Real-World Cardiovascular Outcomes with a Carbohydrate-Reduced Telemedicine Intervention
Shanmugam, P. V.; Roberts, C. G.; Athinarayanan, S. J.; Wolfberg, A. J.; Raskin, S.; Lopez-Jimenez, F.
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ImportanceCarbohydrate-reduced nutrition improves multiple metabolic risk factors, but its influence on long-term cardiovascular (CV) outcomes remains uncertain. ObjectiveTo evaluate the impact of an individualized telemedicine nutrition therapy on the incidence of CV events. DesignClaims-based cohort study of adults with type 2 diabetes or obesity receiving telemedicine nutrition therapy versus a propensity score matched control group between January 1, 2016 and June 1, 2025, with a median follow-up of approximately two years. SettingThe intervention cohort, a US-based nationwide digital health clinic, received individualized telemedicine nutrition and clinical care. The matched control cohort was derived from a commercial claims database. ParticipantsAdults with type 2 diabetes or obesity and no CV events one year prior to index date. ExposureIndividualized nutrition therapy (INT) program combining telemedicine clinical care and carbohydrate-reduced nutrition counseling. Main Outcomes and MeasuresFour prespecified primary outcomes included 1) 3-point major adverse CV events (MACE), defined as nonfatal myocardial infarction, nonfatal stroke, or death from any cause; 2) 6-point MACE, adding percutaneous coronary intervention, hospitalization for heart failure or unstable angina; 3) all new-onset CV events; and 4) new-onset hypertension. Secondary outcomes included all-cause mortality, and safety outcomes related to arrhythmias. ResultsIn 4,877 participants in each cohort (mean age, 51 [SD 9.5] years; 2,939 [60.3%] female), INT was associated with reduced risk of all primary outcomes. Incidence per 1,000 person-years was 4.1 vs 9.3 for MACE-3, 5.7 vs 10.8 for MACE-6, 27.7 vs 36.9 for all new onset CV disease, and 41.8 vs 49.3 for new-onset hypertension. Hazard ratios were 0.44 (95% CI, 0.29-0.65; P <0.001) for MACE-3, 0.52 (95% CI, 0.37-0.73; P <0.001) for MACE-6, 0.70 (95% CI, 0.59-0.82; P <0.001) for all CV disease, and 0.81 (95% CI, 0.70-0.93; P <0.001) for new-onset hypertension. Conclusions and RelevanceIndividualized telemedicine nutrition therapy was associated with lower CV event incidence compared to controls, suggesting the intervention may confer cardioprotection. KEY POINTSO_ST_ABSQuestionC_ST_ABSWhat is the impact of an individualized telemedicine nutrition program on cardiovascular events? FindingsIn this claims-based cohort study, individuals receiving carbohydrate-reduced nutrition therapy had significantly reduced risk of all primary outcomes compared with matched controls: 56% lower 3-point MACE, 48% lower 6-point MACE, 30% lower risk of all new-onset cardiovascular events, and 19% lower new-onset hypertension. The risk of all-cause mortality was also directionally reduced. MeaningTelemedicine nutrition therapy was associated with favorable cardiovascular outcomes compared to usual care.
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