Background: Inosine pranobex (IsoprinosineÃ?®) is an immunomodulatory drug approved in several countries for\nthe treatment of viral infections. This study compared the efficacy and safety of inosine pranobex versus placebo\nin subjects with clinically diagnosed influenza-like illness, including subjects with laboratory-confirmed acute\nrespiratory viral infections. Subgroup analyses evaluated the efficacy of inosine pranobex compared to placebo\nin otherwise healthy (without related ongoing disease) subjects that were less than 50 years of age and healthy\nsubjects that were at least 50 years of age. The effect of body mass index (BMI) was evaluated in subjects less\nthan 50 years of age.\nMethods: A total of 463 subjects were randomly assigned to receive inosine pranobex (n = 231) or placebo\n(n = 232) in this Phase 4, randomised, double-blind, multicentre study. The primary efficacy endpoint was time to\nresolution of all influenza-like symptoms present at baseline to none. Safety was evaluated through analysis of\nadverse events, vital signs, and physical examinations.\nResults: The difference in time to resolution of all influenza-like symptoms between treatment groups was not\nstatistically significant but showed a faster improvement in subjects in the inosine pranobex group versus those\nin the placebo group - Hazard Ratio = 1.175; (95 % CI: 0.806ââ?¬â??1.714). P-value = 0.324. In the subgroup analysis for\nsubjects less than 50 years of age, statistically significant differences in time to resolution of influenza-like symptoms\nthat favoured the inosine pranobex group over the placebo group were observed in those without related ongoing\ndisease and those who were non-obese (BMI <30 kg/m2). The differences between the inosine pranobex and\nplacebo groups in subjects at least 50 years of age without related ongoing disease and in subjects less than\n50 years of age who were obese (BMI ââ?°Â¥30 kg/m2) were not statistically significant. Inosine pranobex was generally\nwell tolerated, and no deaths were reported.\nConclusions: The study results indicate the safety of inosine pranobex for the treatment of subjects with confirmed\nacute respiratory viral infections and confirm the efficacy of inosine pranobex versus placebo in healthy non-obese\nsubjects less than 50 years of age with clinically diagnosed influenza-like illnesses.
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