Literature Reviews Demonstrate Real-World Drug Safety

Literature Reviews for Real World Evidence Generation

Literature Reviews Demonstrate Real-World Drug Safety

There is increasing demand from payers to gather evidence on the safety of medications used in the general population post-commercialization. Conducting a literature review involving critical appraisal is essential to better understand the research topic and assess the validity of the research findings. A literature review entitled “Long-acting bronchodilators (LABs) and risk of adverse cardiovascular events in chronic obstructive pulmonary disease (COPD): a focused critical review” was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting in June.

The targeted literature review was conducted in PubMed in order to identify all original published research reporting adverse cardiovascular events in patients with COPD taking LABs from clinical trials and observational studies. All identified research abstracts were reviewed for:

  • Study objectives
  • Study population
  • Study design
  • Treatments
  • Sample size and follow-up duration
  • Reported cardiovascular events
  • Main methodological concerns

The search returned 131 citations, of which 15 reported results from original research and were reviewed in detail. Among them, seven studies (47%) were clinical trials and eight (53%) were observational studies. The most frequently reported cardiovascular events included arrhythmias, stroke, angina, myocardial infarction, and cardiovascular death. While none of the clinical trials showed a statistically significant association between the use of LABs and increased risk of cardiovascular events, five observational studies did.

The study concludes that the main limitations to clinical trials were short follow-up duration and exclusion of patients with previous histories of cardiovascular events, while observational studies may be limited to methodological flaws such as immeasurable time bias, protopathic (reverse-causality) bias, and confounded by disease severity. This literature study helped us identify the gap in existing literature and refine our future study methodology in conducting an observational nested case-control study to evaluate the association between use of LABs and risk of cardiovascular events.

Contact us to discuss how literature review studies and other real-world evidence solutions can be leveraged for your product.