Vascular Safety of Ranibizumab in Patients With Diabetic Macular Edema Interview with:

Marco A Zarbin, MD, PhD, FACS
Alfonse Cinotti, MD/Lions Eye Research
Professor and Chair
Institute of Ophthalmology & Visual Science
Rutgers-New Jersey Medical School
Rutgers University Newark, NJ 0710 What is the background for this study? What are the main findings?

  1. Most large, randomized clinical trials are powered to assess the efficacy of drugs or interventions, but they usually do not enroll enough patients to accurately assess the frequency of uncommon, undesirable side effects.
  2. In order to compensate for this deficiency in trial design, investigators aggregate the results of numerous studies all of which address the same clinical question with the same (or similar) drugs/interventions to increase the power to detect uncommon side effects. These aggregate studies can be meta-analyses.
  3. Unfortunately, most meta-analyses do not have the ability to answer some critical questions such as the timing of an adverse event relative to the last exposure to the drug, nor can they compensate fully for differences among the aggregated studies in trial design, length of patient follow-up, or presence pre-existing risk factors for the side effects in question.
  4. A pooled analysis of combined clinical trials using patient level data, however, allows a more in depth analysis of side effects than study level data, which are usually used for most published meta-analyses, because patient level data allow one to incorporate the per-patient duration of exposure to treatment, adjust for imbalances in predefined baseline risk factors, and adjust for the effect of results of single studies on the overall result. What should readers take away from your report?
Response: We conducted a pooled analysis of patient-level data from 6 randomized controlled clinical trials assessing the treatment of diabetic macular edema with ranibizumab. Diabetic macular edema is one of the most common causes of visual loss among working age adults in the United States.
Our goal was to assess the cardiovascular and cerebrovascular safety profile of this highly effective treatment for diabetic macular edema. Ranibizumab works by blocking the action of vascular endothelial growth factor (VEGF). A class effect of this blockade is an increased incidence of complications such as stroke with or without transient ischemic attack, myocardial infarction (MI), and vascular death….
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Source: Medical Research