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Review of the safety and efficacy of exenatide once weekly for the treatment of type 2 diabetes mellitus [Revue de l'efficacité et de l'innocuité d'une administration hebdomadaire d'exénatide pour le traitement du diabète type 2]
Murphy C.E.,Albany College of Pharmacy and Health Sciences
Annals of Pharmacotherapy | Year: 2012
OBJECTIVE: To summarize and evaluate the available literature assessing the efficacy and safety of exenatide once weekly for the treatment of type 2 diabetes mellitus. DATA SOURCES: PubMed (1966-January 2012) and International Pharmaceutical Abstracts (1969-January 2012) were searched using the term exenatide once weekly. Abstracts presented at the European Association for the Study of Diabetes Annual Meeting in 2011 and reference citations from publications were reviewed for inclusion. Eli Lilly and Company and Amylin Pharmaceuticals were contacted for additional unpublished information. STUDY SELECTION AND DATA EXTRACTION: All English-language articles and abstracts were evaluated for inclusion. All randomized controlled trials were included in the review. DATA SYNTHESIS: The efficacy and safety of exenatide once weekly has been evaluated as initial monotherapy and as add-on therapy to metformin, sulfonylureas, and thiazolidinediones in patients with uncontrolled type 2 diabetes for up to 3 years. Results from 6 randomized, comparator-controlled studies in over 3000 patients indicate that treatment with exenatide once weekly results in significant glycemic improvements and weight loss. Gastrointestinal adverse effects and injection site reactions are common, but rarely lead to drug discontinuation. CONCLUSIONS: Exenatide once weekly holds promise as a convenient, efficacious, and well-tolerated antihyperglycemic agent for the treatment of type 2 diabetes. Studies evaluating outcomes such as cardiovascular events or all-cause mortality with exenatide once weekly are lacking.
Bailie G.R.,Albany College of Pharmacy and Health Sciences
American Journal of Health-System Pharmacy | Year: 2012
Purpose. An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. Methods. All AE reports to the Food and Drug Administration (FDA) citing iron sucrose, ferric gluconate, high- and low-molecular- weight iron dextran products, or ferumoxytol from October 2009 through June 2010 were evaluated. The rates of various classifications of reported AEs were calculated on a per-unit-sold basis and, for comparison of products supplied in different unit sizes, also in terms of 100-mg dose equivalents (DEq) of iron. Results. A total of 197 reported AEs were identified (a cumulative rate of 14.1 AEs per million units sold). The rates of all AE classifications combined ranged from 5.25 to 746 per million units sold for iron sucrose and ferumoxytol, respectively; using the other method of calculation, the rates ranged from 5.24 per million DEq (iron sucrose) to 147 per million DEq (ferumoxytol). Relative to iron sucrose and sodium ferric gluconate, ferumoxytol was associated with significantly elevated risks of death (odds ratio [OR], 475 and 156, respectively; p < 0.0001), serious nonfatal AEs (OR, 263 and 121, respectively; p < 0.0001), and all evaluated AE classifications combined (OR, 142 and 109, respectively; p < 0.05). Conclusion. Analysis of reports submitted to FDA revealed large differences among i.v. iron products in reported deaths, serious AEs, other major AEs, and other AEs. Iron sucrose and sodium ferric gluconate were associated with much lower rates of AEs per million units sold than iron dextran or ferumoxytol, which were associated with the highest rates of all reported AE classifications. Copyright © 2012, American Society of Health-System Pharmacists, Inc. All rights reserved.
Scarpace S.L.,Albany College of Pharmacy and Health Sciences
Clinical Therapeutics | Year: 2012
Background: Eribulin mesylate is a halichondrin B analogue that acts as a nontaxane microtubule dynamics inhibitor. Eribulin was approved in the United States in 2010 for the treatment of metastatic breast cancer for patients who have received at least 2 metastatic breast cancer chemotherapeutic regimens, including an anthracycline and a taxane. Eribulin is administered as a single agent at 1.4 mg/m2 IV for 2 to 5 minutes on days 1 and 8 of a 21-day cycle. Objectives: The goals of this article are to review eribulin's medication profile, including pharmacology, pharmacokinetic properties, efficacy, and tolerability. Recommendations are provided at the end of the article based on the published information. Methods: PubMed, the Cochrane Central Register of Controlled Trials, and Clinical Trials.gov were searched from the beginning of each database through January 3, 2012, for relevant articles on human studies published in English. Search terms included eribulin, eribulin mesylate, and Halaven. Clinical trials, case reports, comparative studies, meta-analyses, evaluation studies, controlled clinical trials, and randomized controlled trials were included as search limits. The references from selected articles were also reviewed to identify additional publications. Eisai, the manufacturer of eribulin mesylate, was also contacted for information regarding trials listed in Clinicaltrials.gov but not yet published. Results: One Phase III trial was identified that evaluated eribulin for use in patients with metastatic breast cancer. Four Phase II trials were identified that studied eribulin in patients with head and neck, pancreatic, and non-small cell lung cancers. The median overall survival among previously treated metastatic breast cancer patients treated with eribulin was 13.1 months compared with 10.6 months (P = 0.041) with other active chemotherapy for this setting. In non-small cell lung cancer, median overall survival in eribulin-treated patients has been reported as 9.4 months in an unselected population and varies according to taxane sensitivity: 12.6 months in taxane-sensitive disease versus 8.9 months in taxane-resistant disease. Patients with head and neck or pancreatic cancers did not experience improvements in response rates or survival outcomes when treated with eribulin in clinical trials. Conclusions: Eribulin is approved by the Food and Drug Administration for patients with previously treated metastatic breast cancer and has demonstrated a survival benefit compared with standard treatment options in this setting. Non-small cell lung cancer patients had improved response rates when treated with eribulin in open-label, nonrandomized, Phase II trials reported in abstract form. Eribulin was not effective in the treatment of head and neck or pancreatic cancer in Phase II trials. © 2012 Elsevier HS Journals, Inc.
Lin H.Y.,Albany College of Pharmacy and Health Sciences
Discovery medicine | Year: 2012
The sodium/proton (Na/H) exchanger, Na,K-ATPase, and Ca2+-ATPase are membrane ion pumps whose basal activities may be regulated by local nongenomic actions of thyroid hormone and hormone analogues via a hormone receptor on plasma membrane integrin αvβ3. System A amino acid transport and the activity of P-glycoprotein (P-gp; ABCB1), a multidrug efflux pump, are also modulated by thyroid hormone and αvβ3. Where signal transduction has been studied, the presence of the hormone at the receptor is transduced by mitogen-activated protein kinase (MAPK) isoforms (ERK1/2; p38) or phosphatidylinositol 3-kinase into local actions. The existence of the cell surface receptor offers opportunities to pharmacologically modify actions of these important transport functions with nanoparticulate formulations of T4 and T3 that do not enter the cell. Such formulations may reverse complex intracellular accumulations of H+, Na+, and Ca2+ that occur in clinical settings such as ischemia. In addition, nanoparticulate tetraiodothyroacetic acid (tetrac), a thyroid hormone analogue that inhibits binding of T4 and T3 to integrin αvβ3 as well as certain other functions of the integrin, may reverse P-gp-dependent resistance to anti-cancer drugs in tumor cells.
Pai M.P.,Albany College of Pharmacy and Health Sciences
Advances in Chronic Kidney Disease | Year: 2010
One-third of adult Americans are currently classified as obese. Physiologic changes associated with obesity can potentially alter the clearance of commonly used drugs. Clearance of certain drugs by the kidneys occurs primarily through glomerular filtration and tubular secretion. Obesity has been associated with glomerular hyperfiltration, whereas obesity-related effects on tubular secretion are not well characterized. Estimation of the glomerular filtration rate (GFR) is currently performed using serum creatinine using the Modification of Diet in Renal Disease (MDRD) equation. However, drug dosing guidelines are often based on creatinine clearance (CLcr) using the Cockcroft-Gault equation as a surrogate of GFR. There is a lack of consensus on the most appropriate method for estimation of GFR or CLcr in patients with obesity. The controversy relates to the use of 2 body size descriptors that confound these equations. The Cockcroft-Gault equation relies on total body weight and so overestimates GFR in patients with obesity. The MDRD equation indexes GFR based on a normalized body surface area, that is, mL/min/1.73 m2. Conversion of MDRD estimated GFR to non-normalized body surface area overestimates GFR in patients with obesity. The current review explores current approaches and controversies to estimation of GFR and CLcr among obese patients in clinical practice. The role of the alternate body size descriptor, lean body weight to estimate CLcr in obese patients is reviewed. © 2010 National Kidney Foundation, Inc.