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Well-established Treatment (well-established + treatment)
Selected AbstractsA randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulationHAEMOPHILIA, Issue 5 2007B. V. BYSTED Summary., Recombinant activated factor VIIa (rFVIIa) is a well-established treatment for bleeding episodes in patients with congenital or acquired haemophilia A or B with inhibitors to factors VIII and IX and patients with FVII deficiency. The aim of this trial was to demonstrate bioequivalence between the currently marketed (rFVIIa/NovoSeven®) and a new rFVIIa formulation (VII25) stable at up to 25°C. Furthermore, short-term safety and tolerability of VII25 and pharmacokinetics of both formulations were investigated. In this single-centre, randomized, double-blind, two-way cross-over trial, healthy male subjects received one intravenous bolus injection of rFVIIa and one of VII25, both at 90 ,g kg,1, in a randomized order 2,3 weeks apart. Mean VII25/rFVIIa ratio for area under the plasma activity-time curve from time 0 to last quantifiable activity (primary bioequivalence endpoint), was 0.93, 90% confidence interval (CI) (0.89,0.96), within the predefined bioequivalence range (0.80,1.25). Secondary pharmacokinetic parameters were comparable between formulations. No serious adverse events were observed. Six mild or moderate treatment-emergent adverse events were reported in five subjects. Coagulation-related parameter profiles were similar between rFVIIa and VII25. No clinically abnormal changes were observed for laboratory parameters and no subjects developed FVIIa antibodies. This trial demonstrated bioequivalence between the currently available rFVIIa and VII25 stable at up to 25°C. VII25's ,user-friendly' formulation removes the inconvenience of storing/transporting at 2,8°C, and as the drug substance is the same, the activity and safety established for rFVIIa is maintained. [source] Identification of Hemodynamically Significant Restenosis after Percutaneous Transluminal Coronary Angioplasty in Acute Myocardial Infarction by Transesophageal Dobutamine Stress Echocardiography and Comparison with Myocardial Single Photon Emission Computed TomographyJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 3 2001STEPHAN ROSENKRANZ M.D. Background: Beside thrombolysis, percutaneous transluminal coronary angioplasty (PTCA) has become a well-established treatment for acute myocardial infarction. However, restenosis occurs in approximately 15%-40 % of patients. Despite a frequently occurring infarct-related regional systolic dysfunction at rest, the identification of hemodynamically relevant restenosis seems important in terms of risk stratification, adequate treatment, and possible improvement of prognosis in these patients. This study was designed to assess the role of transesophageal dobutamine stress echocardiography and myocardial scintigraphy for identification of hemodynamically significant restenosis after PTCA for acute myocardial infarction. Methods: Multiplane transesophageal stress echocardiography (dobutamine 5, 10, 20, 30, and 40 ,g/kg per min) studies and myocardial single photon emission computed tomography (SPECT) studies were performed in 40 patients, all of whom underwent PTCA in the setting of acute myocardial infarction , 4 months prior to the test. Repeated coronary angiography was performed in all study patients who showed stress-induced perfusion defects or wall-motion abnormalities, or both. Results: Significant restenosis (, 50%) was angiographically found in 15 (37.5%) of 40 patients. Of these 15 patients, transesophageal dobutamine stress echocardiography identified restenosis in 12 (80%) and myocardial SPECT in 14 (93%), yielding diagnostic agreement in 70% of patients. Echocardiographic detection of restenosis was based mainly on a biphasic response to increasing doses of dobutamine. Sensitivity and specificity for identification of hemodynamically relevant restenosis in individual patients was 80% and 92%, respectively for dobutamine stress echocardiography versus 93% and 68% for myocardial SPECT. Conclusions: Both transesophageal dobutamine stress echocardiography and myocardial SPECT were highly sensitive in identifying significant restenosis after PTCA for acute myocardial infarction. Therefore, either test, as a single diagnostic tool or especially if performed together, are clinically valuable alternatives to coronary angiography for the detection of restenosis after PTCA for acute myocardial infarction. [source] High-risk HPV presence in cervical specimens after a large loop excision of the cervical transformation zone: Significance of newly detected hr-HPV genotypesJOURNAL OF MEDICAL VIROLOGY, Issue 3 2007Maaike A.P.C. van Ham Abstract Large loop excision of the cervical transformation zone (LLETZ) is a well-established treatment for high-grade cervical intraepithelial neoplasia. It has even been postulated that LLETZ is responsible for the elimination of the infectious agent, human papillomavirus (HPV), causing the lesion. Most studies on HPV detection after LLETZ have focused on the persistence of high-risk (hr-) HPV to identify women at risk for residual or recurrent disease. Therefore, the appearance and significance of hr-HPV types newly detected after surgical treatment has not been studied extensively so far. The presence of hr-HPV in 85 high-grade squamous cervical LLETZ biopsies and in the first follow-up smear was determined. In 80 (94%) of the LLETZ biopsies hr-HPV was detected in contrast to 30 (35%) hr-HPV positive follow-up scrapes. Twenty of the 80 hr-HPV positive women (25%) had the same hr-HPV genotypes in their follow-up cervical smears as was found in the corresponding biopsies. In the follow-up smear of 13 women a new hr-HPV genotype was detected and HPV 18 was newly detected in 8 of them. The remarkably high presence of newly detected HPV 18 genotypes may argue for a release or re-activation of this virus from proximal layers of the cervical canal incised during surgery. J. Med. Virol. 79:314,319, 2007. © 2007 Wiley-Liss, Inc. [source] Roentgen stereophotogrammetric analysis and clinical assessment of unipolar versus bipolar hemiarthroplasty for subcapital femur fracture: a randomized prospective studyANZ JOURNAL OF SURGERY, Issue 4 2010Benjamin Jeffcote Abstract Background:, Hemiarthroplasty is a well-established treatment for displaced subcapital fracture, but controversy exists about the optimal implant type. Bipolar hemiarthroplasty has proposed advantages over unipolar hemiarthroplasty in terms of better clinical results and decreased wear of acetabular cartilage. Methods:, This study is a randomized prospective study of 51 patients (52 hips) receiving either bipolar or unipolar hemiarthroplasty for displaced subcapital fractures. The outcome measurements were clinical scores and Roentgen stereophotogrammetric analysis (RSA) analysis to determine the rate of acetabular wear. Results:, Twenty-three patients completed 2-year follow-up. The RSA data demonstrated that there was slightly less acetabular wear by bipolar prostheses than by unipolar. The combined mean three-dimensional wear of the bipolar prostheses was 0.6 mm compared with 1.5 mm for the unipolar prostheses (P= 0.04). The bipolar group generally achieved higher scores in terms of the Harris Hip Score, Western Ontario and McMaster University Index of Osteoarthritis (WOMAC) questionnaire and 6-min walk test. These results were statistically significant at 3 months but not at 12 and 24 months. Conclusion:, This study suggests that while the bipolar prosthesis performs slightly better than the unipolar in terms of acetabular cartilage wear and clinical outcomes, it remains debatable whether the benefits are worth the increased cost of the prosthesis. [source] Hepatic arterial infusion of chemotherapy for advanced hepatocellular carcinomaASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 2 2010Yu-Yun SHAO Abstract Treatment of advanced hepatocellular carcinoma (HCC) remains a significant problem for clinicians. Sorafenib, the only approved agent, improves survival rate, but is associated with a low tumor response rate. Alternative approaches for the treatment of advanced HCC are urgently needed. Hepatic arterial infusion of chemotherapy (HAIC) is a promising modality for the treatment of advanced HCC. Since its introduction, there have been improvements in implantable pumps, in catheter implantation and in the convenience and safety of HAIC in general. Numerous clinical studies have shown that HAIC provides moderate therapeutic efficacy with substantially favorable toxicity profiles in selected patient groups with advanced HCC. However, the lack of large randomized studies means that HAIC is not yet a well-established treatment for advanced HCC. We believe there is an urgent need for the further investigation of HAIC for the treatment of advanced HCC. [source] A pilot study on the use of wet wraps in infants with moderate atopic eczemaCLINICAL & EXPERIMENTAL DERMATOLOGY, Issue 4 2004P. E. Beattie Summary Wet wrap therapy (WWT) is a well-established treatment for severe atopic dermatitis (AD). However little evidence exists to justify widespread use in the community for less severe eczema. We compared the efficacy of WWT with a standard regime of hydrocortisone, to control moderate AD in children. We carried out a single-observer, randomized, controlled pilot study in 19 children under 5 years of age, with AD of 30% or more body surface area, using only 1% hydrocortisone (HC) prior to the study. Group one applied HC once in the morning for 2 weeks, with wet wraps twice daily for week 1, but only at night for week 2. Group two applied HC twice daily without wet wraps. Both applied emollient twice daily and as necessary. The primary outcome measure was the Six Area, Six Sign Atopic Dermatitis (SASSAD) severity score, and the secondary outcome measures were the Infants Dermatology Quality of Life Index (IDQOL), the Dermatitis Family Impact (DFI) score and the weight of topical steroids and emollients used. Over the 2-week active therapy period the mean fall in SASSAD was 8 [95% confidence interval (CI), ,18 to +2; P = 0.11] more in the non-WWT group, the median change in the IDQOL was 2 for Group one and 7 for Group two (95% CI for difference, ,10 to +3; P = 0.24) and the median change in DFI score was 2 for Group one and 5 for Group two (95% CI for difference, ,14 to +2; P = 0.42). This small study has shown that conventional therapy with HC and emollients alone is as effective as WWT for infants with moderately severe, widespread AD, and provides weak evidence to suggest that it may be more effective. We would not advocate routine use of WWT for moderate eczema without further evaluation. [source] Suicidal risk in bipolar I disorder patients and adherence to long-term lithium treatmentBIPOLAR DISORDERS, Issue 5p2 2006Ana Gonzalez-Pinto Objectives:, Among the well-established treatments for bipolar disorder (BPD), lithium continues to offer an unusually broad spectrum of benefits that may include reduction of suicidal risk. Methods:, We examined the association of suicidal acts with adherence to long-term lithium maintenance treatment and other potential risk factors in 72 BP I patients followed prospectively for up to 10 years at a Mood Disorders Research Center in Spain. Results:, The observed rates of suicide were 0.143, and of attempts, 2.01%/year, with a 5.2-fold (95% CI: 1.5,18.6) greater risk among patients consistently rated poorly versus highly adherent to lithium prophylaxis (11.4/2.2 acts/100 person-years). Treatment non-adherence was associated with substance abuse, being unmarried, being male, and having more hypomanic,manic illness and hospitalizations. Suicidal risk was higher with prior attempts, more depression and hospitalization, familial mood disorders, and being single and younger, as well as treatment non-adherence, but with neither sex nor substance abuse. In multivariate analysis, suicidal risk was associated with previous suicidality > poor treatment adherence > more depressive episodes > younger age. Conclusions:, The findings support growing evidence of lower risk of suicidal acts during closely monitored and highly adherent, long-term treatment with lithium and indicate that treatment adherence is a potentially modifiable factor contributing to antisuicidal benefits. [source] | ||||||||||