Bromocriptine-QR (BQR), a unique quick release formulation of micronized bromocriptine, is the only FDA-approved sympatholytic insulin sensitizer for T2D. Previously, circadian-timed (~0600-0800 hr) B-QR dosing reduced a prespecified cardiovascular disease (CVD) composite endpoint in the Cycloset Safety Trial by 40 - 50% within 1 year. Chronically elevated sympathetic tone is a driver of increased postprandial (PP) plasma glucose (G), triglyceride (TG) and free fatty acid (FFA) levels which composite is a major risk factor for CVD, especially in hypertensive (HT) T2D subjects. This study therefore explored the impact of 24 wks BQR therapy versus placebo on average daylong PP G, TG and FFA levels obtained at 1 and 2 hrs following standardized meals at breakfast, lunch, and dinner in normotensive T2D subjects with normal fasting plasma TG (FPTG) levels (< 150 mg/dl) or with FPTG levels ≥ 150, 200, or 300 mg/dl (hyperlipidemic [HL] groups) or in HL - HT T2D subjects. BQR therapy increasingly reduced PP plasma G, TG, and FFA levels (and HbA1c) in the HL groups versus placebo as FPTG level increased from ≥ 150 to ≥ 300 mg/dl, but not in normal lipidemic, normotensive subjects. Moreover, this BQR effect was accentuated in the HL - HT group (See Table). This BQR-induced reduction in all these CVD risk factors in HL and HL - HT T2D subjects may contribute to the therapy’s observed impact to reduce CVD outcomes in the T2D population.
B. Chamarthi: Employee; VeroScience LLC. M. Ezrokhi: Employee; VeroScience LLC. A.H. Cincotta: Employee; VeroScience LLC.
