scholarly journals Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials

2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Anirban Basu ◽  
Vimalanand S Prabhu ◽  
Mary Beth Dorr ◽  
Yoav Golan ◽  
Erik R Dubberke ◽  
...  

Abstract Background Patients with recurrent Clostridium difficile infection (rCDI) are more likely to have a hospital readmission and spend increased time in inpatient settings compared with patients with primary CDI. MODIFY I and II demonstrated that bezlotoxumab significantly reduced rCDI vs placebo. A post hoc within-trial analysis assessed whether bezlotoxumab was associated with a reduction in cumulative inpatient-days. Methods Data were pooled from the MODIFY trials to estimate the cumulative hospitalized days summed over the 84-day follow-up period. We adjusted inpatient use data from pooled MODIFY I and II for survival and censoring to estimate 84-day cumulative inpatient-days, overall and for subgroups. Treatment effects were obtained using recycled predictions based on trial protocol and rCDI risk, and 95% confidence intervals were obtained using 1000 bootstrap replicates. Results Mean cumulative inpatient-days were greater in the placebo arm (14.1 days) vs the bezlotoxumab arm (12.1 days) in the overall population. The mean difference between treatment groups was 2.1 days (95% confidence interval, –0.4 to –3.7). This was consistent in participants with risk factors for rCDI: age ≥65 years, compromised immunity, severe CDI, prior CDI, and ribotype 027/078/244 infection. As the number of risk factors increased, bezlotoxumab resulted in greater reductions in the number of inpatient-days compared with placebo (difference: –1.2 days, –2.3 days, –2.5 days, and –3.0 days for 0, 1, 2, and ≥3 risk factors, respectively). Conclusions Bezlotoxumab was associated with a reduction in cumulative inpatient-days, suggesting that treatment with bezlotoxumab may substantially reduce rCDI-associated health care resource use. Trial registrations. MODIFY I (MK-3415A-001, NCT01241552) and II (MK-3415A-002, NCT01513239)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1563.3-1563
Author(s):  
H. Tamaki ◽  
S. Fukui ◽  
T. Nakai ◽  
G. Kidoguchi ◽  
S. Kawaai ◽  
...  

Background:Currently it is hypothesized that many systemic autoimmune diseases occur due to environmental risk factors in addition to genetic risk factors. Anti-Neutrophil Cytoplasmic Antibody (ANCA) is mainly associated with three systemic autoimmune disease including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA). It is known that ANCA can be positive before clinical symptoms in patients with known diagnosis of GPA and ANCA titers rise before clinical manifestations appear. However, prevalence of ANCA among general population is not well known. It has not been described as well how many of people with positive ANCA eventually develop clinical manifestations of ANCA associated Vasculitis.Objectives:This study aims to estimate prevalence of ANCA in general population without ANCA associated Vasculitis. It also describes natural disease course of people with positive ANCA without ANCA associated Vasculitis. Risk factors for positive ANCA are also analyzed.Methods:This is a single center retrospective study at Center for Preventive Medicine of St. Luke’s International Hospital in Tokyo. ANCA was checked among the patients who wished to between 2018 and 2019. St. Luke’s Health Check-up Database (SLHCD) was utilized to collect the data. The patients whose serum was measured for ANCA were identified. The data for basic demographics, social habits, dietary habits and laboratory data were extracted. The charts of the patients with positive ANCA were reviewed.Results:Sera of total 1204 people were checked for ANCA. Of these 1204 people, 587 (48.8%) are male and the mean age was 55.8 years (32.6 to 79). There were total 11 patients with positive ANCA. Myeloperoxidase ANCA (MPO-ANCA) was positive for 3 patients and proteinase 3 ANCA (PR3-ANCA) was positive for 8 patients. Of these 11 patients, 5 were male (45.5%) and the mean age was 54.6 years. Two patients had history of autoimmune disease (primary biliary cirrhosis and ulcerative colitis). Five patients were evaluated by rheumatologists with the median follow-up period of 274 days. None of them developed clinical signs and symptoms of ANCA associated Vasculitis. Four out of five patients had ANCA checked later, two of which turned negative. The prevalence of ANCA in this cohort was 0.9% (95% confidence interval [95% CI]: 0.5% to 1.6%). Univariate analysis was performed to identify risk factors of positive ANCA. The variables analyzed include age, gender, body mass index (BMI), smoking habits, alcohol intake, dietary habits (fruits, fish, red meat), hypertension, dyslipidemia, and laboratory data. None of these variables demonstrated statistically significant differences except for positive rheumatoid factor (ANCA positive group: 33 % vs ANCA negative group: 9.1%, p value = 0.044).Conclusion:The prevalence of ANCA in this cohort was 0.9% (95% CI: 0.5% to 1.6%). None of them who had a follow-up developed ANCA associated Vasculitis during the follow-up period. Longer follow-up and more patients are necessary to determine natural course of people with positive ANCA.Disclosure of Interests:None declared


2013 ◽  
Vol 118 (1) ◽  
pp. 58-62 ◽  
Author(s):  
William J. Kemp ◽  
Daniel H. Fulkerson ◽  
Troy D. Payner ◽  
Thomas J. Leipzig ◽  
Terry G. Horner ◽  
...  

Object A small percentage of patients will develop a completely new or de novo aneurysm after discovery of an initial aneurysm. The natural history of these lesions is unknown. The authors undertook this statistical evaluation a large cohort of patients with both ruptured and unruptured de novo aneurysms with the aim of analyzing risk factors for rupture and estimating a risk of subarachnoid hemorrhage (SAH). Methods A review of a prospectively maintained database of all aneurysm patients treated by the vascular neurosurgery service of Goodman Campbell Brain and Spine from 1976–2010 was performed. Of the 4718 patients, 611 (13%) had long-term follow-up imaging. The authors identified 27 patients (4.4%) with a total of 32 unruptured de novo aneurysms from routine surveillance imaging. They identified another 10 patients who presented with a new SAH from a de novo aneurysm after treatment of their original aneurysm. The total study group was thus 37 patients with a total of 42 de novo aneurysms. The authors then compared the 27 patients with incidentally discovered aneurysms with the 10 patients with SAH. A statistical analysis was performed, comparing the 2 groups with respect to patient and aneurysm characteristics and risk factors. Results Thirty-seven patients were identified as having true de novo aneurysms. This group had a female predominance and a high percentage of smokers. These 37 patients had a total of 42 de novo aneurysms. Ten of these 42 aneurysms hemorrhaged. De novo aneurysms in both the SAH and non-SAH group were anatomically small (< 10 mm). The estimated risk of hemorrhage over 5 years was 14.5%, higher than the expected SAH risk of small, unruptured aneurysms reported in the ISUIA (International Study of Unruptured Intracranial Aneurysms) trial. There was no statistically significant correlation between hemorrhage and any of the following risk factors: hypertension, diabetes, tobacco and alcohol use, polycystic kidney disease, or previous SAH. There was a statistically significant between-groups difference with respect to patient age, with the mean patient age being significantly older in the SAH aneurysm group than in the non-SAH group (p = 0.047). This is likely reflective of longer follow-up and discovery time, as the mean length of time between initial treatment and discovery of the de novo aneurysm was longer in the SAH group (p = 0.011). Conclusions While rare, de novo aneurysms may have a risk for SAH that is comparatively higher than the risk associated with similarly sized, small, initially discovered unruptured saccular aneurysms. The authors therefore recommend long-term follow-up for all patients with aneurysms, and they consider a more aggressive treatment strategy for de novo aneurysms than for incidentally discovered initial aneurysms.


2018 ◽  
Vol 128 (1) ◽  
pp. 120-125 ◽  
Author(s):  
Robert F. Spetzler ◽  
Joseph M. Zabramski ◽  
Cameron G. McDougall ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  

OBJECTIVEThe Barrow Ruptured Aneurysm Trial (BRAT) is a prospective, randomized trial in which treatment with clipping was compared to treatment with coil embolization. Patients were randomized to treatment on presentation with any nontraumatic subarachnoid hemorrhage (SAH). Because all other randomized trials comparing these 2 types of treatments have been limited to saccular aneurysms, the authors analyzed the current BRAT data for this subgroup of lesions.METHODSThe primary BRAT analysis included all sources of SAH: nonaneurysmal lesions; saccular, blister, fusiform, and dissecting aneurysms; and SAHs from an aneurysm associated with either an arteriovenous malformation or a fistula. In this post hoc review, the outcomes for the subgroup of patients with saccular aneurysms were further analyzed by type of treatment. The extent of aneurysm obliteration was adjudicated by an independent neuroradiologist not involved in treatment.RESULTSOf the 471 patients enrolled in the BRAT, 362 (77%) had an SAH from a saccular aneurysm. Patients with saccular aneurysms were assigned equally to the clipping and the coiling cohorts (181 each). In each cohort, 3 patients died before treatment and 178 were treated. Of the 178 clip-assigned patients with saccular aneurysms, 1 (1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. There was no statistically significant difference in poor outcome (modified Rankin Scale score > 2) between these 2 treatment arms at any recorded time point during 6 years of follow-up. After the initial hospitalization, 1 of 241 (0.4%) clipped saccular aneurysms and 21 of 115 (18%) coiled saccular aneurysms required retreatment (p < 0.001). At the 6-year follow-up, 95% (95/100) of the clipped aneurysms were completely obliterated, compared with 40% (16/40) of the coiled aneurysms (p < 0.001). There was no difference in morbidity between the 2 treatment groups (p = 0.10).CONCLUSIONSIn the subgroup of patients with saccular aneurysms enrolled in the BRAT, there was no significant difference between modified Rankin Scale outcomes at any follow-up time in patients with saccular aneurysms assigned to clipping compared with those assigned to coiling (intent-to-treat analysis). At the 6-year follow-up evaluation, rates of retreatment and complete aneurysm obliteration significantly favored patients who underwent clipping compared with those who underwent coiling.Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Filippo Migliorini ◽  
Francesco Oliva ◽  
Gayle D. Maffulli ◽  
Jörg Eschweiler ◽  
Matthias Knobe ◽  
...  

Abstract Background The medial patellofemoral ligament (MPFL) is always damaged after patellar dislocation. In selected patients, MPFL reconstruction is necessary to restore a correct patellar tracking. Despite the large number of different techniques reported to reconstruct the MPFL, there is no consensus concerning the optimal procedure, and debates is still ongoing. The present study analysed the results after isolated MPFL reconstruction in patients with patellofemoral instability. Furthermore, a subgroup analysis of patients presenting pathoanatomical risk factors was made. Methods In November 2020, the main electronic databases were accessed. All articles reporting the results of primary isolated MPFL reconstruction for recurrent patellofemoral instability were considered for inclusion. Only articles reporting a minimum 12-month follow-up were eligible. Results Data from a total of 1777 knees were collected. The mean age of the patients involved was 22.8 ± 3.4 years. The mean follow-up was 40.7 ± 25.8 months. Overall, the range of motion (+ 27.74; P < 0.0001) and all the other scores of interests improved at last follow-up: Kujala (+ 12.76; P = 0.0003), Lysholm (+ 15.69; P < 0.0001), Tegner score (+ 2.86; P = 0.006). Seventy-three of 1780 patients (4.1%) showed a positive apprehension test. Thirty of 1765 patients (1.7%) experienced re-dislocations, while 56 of 1778 patients (3.2%) showed persisting joint instability. Twenty-five of 1786 patients (1.4%) underwent revision surgeries. Conclusion Isolated MPFL reconstruction for recurrent patellofemoral instability provides reliable surgical outcomes. Patients with pathoanatomical predisposing factors reported worse surgical outcomes.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Selvakumar Kritika ◽  
V. Sujatha ◽  
N. Srinivasan ◽  
Senthil Kumar Renganathan ◽  
Sekar Mahalaxmi

AbstractRegenerative endodontic procedures have gained momentum as a treatment modality of young immature permanent teeth. Literature reports reveal that platelet-rich fibrin (PRF) stimulates growth factors and induces regeneration. This study was undertaken to assess the regenerative potential of non-vital immature permanent maxillary central incisors using PRF with a follow-up for 2 yrs. 19 patients in the age group of 9–25 yrs with immature, non-vital permanent maxillary central incisors (n = 23) with/without signs and/or symptoms of periapical pathosis and open apex were included in this study. In the first appointment, access opening, canal disinfection and triple antibiotic paste placement were done. In the subsequent visit, PRF was prepared and placed inside the canal. Access was sealed with Mineral trioxide aggregate plug and composite. The patient was reviewed up to 24 mths. The mean difference was statistically analyzed using Friedman test followed by Dunn post hoc test and adjusted by Bonferroni correction (p < 0.05). As per AAE guidelines, the primary and secondary goals were achieved. A significant (p < 0.001) gradual increase in the root length, thickness of dentinal walls and decrease in apical diameter were observed. Within the limitations of this study, PRF placement was clinically and radiographically effective in inducing regeneration of non-vital immature permanent teeth.


2000 ◽  
Vol 18 (20) ◽  
pp. 3487-3494 ◽  
Author(s):  
Kaija Holli ◽  
Ritva Valavaara ◽  
Guillermo Blanco ◽  
Vesa Kataja ◽  
Päivi Hietanen ◽  
...  

PURPOSE: In this multicenter trial, toremifene 40 mg/d was compared with tamoxifen 20 mg/d, both given orally for 3 years to postmenopausal, axillary node–positive women after breast surgery. PATIENTS AND METHODS: The first 899 patients (toremifene, n = 459; tamoxifen, n = 440) of the total of 1,480 patients accrued to the trial were included in this scheduled safety analysis. The mean follow-up time was 3.4 years. RESULTS: The two treatment groups were well balanced with respect to patient and disease characteristics. The subjective side-effect profile was similar in both treatment groups. Slightly more vascular complications (deep vein thromboses, cerebrovascular events, and pulmonary embolisms) were seen among tamoxifen-treated patients (5.9%) as compared with toremifene-treated patients (3.5%) (P = .11), whereas bone fractures (P = .09) and vaginal leukorrhea (P = .05) were more common in the toremifene group. The number of subsequent second cancers was similar. The breast cancer recurrence rate was 23.1% (n = 106) in the toremifene group and 26.1% (n = 115) in the tamoxifen group (P = .31). When only patients with estrogen receptor (ER)–positive cancer were considered (n = 556), the risk for breast cancer recurrence was nonsignificantly lower among the toremifene-treated women, with a hazards ratio of 0.74 (90% confidence interval, 0.52 to 1.04; P = .14). The mean time to breast cancer recurrence and overall survival were similar in both groups. CONCLUSION: The side-effect profile of toremifene resembles that of tamoxifen. The efficacy of toremifene seems to be no less than that of tamoxifen. The trend for fewer breast cancer recurrences in the ER-positive subgroup is encouraging, but a longer follow-up is needed to confirm this.


2020 ◽  
Author(s):  
Xiaoqin Yang ◽  
Kaushal Desai ◽  
Neha Agrawal ◽  
Kirti Mirchandani ◽  
Sagnik Chatterjee ◽  
...  

Abstract Background: Neurofibromatosis type 1 (NF1)-related plexiform neurofibromas (PN) can cause substantial morbidity by disfigurement and compression of vital structures. Real-world data on the burden and cost of disease among pediatric patients with NF1 and PN is limited. The objectives of this study were to describe the characteristics, treatment patterns, healthcare resource use (HCRU), and costs of these patients.Results: A total of 383 patients were included in the retrospective analysis of patients aged ≤18 with at least 1 ICD-10-CM diagnosis code for both NF1 and PN enrolled in the MarketScan® Multistate Medicaid database from October 1, 2014 to December 31, 2017. The mean follow-up was 448 days. The mean age was 11.4 years and 52.0% of patients were male. Most patients were diagnosed by a specialist (63.5%). During the follow-up period, pain medications were used by 58.5% of patients, 25.1% were treated with chemotherapy, 7.1% received surgery for PN, 1.6% received MEK inhibitors, and 0.8% received radiation. Mean per patient per year inpatient, outpatient, emergency room, pharmacy, and other visits were 1.4, 17.3, 1.6, 13.6, and 25.8, respectively. Mean ±SD (median) total per patient per year healthcare costs (2018 USD) were $17,275 ±$61,903 ($2,889), with total medical costs of $14,628 ±$56,203 ($2,334) and pharmacy costs of $2,646 ±$13,303 ($26). Inpatient costs were the largest drivers of medical cost, with a mean per patient per year cost of $6,739.Conclusions: This study showed that many pediatric patients diagnosed with NF1 and PN were treated with supportive care only, highlighting a substantial unmet medical need. This study also highlights the considerable economic burden among patients with NF1 and PN.


2018 ◽  
Vol 30 (1) ◽  
pp. 162-167 ◽  
Author(s):  
Dina H Hassanein ◽  
Ahmed Awadein ◽  
Hala Elhilali

Purpose: To analyze the risk factors associated with early and late failure after goniotomy for primary pediatric glaucoma. Methods: A retrospective study was done on infants who underwent goniotomy as the initial surgical procedure for primary pediatric glaucoma, and had a follow-up period ⩾48 months after surgery. Early and late failures were defined as intraocular pressure ⩾18 mmHg or signs of glaucoma progression before and after the end of first year, respectively. Results: A total of 81 eyes of 47 children were included. The mean age at the time of surgery was 6.1 ± 6.7 months, 34 children (72.3%) were bilateral. The mean follow-up was 5.9 ± 2.8 years. Of the included eyes, 41 eyes (50.6%) showed success, 25 eyes (30.9%) showed an early failure, and 15 eyes (18.5%) showed a late failure. The mean survival time was 43 months. However, only surgery before the end of the first month and positive consanguinity of the parents (P < 0.01 for both) were independent risk factors for early and late failure of goniotomy for primary pediatric glaucoma. Patients with late failure showed a statistically significant lower preoperative intraocular pressure (P = 0.02). A larger preoperative corneal diameter and a male gender were associated with higher but statistically insignificant failure rates. There were no differences in the early or late failure rates between unilateral and bilateral cases. Conclusion: A positive consanguinity of the parents and surgery before the end of the first month are the major predictors of failure of goniotomy.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Inge Derad ◽  
Johanna Busch ◽  
Martin Nitschke ◽  
Malte Ziemann

Abstract Background and Aims Posttransplant kidney survival depends on several risk factors. A careful immunogenetic matching and the absence of HLA donor specific antibodies (DSA) seem to determine the longevity of the transplant. Method Screening the presence of donor specific HLA antibodies in our posttransplant outpatients was implemented in 2010 (every 6 months in case of DSA free patients for two years, then yearly, and every 3 months in case of DSA + patients for two years, then twice a year). At the same time a treatment protocol was implemented, omitting reduction of immunosuppressive drugs in case of newly detected DSA, and most important with preventing steroid withdrawal in this case.The present single center study reports the long-term survival and kidney function from patients undergoing HLA-screening after transplantation between 2010 and 2016 with a follow-up until 2018. Using a Kaplan-Meier analysis patients without HLA antibodies (no HLA-ab), with HLA antibodies but without DSA (NDSA), and with donor-specific HLA antibodies (DSA) were compared by logrank-testing. Results A full dataset was obtained from 318 patients. The mean overall survival (patients and organ function) didn´t differ between the three groups, p=0.318: no HLA-ab 7.2 years (95%confidence interval 6.7;7.6), NDSA 6.6 (5.9;7.2), DSA 6.8 (6.1;7.5), overall 7.0 (6.6;7.3), events are given in Table1. Whereas the mean patient survival didn´t differ between the groups (p=0.715), the mean death-censored graft survival differed significantly, p=0.008, with a reduced transplant survival in the patients with HLA antibodies but without donorspecific antibodies: no HLA-ab 8.0 years (95%confidence interval 7.7;8.3), NDSA 7.0 (6.4;7.6), DSA 7.6 (7.1;8.2), overall 7.7 (7.4;8.0), numbers are given in Table1. Conclusion In conclusion, the presence of HLA antibodies was associated with a reduced transplant survival. Patients with HLA antibodies had a worse survival than patients with DSA undergoing HLA screening with a personalised immunosuppressive regimen. Immunosuppressive regimen of the groups, as well as other known risk factors of graft survival have to be further analysed. The results of these multivariate analyses have to be awaited to determine whether the risk for graft loss inferred by HLA antibodies is independent from other factors.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Maria Glans ◽  
Annika Kragh Ekstam ◽  
Ulf Jakobsson ◽  
Åsa Bondesson ◽  
Patrik Midlöv

Abstract Background The area of hospital readmission in older adults within 30 days of discharge is extensively researched but few studies look at the whole process. In this study we investigated risk factors related, not only to patient characteristics prior to and events during initial hospitalisation, but also to the processes of discharge, transition of care and follow-up. We aimed to identify patients at most risk of being readmitted as well as processes in greatest need of improvement, the goal being to find tools to help reduce early readmissions in this population. Methods This comparative retrospective study included 720 patients in total. Medical records were reviewed and variables concerning patient characteristics prior to and events during initial hospital stay, as well as those related to the processes of discharge, transition of care and follow-up, were collected in a standardised manner. Either a Student’s t-test, χ2-test or Fishers’ exact test was used for comparisons between groups. A multiple logistic regression analysis was conducted to identify variables associated with readmission. Results The final model showed increased odds of readmission in patients with a higher Charlson Co-morbidity Index (OR 1.12, p-value 0.002), excessive polypharmacy (OR 1.66, p-value 0.007) and living in the community with home care (OR 1.61, p-value 0.025). The odds of being readmitted within 30 days increased if the length of stay was 5 days or longer (OR 1.72, p-value 0.005) as well as if being discharged on a Friday (OR 1.88, p-value 0.003) or from a surgical unit (OR 2.09, p-value 0.001). Conclusion Patients of poor health, using 10 medications or more regularly and living in the community with home care, are at greater risk of being readmitted to hospital within 30 days of discharge. Readmissions occur more often after being discharged on a Friday or from a surgical unit. Our findings indicate patients at most risk of being readmitted as well as discharging routines in most need of improvement thus laying the ground for further studies as well as targeted actions to take in order to reduce hospital readmissions within 30 days in this population.


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