The medical letter on drugs and therapeutics august 29 2016

AspireAssist - A New Device for Weight Loss The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet... Lifitegrast (Xiidra) for Dry Eye Disease The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte function-associated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of... Sugammadex (Bridion) for Rapid Reversal of Neuromuscular Blockade The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical... An Oral Cholera Vaccine for Travelers (Vaxchora) The FDA has approved Vaxchora (PaxVax), a single-dose, oral, live-attenuated cholera vaccine, to protect against disease caused by Vibrio cholerae serogroup O1 in adults 18-64 years... Addendum: Cannabis and Cannabinoids A reader asked why our Cannabis and Cannabinoids article (Med Lett Drugs Ther 2016; 58:97) did not include our usual Dosage/Cost table. We have now posted one in the article as it appears online....

The Medical Letter ® on Drugs and Therapeutics Volume 58 ISSUE ISSUE No 1433 1502 Volume 56 August 29, 2016 IN THIS ISSUE AspireAssist — A New Device for Weight Loss p 109 Lifitegrast (Xiidra) for Dry Eye Disease p 110 Sugammadex (Bridion) for Rapid Reversal of Neuromuscular Blockade p 112 An Oral Cholera Vaccine for Travelers (Vaxchora) p 113 Addendum: Cannabis and Cannabinoids p 114 Important Copyright Message FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS The Medical Letter, Inc publications are protected by U.S and international copyright laws Forwarding, copying or any distribution of this material is prohibited Sharing a password with a non-subscriber or otherwise making the contents of this site available to third parties is strictly prohibited By accessing and reading the attached content I agree to comply with U.S and international copyright laws and these terms and conditions of The Medical Letter, Inc For further information click: Subscriptions, Site Licenses, Reprints or call customer service at: 800-211-2769 Published by The Medical Letter, Inc • A Nonprofit Organization The Medical Letter publications are protected by US and international copyright laws Forwarding, copying or any other distribution of this material is strictly prohibited For further information call: 800-211-2769 The Medical Letter ® on Drugs and Therapeutics Volume 58 August 29, 2016 Take CME Exams ISSUE ISSUE No 1433 1502 Volume 56 ▶ ALSO IN THIS ISSUE Lifitegrast (Xiidra) for Dry Eye Disease p 110 Sugammadex (Bridion) for Rapid Reversal of Neuromuscular Blockade p 112 An Oral Cholera Vaccine for Travelers (Vaxchora) p 113 Addendum: Cannabis and Cannabinoids p 114 AspireAssist — A New Device for Weight Loss The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy WEIGHT LOSS PROCEDURES —  Surgical treatment of obesity is generally limited to patients with a BMI ≥40, or a BMI ≥35 with an obesity-related comorbidity such as diabetes, hypertension, or hypercholesterolemia Procedures that cause malabsorption (Roux-en-Y gastric bypass and biliopancreatic diversion) lead to greater weight loss, but more adverse effects, than purely restrictive procedures such as adjustable gastric banding or sleeve gastrectomy.1 Gastric balloon devices are inserted endoscopically and can be left in place for up to months; when they are removed, patients generally regain a substantial fraction of the lost weight.2 The subcutaneously implanted Maestro Rechargeable System, which utilizes high-frequency electrical pulses to block vagus nerve signals between the stomach and the brain, is less effective than bariatric surgery.3 THE NEW DEVICE — The AspireAssist device facilitates weight loss in obese patients by allowing them to partially drain their stomach contents after each main meal, reducing the amount of absorbed calories by approximately 30%.4 The device consists of a tube similar to a percutaneous endoscopic gastrostomy (PEG) feeding tube, a port valve, and an external device that contains a connector, a drainage tube with a clamp, and a water reservoir The PEG tube is inserted endoscopically into the stomach and pulled Table Efficacy of Weight Loss Procedures/Devices Procedure/Device Biliopancreatic diversion Roux-en-Y gastric bypass Sleeve gastrectomy Adjustable gastric banding Gastric aspiration (AspireAssist) Gastric balloon (Orbera, ReShape) Vagal blocking therapy (Maestro Rechargeable System) Mean Excess Weight1 Lost ≥70%2 66%2 59%2 47%2 32%3 27-28%4 25%5 Defined as weight above the weight at a BMI of 25 Diet, drugs, and surgery for weight loss Med Lett Drugs Ther 2015; 57:21 CC Thompson et al Gastroenterology 2016; 150(suppl 1): S86, abstract 381 ReShape and Orbera – two gastric balloon devices for weight loss Med Lett Drugs Ther 2015; 57:122 Maestro Rechargeable System for weight loss Med Lett Drugs Ther 2016; 58:54 through a percutaneous incision while the patient is under twilight sedation The disk-shaped port valve is connected to the tube at skin level to hold it in place Approximately 20-30 minutes after a meal, the patient attaches the connector of the external device to the port valve and opens the valve, allowing the stomach contents to drain by gravity into a toilet Food must be thoroughly chewed to fit through the 6-mm drainage tube When drainage stops, the patients flushes the tube and stomach with potable water from the reservoir The process takes 5-10 minutes to complete The connector contains a counter that tracks the number of times the valve is opened; it stops working after 115 cycles (about 5-6 weeks) Follow-up appointments are necessary to replace the connector, confirm that the device is working properly, adjust the length of the tube as the patient loses weight, and provide diet and lifestyle counseling The initial procedure and followup during the first year are expected to cost $8000 to $13,000, according to the manufacturer CLINICAL STUDY — In an open-label, 52-week trial (PATHWAY), available only as an abstract, 171 patients were randomized in a 2:1 ratio to active treatment 109 Published by The Medical Letter, Inc • A Nonprofit Organization The Medical Letter ® Table Contraindications ▶ Previous abdominal surgery that increases the risks associated with gastrostomy tube placement ▶ Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction ▶ Inflammatory bowel disease, ulcers, bleeding lesions, or tumors discovered upon endoscopic exam ▶ History of refractory gastric ulcers ▶ History or evidence of serious pulmonary or cardiovascular disease ▶ Uncontrolled hypertension, coagulation disorders, anemia, severe organ dysfunction such as cirrhosis or severe chronic kidney disease, chronic abdominal pain, or poor general health ▶ Bulimia, binge eating disorder, or night eating syndrome ▶ A physical or mental disability that would affect compliance with therapy ▶ Pregnant or lactating women with AspireAssist plus lifestyle counseling (behavior education, diet, and exercise) or lifestyle counseling alone The active treatment group lost 31.5% of excess weight (12.1% of total body weight), compared to 9.8% (3.5% of total body weight) in the control group, a significant difference A second primary endpoint, at least a 50% response rate (defined as ≥25% excess weight lost) in the active treatment group, was not met because the lower end of the confidence interval was 49%.5,6 ADVERSE EFFECTS — In the PATHWAY trial, adverse effects that occurred in >5% of patients using AspireAssist included abdominal pain or discomfort, peristomal granulation tissue, nausea/vomiting, change in bowel habits, peristomal infection or possible infection, and peristomal bleeding, discharge, inflammation, or irritation Most of these resolved within 30 days Serious adverse events (replacement of the tube, peritonitis without abscess, post-procedure abdominal pain, and nonbleeding prepyloric ulceration) occurred in 3.6% of patients (4 of 111); none of these resulted in death or permanent injury CONCLUSION — The AspireAssist device is less invasive than bariatric surgery for treatment of obesity and might be effective for some patients, but available data are limited and the list of contraindications is extensive The effects of the device on long-term weight loss and quality of life remain to be determined ■ Diet, drugs, and surgery for weight loss Med Lett Drugs Ther 2015; 57:21 ReShape and Orbera – two gastric balloon devices for weight loss Med Lett Drugs Ther 2015; 57:122 Maestro Rechargeable System for weight loss Med Lett Drugs Ther 2016; 58:54 S Sullivan et al Aspiration therapy leads to weight loss in obese subjects: a pilot study Gastroenterology 2013; 145:1245 110 August 29, 2016 Vol 58 (1502) CC Thompson et al The AspireAssist is an effective tool in the treatment of class II and class III obesity: results of a one-year clinical trial Gastroenterology 2016; 150(suppl1):S86, abstract 381 FDA summary of safety and effectiveness data Available at: www.accessdata.fda.gov/cdrh_docs/pdf15/p150024b.pdf Accessed August 11, 2016 ▶ Lifitegrast (Xiidra) for Dry Eye Disease The FDA has approved a 5% ophthalmic solution of lifitegrast (Xiidra – Shire), a lymphocyte functionassociated antigen-1 (LFA-1) antagonist, for treatment of the signs and symptoms of dry eye disease Lifitegrast is the first LFA-1 antagonist to be approved for any indication in the US Pronunciation Key Lifitegrast: lif" i teg' rast Xiidra: zye' dra DRY EYE DISEASE — Ocular surface inflammation leading to dry eyes can be caused by altered tearfilm composition, reduced tear production, poor lid function, environmental conditions, or diseases such as Sjögren’s syndrome Anticholinergic drugs, estrogens, and selective serotonin reuptake inhibitors (SSRIs) can also cause dry eyes Older age and female sex are risk factors STANDARD TREATMENT — Treatments for dry eye disease include artificial tears, ocular insert devices such as Lacrisert, and ophthalmic anti-inflammatory drugs such as cyclosporine (Restasis), corticosteroids, and tetracyclines.1,2 Artificial tear preparations are usually administered every 4-6 hours, but can be used as often as hourly; some clinicians recommend Table Some Prescription Products for Dry Eye Disease Usual Adult Dosage Cost1 Cyclosporine 0.05% unit ophthalmic emulsion – dose vials Restasis (Allergan) drop in each eye q12h2,3 $426.70 Hydroxypropyl cellulose mg inserts ophthalmic insert – Lacrisert (Valeant) insert in each eye once/d4 398.10 Lifitegrast ophthalmic solution – Xiidra (Shire) drop in each eye q12h3 Drug Formulation 5% single-use containers 426.70 Approximate WAC for 30 days' treatment at the usual adult dosage WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price Source: AnalySource® Monthly August 5, 2016 Reprinted with permission by First Databank, Inc All rights reserved ©2016 www.fdbhealth.com/policies/drug-pricing-policy Before use, the unit-dose vial should be inverted repeatedly until a uniform, white, opaque emulsion forms Contact lenses should be removed before instilling the drops, but may be replaced 15 minutes after administration Some patients may require twice-daily use The Medical Letter Vol 58 (1502) ® August 29, 2016 Table Some Lifitegrast Clinical Trials Inferior Corneal Fluorescein Staining Score1 Baseline Change at Day 84 Study Arms Phase 23 (n=116) Lifitegrast 5% Vehicle 1.77 1.65 OPUS-14 (n=588) Lifitegrast 5% Vehicle 1.84 1.81 OPUS-25 (n=718) Lifitegrast 5% Vehicle 2.39 2.40 OPUS-36 (n=711) Lifitegrast 5% Vehicle 2.46 2.46 Eye Dryness Score2 Baseline Change at Day 84 +0.04* +0.38 -0.07* +0.17 51.6 51.8 -0.73 -0.71 -0.80* -0.63 69.7 69.2 40.2 41.6 68.3 69.0 -14.4 -7.2 -15.2* -11.2 -35.3* -22.8 -37.7* -30.5 *p