Analysis 2.11. Comparison 2 Combination HT vs placebo in primary prevention, Outcome 11 Non-fatal MI: time on treatment..... Analysis 3.1. Comparison 3 Estrogen vs placebo in secondary prevention, Outcome 1 Death (all causes

Mediterranean-style diet for the primary and secondary prevention of cardiovascular disease.

Increased consumption of fruit and vegetables for the primary prevention of cardiovascular diseases. Cochrane Database of Systematic Reviews (Number 6). Article Number CD009874.

IMPORTANCEIn patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes. OBJECTIVE To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure. DESIGN, SETTING, AND PARTICIPANTS This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020. INTERVENTIONS Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210). MAIN OUTCOMES AND MEASURESThe primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates. RESULTS Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, −7.6% to 11.5%]; P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, −2.1 [95% CI, −3.8 to −0.3]; P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device.CONCLUSIONS AND RELEVANCE Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference.

Analysis 1.1. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 1 Total cholesterol (mmol/L), change from baseline.. .. .. . Analysis 1.2. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 2 Total cholesterol (mmol/L), change from baseline, subgroup analysis. Analysis 1.3. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 3 LDL-cholesterol (mmol/L), change from baseline.. .. .. . Analysis 1.4. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 4 LDL-cholesterol (mmol/L), change from baseline, subgroup analysis. Analysis 1.5. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 5 HDL-cholesterol (mmol/L), change from baseline.. .. .. . Analysis 1.6. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 6 Triglycerides (mmol/L), change from baseline.. .. .. .. . Analysis 1.7. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 7 Systolic blood pressure (mmHg), change from baseline.. .. . Analysis 1.8. Comparison 1 Mediterranean dietary intervention versus no intervention or minimal intervention (secondary outcomes-CVD risk factors), Outcome 8 Diastolic blood pressure (mmHg), change from baseline.. .. .