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Publication Record


The Pathogenesis and Management of Achalasia: Current Status and Future Directions.
Ates F, Vaezi MF
(2015) Gut Liver 9: 449-63
MeSH Terms: Botulinum Toxins, Deglutition Disorders, Diagnostic Errors, Endoscopy, Digestive System, Esophageal Achalasia, Esophageal Sphincter, Lower, Esophagus, Gastroesophageal Reflux, Humans, Injections, Subcutaneous, Manometry, Neurotransmitter Agents, Recurrence
Show Abstract · Added September 28, 2015
Achalasia is an esophageal motility disorder that is commonly misdiagnosed initially as gastroesophageal reflux disease. Patients with achalasia often complain of dysphagia with solids and liquids but may focus on regurgitation as the primary symptom, leading to initial misdiagnosis. Diagnostic tests for achalasia include esophageal motility testing, esophagogastroduodenoscopy and barium swallow. These tests play a complimentary role in establishing the diagnosis of suspected achalasia. High-resolution manometry has now identified three subtypes of achalasia, with therapeutic implications. Pneumatic dilation and surgical myotomy are the only definitive treatment options for patients with achalasia who can undergo surgery. Botulinum toxin injection into the lower esophageal sphincter should be reserved for those who cannot undergo definitive therapy. Close follow-up is paramount because many patients will have a recurrence of symptoms and require repeat treatment.
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13 MeSH Terms
Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure.
Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B
(2012) Gastroenterology 143: 1473-1481.e3
MeSH Terms: Adolescent, Adult, Aged, Aged, 80 and over, Biomarkers, Citrulline, Dose-Response Relationship, Drug, Double-Blind Method, Endpoint Determination, Female, Humans, Injections, Subcutaneous, Intestinal Absorption, Intestinal Diseases, Intestines, Male, Middle Aged, Parenteral Nutrition, Peptides, Prospective Studies, Short Bowel Syndrome, Treatment Outcome, Video Recording, Young Adult
Show Abstract · Added September 30, 2015
BACKGROUND & AIMS - Teduglutide, a glucagon-like peptide 2 analogue, might restore intestinal structural and functional integrity by promoting growth of the mucosa and reducing gastric emptying and secretion. These factors could increase fluid and nutrient absorption in patients with short bowel syndrome with intestinal failure (SBS-IF). We performed a prospective study to determine whether teduglutide reduces parenteral support in patients with SBS-IF.
METHODS - We performed a 24-week study of patients with SBS-IF who were given subcutaneous teduglutide (0.05 mg/kg/d; n = 43) or placebo (n = 43) once daily. Parenteral support was reduced if 48-hour urine volumes exceeded baseline values by ≥ 10%. The primary efficacy end point was number of responders (patients with >20% reduction in parenteral support volume from baseline at weeks 20 and 24).
RESULTS - There were significantly more responders in the teduglutide group (27/43 [63%]) than the placebo group (13/43 [30%]; P = .002). At week 24, the mean reduction in parenteral support volume in the teduglutide group was 4.4 ± 3.8 L/wk (baseline 12.9 ± 7.8 L/wk) compared with 2.3 ± 2.7 L/wk (baseline 13.2 ± 7.4 L/wk) in the placebo group (P < .001). The percentage of patients with a 1-day or more reduction in the weekly need for parenteral support was greater in the teduglutide group (21/39 [54%]) than in the placebo group (9/39 [23%]; P = .005). Teduglutide increased plasma concentrations of citrulline, a biomarker of mucosal mass. The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n = 2) and placebo (n = 3).
CONCLUSIONS - Twenty-four weeks of teduglutide treatment was generally well tolerated in patients with SBS-IF. Treatment with teduglutide reduced volumes and numbers of days of parenteral support for patients with SBS-IF; ClinicalTrials.gov Number, NCT00798967.
Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.
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24 MeSH Terms
Systemic combination therapy of intravenous continuous 5-fluorouracil and subcutaneous pegylated interferon alfa-2a for advanced hepatocellular carcinoma.
Uchino K, Obi S, Tateishi R, Sato S, Kanda M, Sato T, Arano T, Enooku K, Goto E, Masuzaki R, Nakagawa H, Asaoka Y, Kondo Y, Yamashiki N, Goto T, Shiina S, Omata M, Yoshida H, Koike K
(2012) J Gastroenterol 47: 1152-9
MeSH Terms: Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Antiviral Agents, Carcinoma, Hepatocellular, Cohort Studies, Female, Fluorouracil, Humans, Infusions, Intravenous, Injections, Subcutaneous, Interferon-alpha, Japan, Liver Neoplasms, Male, Middle Aged, Polyethylene Glycols, Recombinant Proteins, Retrospective Studies, Survival Rate, Treatment Outcome
Show Abstract · Added May 2, 2014
BACKGROUND - In Japan, sorafenib is now the first-line therapy for individuals with advanced hepatocellular carcinoma (HCC), but no other treatment is available for such patients. The aim of this study was to assess the efficacy and safety of combination therapy with systemic continuous intravenous infusion of 5-fluorouracil (5-FU) and subcutaneous peginterferon alfa-2a, which was used before sorafenib was introduced to Japan.
METHODS - Two hundred and twenty-three HCC patients, who were not amenable to curative surgery, percutaneous ablation, or transarterial chemoembolization (TACE), and for whom intraarterial chemotherapy was not indicated because of the presence of extrahepatic metastasis or stenosis of the common hepatic artery, received peginterferon alfa-2a (90 μg subcutaneously on days 1, 8, 15, and 22) and 5-FU (500 mg/day intravenously given continuously on days 1-5 and 8-12). We assessed their response to treatment and survival, and treatment safety.
RESULTS - The response rate was 9.4 % (including six patients with complete response) and the disease-control rate was 32.7 %. The median time to progression was 2.0 months. The overall median survival time was 6.5 months (Child-Pugh class A: 9.2 months vs. Child-Pugh class B: 2.8 months). In a multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status >0, Child-Pugh class B, and the presence of macroscopic vascular invasion were independent predictors of poor prognosis. The major grade 3-4 adverse events were leucopenia (13.9 %) and thrombocytopenia (5.8 %). No treatment-related deaths occurred.
CONCLUSIONS - This combination therapy was well tolerated and showed promising efficacy. Further studies are needed to establish the usefulness of this treatment.
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23 MeSH Terms
Efficacy and safety of home-based subcutaneous immunoglobulin replacement therapy in paediatric patients with primary immunodeficiencies.
Borte M, Bernatowska E, Ochs HD, Roifman CM, Vivaglobin Study Group
(2011) Clin Exp Immunol 164: 357-64
MeSH Terms: Brazil, Child, Child, Preschool, Disease-Free Survival, Europe, Female, Follow-Up Studies, Home Infusion Therapy, Humans, Immunoglobulins, Immunologic Deficiency Syndromes, Infections, Injections, Subcutaneous, Male, North America
Show Abstract · Added January 20, 2015
Subcutaneous immunoglobulin infusions are effective, safe and well tolerated in the treatment of primary immunodeficiencies, but only limited data on the treatment of children are available. We investigated the efficacy, safety and pharmacokinetics of home therapy with a 16% liquid human immunoglobulin G preparation (Vivaglobin®) when administered subcutaneously in children with primary immunodeficiencies. Data were analysed from 22 children (2-<12 years) who participated in two prospective, open-label studies (one in Europe/Brazil, one in North America). All children had previously received intravenous immunoglobulins. They started weekly subcutaneous immunoglobulin infusions with an approximately 3-month wash-in/wash-out period, followed by a 6-month (Europe/Brazil) or 12-month (North America) efficacy evaluation period. In Europe/Brazil, subcutaneous doses generally equalled the previous weekly equivalent intravenous doses. In North America, subcutaneous doses during the efficacy evaluation period were 126% (median) of the previous weekly equivalent intravenous doses. Efficacy end-points in both studies included the occurrence of serious bacterial infections and any infections, and serum immunoglobulin G trough levels. Median serum immunoglobulin G trough levels exceeded those during previous intravenous therapy by 13% (North America) and 16% (Europe/Brazil). During the efficacy evaluation period of both studies, none of the children had a serious bacterial infection; the mean overall infection rate/patient year was 4·7 in Europe/Brazil and 5·6 in North America, concurring with previous reports in adults. The adverse event profile was comparable to previous reports in adults. Both studies confirmed the efficacy and safety of subcutaneous immunoglobulin therapy with Vivaglobin in children with primary immunodeficiencies.
© 2011 The Authors. Clinical and Experimental Immunology © 2011 British Society for Immunology.
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15 MeSH Terms
Apolipoprotein A-I modulates regulatory T cells in autoimmune LDLr-/-, ApoA-I-/- mice.
Wilhelm AJ, Zabalawi M, Owen JS, Shah D, Grayson JM, Major AS, Bhat S, Gibbs DP, Thomas MJ, Sorci-Thomas MG
(2010) J Biol Chem 285: 36158-69
MeSH Terms: Animals, Apolipoprotein A-I, Autoimmunity, CD11c Antigen, CD3 Complex, Cell Proliferation, Cholesterol, HDL, Dendritic Cells, Diet, Atherogenic, Female, Flow Cytometry, Humans, Injections, Subcutaneous, Lipids, Lymph Nodes, Lymphocyte Activation, Lymphocyte Count, Macrophages, Male, Mice, Mice, Inbred C57BL, Microscopy, Fluorescence, Receptors, LDL, Skin, T-Lymphocytes, Regulatory
Show Abstract · Added February 11, 2014
The immune system is complex, with multiple layers of regulation that serve to prevent the production of self-antigens. One layer of regulation involves regulatory T cells (Tregs) that play an essential role in maintaining peripheral self-tolerance. Patients with autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis have decreased levels of HDL, suggesting that apoA-I concentrations may be important in preventing autoimmunity and the loss of self-tolerance. In published studies, hypercholesterolemic mice lacking HDL apoA-I or LDLr(-/-), apoA-I(-/-) (DKO), exhibit characteristics of autoimmunity in response to an atherogenic diet. This phenotype is characterized by enlarged cholesterol-enriched lymph nodes (LNs), as well as increased T cell activation, proliferation, and the production of autoantibodies in plasma. In this study, we investigated whether treatment of mice with lipid-free apoA-I could attenuate the autoimmune phenotype. To do this, DKO mice were first fed an atherogenic diet containing 0.1% cholesterol, 10% fat for 6 weeks, after which treatment with apoA-I was begun. Subcutaneous injections of 500 μg of lipid-free apoA-I was administered every 48 h during the treatment phase. These and control mice were maintained for an additional 6 weeks on the diet. At the end of the 12-week study, DKO mice showed decreased numbers of LN immune cells, whereas Tregs were proportionately increased. Accompanying this increase in Tregs was a decrease in the percentage of effector/effector memory T cells. Furthermore, lipid accumulation in LN and skin was reduced. These results suggest that treatment with apoA-I reduces inflammation in DKO mice by augmenting the effectiveness of the LN Treg response.
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25 MeSH Terms
Nitro-fatty acids reduce atherosclerosis in apolipoprotein E-deficient mice.
Rudolph TK, Rudolph V, Edreira MM, Cole MP, Bonacci G, Schopfer FJ, Woodcock SR, Franek A, Pekarova M, Khoo NK, Hasty AH, Baldus S, Freeman BA
(2010) Arterioscler Thromb Vasc Biol 30: 938-45
MeSH Terms: Actins, Animals, Anti-Inflammatory Agents, Antioxidants, Aortic Diseases, Apolipoproteins E, Atherosclerosis, Cell Adhesion Molecules, Cells, Cultured, Chemokine CCL2, Collagen, Disease Models, Animal, Dose-Response Relationship, Drug, Foam Cells, Injections, Subcutaneous, Lipoproteins, LDL, Male, Mice, Mice, Knockout, Oleic Acids, Oxidants, Oxidative Stress, Phosphorylation, STAT1 Transcription Factor, Signal Transduction
Show Abstract · Added March 27, 2013
OBJECTIVE - Inflammatory processes and foam cell formation are key determinants in the initiation and progression of atherosclerosis. Electrophilic nitro-fatty acids, byproducts of nitric oxide- and nitrite-dependent redox reactions of unsaturated fatty acids, exhibit antiinflammatory signaling actions in inflammatory and vascular cell model systems. The in vivo action of nitro-fatty acids in chronic inflammatory processes such as atherosclerosis remains to be elucidated.
METHODS AND RESULTS - Herein, we demonstrate that subcutaneously administered 9- and 10-nitro-octadecenoic acid (nitro-oleic acid) potently reduced atherosclerotic lesion formation in apolipoprotein E-deficient mice. Nitro-fatty acids did not modulate serum lipoprotein profiles. Immunostaining and gene expression analyses revealed that nitro-oleic acid attenuated lesion formation by suppressing tissue oxidant generation, inhibiting adhesion molecule expression, and decreasing vessel wall infiltration of inflammatory cells. In addition, nitro-oleic acid reduced foam cell formation by attenuating oxidized low-density lipoprotein-induced phosphorylation of signal transducer and activator of transcription-1, a transcription factor linked to foam cell formation in atherosclerotic plaques. Atherosclerotic lesions of nitro-oleic acid-treated animals also showed an increased content of collagen and alpha-smooth muscle actin, suggesting conferral of higher plaque stability.
CONCLUSION - These results reveal the antiatherogenic actions of electrophilic nitro-fatty acids in a murine model of atherosclerosis.
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25 MeSH Terms
Teriparatide is safe and effectively increases bone biomarkers in institutionalized individuals with osteoporosis.
Ryder KM, Tanner SB, Carbone L, Williams JE, Taylor HM, Bush A, Pintea V, Watsky MA
(2010) J Bone Miner Metab 28: 233-9
MeSH Terms: Aged, Biomarkers, Bone Density Conservation Agents, Bone Resorption, Bone and Bones, Calcium, Drug Monitoring, Female, Humans, Hypercalcemia, Hypokinesia, Injections, Subcutaneous, Institutionalization, Male, Mentally Disabled Persons, Middle Aged, Osteogenesis, Osteoporosis, Osteoporosis, Postmenopausal, Teriparatide, Time Factors, Treatment Outcome
Show Abstract · Added January 20, 2015
Institutionalized adults with severe developmental disabilities have a high rate of minimal trauma and appendicular fracture. There is little information about osteoporosis treatment in this population. In this efficacy and safety study, men and women with severe developmental disabilities and osteoporosis received 20 mcg teriparatide subcutaneously daily for 18-24 months. Markers of bone formation [procollagen type 1 intact N-terminal propeptide (P1NP)] and resorption [C-telopeptide (CTx)] were measured at three-month intervals. Serum calcium was measured at two-week intervals for 12 weeks and thereafter at three-month intervals. Twenty-seven individuals received at least one injection. The incidence of hypercalcemia was 11.1% but was persistent and led to medication discontinuation in only one participant. Biomarkers of bone formation increased rapidly, doubling by three months. At 12 months, P1NP and CTx remained elevated from baseline; P1NP had risen from 66.95 +/- 83.71 microg/l (mean +/- SD) to 142.42 +/- 113.85 microg/l (P = 0.05), and CTx had increased from 0.377 +/- 0.253 to 1.016 +/- 1.048 ng/ml (P = 0.01). The majority of participants had an increase in P1NP of over 10 microg/l. In conclusion, teriparatide is safe and effective in developmentally disabled institutionalized adults. Serial calcium measurements are warranted, particularly during the first three months of therapy.
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22 MeSH Terms
Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma.
Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA
(2009) J Clin Oncol 27: 3584-90
MeSH Terms: Administration, Oral, Adult, Aged, Carcinoma, Renal Cell, Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Indoles, Injections, Subcutaneous, Interferon-alpha, Kaplan-Meier Estimate, Kidney Neoplasms, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Invasiveness, Neoplasm Metastasis, Neoplasm Staging, Probability, Proportional Hazards Models, Pyrroles, Sunitinib, Survival Analysis, Treatment Outcome
Show Abstract · Added March 7, 2014
PURPOSE - A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-alpha) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported.
PATIENTS AND METHODS - Seven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN-alpha 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up.
RESULTS - Median overall survival was greater in the sunitinib group than in the IFN-alpha group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051) per the primary analysis of unstratified log-rank test (P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN-alpha group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor-signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-alpha (P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-alpha (P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).
CONCLUSION - Sunitinib demonstrates longer overall survival compared with IFN-alpha plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.
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28 MeSH Terms
Injectable biodegradable polyurethane scaffolds with release of platelet-derived growth factor for tissue repair and regeneration.
Hafeman AE, Li B, Yoshii T, Zienkiewicz K, Davidson JM, Guelcher SA
(2008) Pharm Res 25: 2387-99
MeSH Terms: Absorbable Implants, Animals, Biomechanical Phenomena, Bone Regeneration, Cell Line, Cross-Linking Reagents, Drug Carriers, Elasticity, Hydrolysis, Injections, Subcutaneous, Isocyanates, Kinetics, Male, Mice, Osteoblasts, Platelet-Derived Growth Factor, Polyurethanes, Porosity, Rats, Rats, Sprague-Dawley, Solubility, Temperature, Tissue Engineering, Tissue Scaffolds
Show Abstract · Added December 10, 2013
PURPOSE - The purpose of this work was to investigate the effects of triisocyanate composition on the biological and mechanical properties of biodegradable, injectable polyurethane scaffolds for bone and soft tissue engineering.
METHODS - Scaffolds were synthesized using reactive liquid molding techniques, and were characterized in vivo in a rat subcutaneous model. Porosity, dynamic mechanical properties, degradation rate, and release of growth factors were also measured.
RESULTS - Polyurethane scaffolds were elastomers with tunable damping properties and degradation rates, and they supported cellular infiltration and generation of new tissue. The scaffolds showed a two-stage release profile of platelet-derived growth factor, characterized by a 75% burst release within the first 24 h and slower release thereafter.
CONCLUSIONS - Biodegradable polyurethanes synthesized from triisocyanates exhibited tunable and superior mechanical properties compared to materials synthesized from lysine diisocyanates. Due to their injectability, biocompatibility, tunable degradation, and potential for release of growth factors, these materials are potentially promising therapies for tissue engineering.
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24 MeSH Terms
Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children.
Shankar V, Haque A, Churchwell KB, Russell W
(2007) Intensive Care Med 33: 1173-1178
MeSH Terms: Adolescent, Child, Cohort Studies, Diabetic Ketoacidosis, Female, Humans, Hypoglycemic Agents, Injections, Subcutaneous, Insulin, Insulin Glargine, Insulin, Long-Acting, Intensive Care Units, Pediatric, Length of Stay, Male, Retrospective Studies, Treatment Outcome
Show Abstract · Added March 24, 2014
OBJECTIVE - To study the effect of subcutaneous administration of insulin glargine on the rate of resolution of acidosis and intravenous insulin infusion requirement in children with moderate and severe diabetic ketoacidosis (DKA).
STUDY DESIGN - Retrospective cohort study.
SETTING - Pediatric intensive care unit of a university-based children's hospital.
PATIENTS - Children with moderate to severe DKA admitted between March 2001 and February 2003.
RESULTS - The outcomes of children who received 0.3 units/kg of subcutaneous insulin glargine in the first 6 h of management in addition to the standard treatment (n=12) were compared with those of children who received standard treatment alone (n=59). Measured outcomes included dose of intravenous insulin required, duration of insulin infusion and acidosis correction time. The two groups were similar in demographics and severity of illness. The mean time for acidosis correction (venous pH>or=7.3) in the insulin glargine group was shorter than the standard therapy group (12.4+/-2.9 h and 17.1+/-6.2 h respectively, p<0.001). The insulin infusion time was shorter in the insulin glargine group (14.8+/-6.0 h vs 24.4+/-9.0 h, p<0.001). There was a trend towards shorter total hospital stay in the glargine group (3.2+/-1.0 days vs 3.72+/-1.06 days).
CONCLUSIONS - In our small series of children with moderate and severe DKA, supplementing with subcutaneous insulin glargine led to a faster resolution of acidosis without any adverse effects. This could potentially lead to a shorter need for insulin infusion and a shorter ICU length of stay.
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16 MeSH Terms