Case reports - 2 patients benefit from a new multi-modal pharmacological treatment concept

Modern therapeutic approaches for stroke and traumatic brain injury go further than just focusing on patient survival, they also aim for the prospect of a good quality of life even despite poor prognoses.

In a recently published case series Clinical Case Reports by Wiley Publishing, Dr. Trimmel, chief physician at the Wiener Neustadt Regional Hospital, one of the most important TBI treatment center in Austria, reported on two young men who were seriously injured in a motorcycle- and ski accident. Upon admission to hospital, a GCS score of 4 and 3, was found.

This case series focuses on a new multi-modal pharmacological treatment concept: the long-term administration of high-dose Cerebrolysin^®.

SHORT DESCRIPTION OF CASES

The two cases presented young men aged 29 and 30 years, with polytrauma and severe head trauma, who were treated with daily dosages of 50ml Cerebrolysin^® and 3g of citicoline for 21 consecutive days. Treatment started immediately after hospitalization. Despite an unfavorable overall outcome prognosis based on their Injury Severity Scores (ISS) and Revised Trauma Scores (RTS), their recovery was surprisingly encouraging, leading to a GOS score of 6 and 5 and an mRS score of 2 and 4 after one year. Both patients can take care of their activities of daily living more or less independently and have expressed in post-treatment interviews to enjoy their lives while being aware of certain limitations.

RATIONALE FOR TREATMENT CONCEPT

The treatment concept developed by Dr. Trimmel is based on previous experience with the neuroprotective agent citicoline. Despite some treatment signals, findings are in line with the published literature, according to which all RCTs with citicoline as a monomodal treatment approach did not show significant improvements in TBI.

Upon publication of the CAPTAIN II study, which showed a significant superiority of Cerebrolysin^® versus placebo, Prof. Trimmel started to combine both compounds, which led to the impressive results documented in the published case series.

The rational for this approach was that both compounds have neuroprotective properties. By supporting the regeneration of cell membranes, promoting blood-brain barrier integrity, and reducing neuroinflammation, those mediators can be reduced that often lead to the secondary damage after TBI.

CEREBROLYSIN^®– AN ESSENTIAL COMPOUND SUPPORTING THE EFFICACY OF OTHER TREATMENTS

While this is the first publication to describe the synergies of citicoline and Cerebrolysin^®, synergies of Cerebrolysin^® and other standard treatments are already well known from previous clinical trials.

• Alvarez et al. 2011 have shown that Cerebrolysin^® in combination with donepezil improves outcome and responder rates in patients with Alzheimer’s disease.
• In Lang et al. 2013, it was shown that Cerebrolysin^®, when added to thrombolysis treatment with rtPA, accelerates the recovery and improves the NIHSS responder rate, suggesting an increased response to rtPA.
• The CARS study by Muresanu et al. 2016 showed that the combination of Cerebrolysin^® with physiotherapy leads to a highly significant motor recovery.

The treatment effects observed in these combinations furthermore indicate that there is no limitation on the use of Cerebrolysin^® with regard to the type of stroke or the time of the treatment start.

SUMMARY

This case series is consistent with findings from clinical studies, according to which Cerebrolysin^® can enhance the efficacy of therapeutic measures that achieve only limited success as monotherapy. Compounds that failed as monotherapy in clinical trials, such as citicoline, or whose efficacy and responder rates limit the success of treatment, such as rtPA or cholinesterase inhibitors, seem to benefit from the combination with Cerebrolysin^®: Improved chance of survival and improved prognosis for a favorable long-term outcome.

CONCLUSION
For indications that require a multi-modal treatment approach due to the complexity of the clinical manifestation, as in severe stroke or TBI, Cerebrolysin^® is a very potent pharmacological compound to enhance long-term outcome.