Pidotimod: a review of its pharmacological features and clinical effectiveness in respiratory tract infections

ABSTRACT

Introduction: The majority of acute respiratory tract infections (RTIs) are caused by viruses and the overzealous use of antibacterial drugs, when not really required, is a cause for concern. This has led to evaluation of alternative approaches such as boosting the immune response in individuals who are most vulnerable to develop RTIs such as the very young and the elderly.

Areas covered: This article overviews the immunostimulant activity and pharmacokinetic properties of pidotimod, and focuses on assessing its role in the treatment and prevention of acute RTIs through evaluation of clinical trials and real-world evidence. Articles were obtained from a full search of Medline, and this was augmented by published clinical studies known to the authors and manufacturer.

Expert opinion: Pidotimod’s activity was shown to be mediated via multiple pathways of the immune system. Comparison with placebo demonstrated significant advantages for pidotimod in terms of reduced reinfection rates [OR 0.20, 95% CI 0.12 to 0.33; p < 0.00001], a lesser need for antibiotics [mean difference −2.65, 95% CI −3.68 to −1.62; p < 0.00001] and rescue medications, and decreased absenteeism [mean difference-2.99, 95% CI −4.03 to −1.95; p < 0.00001]. No safety concerns were raised in these studies.

KEYWORDS:

• Acute respiratory tract infections
• recurrent respiratory tract infections
• immunostimulants
• pidotimod

Article highlights

• The very young (immaturity of the immune system) and the elderly (immunosenescence) are at increased risk from acute and recurrent respiratory tract infections (RTIs).

• The majority of acute RTIs are caused by viruses and the widespread use of antibacterial drugs is both inappropriate and a concern.

• This has led to a review of alternative approaches such as boosting the immune response.

• Pidotimod is a dipeptide which acts via multiple pathways of the immune system.

• The evidence from clinical trials and observational studies with pidotimod in RTIs is generally very positive. Not only does it reduce reinfection rates, the need for antibiotics, and the number and severity of symptoms associated with RTIs, pidotimod also decreased disease burden and improved QoL (days off school/kindergarten/work; use of rescue medications; and consultation time and hospitalization).

• No safety concerns were raised in these studies.

• The consistency of findings across so many clinical trials provides support for the effectiveness of pidotimod in RTIs.

• Pidotimod is therefore a useful management option in children and adults with RTIs.

Acknowledgments

Editorial assistance was provided by Dr Steve Clissold (Content Ed Net, Spain) and Carlos Vila (Almirall, Spain) and was funded by Almirall SA, Barcelona, Spain.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

The manuscript was funded by Almirall SA, Barcelona, Spain.