Holter monitoring for the screening of cardiac disease in diabetes mellitus: The non-invasive Holter monitoring observation of new cardiac events in diabetics study.

We investigated the usefulness of Holter monitoring to detect cardiac disease and predict future cardiovascular risk in asymptomatic diabetic patients. This is a multi-centre, prospective study in 406 asymptomatic diabetic patients. They were categorized into three groups based on findings of Holter monitoring. A total of 377 met inclusion criteria and were classified as low (n = 172), moderate (n = 136) and high risk (n = 69). In total, 86 in moderate and 53 in high risk receive further evaluation. In total, 29 in moderate and 25 in high risk were diagnosed as cardiac disease and 12 required additional treatment, including coronary intervention. Over 1.8 years of mean follow-up, 11 (16.5 per 1000 person-years) experienced cardiovascular events. The cumulative incidence in moderate and high risk was higher than that in low risk (p = 0.029 and p = 0.014, respectively). Our study suggests that Holter monitoring may be a useful screening tool to detect cardiac disease and predict future cardiovascular risk in asymptomatic diabetic patients

Adjuvant Oral Uracil-Tegafur with Leucovorin for Colorectal Cancer Liver Metastases: A Randomized Controlled Trial

<div><p>Background</p><p>The high recurrence rate after surgery for colorectal cancer liver metastasis (CLM) remains a crucial problem. The aim of this trial was to evaluate the efficacy of adjuvant therapy with uracil-tegafur and leucovorin (UFT/LV).</p><p>Methods</p><p>In the multicenter, open-label, phase III trial, patients undergoing curative resection of CLM were randomly assigned in a 1:1 ratio to either the UFT/LV group or surgery alone group. The UFT/LV group orally received 5 cycles of adjuvant UFT/LV (UFT 300mg/m² and LV 75mg/day for 28 days followed by a 7-day rest per cycle). The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included overall survival (OS).</p><p>Results</p><p>Between February 2004 and December 2010, 180 patients (90 in each group) were enrolled into the study. Of these, 3 patients (2 in the UFT/LV group and 1 in the surgery alone group) were excluded from the efficacy analysis. Median follow-up was 4.76 (range, 0.15–9.84) years. The RFS rate at 3 years was higher in the UFT/LV group (38.6%, n = 88) than in the surgery alone group (32.3%, n = 89). The median RFS in the UFT/LV and surgery alone groups were 1.45 years and 0.70 years, respectively. UFT/LV significantly prolonged the RFS compared with surgery alone with the hazard ratio of 0.56 (95% confidence interval, 0.38–0.83; P = 0.003). The hazard ratio for death of the UFT/LV group against the surgery alone group was not significant (0.80; 95% confidence interval, 0.48–1.35; P = 0.409).</p><p>Conclusion</p><p>Adjuvant therapy with UFT/LV effectively prolongs RFS after hepatic resection for CLM and can be recommended as an alternative choice.</p><p>Trial Registration</p><p>UMIN Clinical Trials Registry <a href="http://www.umin.ac.jp/ctr/index.htm" target="_blank">C000000013</a></p></div

Results of subgroup analyses.

<p>A: The recurrence-free survival curves of the UFT/LV group (red line) and surgery alone group (black line) are shown for patients with a single liver metastasis. B: The recurrence-free survival curves of the two groups are shown for patients with multiple liver metastases. C: The recurrence-free survival curves of the two groups are shown for patients with synchronous liver metastases. D: The recurrence-free survival curves of the two groups are shown for patients with metachronous liver metastases.</p

Locations and treatments of first recurrence.

<p>Locations and treatments of first recurrence.</p

Results of analyses of the primary and secondary endpoints.

<p>A: The recurrence-free survival curves of the UFT/LV group (red line) and surgery alone group (black line) group are shown. The 3-year recurrence-free rate was significantly higher in the UFT/LV group than in the surgery alone group (38.6% vs. 32.3%, P = 0.003). B: The overall survival curves of the two groups are shown. The 5-year overall survival rates of the two groups were similar (66.1% vs. 66.8%, P = 0.409).</p

Baseline characteristics.

<p>Baseline characteristics.</p

The trial profile.

<p>The Participant flow is shown.</p