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Clinical End Points (clinical + end_point)
Selected AbstractsMigraine Management: Contrasting Patient Preferences With Current Clinical End Points: IntroductionHEADACHE, Issue 2002Peter J. Goadsby MD No abstract is available for this article. [source] Interactive effect of retinopathy and macroalbuminuria on all-cause mortality, cardiovascular and renal end points in Chinese patients with Type 2 diabetes mellitusDIABETIC MEDICINE, Issue 7 2007P. C. Y. Tong Abstract Aims To examine the effect of albuminuria and retinopathy on the risk of cardiovascular and renal events, and all-cause mortality in patients with Type 2 diabetes. Methods A post-hoc analysis of 4416 Chinese patients without macrovascular complications at baseline (age 57.6 ± 13.3 years). Glomerular filtration rate (eGFR) was estimated by the abbreviated Modification of Diet in Renal Disease Study Group Formula, further adjusted for Chinese ethnicity. Clinical end points were all-cause mortality, cardiovascular events (heart failure or angina, myocardial infarction, lower limb amputation, re-vascularization procedures and stroke) and renal end points (reduction in eGFR by more than 50% or eGFR < 15 ml/min/1.73 m2 or death as a result of renal causes or need for dialysis). Results Compared with individuals without complications, subjects with retinopathy and macroalbuminuria had higher rates of cardiovascular events (14.1 vs. 2.4%), renal events (40.0 vs. 0.8%) and death (9.3 vs. 1.7%, P < 0.001). For composite event of death, cardiovascular and renal events, the presence of retinopathy, microalbuminuria alone, macroalbuminuria alone, retinopathy with microalbuminuria or retinopathy with macroalbuminuria increased the risk [hazard ratio (95% CI)] by 1.61 (1.05 to 2.47; P = 0.04), 1.93 (1.38 to 2.69; P < 0.001), 4.34 (3.02 to 6.22; P < 0.001), 2.59 [1.76 to 3.81; P < 0.001) and 6.83 (4.89 to 9.55; P < 0.001) fold, respectively. The relative excess risk as a result of interaction between retinopathy and macroalbuminuria was 15.31, implying biological interaction in the development of renal events. Conclusions In Chinese patients with Type 2 diabetes, retinopathy interacts with macroalbuminuria to increase the risk of composite cardio-renal events. [source] Significance of white blood cell count and its subtypes in patients with acute coronary syndromeEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 5 2009G. Huang Abstract Background, Inflammation plays a role in the pathogenesis of coronary atherosclerosis. Materials and methods, Six hundred twenty-three patients with acute coronary syndrome (ACS) referred for coronary angiography for the first time in our hospital were enrolled in this study. White blood cell and its subtypes were measured on admission. The study population was divided into three groups based on total white blood cell count and followed up. Clinical end points were major adverse cardiac events (MACEs), including cardiogenic death, stroke, heart failure, non-fatal myocardial infarction, rehospitalization for angina pectoris. Results, The median age was 68 years (range 31,92) and 64·2% of the patients were men. The median white blood cell count was 6·48 × 109 L,1 (range 2·34,27·10 × 109 L,1). The median follow-up duration was 21 months (range 1,116) and MACEs occurred in 167 patients. The multivariable Cox proportional hazards regression model revealed that neutrophil count [Relative risk = 1·098, 95% Confidence interval (CI): 1·010,1·193, P = 0·029) was a risk factor for MACEs. The logistic regression model revealed that lymphocyte count [Odds ratio (OR) = 1·075, 95% CI: 1·012,1·142, P = 0·018] and monocyte count (OR = 8·578, 95% CI: 2·687,27·381, P < 0·001) were predictive of stenosis , 75%; Neutrophil proportion (OR = 1·060, 95% CI: 1·007,1·115, P = 0·026), monocyte count (OR = 12·370, 95% CI: 1·298,118·761, P = 0·029) were predictive of the presence of multivessel disease. Kaplan,Meier analysis of short-term and long-term cumulative survival showed no significant statistical differences among three groups. Conclusions, Neutrophil count adds prognostic information to MACEs in ACS. Monocyte count and lymphocyte count are predictive of severity of coronary atherosclerosis. [source] Results of a Survey of 5,700 Patient Monopolar Radiofrequency Facial Skin Tightening Treatments: Assessment of a Low-Energy Multiple-Pass Technique Leading to a Clinical End Point AlgorithmDERMATOLOGIC SURGERY, Issue 8 2007FRCP, FRCPC, JEFFREY S. DOVER MD INTRODUCTION Monopolar radiofrequency is an effective means of nonsurgical facial skin tightening. OBJECTIVE The objective of this study was to determine whether using larger tips at lower energy and multiple passes, using patient feedback on heat sensation and treating to a clinical end point of visible tightening, would yield better results than single passes with small tips at high energy, as measured by patient and physician satisfaction. METHODS Fourteen physicians from four specialties were surveyed to determine the answers to the following three questions. (1) Is patient's feedback on heat sensation a valid and preferred method for optimal energy selection? (2) Do multiple passes at moderate energy settings yield substantial and consistent efficacy? (3) Is treating to a clinical end point of visible tightening predictable of results? RESULTS A total of 5,700 patient treatments were surveyed. Comparisons were made using the original algorithm of high-energy, single pass to the new algorithm of lower energy and multiple passes with visible tightening as the end point of treatment. Using the original treatment algorithm, 26% of patients demonstrated immediate tightening, 54% observed skin tightening 6 months after treatment, 45% found the procedure too painful, and 68% of patients found the treatment results met their expectations. With the new multiple-pass algorithm, 87% observed immediate tightening, 92% had the tightening six months after treatment, 5% found the procedure too painful, while 94% found the treatment results met their expectations. CONCLUSIONS Patient feedback on heat sensation is a valid, preferable method for optimal energy selection in monopolar radiofrequency skin-tightening treatments. [source] Prediction of poor survival by cyclooxygenase-2 in patients with T4 nasopharyngeal cancer treated by radiation therapy: Clinical and in vitro studiesHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 6 2005Wen-Cheng Chen MD Abstract Background. This study was undertaken to determine the status of cyclooxygenase-2 (COX-2) in nasopharyngeal cancer (NPC) in Taiwanese patients and its relationship to survival after radiotherapy (RT). In addition, the effect of NS-398, a potent selective COX-2 inhibitor, was tested in vitro alone and in combination with radiation on NPC-BM1 human NPC cells as a prelude to using this drug along with RT in the treatment of patients with NPC. Methods. Thirty-seven patients diagnosed with T4N0,3M0 NPC were enrolled into this study. COX-2 expression was determined by immunohistochemical staining of formalin-fixed, paraffin-embedded tumor tissue. Patient survival was the clinical end point. The effects of COX-2 expression on cell survival and radioresistance was tested in vitro using the selective COX-2 inhibitor NS-398 in conjunction with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazonium bromide (MTT) and clonogenic assays. Results. COX-2 immunoreactivity was detected in 62% of NPC tumors, and expression levels were high in 43%. Survival analysis showed the 5-year overall survival rates for patients who had high COX-2 expression was 27% compared with 60% for those with low/absent expression (p = .047). Pattern of failure analysis showed no significant difference between high and low COX-2 expression in locoregional failure (27% vs 25%, p = .91). However, patients with N0 to N1 disease and high COX-2 expression had a significantly higher incidence of distant metastasis compared with patients with stage N0 to N1 disease and low COX-2 expression (83% vs 15%, p = .004). This difference was not observed in patients with N2 to N3 disease. This difference contributed to worse survival of patients whose tumors had high COX-2 expression levels. The selective COX-2 inhibitor NS-398 was directly cytotoxic to NPC-BM1 cells in vitro, as judged in an MTT assay (viable cells decreased from 92% to 76%, 52%, and 22%, with increases of NS-398 from 20 to 40, 60, and 80 ,M, respectively). Radiation-induced cell death was also increased by treatment with NS-398. At a 10% survival level, 40 ,M NS-398 increased radiation cytotoxicity by a factor of 1.37, whereas 60 ,M increased it by a factor of 4.9. Conclusions. COX-2 overexpression is a predictor for poor survival for advanced stage NPC. In vitro, NS-398 radiosensitizes the NPC-BM1 cell line, providing a basis for testing the combination of COX-2 inhibitors with radiation in the treatment of patients with NPC. © 2005 Wiley Periodicals, Inc. Head Neck27: XXX,XXX, 2005 [source] What Do Patients With Migraine Want From Acute Migraine Treatment?HEADACHE, Issue 2002Richard B. Lipton MD Migraine is a common chronic condition with an ever-expanding therapeutic armamentarium. As therapeutic options multiply, it is increasingly important to understand patients' attitudes and preferences regarding various treatment characteristics. Several strategies have evolved to establish treatment priorities in migraine and rationalize and prioritize end points and outcomes to meet the needs of patients. A survey of a population-based sample of migraineurs indicated that an overwhelming majority of patients consider complete relief of head pain, no recurrence, and rapid onset of action as important or very important attributes of acute migraine therapy. An analysis of the relationship between clinical end points and satisfaction found that more than 90% of patients who were pain-free at 2 hours were at least somewhat satisfied with treatment, but satisfaction was dependent on relatively rapid relief. Using a "willingness-to-pay" approach, results indicated that while patients will pay more for migraine treatment that produces rapid, consistent relief without adverse effects or recurrence, speed of complete relief is the most valued attribute. By assessing physician preferences and practices, degree of pain relief and rapid onset were identified as the most important attributes of acute therapy. Based on results from preference studies of triptans, 50% of patients cited more rapid pain relief as the most important determinant of treatment preference. Based on these various approaches, the consensus view is that both clinicians and patients desire a broad range of positive migraine treatment attributes, but rapid onset of complete pain relief is a particularly important priority. [source] Angiogenesis of the heartMICROSCOPY RESEARCH AND TECHNIQUE, Issue 2 2003Michael J.B. Kutryk Abstract Despite continued advances in the prevention and treatment of coronary artery disease, there are still a large number of patients who are not candidates for the conventional revascularization techniques of balloon angioplasty and stenting, or coronary artery bypass grafting (CABG). Therapeutic angiogenesis, in the form of the administration of growth factor protein or gene therapy, has emerged as a promising new method of treatment for patients with coronary artery disease. The goal of this strategy is to promote the development of supplemental blood conduits that will act as endogenous bypass vessels. New vessel formation occurs through the processes of angiogenesis, vasculogenesis, and arteriogenesis, under the control of growth factors such as those that belong to the vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF) and angiopoeitin (Ang) families of molecules. Preclinical studies have suggested that such an approach is both feasible and effective; however many questions remain to be answered. This review will address the elements of pharmacologic revascularization, focusing on gene and protein-based therapy. The important growth factors, the vector (for gene therapy), routes of delivery, the desired therapeutic effect, and quantifiable clinical end points for trials of angiogenesis will all be addressed. Microsc. Res. Tech. 60:138,158, 2003. © 2003 Wiley-Liss, Inc. [source] Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: Application of a latent linear trajectory modelARTHRITIS & RHEUMATISM, Issue 7 2007Lynne Shand Objective To explore the relationship between changes in the severity of skin disease and morbidity and mortality in patients with diffuse cutaneous systemic sclerosis (dcSSc). Methods From a large single-center cohort, we identified 225 patients with dcSSc for whom serial clinical information was available from within 24 months of the onset of the first non,Raynaud's phenomenon manifestation of SSc. The end points analyzed included death and heart, lung, kidney, and gastrointestinal tract involvement. Latent linear trajectory modeling (LTM) was applied to identify patients with a similar trajectory of modified Rodnan skin thickness score (MRSS) changes over the first 3 years of followup. Clinical outcomes were compared between 3 different LTM subgroups. Results LTM permitted classification of 131 patients (58%) into 1 of 3 subgroups with different skin score trajectories. Survival was lowest in the subgroup of patients who had a high baseline skin score and experienced little improvement during followup (P = 0.003). However, the frequency of clinical end points was similar in the subgroup with the most favorable trajectory (i.e., a low initial MRSS and subsequent improvement) and the subgroup with a high baseline MRSS and no improvement. Interestingly, the end point frequency was greatest in the subgroup with a high initial MRSS and subsequent improvement, suggesting that sustained severe skin disease does not necessarily predict the number of visceral complications, and that the relationship between the skin score and internal organ involvement in dcSSc is more complex than previously thought. Conclusion Although mortality was highest among patients with the worst skin-related outcomes, no simple relationship between burden of disease and change in skin score was observed. [source] Trials and tribulations associated with angina and traditional therapeutic approachesCLINICAL CARDIOLOGY, Issue S1 2007Prakash C. Deedwania M.D. Abstract Ischemic heart disease is the foremost cause of death in the United States and the developed countries. Stable angina is the initial manifestation of ischemic heart disease in one half of the patients and becomes a recurrent symptom in survivors of myocardial infarction (MI) and other forms of acute coronary syndromes (ACS). There are multiple therapeutic modalities currently available for treatment of anginal symptoms in patients with stable CAD. These include anti-anginal drugs and myocardial revascularization procedures such as coronary artery bypass graft surgery (CABGS), percutaneous transluminal coronary angioplasty (PTCA) and percutaneous coronary intervention (PCI). Anti-anginal drug therapy is based on treatment with nitrates, beta blockers, and calcium channel blockers. A newly approved antianginal drug, ranolazine, is undergoing phase III evaluation. Not infrequently, combination therapy is often necessary for adequate symptom control in some patients with stable angina. Howerever, there has not been a systematic evaluation of individual or combination antianginal grug therapy on hard clinical end points in patients with stable angina. Most revascularization trials that have evaluated treatment with CABGS, PTCA, or PCI in patients with chronic CAD and stable angina have not shown significant improvement in survival or decreased incidence of non-fatal MI compared to medical treatment. In the CABGS trials, various post-hoc analyses have identified several smaller subgroups at high-risk in whom CABGS might improve clinical outcomes. However, there are conflicting findings in different reports and these findings are futher compromised due to the heterogeneous groups of patients in these trials. Moreover, no prospective randomized controlled trial (RCT) has confirmed an advantage of CABGS, compared to medical treatment, in reduction of hard clinical outcomes in any of the high-risk subgroups. Based on the available data, it appears reasonable to conclude that for most patients (except perhaps in those with presence of left main disease > 50% stenosis) there is no apparent survival benefit of CABGS compared to medical therapy in stable CAD patients with angina. Although these trial have reported better symptom control associated with the revascularization intervention in most patients, this has not been adequately compared using modern medical therapies. Available data from recent studies also suggest treatment with an angiotensin converting enzyme inhibitor (ACEI), a statin and a regular exercise regimen in patients with stable CAD and angina pectoris. Copyright © 2007 Wiley Periodicals, Inc. [source] | ||||||||||