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Real-world treatment patterns of gastrointestinal neuroendocrine tumors: A claims database analysis

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World Journal of Gastroenterology 2017年第33期23卷 6128-6136页

作者： Al B Benson III Michael S Broder Beilei Cai Eunice Chang Maureen P Neary Elya Papoyan Northwestern University Partnership for Health Analytic Research novartis pharmaceuticals

AIM To describe real-world treatment patterns of gastrointestinal neuroendocrine tumors(GI NET).METHODS In this retrospective cohort study,we used 2009-2014 data from 2 United States commercial claims databases to examine newly pharmacologically treated patients using tabular and graphical techniques. Treatments included somatostatin analogues(SSA),cytotoxic chemotherapy(CC),targeted therapy(TT),interferon(IF) and combinations. We identified patients at least 18 years of age,with ≥ 1 inpatient or ≥ 2 outpatient claims for GI NET who initiated pharmacologic treatment from 7/1/09-6/30/14. A 6 mo clean period prior to first treatment ensured patients were newly treated. Patients were followed until end of enrollment or the study end date,whichever was *** We identified 2258 newly treated GI NET patients: mean(SD) age was 55.6 years(SD = 9.7),47.2% of the patients were between 55 and 64 years,and 48.8% were female. All regions of the United States were represented. 59.6% started first-line therapy with SSA monotherapy(964 with octreotide LAR,380 with octreotide SA,and 1 with lanreotide),33.3% CC,3.6% TT,and 0.5% IF. The remainder received combinations. Mean follow up was 576 d. Overall mean first-line therapy duration was 361 d(449 d for SSA,215 for CC,267 for TT). 58.9% of patients had no pharmacological treatment beyond first line. The most common secondline was combination therapy with SSA. In graphical pattern analysis,there was no clear pattern visible after first line *** In this study,60% of patients initiated treatment with SSA alone or in combination. The relatively long time to discontinuation suggests possible sustained effectiveness and tolerability.

关键词： Gastrointestinal neuroendocrine tumors Treatment patterns Insurance claims Somatostatin analogue Targeted therapy Chemotherapy

Effect of Tongluojiunao injection made from Sanqi(Radix Notoginseng) and Zhizi(Fructus Gardeniae) on brain microvascular endothelial cells and astrocytes in an in vitro ischemic model

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Journal of Traditional Chinese Medicine 2014年第6期34卷 725-732页

作者： Weihong Li Xingguang Li Qinghong Du Feng Li Yuan zhu Yang Liu Jie Ma Liangqin Wan Fanghe Li Sai Zhang School of Preclinical Medicine Beijing University of Chinese Medicine Encephalopathy Center Jiangsu Province Hospital of Traditional Chinese Medicine Medical Affairs Novartis Pharmaceuticals (China)

OBJECTIVE: To explore the effect of Tongluojiunao injection(TLJN) prepared with Sanqi(Radix Notoginseng) and Zhizi(Fructus Gardeniae) on the interaction between brain microvascular endothelial cells(BMECs) and astrocytes in an in vitro ischemic ***: First, an in vitro model of cerebral ischemia in BMECs or astrocytes was established by oxygen-glucose deprivation(OGD). TLJN was used as a medicine of intervention. The OGD-injuredBMECs were cultured in various astrocyte-conditioned media. Cell activity, alkaline phosphatase(AKP) and γ-glutamyl transpeptidase(γ-GT) activity,interleukin-1 beta(IL-1β), and tumor necrosis factor alpha(TNF-α) content in BMECs were ***, OGD-injured astrocytes were cultured in various BMEC-conditioned media. Cell activity, as well as expression of brain-derived neurotrophic factor(BDNF) and glial cell-derived neurotrophic factor(GDNF) in astrocytes, were ***: The results of paracrine signaling of normal BMECs or astrocytes showed a protective effect on each other: conditioned media from normal astrocytes improved cell viability, AKP, and γ-GT activity, and reduced IL-1β and TNF-α content of injured BMECs; conditioned media from normal BMECs improved cell viability and expression of BDNF and GDNF in injured astrocytes. However, once the BMECs or astrocytes were injured by OGD, the protective effect decreased or disappeared. The above-mentioned protective induction was effectively recovered by TLJN ***: The therapeutic benefit of TLJN was achieved by recovering two-way induction between BMECs and astrocytes, enhancing activity of injured BMECs and astrocytes, stabilizing enzymatic barriers, promoting expression of neurotrophic factors, and inhibiting inflammatory cytokines.

关键词： Endothelial cells Astrocytes Paracrine communication Oxygen-glucose-deprivation Ton-gluojiunao injection

AMPK promotes the survival of colorectal cancer stem cells

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Animal Models and Experimental Medicine 2018年第2期1卷 134-142页

作者： Bing Guo Xin Han Diane Tkach Shu-Guang Huang Dong Zhang Pfizer Research novartis pharmaceuticals Department of Biomedical Sciences College of Osteopathic Medicine New York Institute of Technology

Background: Colorectal cancer(CRC) is the third most commonly diagnosed cancer in males and the second in females worldwide in 2012. In the past 20 years, strong evidence suggests that cancer stem cells are the main culprit of cancer metastasis,chemotherapy resistance, and ***: To further understand the unique biological properties of cancer stem cells and uncover novel molecular targets to eradicate them, we first established a panel of patient-derived xenograft(PDX) tumor models using tumors surgically removed from human colorectal cancer patients. We then isolated CRC cancer stem cells based on their ALDH activity using fluorescent-activated cell sorting(FACS)and characterized their metabolic ***: Interestingly, we found that the CRC cancer stem cells(ie, CRC cells with higher ALDH activity, or ALDH+) express higher level of antioxidant genes and have lower level of reactive oxygen species(ROS) than non-CRC cancer stem cells(ie, CRC cells with lower ALDH activity, or ALDHà). The CRC cancer stem cells also possess more mitochondria mass and show higher mitochondrial activity. More intriguingly,we observed higher AMP-activated protein kinase(AMPK) activities in these CRC cancer stem cells. Inhibition of the AMPK activity using 2 AMPK inhibitors, Compound C and Iodotubercidin, preferentially induces cell death in CRC cancer stem ***: We propose that AMPK inhibitors may help to eradicate the CRC cancer stem cells and prevent the relapse of CRCs.

关键词： AMP-activated protein kinase cancer metabolism colorectal cancer stem cells patient-derived xenograft

Novel therapeutic approaches for hepatocellulcar carcinoma: Fact and fiction

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World Journal of Gastroenterology 2008年第11期14卷 1641-1642页

作者： Yuan-Yuan Zhang Harry Hua-Xiang Xia Department of Microbiology and Microbial Engineering School of Life Sciences Fudan University Shanghai 200433 China novartis pharmaceuticals Corporation East Hanover New Jersey United States

Hepatocellular carcinoma(HCC)is the most common primary liver cancer and accounts for 80%-90% of this class of *** far,understanding of its pathogenesis and effective therapeutic methods are rather *** this issue,11 invited review articles are published to address current advance of underlying molecular mechanisms for the deve-lopment of HCC, and novel therapeutic approaches for *** series of review articles provide an in-depth unders-tanding of HCC that has led to or may lead to the development of novel therapies for HCC.

关键词： Hepatocellular carcinoma Pathogenesis Treatment

Changes in weight and metabolic parameters following long-term iloperidone use: A meta-analysis of data from 9 Phase II and III trials of iloperidone

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Open Journal of Psychiatry 2012年第4期2卷 414-422页

作者： Marla Hochfeld Saeeduddin Ahmed Xiangyi Meng Adam Winseck novartis pharmaceuticals Corporation East Hanover USA

Objective: To determine the impact of iloperidone treatment on metabolic parameters. Methods: Data were analyzed from 3210 patients who received iloperidone and 587 patients who received placebo for up to 2 years during 9 Phase II and Phase III studies (integrated safety database). Patients were pooled by most frequent iloperidone dose into 3 groups: 4 - 8 mg/d, 10 - 16 mg/d, and 20 - 24 mg/d. Laboratory data from 8 studies were random (fasting and nonfasting) while patients from 1 study (n = 447) were all sampled at fasting. Results: Mean (standard deviation [SD]) weight gain from baseline to endpoint was 2.1 (6.8) kg for all patients on iloperidone. Fasting mean (SD) total cholesterol changes from baseline to end of study were 8.2 (31.6) for iloperidone and -2.2 (35.2) mg/dL for placebo. Fasting mean (SD) triglyceride changes during this period were iloperidone: -0.83 (82.3);placebo: 16.5 (113.1) mg/dL. Fasting mean (SD) glucose changes were iloperidone: 6.6 (24.0);placebo: -0.05 (17.0) mg/dL from baseline to end of study. Glycosylated hemoglobin levels were unchanged following iloperidone treatment. Conclusion: These data suggest a metabolic profile for iloperidone of modest weight gain accompanied by small changes in lipids and glucose that are unlikely to be of clinical concern.

关键词： Dyslipidemia Glucose Iloperidone Long-Term Metabolic Weight

Ascitic Fluid Analysis in the Differential Diagnosis of Ascites:Focus on Cirrhotic Ascites

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Journal of Clinical and Translational Hepatology 2014年第1期2卷 58-64页

作者： Lin-Lin Huang Harry Hua-Xiang Xia Sen-Lin Zhu Department of Gastroenterology the First Affiliated Hospital Sun Yat-sen University Guangzhou China novartis pharmaceuticals Corporation East Hanover NJ USA

Ascites is the pathologic accumulation of fluid within the peritoneal *** many diseases can cause ascites,in particular cirrhosis,samples of ascitic fluid are commonly analyzed in order to develop a differential *** concept of transudate versus exudate,as determined by total protein measurements,is outdated and the use of serumascites albumin gradient as an indicator of portal hypertension is more *** dehydrogenase (LDH),vascular endothelial growth factor (VEGF),and other tumor markers can be helpful in distinguishing between malignant and benign *** and adenosine deaminase levels may support a diagnosis of tuberculous disease,and amylase level may indicate a diagnosis of *** the specificity and sensitivity of laboratory results,accurate diagnosis should be based on both laboratory data and clinical iudgment.

关键词： Ascitic fluid analysis Differential diagnosis Ascites Cirrhosis

Preclinical safety in small molecule oncology drug development

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Preclinical safety in small molecule oncology drug developme...

Effect of vildagliptin as add-on therapy to a low-dose metformin

中国毒理学会第九次全国毒理学大会

作者： Li Li Preclinical Safety （PCS） Novartis Pharmaceuticals

The unmet medical needs in cancer demanded the delivery of new and effective cancer therapy expeditiously. The non-clinical and clinical development of small molecule cancer drugs has been simplified and refocused over the last decade. ICH S9 guidance provided the framework for a more flexible preclinical safety program to enable speedy entry and progress of human studies, and yet ensure patient ***-clinical safety profiling approaches spanning from profiling activities to lead optimization and support for late-stage clinical development and, finally to support for marketing authorization application of oncology drug candidates. The presentation will provide an overview of current approaches to the discovery and development of small molecule cancer drugs, highlighting regulatory changes because of implementing ICH S9 guideline, current challenges and future opportunities. In addition, mitigation efforts will be described how to reduce the high attrition rate during clinical drug development.

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World Journal of Diabetes 2010年第1期1卷 19-26页

作者： Claudia Filozof Sherwyn Schwartz James E Foley Diabetes Principal Medical Scientific Expert Novartis Pharma AG Diabetes and Glandular Disease Clinic novartis pharmaceuticals Corporation

AIM:To evaluate the efficacy and safety of the addition of vildagliptin to low-dose metformin and compare it to an uptitration of metformin in type 2 diabetes mellitus(T2DM) patients who have inadequate control with metformin ***:Eligible patients were randomized to receive vildagliptin 100 mg qd or metformin(500 mg qd for 2 wk and then 500 mg bid) added to open label me tformin 500 mg bid for the 24 *** primary endpoi nt was baseline to endpoint hemoglobin A1c(HbA1c) ***:The adjusted mean change from baseline in HbA1c at the 24th wk was-0.51% in the vildagliptin/metformin group(mean baseline HbA1c:7.4%) and-0.37% in the metformin monothera py group(mean baseline HbA1c:7.3%).The mean diffe rence was-0.14% with 95% Confidence Interval(-0.24%,-0.05%).As non-inf e riority(margin of 0.4%) was achieved,a test for superiority was *** test showed statistically significant superiority of the combination over monotherapy group(P = 0.002).Gastrointestinal(GI) adverse events were signif icantly more frequent in the metformin group than the combin ation group(21.0% vs 15.4%,P = 0.032).CONCLUSION:In patients with T2DM inadequately controlled with metformin up to 1000 mg daily,the addition of vildagliptin 100 mg daily achieved larger HbA1c reduction with fewer GI events than with increa sing the metformin dose.

关键词： Vildagliptin Metformin Dipeptidyl peptid ase-4 Hemoglobin A1c Glucagon-like peptide-1 Gastrointestinal side effects

A randomized,double-blind,placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation

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World Journal of Gastroenterology 2007年第5期13卷 732-739页

作者： San-Ren Lin Mei-Yun Ke Jin-Yan Luo Yao-Zong Yuan Ji-Yao Wang Shelley diTommaso Verena Walter Jiaqing Huang The 3rd Hospital Beijing Medical University Beijing China Peking Union Medical College Hospital BeijingChina The 2nd Hospital of Xian Jiaotong University Shanxi China Shanghai Ruijin Hospital Shanghai China Shanghai Zhongshan Hospital Shanghai China novartis Pharma AG Basel Switzerland novartis pharmaceuticals Corp East HanoverNew Jersey United States

AIM： To evaluate the efficacy and safety of tegaserod, 6 mg twice daily （b.i.d.）, in men and women with chronic constipation （CC） from China. METHODS： This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatmentfree baseline period, patients were randomized to receive either tegaserod （6 mg b.i.d.） or placebo （b.i.d.） for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements （CSBMs） during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients＇ daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events （AEs）. RESULTS： A total of 607 patients were randomized to receive either tegaserod （n = 304） or placebo （n = 303）. Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo （1.39 vs 0.91, P = 0.0002）. A statistically significant difference in favor of tegaserod was also observed for a mean increase ≥ 1 CSBM/wk over wk 1-4 （47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018） and for the absolute number of≥ 3 CSBMs/wk over wk 1-4 （25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021）. Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod （3.6%） compared with placebo （1.7%）. CONCLUSION： Tecjaserod treatment improved multiple symptoms of CC and was associated with a fa

关键词： Chronic constipation tegaserod China Complete spontaneous bowel movement Placebocontrolled Stool