Showing papers by "Ochsner Medical Center published in 2015"

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

Abstract: BackgroundThe treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. MethodsIn this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), ampu...

Effect of Creatine Monohydrate on Clinical Progression in Patients With Parkinson Disease A Randomized Clinical Trial

Abstract: Importance There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies. Objective To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease. Design, Setting, and Patients The Long-term Study 1, a multicenter, double-blind, parallel-group, placebo-controlled, 1:1 randomized efficacy trial. Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson disease. Participants were enrolled from March 2007 to May 2010 and followed up until September 2013. Interventions Participants were randomized to placebo or creatine (10 g/d) monohydrate for a minimum of 5 years (maximum follow-up, 8 years). Main Outcomes and Measures The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up, compared between the 2 treatment groups using a global statistical test. Clinical status was defined by 5 outcome measures: Modified Rankin Scale, Symbol Digit Modalities Test, PDQ-39 Summary Index, Schwab and England Activities of Daily Living scale, and ambulatory capacity. All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5-4775) indicate worse outcomes. Results The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249-2470) and for creatine was 2414 (95% CI, 2304-2524). The global statistical test yielded t 1865.8 = −0.75 (2-sided P = .45). There were no detectable differences ( P Conclusions and Relevance Among patients with early and treated Parkinson disease, treatment with creatine monohydrate for at least 5 years, compared with placebo did not improve clinical outcomes. These findings do not support the use of creatine monohydrate in patients with Parkinson disease. Trial Registration clinicaltrials.gov Identifier:NCT00449865

Circulating CXCR5+CD4+helper T cells in systemic lupus erythematosus patients share phenotypic properties with germinal center follicular helper T cells and promote antibody production.

Abstract: ObjectiveSystemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies. Recently, a specific highly activated T helper cell subset, follicular helper T (Tfh) cell, has emerged as a key immunoregulator of germinal center (GC) formation and high-affinity antibody production. To identify the pathophysiological role of Tfh cells in SLE patients, we compared the phenotypic and functional properties of circulating Tfh-like cells in lupus patients to GC-Tfh cells, and correlated the percentage of Tfh-like cells with autoantibody production and SLE disease activity.MethodsPeripheral blood was collected from 29 lupus patients and 25 healthy controls. Tonsils were obtained surgically from non-SLE controls and used as a source of GC-Tfh cells. Tfh cells were defined by their signature surface markers (CXCR5, ICOS, CD57, PD-1 and BTLA) via flow cytometry. IL-21 expression levels from Tfh cells were measured by real-time PCR and intracellular staining. The function of Tf...

Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes

Abstract: Aims/hypothesis Canagliflozin, a sodium glucose co-transporter 2 inhibitor, reduces HbA1c, body weight and systolic BP (SBP) in patients with type 2 diabetes. As weight loss is known to reduce both HbA1c and SBP, these analyses were performed to evaluate the contribution of weight loss resulting from treatment with canagliflozin to HbA1c and SBP reductions in patients with type 2 diabetes.

Long-term Follow-up Study of Fecal Microbiota Transplantation for Severe and/or Complicated Clostridium difficile Infection: A Multicenter Experience

Abstract: Goal Our aim was to investigate fecal microbiota transplantation (FMT) efficacy in patients with severe and/or complicated Clostridium difficile infection (CDI). Background FMT is successful for recurrent CDI, although its benefit in severe or complicated CDI has not specifically been evaluated. Study methods A multicenter long-term follow-up study was performed in patients who received FMT for severe and/or complicated CDI (diagnosed using standard criteria). Pre-FMT and post-FMT questionnaires were completed. Study outcomes included cure rates and time to resolution of symptoms. Results A total of 17 patients (82% inpatients, 18% outpatients) were included (76.4% women; mean age, 66.4 y; mean follow-up, 11.4 mo). Patients had severe and complicated (76.4%) or either severe or complicated (23.6%) CDI. Sixteen patients (94.1%) had diarrhea, which resolved in 12 (75%; mean time to resolution, 5.7 d) and improved in 4 (25%) after FMT. Eleven patients (64.7%) had abdominal pain, which resolved in 8 (72.7%; mean time to resolution, 9.6 d) and improved in 3 (27.3%) after FMT. Two of 17 patients experienced early CDI recurrence (≤90 d) after FMT (primary cure rate, 88.2%); and in 1 patient, a second FMT resulted in cure (secondary cure rate, 94.1%). Late CDI recurrence (≥90 d) was seen in 1 of 17 patients (5.9%) in association with antibiotics and was successfully treated with a repeat FMT. No adverse effects directly related to FMT occurred. Conclusions FMT was successful and safe in this cohort of patients with severe or complicated CDI. Primary and secondary cure rates were 88.2% and 94.1%, respectively.

Endovascular therapy for acute ischaemic stroke: a systematic review and meta-analysis of randomized trials.

Abstract: Aims Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular therapy (EVT) for acute ischaemic stroke has shown conflicting results. The purpose of this meta-analysis was to systematically examine clinical outcomes in RCTs comparing the use of intravenous (IV) fibrinolysis alone to IV fibrinolysis plus EVT, for the treatment of acute ischaemic stroke. Methods and results We selected English language RCTs, comparing EVT plus IV tissue-type plasminogen activator (tPA) (if eligible) with IV tPA alone in eligible patients for the treatment of acute ischaemic stroke. The primary endpoint was good functional outcome [modified Rankin Scale (mRS) of 0–2]. Other major endpoints of interest were all-cause mortality and symptomatic intracerebral haemorrhage (sICH). The meta-analysis included 8 RCTs that randomized 2423 patients with large-vessel, anterior-circulation stroke. EVT significantly improved the rate of functional independence (90-day mRS of 0–2) when compared with IV fibrinolysis [odds ratio (OR) 1.73, 95% confidence interval (CI) 1.18–2.53, number needed to treat (NNT) = 9.3]. The all-cause mortality was lower with EVT compared with the control group; however, the result did not reach statistical significance (OR 0.89, 95% CI 0.68–1.15). The rate of sICH was not higher with EVT (OR 1.07, 95% CI 0.73–1.56). Analyses from only the recent trials (reported in 2014–15) showed further benefit (OR of mRS 0–2: 2.42, 95% CI 1.91–3.08, NNT = 5) with similar safety results. Conclusion In centres with advanced systems of stroke care, EVT significantly improved functional outcomes (without compromising safety) in patients with acute ischaemic stroke due to anterior circulation, large artery occlusion, compared with standard therapy.

Incidence of cardiovascular events and gastrointestinal bleeding in patients receiving clopidogrel with and without proton pump inhibitors: an updated meta-analysis.

Abstract: Background: Dual antiplatelet therapy is the standard of care after coronary stent placement but increases the bleeding risk. The effects of proton pump inhibitors (PPIs) on clopidogrel metabolism have been described, but the clinical significance is not yet definitive. We aimed to do an updated meta-analysis comparing outcomes in patients receiving clopidogrel with and without PPIs. Methods: We systematically searched PubMed, Scopus and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCTs) and controlled observational studies in patients taking clopidogrel stratified by concomitant PPI use. Heterogeneity was examined with the Cochran Q test and I 2 statistics; p values inferior to 0.10 and I 2 >25% were considered significant for heterogeneity. Results: We included 39 studies with a total of 214 851 patients, of whom 73 731 (34.3%) received the combination of clopidogrel and a PPI. In pooled analysis, all-cause mortality, myocardial infarction, stent thrombosis and cerebrovascular accidents were more common in patients receiving both drugs. However, among 23 552 patients from eight RCTs and propensity-matched studies, there were no significant differences in mortality or ischaemic events between groups. The use of PPIs in patients taking clopidogrel was associated with a significant reduction in the risk of gastrointestinal bleeding. Conclusions: The results of our meta-analysis suggest that PPIs are a marker of increased cardiovascular risk in patients taking clopidogrel, rather than a direct cause of worse outcomes. The pharmacodynamic interaction between PPIs and clopidogrel most likely has no clinical significance. Furthermore, PPIs have the potential to decrease gastrointestinal bleeding in clopidogrel users.

Outcomes After Carotid Artery Stenting in Medicare Beneficiaries, 2005 to 2009

Abstract: Importance Despite increased carotid artery stenting (CAS) dissemination following the 2005 National Coverage Determination, to our knowledge, periprocedural and long-term outcomes have not been described among Medicare beneficiaries. Objective To describe the incidence of outcomes during and after the periprocedural period among Medicare beneficiaries undergoing CAS. Design, Setting, and Participants Observational study with a mean follow-up time of approximately 2 years among 22 516 fee-for-service Medicare beneficiaries at least 66 years old undergoing CAS (2005-2009) who were linked to the Centers for Medicare & Medicaid Services’ CAS database. Database procedure dates were required to fall during a Medicare hospitalization for CAS. Main Outcomes and Measures Periprocedural (30-day) and long-term risks of mortality and stroke or transient ischemic attack, as well as periprocedural myocardial infarction. Subgroups were based on sociodemographic, clinical, and center-level factors, as well as the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial or Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) enrollment criteria. Results The mean patient age was 76.3 years, 60.5% were male, 93.8% were of white race, 91.2% were at high surgical risk, 47.4% were symptomatic, and 97.4% had carotid stenosis of at least 70%. Crude 30-day mortality, stroke or transient ischemic attack, and myocardial infarction risks were 1.7% (95% CI, 1.5%-1.8%), 3.3% (95% CI, 3.0%-3.5%), and 2.5% (95% CI, 2.3%-2.7%), respectively. Mortality during a mean follow-up time of 2 years was 32.0% (95% CI, 31.0%-33.0%), with rates of 37.3% (95% CI, 35.8%-38.7%) among symptomatic patients and 27.7% (95% CI, 26.4%-28.9%) among asymptomatic patients. Older age, symptomatic carotid stenosis, and nonelective hospital admission were associated with increased adjusted hazards of mortality and stroke or transient ischemic attack during and after the periprocedural period. The presence of a stroke center, government ownership, and a hospital bed capacity of 500 or more were associated with increased adjusted hazards of periprocedural mortality and stroke or transient ischemic attack. Few patients met the SAPPHIRE trial or CREST enrollment criteria primarily because physicians did not meet proficiency requirements either due to exceeding periprocedural complication trial thresholds or not meeting minimum CAS volume requirements. Conclusions and Relevance Competing risks may limit the benefits of CAS in certain Medicare beneficiaries, particularly among older and symptomatic patients who have higher periprocedural and long-term mortality risks. The generalizability of trials like the SAPPHIRE or CREST to the Medicare population may be limited, underscoring the need to evaluate real-world effectiveness of carotid stenosis treatments.

Association among weight change, glycemic control, and markers of cardiovascular risk with exenatide once weekly: a pooled analysis of patients with type 2 diabetes

Abstract: Background Overweight or obesity contributes to the development of type 2 diabetes mellitus (T2DM) and increases cardiovascular risk. Exenatide, a glucagon-like peptide-1 receptor agonist, significantly reduces glycated hemoglobin (A1C) and body weight and improves cardiovascular risk markers in patients with T2DM. As weight loss alone has been shown to reduce A1C and cardiovascular risk markers, this analysis explored whether weight loss contributed importantly to clinical responses to exenatide once weekly.

Preservation of multidimensional quality of life after endoscopic pituitary adenoma resection.

Abstract: OBJECT Pituitary adenomas are well suited to resection by a minimal-access endoscopic technique. Validation of this approach requires prospective outcome studies to determine the impact on quality of life (QOL). This study aims to assess the effect of endoscopic pituitary adenoma resection on site-specific and sinonasal-related QOL before and after endoscopic surgery using validated instruments. METHODS Consecutive adult patients undergoing endoscopic endonasal resection of pituitary adenoma were prospectively enrolled from a single tertiary care center. All patients completed the Anterior Skull Base Questionnaire (ASBQ) and the 22-Item Sino-Nasal Outcome Test (SNOT-22) preoperatively and then at regular intervals after surgery to assess their perceived QOL with regard to hormonal, surgical, and anatomical factors. RESULTS Eighty-one of 114 patients were eligible for study; median follow-up was 16 months. This cohort included 24 (29.6%) nonsecreting macroadenomas and 57 (70.4%) hypersecreting tumors. Ther...

Proximal versus distal embolic protection for carotid artery stenting: a national cardiovascular data registry analysis.

Abstract: Objectives The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS) Background P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS Methods We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013 We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory Results P-EPDs were used in 590 of 10,246 cases (58%) Patients treated with P-EPDs had higher rates of symptomatic lesion status (468% vs 397%, p Conclusions Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible

Efficacy and safety of canagliflozin by baseline HbA1c and known duration of type 2 diabetes mellitus.

Abstract: Aims Canagliflozin, a sodium glucose co-transporter 2 inhibitor, has demonstrated glycemic improvements across studies of patients with type 2 diabetes mellitus (T2DM). The impact of canagliflozin on HbA 1c lowering was assessed by baseline HbA 1c and known duration of T2DM. Methods This post hoc analysis pooled data from patients with T2DM enrolled in four 26-week, placebo-controlled, Phase 3 studies of canagliflozin (N=2313). Change in HbA 1c from baseline to Week 26 was assessed in the overall population and in subgroups by baseline HbA 1c ( Results Relative to placebo, canagliflozin 100 and 300mg provided greater HbA 1c reductions in the overall population. Progressively larger placebo-subtracted reductions in HbA 1c with canagliflozin 100 and 300mg were seen with increasing baseline HbA 1c . HbA 1c reductions were similar across subgroups based on known duration of T2DM. Both canagliflozin doses were generally well tolerated across subgroups, with a safety and tolerability profile consistent with that seen in Phase 3 studies. Conclusions Canagliflozin provided glycemic improvements in patients with T2DM across a range of baseline HbA 1c and known duration of T2DM.

Personal health technology: A new era in cardiovascular disease prevention

Abstract: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide yet the majority of related risk factors are largely preventable (primary prevention [PP]) and effectively treatable (secondary prevention [SP]) with healthy lifestyle behaviors. The use of information and communication technology (ICT) offers a unique approach to personal health and CVD prevention, as these mediums are relatively affordable, approachable, and accessible. The purpose of this review is to provide an overview of ICT-driven personal health technologies and their potential role in promoting and supporting self-care behaviors for PP and SP of CVD. In this review, we focus on technological interventions that have been successful at supporting positive behavior change in order to determine which tools, resources, and methods are most appropriate for delivering interventions geared towards CVD prevention. We conducted a literature search from a range of sources including scholarly, peer-reviewed journal articles indexed in PubMed and CINAHL, gray literature, and reputable websites and other Internet-based media. A synthesis of existing literature indicates that the overall efficacy of ICT-driven personal health technologies is largely determined by: 1) the educational resources provided and the extent to which the relayed information is customized or individually tailored; and 2) the degree of self-monitoring and levels of personalized feedback or other interactions (e.g. interpersonal communications). We conclude that virtually all the technological tools and resources identified (e.g. Internet-based communications including websites, weblogs and wikis, mobile devices and applications, social media, and wearable monitors) can be strategically leveraged to enhance self-care behaviors for CVD risk reduction and SP but further research is needed to evaluate their efficacy, cost-effectiveness, and long-term maintainability.

High dose statin loading prior to percutaneous coronary intervention decreases cardiovascular events: a meta-analysis of randomized controlled trials.

Abstract: Objective We performed a meta-analysis of randomized controlled trials of statin loading prior to percutaneous coronary intervention (PCI). Background Statin loading prior to PCI has been shown to decrease peri-procedural myocardial infarction (pMI) but less is known regarding the clinical benefit of pre-procedural statin loading. Methods We searched for trials of statin naive patients presenting with stable angina or NSTE-ACS and treated with statins prior to PCI. We evaluated the incidence of pMI and major cardiac events including spontaneous myocardial infarction, death, and target vessel revascularization. Results Out of 1,210 articles, 14 randomized controlled trials were included in this meta-analysis. Among 3,146 patients, 1,591 patients were randomized to a loading dose of statin before PCI and 1,555 patients were given statin therapy initiated only after the PCI. Statin loading prior to PCI was associated with a 56% relative reduction in pMI (OR: 0.44, 95% CI: 0.35–0.56; P < 0.00001). There was a 41% reduction in clinical events in follow-up in the group of patients treated with statin loading prior to PCI (OR: 0.59, 95% CI: 0.38–0.92, P = 0.02). When stratified according to the clinical presentation, the results were only significant for those patients with NSTE-ACS (OR: 0.18, 95% CI: 0.07–0.47; P = 0.0005) and was not noted in the group of patients who underwent PCI for stable angina (OR: 0.92, 95% CI: 0.53–1.61; P = 0.78). Conclusions High dose statin therapy given prior to PCI in patients with NSTE-ACS is associated with a reduction in pMI and short-term clinical events. © 2013 Wiley Periodicals, Inc.

Longevity and cost of implantable intrathecal drug delivery systems for chronic pain management: A retrospective analysis of 365 patients

Abstract: Objectives Intrathecal drug delivery systems represent an important component of interventional strategies for refractory chronic pain syndromes. Continuous intrathecal administration of opioids results in higher subarachnoid drug concentrations, improved pain scores, and less frequent side effects when compared with systemic opioid administration. Substantial costs arise at the time of surgical implantation and at revision for battery depletion or treatment of a complication. Despite current widespread use, the real-world longevity and cost of implanted intrathecal pumps (ITP) has not been fully quantified.

Hyponatremia: Incidence, risk factors, and consequences in the elderly in a home-based primary care program

Abstract: Aims To determine the incidence, risk factors, etiology, and associations of hyponatremia in community-dwelling elderly with geriatric morbidity and mortality. Materials Elderly participants of a single center home-based primary care program were included. Method Retrospective chart review was conducted on demographic and clinical variables, comorbid diseases, frailty by Fried criteria and biochemical tests over a 1-year period. Primary outcome measure was a composite of falls, fractures due to falls, and hospitalization witnessed within the first year of enrollment into the program. Secondary outcome was all-cause mortality. Results The study population (n = 608) had a mean age of 84.3 ± 9.3 years and was largely female (77.1%) and African-American (89.5%). Mean follow-up was 41.5 months. Frailty was seen in 44.4%. Incidence of allcause mortality was 26.9%. Initial hyponatremia occurred in 8.71% (n = 53), and persistent hyponatremia (> 6 months of low serum sodium) in 4.1% (n = 25) of the study population. The major causes of hyponatremia included multiple potential causes, idiopathic syndrome of inappropriate antidiuretic hormone (SIADH) and medications (thiazides and selective serotonin reuptake inhibitor (SSRI)). Primary outcome was independently associated with frailty (Odds ratio (OR) of 2.33) and persistent but not initial hyponatremia (OR 3.52). Secondary outcome was independently associated with age > 75 years (OR 2.88) and Afro-American race (OR 2.09) only but not to frailty or hyponatremia. Conclusions Hyponatremia is common in home-bound elderly patients and its persistence independently contributes to falls, fractures, and hospitalization but not mortality. Our study highlights a new association of hyponatremia with frailty and underscores the need to study time-dependent association of hyponatremia with epidemiological outcomes.

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus

Abstract: Background. Type 2 diabetes (T2DM) patients, including those in good glycemic control, have an increased risk of cardiovascular disease (CVD). Maintaining good glycemic control may reduce long-term CVD risk. However, other risk factors such as elevated vascular sympathetic tone and/or endothelial dysfunction may be stronger potentiators of CVD. This study evaluated the impact of bromocriptine-QR, a sympatholytic dopamine D2 receptor agonist, on progression of metabolic disease and CVD in T2DM subjects in good glycemic control (HbA1c ≤7.0%). Methods. 1834 subjects (1219 bromocriptine-QR; 615 placebo) with baseline HbA1c ≤7.0% derived from the Cycloset Safety Trial (this trial is registered with ClinicalTrials.gov Identifier: NCT00377676), a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were evaluated. Treatment impact upon a prespecified composite CVD endpoint (first myocardial infarction, stroke, coronary revascularization, or hospitalization for angina/congestive heart failure) and the odds of losing glycemic control (HbA1c >7.0% after 52 weeks of therapy) were determined. Results. Bromocriptine-QR reduced the CVD endpoint by 48% (intention-to-treat; HR: 0.52 [0.28−0.98]) and 52% (on-treatment analysis; HR: 0.48 [0.24−0.95]). Bromocriptine-QR also reduced the odds of both losing glycemic control (OR: 0.63 (0.47−0.85), ) and requiring treatment intensification to maintain HbA1c ≤7.0% (OR: 0.46 (0.31−0.69), ). Conclusions. Bromocriptine-QR therapy slowed the progression of CVD and metabolic disease in T2DM subjects in good glycemic control.

Progression to insulin therapy among patients with type 2 diabetes treated with sitagliptin or sulphonylurea plus metformin dual therapy.

Abstract: Aim To assess time to insulin initiation among patients with type 2 diabetes mellitus (T2DM) treated with sitagliptin versus sulphonylurea as add-on to metformin. Methods This retrospective cohort study used GE Centricity electronic medical records and included patients aged ≥18 years with continuous medical records and an initial prescription of sitagliptin or sulphonylurea (index date) with metformin for ≥90 days during 2006–2013. Sitagliptin and sulphonylurea users were matched 1 : 1 using propensity score matching, and differences in insulin initiation were assessed using Kaplan–Meier curves and Cox regression. We used conditional logistic regression to examine the likelihood of insulin use 1–6 years after the index date for each year. Results Propensity score matching produced 3864 matched pairs. Kaplan–Meier analysis showed that sitagliptin users had a lower risk of insulin initiation compared with sulphonylurea users (p = 0.003), with 26.6% of sitagliptin users initiating insulin versus 34.1% of sulphonylurea users over 6 years. This finding remained significant after adjusting for baseline characteristics (hazard ratio 0.76, 95% confidence interval 0.65–0.90). Conditional logistic regression analyses confirmed that sitagliptin users were less likely to initiate insulin compared with sulphonylurea users [odds ratios for years 1–6: 0.77, 0.79, 0.81, 0.57, 0.29 and 0.75, respectively (p < 0.05 for years 4 and 5)]. Conclusions In this real-world matched cohort study, patients with T2DM treated with sitagliptin had a significantly lower risk of insulin initiation compared with patients treated with sulphonylurea, both as add-on to metformin.

A phase II clinical trial of weekly paclitaxel and carboplatin in combination with panitumumab in metastatic triple negative breast cancer

Abstract: Purpose: Women with metastatic triple negative breast cancer (TNBC) can have a poor prognosis with treatment limited to cytotoxic chemotherapy. The identification of effective therapies that may limit exposure to cytotoxic chemotherapy and lead to prolonged survival is an unmet medical need. We tested an inhibitor of the epidermal growth factor receptor, panitumumab in combination with chemotherapy. Methods: We conducted a single arm clinical trial in women with metastatic or locally advanced TNBC to paclitaxel 80 mg/m2 and carboplatin AUC of 2 on days 1, 8, and 15 and panitumumab 6 mg/kg on days 1 and 15 for a cycle length of 28 days. The objectives were to evaluate the response rate and safety of the combination in comparison to historical controls. Results: Fourteen patients with TNBC were enrolled with a median age of 53 years. The majority of women were African American (64.3%) with visceral metastasis (64.2%). Hematologic toxicities, particularly neutropenia and thrombocytopenia, were a major cause ...