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A Controlled Epidemiological Study: The Safety Profile of ProHeart 6 & Two Monthly Heartworm Preventives in Dogs PowerPoint Presentation
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A Controlled Epidemiological Study: The Safety Profile of ProHeart 6 & Two Monthly Heartworm Preventives in Dogs Purdue University Larry Glickman, VMD, DrPH Nita Glickman, PhD, MPH George Moore, DVM, MS, DACVIM COMSYS David Hasza, PhD January 31, 2004 Banfield Pet Hospital Locations

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slide1

A Controlled Epidemiological Study:The Safety Profile of ProHeart 6 & Two Monthly Heartworm Preventivesin Dogs

Purdue University

Larry Glickman, VMD, DrPH

Nita Glickman, PhD, MPH

George Moore, DVM, MS, DACVIM

COMSYS

David Hasza, PhD

January 31, 2004

advantages of banfield medical records for drug ae post marketing surveillance
Advantages of Banfield Medical Recordsfor Drug AE Post-Marketing Surveillance
  • Banfield serves ~ 2% of US dog population
    • Representative of dog breeds nationally
  • Electronic data warehouse: all medical records standardized & computerized
  • Routine quality assurance record review
  • Routine review of all deaths for causality
  • More complete ascertainment of AEs
    • Follow-up calls to all clients after each visit
    • All drugs/vaccines warranted
slide4

Methods

  • All dog visits (encounters): Jan 1, 2002 to Aug 31, 2004
  • Each encounter evaluated for potential AEs over subsequent 30 days
  • Each encounter categorized as:
    • ProHeart 6 (yes/no)
    • monthly heartworm preventive (yes/no)
    • vaccine (yes/no)
    • none of the above
  • AE rates calculated per 10,000 encounters and 10,000 days at risk
  • AE rates evaluated both with and without adjustment for potential confounding factors, such as age, concurrent vaccine use, etc.
rate per 10 000 of any ae by treatment category
Rate per 10,000 of Any AEby Treatment Category

Total Number of Encounters = 6,800,061

risk of liver disease by age for proheart 6
Risk of Liver Diseaseby Age for ProHeart 6

Risk(1yr old) = 0.854*1.043 = 0.89; Risk(7yr old) = 0.853*1.043**7 = 1.14

Risk(age yrs) = OR(ProHeart6) * OR(ProHeart6*age interaction)**age

conclusions
Conclusions
  • Safety profile of ProHeart 6 similar to 2 monthly heartworm preventives, except:
    • Biologically unexplained and small increased risk of mast cell tumor following ProHeart 6 administration
    • 23% increased risk of death following most commonly used monthly heartworm preventive (heartworm 1)
  • AEs probably underestimated for monthly heartworm preventives vs. injectable heartworm preventives because:
    • DVMs less likely to observe AEs with oral products
    • Owners less likely to administer oral products
conclusions continued
Conclusions (continued)
  • This controlled epidemiological study:
    • Adjusted for effects of concurrent vaccination and other potential confounding factors
    • Unlike passive reporting systems, calculated incidence rates and compared AEs between heartworm preventives
    • Utilized recorded medical events rather than unfiltered and potentially biased reports from DVMs and dog owners
    • Tested causal hypotheses generated by spontaneous reports to FDA and FDAH
conclusions continued20
Conclusions (continued)
  • The safety profile of ProHeart 6 in this controlled epidemiological study was favorable compared with 2 monthly heartworm preventives
  • Therefore, we conclude there is no scientific rationale for the continued withdrawal of ProHeart 6 from the market