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Bocquet A.,University of Franche Comte | Lachambre E.,Nestle | Kempf C.,CK Consulting | Beck L.,Nestle
Journal of Pediatric Gastroenterology and Nutrition | Year: 2013

OBJECTIVE: The aim of the present study was to compare the effect of Bifidobacterium animalis subspecies lactis (B lactis) alone or with 90% galacto-oligosaccharide (GOS) and 10% fructo-oligosaccharide (FOS) on infections in infants. METHODS: In a multicenter trial, healthy, term, newborn infants ages 42 days or younger whose mothers had decided not to breast-feed beyond this age received infant and follow-on formulas containing B lactis (10 colony-forming units/g) + GOS/FOS (0.4 g/100 mL, intention-to-treat, n = 261) or B lactis alone (10 colony-forming units/g, intention-to-treat, n = 267). Investigators accessed computer-generated randomization sequences via a remote server. Infants were exclusively fed formulas until 4 to 6 months of age and along with complementary feeding thereafter up to 12 months. The primary outcome was the mean number of annual infections reported by the investigators. Secondary outcomes were mean gains in anthropometric measurements, frequency of antibiotic use, and occurrence of adverse events based on investigators' records at each visit and gastrointestinal tolerance (daily stool frequency and consistency) and volume of formula intake recorded in 6-day diaries by parents. RESULTS: Mean ± standard deviation infection rates in infants followed up to 12 months (full analysis set) were 4.9 ± 3.2 per infant per year in the B lactis + GOS/FOS group (n = 219) and 4.5 ± 3.0 per infant per year in the B lactis group (n = 220; analysis of variance, P = 0.18). Mean daily weight gain was slightly lower in the B lactis + GOS/FOS than the B lactis group (16.1 ± 2.9 vs 16.6 ± 2.6 g/day, P = 0.046), but was not clinically significant. Other outcomes were not significantly different between groups. CONCLUSIONS: Formulas containing B lactis + GOS/FOS did not reduce infection rates beyond those containing only B lactis. Copyright © 2013 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.


Hammond J.,ETHICON,Inc. | Kozma C.,CK Consulting | Hart J.C.,ETHICON,Inc. | Nigam S.,Johnson and Johnson | And 3 more authors.
Annals of Surgical Oncology | Year: 2011

Background: Previous studies have reported VTE rates during surgical stays in hospitals or by diagnoses over extended periods without being linked to specific surgical events. The purpose of this project was to assess the potential rate of venous thromboembolism in patients with cancer after a surgical procedure within the immediate posthospital admission period of 30 days, with special emphasis in increased sensitivity of detection. Methods: Patients with cancer who had a major surgery were identified in a large commercial (non-Medicare) database containing data from more than 22 million patients in the United States. Those with a new diagnosis of VTE within 30 days postadmission for surgery were identified. Additional drug-based criteria were used to vary the VTE definition in a sensitivity analysis. VTE rates are reported for each of the surgical procedure group and overall. Results: The overall 30-day VTE rate was 3.5% with a diagnosis based definition, with rates ranging by procedure from 1.8 to 13.2%. Esophageal resection patients have a VTE rate of 13.2% (95% confidence interval (CI), 8.8-18.9%), whereas prostatectomy patients have a VTE rate of 1.8% (95% CI, 1.5-2.1%). Of the 3.5% of patients with a VTE diagnosis on or before postoperative day 30, 73% of those have the VTE diagnosis by day 14. Another 1.15% is added to the overall VTE rate as the definition sensitivity is increased with outpatient pharmacy claims data. Conclusions: Using administrative data from large populations provides valuable insight into the potential VTE rates that occur within the 30-day post period after various cancerrelated surgeries. The information can be used by surgeons as one component of the benefit-risk decision regarding postoperative VTE prophylaxis in surgical patients. © Society of Surgical Oncology 2011.


Hays S.,Hopital de la Croix Rousse | Hays S.,Rhone Alpes Human Nutrition Research Center | Jacquot A.,Hopital A de Villeneuve | Gauthier H.,Hopital Femme Mere Enfant | And 15 more authors.
Clinical Nutrition | Year: 2016

Background & aims: Recent studies have suggested that the gut microflora has metabolic effects. We aimed to evaluate postnatal growth in preterm infants who received different probiotic supplements, and to assess the safety of probiotic administration. Methods: This prospective, randomized, double-blind, controlled trial was performed at three tertiary care neonatal units. Preterm infants were randomly assigned to receive daily supplementation over 4-6 weeks with placebo (group C) or probiotics (group P). Group P comprised three subgroups: P1 received Bifidobacterium lactis, P2 received Bifidobacterium longum, and P3 received B. lactis and B. longum. We assessed postnatal growth during the supplementation period and up to a corrected gestational age (GA) of 41 weeks when body composition was assessed using whole-body dual-energy X-ray absorptiometry. Aerobic and anaerobic blood cultures were performed on suspicion of late-onset sepsis. Results: The study comprised 199 preterm infants with a mean GA of 29.1 ± 1.4 weeks and a mean birth weight of 1173 ± 210 g, who received a placebo (group C, n = 52) or probiotics (group P, n = 147) from the first week of life. At the end of the supplementation period, no statistically significant differences were seen between the groups in relation to the mean body weight (group C = 1906 ± 23 g, group P = 1875 ± 14 g, p = 0.25), length, or head circumference. The incidence rates of necrotizing enterocolitis and late-onset sepsis were similar in the two groups. At the corrected GA of 41 weeks, there were no differences between the groups with respect to anthropometric measurements or body composition analysis. Conclusions: Preterm infants receiving Bifidobacterium supplements did not exhibit better postnatal growth compared with those who received placebo treatment. No adverse effects were associated with probiotic administration. Registered under ClinicalTrials.gov Identifier no. NCT01379417. © 2015.


Virdi N.,LifeScan | Daskiran M.,Office of Evidence Based Medicine | Nigam S.,Office of Evidence Based Medicine | Kozma C.,CK Consulting | Raja P.,LifeScan
Diabetes Technology and Therapeutics | Year: 2012

Background: The value of self-monitoring of blood glucose (SMBG) for persons with type 2 diabetes who do not use insulin remains controversial. This observational study compares the likelihood of medication adherence and change in glycated hemoglobin (A1C) for non-insulin-using patients using SMBG versus those not using SMBG. The study also assessed the association between diabetes medication adherence and SMBG use. Patients and Methods: Data were extracted on 5,172 patients who began non-insulin diabetes medication between October 1, 2006, and March 31, 2009. The study assessed change in A1C associated with SMBG use and testing frequency at different categorical levels of baseline A1C. The likelihood of medication adherence for SMBG users was compared with that for non-SMBG users at different categorical levels of baseline A1C. The study further explored the interactions between SMBG use and medication adherence on change in A1C. Results: SMBG users had greater reductions in A1C compared with nonusers when the baseline A1C was ≥7%. Increasing SMBG frequency was associated with greater reductions in A1C. The study also examined the associations among SMBG use, medication adherence, and change in A1C. SMBG users had greater decreases in A1C for both medication-adherent and -nonadherent patients. As expected, medication adherence was associated with greater reductions in A1C for both SMBG nonusers and users. It is interesting that medication-nonadherent SMBG users had similar reductions in A1C compared with medication-adherent non-SMBG users. Conclusions: Both SMBG use and medication adherence were associated with similar degrees of A1C reduction after controlling for baseline A1C, suggesting that both factors may be important for attaining glycemic control. © Copyright 2012, Mary Ann Liebert, Inc. 2012.


Kozma C.M.,CK Consulting | Paris A.L.,Vigilytics LLC | Plauschinat C.A.,Novartis | Slaton T.,308 Canaberry Drive | Mackowiak J.I.,Center for Outcomes Research
BMC Pulmonary Medicine | Year: 2011

Background: The purpose of this analysis was to compare health care costs and utilization among COPD patients who had long-acting beta-2 agonist (LABA) OR long-acting muscarinic antagonist (LAMA); LABA AND LAMA; or LABA, LAMA, AND inhaled corticosteroid (ICS) prescription claims.Methods: This was a 12 month pre-post, retrospective analysis using COPD patients in a national administrative insurance database. Propensity score and exact matching were used to match patients 1:1:1 between the LABA or LAMA (formoterol, salmeterol, or tiotropium), LABA and LAMA (tiotropium/formoterol or tiotropium/salmeterol), and LABA, LAMA and ICS (bronchodilators plus steroid) groups. Post-period comparisons were evaluated with analysis of covariance. Costs were evaluated from a commercial payer perspective.Results: A total of 523 patients were matched using 29 pre-period variables (e.g., demographics, medication exposure). Post-match assessments indicated balance among the cohorts. COPD-related costs differed among groups (LABA or LAMA $2,051 SE = 91; LABA and LAMA $2,823 SE = 62; LABA, LAMA and ICS $3,546 SE = 89; all p < .0001) with the differences driven by study medication costs. However, non-study COPD medication costs were higher for the LABA or LAMA therapy group ($911 SE = 91) compared to the LABA and LAMA therapy group ($668 SE = 58; p = 0.0238) and non-study respiratory medications were approximately $100 greater for the LABA or LAMA therapy group relative to both LABA and LAMA (p = .0018) and LABA, LAMA, and ICS (p = .0071) therapy groups. While there was no observed difference in outpatient costs, there was a slightly higher number of outpatient visits per patient in the LABA and LAMA (25.5 SE = 0.9, p = 0.0070) relative to the LABA or LAMA therapy group (22.3 SE = 0.8) and higher utilization (89.7% of patients) with COPD visits in the LABA and LAMA therapy group relative to both the LABA or LAMA (73.8%; p < .0001) and LABA, LAMA and ICS therapy groups (85.3; p = 0.0305).Conclusions: Significant cost differences driven mainly by pharmaceuticals were observed among LABA or LAMA, LABA and LAMA and LABA, LAMA and ICS therapies. A COPD-related cost offset was observed from single bronchodilator to two bronchodilators. Addition of an ICS with two bronchodilators resulted in higher treatment costs without reduction in other COPD-related costs compared with two bronchodilators. © 2011 Kozma et al; licensee BioMed Central Ltd.

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