Introduction: Compared with low-molecular-weight heparin (LMWH) and warfarin, the oral anticoagulant rivaroxaban has advantages such as simplified care that may lead to less healthcare resource utilization (HRU). Objective: To compare HRU (hospitalization, emergency room [ER], and outpatient [OP] visit) among deep vein thrombosis (DVT) patients who received rivaroxaban or LMWH/warfarin in the outpatient setting. Methods: A retrospective matched-cohort analysis was conducted using the Truven Health Analytic MarketScan Claims database from 1/2011-12/2013. Adult patients with a primary diagnosis of DVT during an OP/ER visit after November 02, 2012, and who initiated treatment on the same day with rivaroxaban or LMWH/warfarin were identified. Patients were observed within 1, 2, 3, and 4 weeks after their DVT diagnosis. Mean number of all-cause and VTE (DVT or PE)-related hospitalizations and other HRU were evaluated using Lin’s method. Results: All of the 512 rivaroxaban patients were well-matched with LMWH/warfarin patients. Mean all-cause number of hospitalizations was significantly lower for rivaroxaban compared to LMWH/warfarin users within 1 week (0.012 vs 0.032; P=0.044) and 2 weeks (0.022 vs 0.048; P=0.040), and numerically lower within 3 weeks (0.038 vs 0.061; P=0.112) and 4 weeks (0.045 vs 0.078; P=0.058). Corresponding mean number of VTE-related hospitalizations was significantly lower for rivaroxaban within 1 week (0.008 vs 0.028; P=0.020) and 2 weeks (0.016 vs 0.042; P=0.020), numerically lower within 3 weeks (0.030 vs 0.052; P=0.074), and significantly lower within 4 weeks (0.034 vs 0.068; P=0.036). Corresponding all-cause OP visits were significantly lower for rivaroxaban users, while ER visits were similar between cohorts (Table 1). Conclusion: DVT patients treated with rivaroxaban following an OP/ER visits had significantly fewer hospitalizations and outpatient visits during the first weeks compared to matched LMWH/warfarin users.
While walnut trees on Juglans hindsii x J. regia ‘Paradox’ rootstocks are highly susceptible to crown gall, it is unknown whether this bacterial disease is acquired in the nursery or the orchard. We selected two groups of gall-free trees in nurseries, those adjacent to trees with and without galls. Two years after being transplanted in the orchard, trees in the group adjacent to those with galls had significantly greater — more than four times more — crown gall incidence than those adjacent to trees without galls (14% versus 3%). In addition, trees in prolonged (17-day), bare-root, unrefrigerated storage before transplanting were associated with higher crown-gall incidence. We also found that crown gall can decrease walnut tree productivity. For every quarter of trunk circumference that was galled, there was a 12% decrease in cumulative nut yield over the first 4 years of production.
The efficacy, safety and tolerability of topiramate has been demonstrated in three large multicenter, randomized, double‐blind, placebo‐controlled trials. To characterize the time course of adverse events (AEs) that led to treatment discontinuation in ≥2% of patients who received topiramate 100 mg/day during three pivotal, multicenter, randomized, double‐blind, placebo‐controlled, and 26‐week trials. The pooled population comprised all randomized patients who reported safety data during the double‐blind phase (topiramate 100 mg/day, n = 386; placebo n = 372), which consisted of a 4‐week titration period and a 22‐week maintenance period. Incidence, time to onset, and cumulative mean rate of AEs were assessed. Overall, AEs led to treatment discontinuation in 24.9% of patients receiving topiramate 100 mg/day and 11.0% receiving placebo ( P < 0.001). AEs leading to discontinuation during the double‐blind phase in ≥2% of patients included paresthesia (8.0% discontinued), any cognitive symptoms (7.3% discontinued), fatigue (4.7% discontinued), insomnia (3.4% discontinued), nausea (2.3% discontinued), loss of appetite, anxiety, and dizziness (2.1% discontinued because each AE). Most AEs began during the titration period. Paresthesia, any cognitive symptoms, nausea, and loss of appetite occurred at a higher rate in the topiramate group than in the placebo group ( P < 0.01). AEs leading to discontinuation of topiramate are probably to occur during dose titration. If a patient has not experienced one of these AEs within the first 6 weeks of initiating topiramate 100 mg/day, these AEs are unlikely to occur.
Two brothers, presented at ages 6 and 3, for evaluation of dystonia present from early infancy. Muscle strength was normal and the deep tendon reflexes brisk. Borderline intelligence, chorea, and abnormal electroencephalograms further documented the presence of cerebral disease. In the skeletal muscle, the A-fibers (dark reacting to adenosine triphosphatase pH 9.4) were abnormally small and contained ringbinden. These muscle findings are considered the result of an abnormal cerebral influence on the developing motor unit. Because of the unity of the neuromuscular system, abnormalities distant from the motor unit may be reflected in muscle fiber size and structure.
This multicenter, double-blind, placebo-controlled, randomized study of 45 patients evaluated the short-term effects of an oral contraceptive [Ortho Tri-Cyclen, 180–250 μg of norgestimate (NGM) and 35 μg of ethinyl estradiol (EE)] on biochemical markers of bone resorption, formation, and osteoprotegerin in young women (mean age ± sd, 26.5 ± 6.3 yr) with hypothalamic amenorrhea and osteopenia. Body fat, endocrine, and cognitive function were evaluated as secondary endpoints. Biomarkers of bone metabolism were measured at baseline and after three cycles of NGM/EE or placebo. There were significant decreases in mean values of N-telopeptide [mean (sd), −13.4 (13.4) vs. 1.2 (23.8) nmol bone collagen equivalents (BCE)/mmol creatinine (Cr); P = 0.001] and deoxypyridinoline [−1.2 (2.9) vs. −0.5 (1.5) nmol deoxypyridinoline/mmol Cr; P = 0.021] as well as significant decreases in bone specific alkaline phosphatase [−5.1 (3.5) vs. 0.4 (3.1) ng/ml; P < 0.001], osteocalcin [−5.9 (3.6) vs. −2.9 (3.7); P = 0.016], and procollagen of type I propeptide [−35.2 (44.6) vs. −0.2 (30.0) ng/ml; P = 0.025], but not osteoprotegerin [0.39 (1.46) vs. −0.2 (0.49) pmol/liter; P = 0.397] in the NGM/EE vs. placebo group. There were no significant differences between groups with respect to changes in cognitive function, mood, body weight, body mass index, body fat, percentage of body fat, and all endocrine levels except FSH, [−3.7 (3.8) vs. −0.6 (2.1) IU/liter; P < 0.001, NGM/EE vs. placebo]. No serious adverse events were reported in either group. These results suggest that NGM/EE decreases bone turnover in osteopenic premenopausal women with hypothalamic amenorrhea. Further studies are needed to determine whether estrogen will increase bone density in this population.
To examine the association between adherence and site of care among individuals with inflammatory bowel disease (IBD) treated with infliximab. Adult patients with new claim(s) for infliximab (no claims for at least 360 days) between January 1, 2006 to December 31, 2009 and ≥2 IBD diagnoses of Crohn’s disease (CD; ICD-9-CM: 555.XX) or ulcerative colitis (UC; ICD-9-CM: 556.XX) were identified from Thomas Reuters Marketscan® Databases. Patients were required to be continuously enrolled for 12 months before and after infliximab initiation (index date). Patients with evidence of another biologic or rheumatoid arthritis (ICD-9-CM: 714.XX) were excluded. Being adherent was defined as having an infliximab medication possession ratio (MPR) of ≥80%. MPR was calculated as the sum of unduplicated days of therapy based on infusion dates and duration of action from prescribing information, divided by 360 days. Site of care was obtained from the first infliximab infusion claim. Sites were divided into three settings: office, outpatient hospital and “other” (e.g., home, ER). Odds of being adherent versus non-adherent were compared for these settings in a logistic model controlling for patient characteristics and resource use variables. 1646 IBD patients were identified; 57.4% CD and 42.6% UC. The mean (SD) age was 44.4 (15.6) years and 51.7% were male. On index, 1,052 (63.9%) patients had a site of care for office on their first infliximab infusion claim, 510 (31.0%) had outpatient hospital, and 84 (5.1%) had “other”. Patients in the office setting had greater odds of being adherent relative to outpatient hospital (p<0.0001; OR 2.5, 95% CI [1.9, 3.2]) and ‘other’ (p=0.0039; OR 2.1, 95% CI [1.3, 3.4]). Outpatient hospital was not significantly different than the ‘other’ location (p=0.5204). Findings suggest that having an office site of care is associated with increased infliximab adherence relative to the outpatient hospital setting.
We have reported that in the dog gastric secretion and motility are depressed considerably during the first 30 minutes after injection of insulin. Recently, we have described a similar observation on the gastric secretion of patients with active duodenal ulcer. It was felt to be necessary to confirm the latter results in a comparable group of normal subjects. The stomach of a patient with active duodenal ulcer appears to be in a state of irritability and of secretory stimulation. Therefore, results obtained in such patients need not be applicable to normal subjects. PROCEDURE Thirty-three healthy male prisoners volunteered as subjects for the test. Their ages varied between 25 and 54 years, with an average age of 40 years. A careful history was taken and physical examination was given in order to exclude disease, particularly peptic ulcer. Persons who at any time had taken baking soda or other drugs used in ulcer
Objective: To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities.Methods: Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire. Cognitive debriefing interviews were conducted with patients to determine the clarity and content of the instructions, items, and response scales, and the ease of completing the instrument. Psychometric evaluation was performed with patients who had undergone surgery and received IV PCA for postoperative pain management. Item and scale quality and the internal consistency reliability of the questionnaire were assessed. Construct validity was evaluated by examining the relationship between subscales of the questionnaire with patient-reported outcome measures. Known-groups validity was determined by assessing the instrument's ability to differentiate between patients with versus without an IV PCA problem. A potential limitation of this study was the exclusive sampling of patients who had experience with IV PCA.Results: The Patient Ease-of-Care (EOC) Questionnaire included 23 items in the following subscales: Confidence with Device, Comfort with Device, Movement, Dosing Confidence, Pain Control, Knowledge/Understanding, and Satisfaction. Coefficient alpha reliability estimates were ≥0.66 for Overall EOC (includes all subscales except Satisfaction) and all EOC subscales. Construct validity was supported by the moderate relationship between the Pain Control subscale and measures of pain severity and pain interference; additional evidence of construct validity was provided by correlations of the Confidence with Device subscale, the Satisfaction subscale, and Overall EOC with measures of pain severity, pain interference, and satisfaction. Significant mean score differences were reported between participants with and without IV PCA problems for Overall EOC and for the Comfort with Device, Confidence with Device, Movement, Pain Control, and Satisfaction subscales indicating known-groups validity.Conclusions: Results provide evidence for the reliability and validity of the Patient EOC Questionnaire as a measure of the ease of use that patients associate with PCA systems and may be useful for evaluating emerging PCA modalities.