JAMA. 2014;311(17):1742-1749. doi:10.1001/jama.2014.2624. doi:10.1001/jama.2014.5052 @article{doi:10.1001/jama.2014.5052, author = {Castro M and King TS and Kunselman SJ and et al}, title = {Effect of vitamin d3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin d levels: The vida randomized clinical trial}, journal = {JAMA}, volume = {}, number = {}, pages = {}, year = {2014}, doi = {10.1001/jama.2014.5052}, URL = { + http://dx.doi.org/10.1001/jama.2014.5052}, eprint = {/data/Journals/JAMA/0/joi140058.pdf} } --------------------------------------- JAMA. 2014;312(15):1520-1530. doi:10.1001/jama.2014.13204. Results A total of 475 patients were included in the final analysis (237 in the vitamin D3 group and 238 in the placebo group). The median (IQR) length of hospital stay was not significantly different between groups (20.1 days [IQR, 11.1-33.3] for vitamin D3 vs 19.3 days [IQR, 11.1-34.9] for placebo; P = .98). Hospital mortality and 6-month mortality were also not significantly different (hospital mortality: 28.3% [95% CI, 22.6%-34.5%] for vitamin D3 vs 35.3% [95% CI, 29.2%-41.7%] for placebo; hazard ratio [HR], 0.81 [95% CI, 0.58-1.11]; P = .18; 6-month mortality: 35.0% [95% CI, 29.0%-41.5%] for vitamin D3 vs 42.9% [95% CI, 36.5%-49.4%] for placebo; HR, 0.78 [95% CI, 0.58-1.04]; P = .09). For the severe vitamin D deficiency subgroup analysis (n = 200), length of hospital stay was not significantly different between the 2 study groups: 20.1 days (IQR, 12.9-39.1) for vitamin D3 vs 19.0 days (IQR, 11.6-33.8) for placebo. Hospital mortality was significantly lower with 28 deaths among 98 patients (28.6% [95% CI, 19.9%-38.6%]) for vitamin D3 compared with 47 deaths among 102 patients (46.1% [95% CI, 36.2%-56.2%]) for placebo (HR, 0.56 [95% CI, 0.35-0.90], P for interaction = .04), but not 6-month mortality (34.7% [95% CI, 25.4%-45.0%] for vitamin D3 vs 50.0% [95% CI, 39.9%-60.1%] for placebo; HR, 0.60 [95% CI, 0.39-0.93], P for interaction = .12). Conclusions and Relevance Among critically ill patients with vitamin D deficiency, administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, hospital mortality, or 6-month mortality. Lower hospital mortality was observed in the severe vitamin D deficiency subgroup, but this finding should be considered hypothesis generating and requires further study. --------------------------------------- JAMA. 2014;312(21):2234-2243. doi:10.1001/jama.2014.15825 Results At a mean follow-up time of 4.0 (SD, 1.7) years, the primary outcome event rates were not significantly different between the CCTA and the control groups (6.2% [28 events] vs 7.6% [34 events]; hazard ratio, 0.80 [95% CI, 0.49-1.32]; P = .38). The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups (4.4% [20 events] vs 3.8% [17 events]; hazard ratio, 1.15 [95% CI, 0.60-2.19]; P = .68). Conclusions and Relevance Among asymptomatic patients with type 1 or type 2 diabetes, use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization at 4 years. These findings do not support CCTA screening in this population. ------------------------------------------ JAMA. 2015;314(23):2524-2534. doi:10.1001/jama.2015.16700 < Previous ArticleNext Article > Original Investigation | December 15, 2015 Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease A Randomized Clinical Trial Christopher J. Hawkey, FMedSci1; Matthieu Allez, PhD2; Miranda M. Clark, BSc(Hons)1; Myriam Labopin, MD3; James O. Lindsay, PhD4; Elena Ricart, PhD5; Gerhard Rogler, PhD6; Montserrat Rovira, MD7; Jack Satsangi, DPhil8; Silvio Danese, PhD9; Nigel Russell, MD10; John Gribben, MD11; Peter Johnson, MD12; Jerome Larghero, MD13; Catherine Thieblemont, PhD14; Sandro Ardizzone, MD15; Daan Dierickx, PhD16; Adalberto Ibatici, MD17; Timothy Littlewood, MD18; Francesco Onida, MD19; Urs Schanz, MD20; Severine Vermeire, PhD21; Jean-Frederic Colombel, MD22,23; Jean-Paul Jouet, MD24; Elizabeth Clark, MSc25; Riccardo Saccardi, MD26; Alan Tyndall, FRACP27; Simon Travis, DPhil28; Dominique Farge, PhD29 [+] Author Affiliations JAMA. 2015;314(23):2524-2534. doi:10.1001/jama.2015.16700. Text Size: A A A Article Figures Tables Supplemental Content References CME ABSTRACT ABSTRACT | INTRODUCTION | METHODS | RESULTS | DISCUSSION | CONCLUSIONS | ARTICLE INFORMATION | REFERENCES Importance Case reports and series suggest hematopoietic stem cell transplantation (HSCT) may benefit some patients with Crohn disease. Objective To evaluate the effect of autologous HSCT on refractory Crohn disease. Design, Setting, and Participants Parallel-group randomized clinical trial conducted in 11 European transplant units from July 2007 to September 2011, with follow-up through March 2013. Patients were aged 18 to 50 years with impaired quality of life from refractory Crohn disease not amenable to surgery despite treatment with 3 or more immunosuppressive or biologic agents and corticosteroids. Interventions All patients underwent stem cell mobilization before 1:1 randomization to immunoablation and HSCT (n = 23) or control treatment (HSCT deferred for 1 year [n = 22]). All were given standard Crohn disease treatment as needed. Main Outcomes and Measures Sustained disease remission at 1 year, a composite primary end point comprising clinical remission (Crohn Disease Activity Index (CDAI) <150 [range, 0-600]), no use of corticosteroids or immunosuppressive or biologic drugs for at least the last 3 months, and no endoscopic or radiological evidence of active (erosive) disease anywhere in the gastrointestinal (GI) tract. Secondary outcomes were individual components of the primary composite outcome and other measures of disease activity, laboratory results, quality of life and functional status, and GI tract imaging. Results Twenty-three patients underwent HSCT and 22 received standard Crohn disease treatment (controls). Sustained disease remission was achieved in 2 patients undergoing HSCT (8.7%) vs 1 control patient (4.5%) (absolute difference, 4.2% [95% CI, −14.2% to 22.6%]; P = .60). Fourteen patients undergoing HSCT (61%) vs 5 control patients (23%) had discontinued immunosuppressive or biologic agents or corticosteroids for at least 3 months (difference, 38.1% [95% CI, 9.3% to 59.3%]; P = .01). Ten vs 2 patients had a CDAI less than 150 (remission) at the final evaluation, 8 (34.8%) vs 2 (9.1%) for 3 or more months (difference, 25.7% [95% CI, 1.1% to 47.1%]; P = .052). Eight (34.8%) vs 2 (9.1%) patients were adjudicated free of active disease on endoscopy and radiology at final assessment (difference, 25.7% [95% CI, 1.1% to 47.1%]; P = .054). There were 76 serious adverse events in patients undergoing HSCT vs 38 in controls. One patient undergoing HSCT died. Conclusions and Relevance Among adult patients with refractory Crohn disease not amenable to surgery who had impaired quality of life, HSCT, compared with conventional therapy, did not result in a statistically significant improvement in sustained disease remission at 1 year and was associated with significant toxicity. These findings do not support the widespread use of HSCT for patients with refractory Crohn disease. Trial Registration clinicaltrials.gov Identifier:NCT00297193