NEARMEDIC Presents Results of Kagocel Unique Post-Authorization Trial

2016-11-02 13:34

At the 3d Sochi Scientific and Practical Conference "Socially significant and particularly dangerous infectious diseases", the NEARMEDIC company presented the results of a unique post-authorization study of the drug Kagocel in the framework of the international project "Treatment of SARS and influenza in routine clinical practice".

The unique project was launched In November 2013, and was conducted jointly by NEARMEDIC and the International Society of Internal Medicine in cooperation with the Eurasian Society of Infectionists and the First Moscow State Medical University (1st MSMU) n. a. I. M. Sechenov. The data obtained in the study is unprecedented in its scope. The project involved 262 medical centers from Russia, Moldova, Armenia, and Georgia, and over 18,000 patients aged between 18 and 93 years with proven cases of SARS and influenza. The team of researchers included primary care specialists, physicians, family doctors and general practitioners.

Non-intervention trials are programs that provide for the collection of data on the course of diseases, the efficacy and safety of therapy regimens and specific medications in routine practice, without interfering with the treatment process, with the drug prescribed in the usual way, according to instructions. This approach made it possible to obtain objective data important for the understanding of the peculiarities of influenza and other SARS. The doctors were able to conduct an independent analysis of the dynamics of treatment with Kagocel and assess the safety profile of the drug.

Kagocel, as part of the influenza and SARS complex therapy, had demonstrated its efficiency in patients of different age groups and varying severity of the disease regardless of the time of prescription, including delayed treatment, and a high level of security. In the course of therapy with the drug, rapid relief of all the symptoms of SARS (fever, weakness, pain in muscles and joints, rhinitis, sore throat, cough, scleritis or conjunctivitis, headache, fever) had been noted. The use of Kagocel had a proven result of a 51 percent reduction in the number of complications among patients who received systemic antibacterial drugs.

Invited to participate in the project were experts from the 1st MSMU n. a. I. M. Sechenov, who partly took up statistical data processing and their clinical interpretation. The study received five approvals by ethics committees, including the Freiburg Ethics Commission International. "The project was not a clinical study and was carried out at the company's initiative exclusively. It is not only about the collection of data on the efficiency and safety of treatment with our drug. This is an opportunity to obtain objective data that is important for understanding the peculiarities of influenza and other acute respiratory viral infections in routine clinical practice," stressed the NEARMEDIC Corporate Development Director Roman Bolgarin.