Trial Files: Triple Combo Pill for T2DM, Personalized Diet for CV Health, G-CSF for Alcoholic Hepatitis
Efficacy and tolerability of initial triple combination therapy with metformin, dapagliflozin and saxagliptin compared with stepwise add-on therapy in drug-naïve patients with type 2 diabetes (TRIPLE-AXEL study): A multicentre, randomized, 104-week, open-label, active-controlled trial
Kim NH et al. Diabetes, Obesity and Metabolism (June 2024)
Bottom line: This was a 104-week, multicentre, randomized, open-label trial comparing initial triple combination therapy (TCT) to conventional stepwise add-on therapy (SAT) in 105 patients with newly diagnosed type 2 diabetes not yet on medication (HbA1c 8-11%). TCT was comprised of 1000 mg of metformin, 10 mg of dapagliflozin, and 5 mg of saxagliptin once daily, whereas SAT was initiated with metformin, followed by glimepiride and sitagliptin. The primary outcome was the proportion of patients who achieved an HbA1c level of less than 6.5% without hypoglycaemia, weight gain of 5% or higher, or discontinuation of drugs due to adverse events at week 104. Though HbA1c reduction from baseline was similar between the groups, TCT was found to be more effective in achieving the primary outcome (39.0% vs. 17.1% for SAT) with a risk difference of 22.0 (95% confidence interval 3.0, 40.8; P = 0.027). The incidence of hypoglycemia, weight gain, or discontinuation of drugs was 16.7% and 62.0% in the TCT and SAT groups, respectively (P<0.001). TCT was well-tolerated and had fewer adverse events compared to SAT. These findings suggest that TCT may be a novel strategy for initial combination therapy in T2D patients.
Effects of a personalized nutrition program on cardiometabolic health: a randomized controlled trial
Bermingham K et al. Nature Medicine (May 2024)
Bottom Line: This randomized clinical trial compared the effectiveness of a personalized dietary program (PDP) versus general dietary advice (control) on cardiometabolic health in a population of 347 participants aged 41-70 years who were generally representative of the average US population. The PDP utilized individual postprandial glucose and triglyceride (TG) responses to foods, microbiomes, and health history to create personalized food scores in an 18-week app-based program. The control group received standard care dietary advice based on the US Department of Agriculture Guidelines for Americans, 2020-2025. Primary outcomes included serum low-density lipoprotein cholesterol and TG concentrations at baseline and 18 weeks. There was a significant reduction in serum triglyceride concentrations in the PDP group compared to the control group (mean difference = −0.13 mmol l−1; log-transformed 95% confidence interval = −0.07 to −0.01, P = 0.016). Secondary outcomes, including body weight, waist circumference, HbA1c, diet quality, and microbiome (beta-diversity) (P<0.05), also showed improvements, particularly in highly adherent PDP participants. No serious adverse events were reported. In conclusion, personalized dietary advice may lead to improvements in cardiometabolic health compared to standard dietary advice.
Granulocyte colony stimulating factor improves Prednisolone responsiveness and 90-day survival in steroid eligible severe Alcohol associated Hepatitis: The GPreAH Study a randomized trial
Mishra AK et al. The American Journal of Gastroenterology (August 2024)
Bottom Line: This randomized controlled trial studied the safety and efficacy of combination therapy with granulocyte colony stimulating factor (GCSF) + Prednisolone (GPred) compared to GCSF-only and Prednisolone-only therapy in steroid eligible patients with severe alcohol-associated-hepatitis (SAH). Eligible SAH patients were those with Maddrey Discriminant Function scores of 32-90. The study included 126 participants and the primary outcome was 90-day survival rate. The results showed that the combination therapy group had a statistically significant improvement in 90-day survival (88.1%) compared to the Prednisolone-only (64.3%) and GCSF-only (78.6%) groups (p =0.03, Prednisolone vs. GPred). There was no significant difference in 28 day survival between the three groups and GPred had more responders by day 7 (92.9% vs. 71.4% vs. 76.2%). Additionally, the combination therapy group had a lower incidence of new infections, acute kidney injury, hepatic encephalopathy, and rehospitalizations. The conclusion is that the addition of GCSF to prednisolone improves steroid responsiveness and 90-day survival in SAH patients, with fewer infections and new onset complications.
Trial Files Issue #2024-18
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