Memorandum

Virta one-year CVD biomarker results show improvements in 22 of 26 metrics; Commercial deals signed in Indiana – May 14, 2018

Executive Highlights

  • Virta Health announced very positive one-year CVD biomarker results from its non-randomized, controlled study (n=349 people with type 2 diabetes), with results published in Cardiovascular Diabetology. In 262 individuals participating in Virta’s low-carb/high-fat ketogenic diet (<30 grams of carbs/day) and tech-enabled remote care, 22 of 26 cardiovascular risk factors significantly improved, including blood pressure, triglycerides, hsCRP, ApoB, and more. The control group (n=87) had no such improvements. There was a mean ~10% increase in total LDL-C, though the more nuanced LDL partitioning changed in a positive direction – and some studies suggest this is a more sensitive CVD risk factor than LDL-C alone.

  • Impressively, these results were achieved alongside reductions in antihypertensive medication (-11%) and diuretics (-10%). Noted CEO Sami Inkinen, “Traditional approaches to chronic disease have conditioned both patients and payers to think pharmaceuticals are essential and that negative side effects are unavoidable. The Virta Treatment is changing this status quo.” These data add to Virta’s previously published results from the same study showing 60% type 2 diabetes reversal, 1.3% A1c reduction (baseline: 7.6%), and an impressive 12% weight loss (~30 lbs).

  • These positive data counter the misconception that low-carb, high-fat diets might increase CVD risk; in fact, the dietary approach suggests reduced risk in this study. Notably, ≤1% of those who participated in Virta’s program demonstrated CVD changes outside the range of that observed in the usual care population (n=87). Still, it’s important to note that Virta’s study was not a formal cardiovascular outcomes trial, but the evidence is certainly suggestive of CVD risk improvement.

  • Virta also recently signed commercial deals with the Tippecanoe County Government and the City of Lafayette in Indiana (Note: Lafayette is the largest city in Tippecanoe County). The Virta program will be provided as a fully-covered healthcare benefit to employees of both entities.

    Virta Health announced very positive one-year CVD biomarker results from its non-randomized, controlled study in 349 people with type 2 diabetes. The 262 individuals participating in the company’s low-carb/high-fat ketogenic diet (<30 grams of carbs/day) plus tech-enabled remote care intervention saw significant improvements in 22 of 26 cardiovascular (CVD) risk factors, while the control group (n=87) did not. The promising preliminary data were published in Cardiovascular Diabetology and add to Virta’s previously published results from the same study showing 60% type 2 diabetes reversal, 1.3% A1c reduction (baseline: 7.6%), and a remarkable 12% weight loss (~30 lbs). The study is slated to continue out to five years (June 2020).

    The self-selected treatment group of 262 type 2 participants were compared to an independently-recruited control group of 87 type 2 adults who received usual care. 83% of participants in the treatment group remained enrolled in Virta’s program at one year. Among the improved CVD biomarkers in the Virta group were systolic blood pressure, diastolic pressure, hsCRP, triglycerides, HDL-C, LDL particle size, and white blood cell count (see below for full results). These positive results came alongside significant reductions in the treatment group’s use of antihypertensive medication (-11%) and diuretics (-10%). 10-year atherosclerosis CVD risk and lipoprotein insulin resistance also declined significantly by 12% and 20%, respectively. No significant changes were observed in the control group.

    There was a 10% increase in total LDL cholesterol (LDL-C), though this result is actually somewhat nuanced. The authors note that (i) both ApoB and LDL particle number (LDL-P), biomarkers, found to be better predictors of CVD risk, did not change significantly in the treatment group; and (ii) The reduction in the more damaging small LDL particles, shift toward greater LDL particle size, and decrease in very-low-density lipoprotein particles (VLDL-P) are encouraging. Indeed, in the Framingham Offspring Study, LDL-P outperformed LDL-C for predicting CVD, and well-respected health experts Dr. Peter Attia and Kris Kresser have written extensively on this topic (here and here). The key nuance is that LDL-P and LDL-C are sometimes discordant, meaning it’s possible to have normal or even low LDL-C, but a high number of LDL particles. What matters for CVD, many now believe, is the number of LDL particles – especially the small ones.

    Taken together with 12% decreased weight, significantly improved A1c (-1.3%), and 94% of patients on insulin (n=63) eliminating or reducing their insulin therapy, Virta users have substantially improved metabolic profiles overall. Noted CEO Sami Inkinen, “Traditional approaches to chronic disease have conditioned both patients and payers to think pharmaceuticals are essential and that negative side effects are unavoidable. The Virta Treatment is changing this status quo. Our patients … don’t have to rely on expensive drugs or complex medical procedures as their only treatment options.” Of course, a randomized study examining adjudicated CV events would be necessary to determine true impact. We also are very interested to see which patients do well under a combination approach.

    Importantly, ≤1% of Virta-treated participants demonstrated changes outside the range of that observed in the usual care population, addressing concerns of possible extreme adverse reactions to a ketogenic diet. Given that low-carb diets generally involve an increase in fat intake, the potential for increased CVD risk is a common criticism. These results provide a strong counter hypothesis, suggesting that the low-carb, high-fat approach improves most CVD biomarkers and makes people with type 2 diabetes healthier. Still, it’s important to note that the study was not a formal cardiovascular outcomes trial and should therefore not be taken to definitively indicate CVD benefits. That said, our curiosity about Virta’s potential to reduce CV events is certainly piqued, and we’d absolutely love to see a CVOT pit a cardioprotective agent and Virta’s remote care-guided ketogenesis head-to-head!

    • Virta told us in February that it currently places ~50% of its fees at risk based on clinical outcomes (primarily A1c reductions) for each patient treated, though we wonder if CV biomarker improvement will play a bigger role in reimbursement given these results.

    • Virta’s positive CVD results preceded news of Virta’s recently-established commercial partnerships with the Tippecanoe County Government and the City of Lafayette in Indiana (Note: Lafayette is the largest city in Tippecanoe County). In a huge win, the Virta Treatment will be provided as a fully-covered healthcare benefit to employees of both entities. The press release notes that over 10,000 individuals live with type 2 diabetes in Tippecanoe County alone, costing the county ~$56 million annually, though no details were given on the number of employees for either government. Given that the Virta Treatment was previously estimated to save ~$9,600/individual in the first 24 months, these partnerships have the potential to make a sizable dent in Indiana’s healthcare costs.

    -- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close