Sunday, October 25, 2020

FDA Quietly Issues 2020 Update on diet-associated DCM at Kansas State Forum

    09/29/2020, Kansas State held a virtual forum where stakeholders and researchers presented on the topic of Dilated Cardiomyopathy and diet. Speakers included industry members, veterinary researchers, and members of the FDA. On 10/16/2020, Kansas State distributed the materials online

    Perhaps most noteworthy in the materials is an update from the FDA, though their website has remained quiet since the July 2019 release. In the opening remarks to the forum, FDA's Dr. Steven Solomon says "We have tried to be careful in our messaging, and we recognize going forward not to speak on this topic publicly unless we are clarifying information or have something substantive to share. As I have said on numerous occasions, we are not looking to put out any additional information until we have more scientific certainty. ... Although CVM’s investigation must be driven by science and our public health mission, we are acutely aware that promoting transparency and public awareness may not be kind to everyone’s bottom line. I empathize with those of you who have experienced adverse consequences in your businesses, and with those of you in the veterinary community who have had your own challenges in sharing your scientific findings and trying to determine what type of diets to recommend to your clients and their pets."

What's important for pet owners to know is that these findings continue to support that there is a link between certain diets and the development of dilated cardiomyopathy.

The report is now publicly available, and the FDA is reportedly in the works of determining how to most effectively communicate updates on their findings to the public. In the meantime, and in the interest of transparency, here are the highlights of what was provided at the forum:

  • As of 07/20/2020, the FDA has received over 1100 reports of DCM
  • Clinical information has been collected by Vet-LIRN for 161 dogs in order to track and characterize their recovery. Group One represents 121 of the dogs reported between 1/2018 and 8/2019. 107 of those dogs (88%) have had a full or partial recovery. 
    • 23 (19%) fully recovered, 84 (69%) partially recovered
    • All dogs that recovered received a change in diet, and the majority also received taurine, a dietary supplement, and pimobendan, a drug that slows, but does not reverse, cardiac disease. 
    • Recovery time for fully recovered dogs ranged from 6-12 months, with a few dogs taking 2 years
    • Dogs that presented with severely low taurine recovered more than dogs presented with slightly low, normal, or high taurine
  • Group Two represents 40 of the dogs reported between 11/2019 and 7/2020 and is preliminary data
    • 30 (75%)dogs have recovered partially and 5 (12%) have recovered fully
    • Trends aligned with Group One
  • Taken directly from the FDA materials on diet at time of diagnosis:
    • "For fully and partially recovered cases on a case-based evaluation, of the 107 fully and partially recovered cases: 
    • 2 of the 107 cases did not have enough information to determine grain or grain-free exposure status, and 4 of the 107 did not have enough information to determine pulse exposure status.
    • 98 of 105 (93% of cases) ate grain-free foods.
    • 90% (95 of the 105 cases) only ate grain-free foods.
    • Of the 7 that ate grain-containing foods without eating grain-free foods: 
    • 4 of the 7 ate a vegan diet with whole peas as the first ingredient. 
    • 2 of 7 ate chicken or lamb and rice diets containing split peas. 
    • 1 of 7 ate lamb meal and rice. 
    • 97% of cases (100/103) were exposed to whole pulse ingredients in their diets.
    • 0% of cases were exposed to diets with meat by-products or poultry by-products."
  • Taken directly from the FDA materials on diet fed during recovery:
  • "For Group One fully recovered cases – Recovery diets, on a PRODUCT basis: 
    • 96% of the reported diets fed in the recovery period are grain-containing, although 3 were “hydrolyzed protein” diets – 2 with corn starch, 1 with brewer’s rice. For this analysis, I considered corn starch a grain (or grain derivative), although it was harder to categorize. Brewer’s rice is a grain. 
    • Only 8% of reported recovery diets had peas in the top ingredients, 4% had whole peas, and none had lentils.
    • Animal-source proteins: 42% of the recovery diets contained meat by-products or poultry by-products (primarily poultry by-products).
    • 8% of the recovery diets had lamb meal, whereas 34% had lamb meal in the before diagnosis phase."

    Recovery seen with a change in diet is consistent with an underlying dietary etiology to these cases. Secondary DCM is only known to resolve when the underlying cause is addressed, and the additional therapeutic measures (pimobendan and ACE inhibitors) have not been documented to reverse cardiac disease, only stabilize patients, slow disease progression, and prolong patient survival. These findings further support that some aspect of legume-rich, grain-free diets contributes to the development of dilated cardiomyopathy and underscore the need for continued research. 

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