Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes.

BACKGROUND & AIMS: Whether vitamin D affects lipid profile and cardiovascular disease (CVD) risk is controversial. We evaluated the effect of oral daily vitamin D supplementation on lipid profile and CVD risk in patients with well-controlled type 2 diabetes. METHODS: Secondary analysis in the vitamin D for established type 2 diabetes (DDM2) study, a double-blind, randomized, placebo-controlled clinical trial. 127 patients (mean age 60 years) with stable (HbA1c ≤ 7.5%) diabetes managed with lifestyle only or lifestyle plus metformin were randomized to receive 4000 IU/day of vitamin D3 (n = 66) or placebo (n = 61) for 48 weeks. Changes in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides [TG] and TG/HDL ratio), C-reactive protein and CVD risk (calculated according the American College of Cardiology/American Heart Association [ACC/AHA] guidelines) were assessed at week 24 and 48. RESULTS: The mean [±SEM] plasma 25-hydroxyvitamin D [25(OH)D] level was higher in the vitamin D vs. the placebo group (20.5 ± 1.18 vs. -1.6 ± 1.2 ng/mL respectively; p < 0.001). There was no statistically significant change in lipid profile, C-reactive protein or CVD risk. Among patients who were not on cholesterol medication (n = 32), vitamin D supplementation reduced TG compared to placebo at week 48 (-18.74 ± 8.91 vs. 9.69 ± 8.60 mg/dL respectively; p = 0.032). CONCLUSION: One year supplementation with vitamin D3 at 4000 IU/day did not affect lipid profile, C-reactive protein and CVD risk in patients with stable type 2 diabetes not selected for vitamin D deficiency, with the exception of improvement of TG among patients not on cholesterol medication. REGISTRATION: ClinicalTrials.gov Identifier NCT01736865.

Treatment Effect or Effective Treatment? Cardiac Compression Fraction and End-tidal Carbon Dioxide Are Higher in Patients Resuscitative Endovascular Balloon Occlusion of the Aorta Compared with Resuscitative Thoracotomy and Open-Chest Cardiac Massage.

The purpose of this study is to compare end-tidal carbon dioxide (EtCO2) during resuscitation of open-chest cardiac massage (OCCM) with aortic cross-clamp (ACC) versus receiving resuscitative endovascular balloon occlusion of the aorta (REBOA) with closed-chest compressions (CCCs). Patients who received REBOA were compared with patients receiving OCCM for traumatic arrest using continuous vital sign monitoring and videography. Thirty-three patients were enrolled in the REBOA group and 18 patients were enrolled in the OCCM group. Of the total patients, 86.3 per cent were male with a mean age of 36.2 ± 13.9 years. Ninety-four percent of patients suffered penetrating trauma in the OCCM group compared with 30.3 per cent of the REBOA group (P = <0.001). Before aortic occlusion (AO), there was no difference in initial EtCO2 values, but mean, median, peak, and final EtCO2 values were lower in OCCM (P < 0.005). During CPR after AO, the initial, mean, and median values were higher with REBOA (P = 0.015, 0.036, and 0.038). The rate of return of spontaneous circulation was higher in REBOA versus OCCM (20/33 [60.1%] vs 5/18 [33.3%]; P = 0.04), and REBOA patients survived to operative intervention more frequently (P = 0.038). REBOA patients had greater total cardiac compression fraction (CCF) before AO than OCCM (85.3 ± 12.7% vs 35.2 ± 18.6%, P < 0.0001) and after AO (88.3 ± 7.8% vs 71.9 ± 24.4%, P = 0.0052). REBOA patients have higher EtCO2 and cardiac compression fraction before and after AO compared with patients who receive OCCM.

Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study.

PURPOSE: We compared the efficacy and safety of the currently recommended dose of pentosan polysulfate sodium with a third of the daily dose and with placebo. MATERIALS AND METHODS: In this multicenter, double-blind, randomized, placebo controlled study 368 adults with interstitial cystitis/bladder pain syndrome, defined as an ICSI total score of 8 or greater and a score of greater than 0 on the 4 ICSI component items, received pentosan polysulfate sodium 100 mg once daily or 3 times daily, or matching placebo for 24 weeks. Study eligibility was not based on cystoscopy findings. ICSI was administered at baseline, and at weeks 4, 8, 12, 18 and 24. Unblinded interim analysis performed at 6 years with 54% of the target number of 645 patients enrolled resulted in early study termination. RESULTS: There was no statistically significant difference between the pentosan polysulfate sodium group and the placebo group or between the 2 pentosan polysulfate sodium groups for the primary end point, defined as responder achieving a 30% or greater reduction from the baseline ICSI total score at study end. This primary end point was achieved by 48 of 118 patients (40.7%) in the placebo group, and by 51 of 128 (39.8%) and 52 of 122 (42.6%) in the pentosan polysulfate sodium 100 mg once daily and 3 times daily groups, respectively. Pentosan polysulfate sodium was well tolerated with a similar percent of patients (range 10.2% to 13.3%) across the groups discontinuing due to an adverse event. CONCLUSIONS: Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs placebo for pentosan polysulfate sodium at the currently established dose or at a third of the daily dose.

Immunohistochemical profile and fluorescence in situ hybridization analysis of diffuse large B-cell lymphoma in northern China.

CONTEXT: Gene expression profiling of diffuse large B-cell lymphoma using complementary DNA microarrays has revealed 2 major prognostic groups in Western countries: germinal center B-cell-like and nongerminal center B-cell-like lymphomas. Immunohistochemical analysis using antibodies specific for CD10, BCL6, and MUM1 has been proposed as a surrogate for gene expression profiling. OBJECTIVE: To study the immunohistochemical features of diffuse large B-cell lymphoma cases from northern China because geographic differences for this disease are known to exist. DESIGN: Morphologic, immunohistochemical, and fluorescence in situ hybridization analyses of 63 cases of diffuse large B-cell lymphoma from northern China. RESULTS: There were 38 men and 25 women with a median age of 57 years (range, 12-87 years). CD10 was positive in 19 cases (30%), BCL6 was positive in 22 cases (35%), and MUM1 was positive in 32 cases (51%). Twenty-one (33%) cases were germinal center B-cell-like lymphoma, and 42 (67%) were nongerminal center B-cell-like lymphoma. BCL2 was expressed more often in nongerminal center B-cell-like disease versus germinal center B-cell-like disease (60% versus 24%, P = .01) and in nodal versus extranodal (64% versus 30%, P = .01) cases. Fluorescence in situ hybridization analysis showed BCL6, MYC , and BCL2 rearrangements in 11 of 32 (34%), 8 of 27 (30%), and 11 of 50 (22%) cases, respectively. CONCLUSIONS: These results add to what is known about the geographic variation of diffuse large B-cell lymphomas. In northern China, the frequency of the germinal center B-cell-like type and BCL6 expression and/or BCL6 rearrangement is less and the frequency of MYC rearrangement is greater than have been reported in Western countries.