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In Brief: Four EASD Trials to Note

— Aggressive therapy cuts range of risk factors; caffeine tied to mortality benefit; and more

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LISBON -- With type 2 diabetes cardiovascular outcome trials as one of the major themes here at the European Association for the Study of Diabetes conference here -- the largest international scientific meeting for diabetes -- J-DOIT3 (Japan Diabetes Optimal Integrated Treatment Study) was one of the several headliners, joining the likes of TOSCA.IT, EXSCEL, and ACE trials.

Here are the findings from J-DOIT3, as well as other major studies presented here.

Intensive therapy for the treatment of type 2 diabetes helped reduce a composite of heart-related outcomes, including myocardial infarction, revascularization, stroke, and all-cause mortality versus standard care (adjusted 24% between-group difference). A multifactorial intervention for controlling blood pressure, lipid, and glucose levels with aggressive targets was tested. Other outcomes, including blood pressure, LDL-C levels, and HbA1c were also reported to be lower among patients on intensive therapy (123/71 mm Hg 85 mg/dL, and 6.8%, respectively; vs. 129/74 mm Hg, 104 mg/dL, and 7.2% in controls).

"The results of J-DOIT3 suggest that a multifactorial intervention with stricter targets than those recommended by current guidelines has benefit for the suppression of stroke and nephropathy in patients with type 2 diabetes even as compared with the current standard care," senior study author Takashi Kadowaki, MD, PhD, of the University of Tokyo explained in a statement. "A follow-up observational study is currently evaluating legacy effects on macrovascular complications and all-cause mortality as well as microvascular complications."

Among women with diabetes, higher caffeine consumption was associated with significantly lower all-cause mortality during follow-up, although no relationship was seen among men with diabetes. Compared to women who didn't consume any caffeine, this relationship also appear to be dependent on daily dosage (P=0.007 for all):

  • <100mg of caffeine per day (adjusted HR 0.49, 95% CI 0.33-0.74)
  • 100 to <200mg (0.43, 95% CI 0.26-0.70)
  • ≥200mg (0.34, 95% CI 0.20-0.57)

Not only was dosage a factor in associated risk among women, but so was the source of said caffeine. Tea drinkers reported a lower cancer-mortality risk, while coffee drinkers had a lower risk of all-cause and cardiovascular-related mortality -- all statistically significant.

"Our results may suggest that advising women with type 2 diabetes to drink more caffeine may reduce their mortality," said lead author João Sérgio Neves, MD, of São João Hospital Center in Portugal, during a press conference. "We have to perform further studies to confirm these benefits and new research should also focus in the difference in men and women regarding the effect of caffeine consumption."

Somatostatin 0.1% and brimonidine tartrate 0.2% eye drops lowered the risk of optic nerve degeneration progression in early diabetic retinopathy in patients with detectable neurodegeneration at baseline, according to the first clinical trial to assess neuroprotective, topical agents. However, when compared to placebo, neither type of eyedrops were able to significantly reduce new cases of neurodegeneration when measured with multifocal electroretinography.

The three-arm trial also found a high number of local adverse events with use of the brimonidine tartrate drops, which may limit its capacity for long-term treatment.

Using a clustering method, researchers on the DIRECT study identified subgroups of the type 2 diabetes population that may predict their rate of disease progression. Three groups in particular were identified: insulin resistant, β-cell deficient, and those with a mix of both.

Based on an analysis of nearly 800 individuals, those considered "insulin resistant" at baseline tended to receive higher doses of metformin compared to those who were β-cell deficient and also had a faster rate of progression (increasing HbA1c) over an 18-month period.

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    Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.