We analyzed participants with type 2 diabetes (n=46) within a larger weight loss trial (n=146) who were randomized to 48 weeks of a low-carbohydrate diet (LCD; n=22) or a low-fat diet + orlistat (LFD+O; n=24).
At baseline, mean BMI was 39.5 kg/m2 (SD 6.5) and HbA1c 7.6% (SD 1.3). Although the interventions reduced BMI similarly (LCD −2.4 kg/m2; LFD+O −2.7 kg/m2, p= 0.7), LCD led to a relative improvement in hemoglobin A1c: −0.7% in LCD vs. +0.2% in LFD+O (difference −0.8%, 95% CI= −1.6, −0.02; p=0.045). LCD also led to a greater reduction in antiglycemic medications using a novel medication effect score (MES) based on medication potency and total daily dose; 70.6% of LCD vs. 30.4% LFD+O decreased their MES by ≥50% (p=0.01).
Lowering dietary carbohydrate intake demonstrated benefits on glycemic control beyond its weight loss effects, while at the same time lowering antiglycemic medication requirements.
Background:
Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety of concomitant use of PPIs and DAPT in the postdischarge treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) patients.
Methods and Results:
We searched for clinical studies in MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews, from 1995–2012. Reviewers screened and extracted data, assessed applicability and quality, and graded the strength of evidence. We performed meta-analyses of direct comparisons when outcomes and follow-up periods were comparable. Thirty-five studies were eligible. Five (4 RCTs, 1 observational) assessed the effect of omeprazole when added to DAPT; the other 30 (observational) assessed the effect of PPIs as a class compared with no PPIs. Random-effects meta-analyses of the studies assessing PPIs as a class consistently reported higher event rates in patients receiving PPIs for various clinical outcomes at 1 year (composite ischemic endpoints, all-cause mortality, nonfatal MI, stroke, revascularization, and stent thrombosis). However, the results from RCTs evaluating omeprazole compared with placebo showed no difference in ischemic outcomes, despite a reduction in upper gastrointestinal bleeding with omeprazole.
Conclusions:
Large, well-conducted observational studies of PPIs and RCTs of omeprazole seem to provide conflicting results for the effect of PPIs on cardiovascular outcomes when coadministered with DAPT. Prospective trials that directly compare pharmacodynamic parameters and clinical events among specific PPI agents in UA/NSTEMI patients treated with DAPT are warranted.
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