight against cancer and infectious
diseases, and it suggests direct comparisons between mRNA expression platforms for
optimal immunization.
 Practical Implications

● This paper explores the potential of mRNA vaccines in vaccinology, highlighting their
potential to combat cancer and infectious diseases like influenza, Ebola, Zika,
Streptococcus, and T. gondii.

● However, challenges like mRNA instability, high innate immunogenicity, and inefficient
in vivo delivery remain.

● The paper suggests further research to optimize effectiveness, safety and direct
comparisons between mRNA expression platforms.
 Limitations
● The paper does not provide a comprehensive review of all mRNA
vaccine candidates in development, and it does not address the
potential for mRNA vaccines to induce immune tolerance or
autoimmunity.

● Additionally, the paper does not provide a detailed analysis of the

safety and efficacy of mRNA vaccines in clinical trials, and it does
not address the potential for mRNA vaccines to cause adverse
effects, such as inflammation or allergic reactions.

● Finally, the paper does not provide a detailed analysis of the cost-
effectiveness of mRNA vaccines compared to other vaccine
platforms.
 References

● Ray, K. K., Landmasses, U., Leiter, L. A., Kallen, D., Dufour, R., Karakas, M., ...
& Katelin, J. J. (2017). Incisura in patients at high cardiovascular risk with elevated LDL
cholesterol. New England Journal of Medicine, 376(15), 1430-1440.

● Birbaumer, N., & Cohen, L. G. (2007). Brain-computer interfaces: communication

and restoration of movement in paralysis. The Journal of physiology, 579(Pt 3), 621–636.
https://doi.org/10.1113/jphysiol.2006.125633

● Pardi, N., Hogan, M., Porter, F. et al. mRNA vaccines — a new era in
vaccinology. Nat Rev Drug Discov 17, 261–279 (2018).
https://doi.org/10.1038/nrd.2017.243
THANK YOU!