The medical letter on drugs and therapeutics june 23 2014

The Medical Letter ® On Drugs and Therapeutics Published by The Medical Letter, Inc • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofit Publication IN THIS ISSUE (starts on next page) Low-Dose Aspirin for Prevention of Preeclampsia p 49 Luliconazole Cream (Luzu) for Tinea Infections p 50 Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis p 51 Important Copyright Message The Medical Letter® publications are protected by US 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 US 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 FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS 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 Published by The Medical Letter, Inc • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofit Publication Volume 56 (Issue 1445) June 23, 2014 ALSO IN THIS ISSUE Luliconazole Cream (Luzu) for Tinea Infections p 50 Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis p 51 Low-Dose Aspirin for Prevention of Preeclampsia The American College of Obstetricians and Gynecologists (ACOG) and the US Preventive Services Task Force (USPSTF) have recommended that women at risk for preeclampsia take low-dose aspirin daily after the first trimester.1,2 PREECLAMPSIA — Preeclampsia is a multisystem disorder characterized by hypertension and proteinuria that occurs after 20 weeks’ gestation and can result in significant maternal and fetal morbidity and mortality In severe cases, the mother may have severe headache, visual disturbances, thrombocytopenia, renal insufficiency, and impaired liver function, with an increased risk of seizures (eclampsia), pulmonary edema, stroke, and death In the fetus, preeclampsia can cause intrauterine growth restriction, premature delivery, and death Delivery is the only definitive treatment A NEW REVIEW — An analysis of 21 randomized controlled trials and observational studies in women at high or average risk for preeclampsia found that daily low-dose aspirin (50-150 mg/day) started as early as the second trimester was associated with absolute risk reductions of 2-5% for preeclampsia, 1-5% for intrauterine growth restriction, and 2-4% for preterm birth None of these reductions were statistically significant.3 RECOMMENDATIONS — ACOG recommends lowdose aspirin (60-80 mg/day) beginning in the late first trimester for women with a history of early-onset preeclampsia and preterm delivery at 35 years, previous adverse pregnancy outcome, >10-year interval between pregnancies, or mother who was born with a low birth weight or was small for gestational age).2 ADVERSE EFFECTS — Low-dose aspirin taken after the first trimester has not been shown to increase the risk of antepartum or postpartum bleeding in the mother or the newborn infant The largest available controlled trial of low-dose aspirin in pregnancy found no increase in bleeding and no effect on the development of the infant up to age 18 months.4 CONCLUSION — The evidence that low-dose aspirin (81 mg/day) taken after 12 weeks’ gestation reduces the risk of preeclampsia in women at risk for this disorder is limited, but use of low-dose aspirin for this indication generally appears to be safe □ The American College of Obstetricians and Gynecologists Hypertension in pregnancy Available at: http://www.acog.org/ Resources_And_Publications/Task_Force_and_Work_Group_ Reports/Hypertension_in_Pregnancy Accessed June 16, 2014 U.S Preventive Services Task Force Low-dose aspirin for the prevention of morbidity and mortality from preeclampsia: U.S Preventive Services Task Force recommendation statement draft Available at: http://www.uspreventiveservicestaskforce.org/ uspstf14/asprpreg/asprpregdraftrec.htm Accessed June 16, 2014 JT Henderson et al Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: a systematic evidence review for the U.S Preventive Services Task Force Ann Intern Med 2014; 160:695 CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women Lancet 1994; 343:619 FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS 49 Luliconazole Cream (Luzu) for Tinea Infections The FDA has approved luliconazole (Luzu Cream, 1% – Valeant) for treatment of tinea pedis, tinea cruris, and tinea corporis infections DRUGS FOR TINEA PEDIS — Tinea pedis is the most common form of tinea infection It is generally treated with a topical allylamine, benzylamine, or imidazole antifungal for weeks (see Table 1) Allylamines are more active in vitro than imidazoles against the dermatophytes that cause the disease, but cure rates for allylamines, benzylamines, and imidazoles have generally been similar Cure rates have been lower with tolnaftate, and nystatin is not effective Relapse is common with all of these drugs PHARMACOLOGY — Maximum plasma concentrations of luliconazole were low but measurable after topical application of about 3.5 grams of cream daily for 15 days in patients with moderate to severe tinea pedis or tinea cruris and were about 8-fold higher in patients treated for tinea cruris CLINICAL STUDIES — Luliconazole applied once daily for 14 days was compared to its vehicle alone in unpublished, randomized, double-blind trials (summarized in the package insert) in a total of 423 patients with culture-proven tinea pedis Complete clearance (clinical and mycological cure) at weeks post-treatment (the primary endpoint) occurred in the studies in 26% and 14% of patients treated with the active drug compared to 2% and 3% of those treated with the vehicle alone Mycological cure occurred in the studies in 62% and 56% of patients treated with the active drug compared to 18% and 27% of those treated with the vehicle alone In one similar published trial, 11 of 41 patients (27%) treated for weeks with luliconazole and of 22 (9%) treated with the vehicle alone achieved complete clearance at weeks post-treatment (the primary endpoint).1 A randomized, double-blind, controlled trial of luliconazole once daily for days in 256 patients with tinea cruris found that 35 of 165 patients (21%) treated with the active drug and of 91 (4%) treated with the vehicle alone achieved complete clearance at 21 days post-treatment Mycological cure occurred in 78% of those treated with luliconazole compared to 45% of those treated with the vehicle alone.2 Table Some Topical Antifungals for Tinea Pedis Infection Drug Some Available Formulations1 Usual Adult Dosage2 Cream, gel Cream Cream, gel once/d x 2-4 wks4 bid x 1-2 wks7 Cream Cream once/d x wks or bid x wk Cream, solution Cream Cream Cream Cream Cream, powder spray, powder Liquid spray, powder spray, powder Liquid spray, powder spray, powder Cream, lotion Cream Cream, solution bid x wks Cost3 Allylamines Naftifine – Naftin (Merz) Terbinafine6 – generic Lamisil AT6 (Novartis Consumer) $294.105 5.30 7.20 Benzylamines Butenafine – Mentax (Mylan) Lotrimin Ultra6 (MSD Consumer) 90.10 7.10 Imidazoles Clotrimazole6 – generic Lotrimin AF (MSD Consumer) Econazole – generic Ketoconazole – generic Luliconazole – Luzu (Valeant) Miconazole6 – generic Lotrimin AF (MSD Consumer) Desenex (Novartis Consumer) Oxiconazole – Oxistat (PharmaDerm) Sertaconazole – Ertaczo (Valeant) Sulconazole – Exelderm (Ranbaxy) once/d x wks once/d x wks once/d x wks bid x wks once/d or bid x wks bid x wks bid x wks 1.80 8.60 13.90 41.70 380.008 2.06 5.40 4.30 315.90 351.708 136.50 Other Ciclopirox – generic Loprox (Valeant) Tolnaftate – generic Tinactin (MSD Consumer) Gel, cream, lotion Gel Cream, lotion, solution, powder, spray, gel Cream, liquid spray, powder spray, powder bid x wks bid x wks 64.50 627.809 2.70 7.20 Other formulations may be available for other indications Dosing schedule may vary based on formulation Approximate wholesale acquisition cost (WAC) for the number of tubes of cream or gel or bottles of powder spray needed for one course of treatment at the lowest usual dosage (about 0.5 g/application) Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) June 5, 2014 Reprinted with permission by FDB, Inc All rights reserved ©2014 www.fdbhealth.com/policies/drug-pricing-policy Actual retail prices may be higher Four weeks for the 1% cream or gel; weeks for the 2% formulations The 1% gel should be applied bid Cost of a 45-g tube of Naftin 2% cream Available without a prescription One week between the toes; weeks on bottom or sides of foot Cost of 60 g Cost of 100 g 50 The Medical Letter • Volume 56 • Issue 1445 • June 23, 2014 ADVERSE EFFECTS — Luliconazole was well tolerated in the clinical trials; adverse effects were similar to those reported with use of the vehicle alone Mild application site reactions occurred in a few patients Safety trials in animals found that luliconazole cream had minimal potential for irritation and did not show a potential for sensitization, phototoxicity, or photoallergenicity Luliconazole is classified as category C (embryofetal toxicity in animals at high doses; no adequate human studies) for use during pregnancy DOSAGE AND ADMINISTRATION — Luzu is available in 30- and 60-gram tubes For treatment of tinea pedis, it should be applied to affected areas and to about inch of the adjacent areas once daily for weeks Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis The FDA has approved another solution of the aminoglycoside antibiotic tobramycin (Bethkis – Chiesi/Cornerstone) for oral inhalation via a nebulizer for management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa INHALED ANTIBIOTICS FOR CF — Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic P aeruginosa infection in patients with CF.1 Tobramycin and aztreonam (Cayston) are the only antibiotics that are FDA-approved for such use Bethkis delivers the same dose of tobramycin as an older formulation (Tobi, and generics), but in a more concentrated solution An orally inhaled dry powder formulation of tobramycin (Tobi Podhaler) was approved by the FDA in 2013 It is more convenient to administer than the nebulizer solution, which may improve patient adherence, but it can cause more cough, dysphonia, and dysgeusia.2,3 Inhaled tobramycin is generally preferred over inhaled Application instructions are the same for tinea cruris and tinea corporis, but the recommended treatment duration is one week CONCLUSION — Luliconazole (Luzu Cream, 1%) appears to be moderately effective for treatment of tinea pedis and tinea cruris infections There is no evidence that it is more effective than other topical antifungals that are available generically or over the counter at a much lower cost □ M Jarratt et al Luliconazole for the treatment of interdigital tinea pedis: A double-blind, vehicle-controlled study Cutis 2013; 91:203 TM Jones et al A randomized, multicenter, double-blind, vehiclecontrolled study evaluating the efficacy and safety of luliconazole cream 1% once daily for days in patients aged >12 years with tinea cruris J Drugs Dermatol 2014; 13:32 aztreonam because more long-term data are available supporting its safety and efficacy CLINICAL STUDIES — In two unpublished doubleblind trials (summarized in the package insert), a total of 306 CF patients with P aeruginosa infection were randomized to receive the new tobramycin inhalation solution or placebo for cycle (28 days on treatment followed by 28 days off) in study and for cycles in study All patients had a baseline forced expiratory volume in one second (FEV1) between 40% and 80% of predicted normal Patients who received tobramycin inhalation solution had statistically significant increases in FEV1 in both studies: 16% vs 5% with placebo in study and 7% vs 1% in study In one published study, Bethkis was compared to Tobi inhalation solution in a randomized, open-label, non-inferiority trial in 324 CF patients >6 years old with chronic P aeruginosa infection After 28 days of treatment, FEV1 increased by 7.0% with the new formulation and by 7.5% with Tobi ; adverse events were similar with the two formulations In a 48-week extension phase, improvements in lung function were Table Inhaled Antibiotics for Cystic Fibrosis Drug Formulations Route Usual Dosage1 ≥6 yrs: 300 mg bid x 28 days ≥6 yrs: 300 mg bid3 x 28 days ≥6 yrs: 112 mg (4 caps) bid3 x 28 days ≥7 yrs: 75 mg tid x 28 days Tobramycin – Bethkis (Chiesi/Cornerstone) Tobi (Novartis) generic Tobi Podhaler (Novartis) 300 mg/4 mL ampule Inhalation via nebuliizer 300 mg/5 mL ampule Inhalation via nebulizer 28 mg capsule Aztreonam lysine – Cayston (Gilead) 75 mg vial of lyophilized powder and mL ampule of diluent Inhalation via dry powder inhaler Inhalation via nebulizer Cost2 $5675.00 7337.70 5769.10 6676.90 6070.80 One cycle consists of 28 days on treatment followed by 28 days off treatment Approximate wholesale acquisition cost for one treatment cycle Source: Analy$ource® Monthly (Selected from FDB MedKnowledge™) June 5, 2014 Reprinted with permission by FDB, Inc All rights reserved ©2014 www.fdbhealth.com/policies/drug-pricing-policy Actual retail prices may be higher Doses should be inhaled as close to 12 hours apart as possible and not less than hours apart The Medical Letter • Volume 56 • Issue 1445 • June 23, 2014 51 maintained in patients who continued to take the new formulation, and no new safety issues were reported.4 ADVERSE EFFECTS — In the controlled clinical trials, adverse effects occurring in >3% of patients treated with the new product and more often than with placebo included a decrease in FEV1, rales, dysphonia, wheezing, and epistaxis Bronchospasm can occur Voice alteration and tinnitus have been reported with use of the older formulation of tobramycin inhalation solution Systemic aminoglycosides can be nephrotoxic and possibly ototoxic, but the low serum concentrations associated with oral inhalation of tobramycin make these effects unlikely Aminoglycosides are classified as category D (positive evidence of fetal harm) for use during pregnancy Whether inhalation of tobramycin could harm a fetus is unknown USE WITH AZITHROMYCIN — Concomitant use of oral azithromycin may antagonize the therapeutic effect of inhaled tobramycin.5 DOSAGE AND ADMINISTRATION — The contents of one 300 mg/4 mL ampule of tobramycin solution should be inhaled by mouth via a nebulizer twice daily The doses should be taken as close to 12 hours apart as possible, and not less than hours apart Bethkis should be administered using the hand-held PARI LC PLUS reusable nebulizer with a PARI Vios air compressor over a period of about 15 minutes Each cycle consists of 28 days on treatment followed by 28 days off Bethkis is supplied in cartons of or 14 foil pouches, each containing single-use 300 mg/4 mL ampules, which should be refrigerated and protected from light CONCLUSION — A new, more concentrated tobramycin inhalation solution (Bethkis) for cystic fibrosis patients with Pseudomonas aeruginosa appears to be similar in efficacy and safety to the older tobramycin nebulizer solution (Tobi) How it compares to tobramycin inhalation powder (Tobi Podhaler) or aztreonam inhalation solution (Cayston) for this indication remains to be determined □ L Máiz et al Inhaled antibiotics for the treatment of chronic bronchopulmonary Pseudomonas aeruginosa infection in cystic fibrosis: systematic review of randomised controlled trials Expert Opin Pharmacother 2013; 14:1135 Tobramycin inhalation powder (Tobi Podhaler) for cystic fibrosis Med Lett Drugs Ther 2013; 55:51 MJ Harrison et al Inhaled versus nebulised tobramycin: a real world comparison in adult cystic fibrosis (CF) J Cyst Fibros 2014 May (epub) H Mazurek et al Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis Pediatr Pulmonol 2014 Jan 24 (epub) JA Nick et al Azithromycin may antagonize inhaled tobramycin when targeting Pseudomonas aeruginosa in cystic fibrosis Ann Am Thorac Soc 2014; 11:342 52 Coming Soon in The Medical Letter: Treatment of Atrial Fibrillation In Brief: Esomeprazole Strontium Ceritinib (Zykadia) for Non-Small Cell Lung Cancer RNS Stimulator Device for Epilepsy Dalbavancin (Dalvance) for Skin and Skin Structure Infections Propanolol (Hemangeol) for Infantile Hemangiomas Oxycodone/Acetaminophen (Xartemis XR) for Pain The Medical Letter ® On Drugs and Therapeutics EDITOR IN CHIEF: Mark Abramowicz, M.D EXECUTIVE EDITOR: Gianna Zuccotti, M.D., M.P.H., F.A.C.P., Harvard Medical School EDITOR: Jean-Marie Pflomm, Pharm.D ASSISTANT EDITORS, DRUG INFORMATION: Susan M Daron, Pharm.D., Corinne Z Morrison, Pharm.D., Michael P Viscusi, Pharm.D CONSULTING EDITORS: Brinda M Shah, Pharm.D., F Peter Swanson, M.D CONTRIBUTING EDITORS: Carl W Bazil, M.D., Ph.D., Columbia University College of Physicians and Surgeons Vanessa K Dalton, M.D., M.P.H., University of Michigan Medical School Eric J Epstein, M.D., Albert Einstein College of Medicine Jane P Gagliardi, M.D., M.H.S., F.A.C.P Duke University School of Medicine Jules Hirsch, M.D., Rockefeller University David N Juurlink, BPhm, M.D., Ph.D., Sunnybrook Health Sciences Centre Richard B Kim, M.D., University of Western Ontario Hans Meinertz, M.D., University Hospital, Copenhagen Sandip K Mukherjee, M.D., F.A.C.C., Yale School of Medicine Dan M Roden, M.D., Vanderbilt University School of Medicine Esperance A.K Schaefer, M.D., M.P.H., Harvard Medical School F Estelle R Simons, M.D., University of Manitoba Neal H Steigbigel, M.D., New York University School of Medicine Arthur M F Yee, M.D., Ph.D., F.A.C.R., Weill Medical College of Cornell University SENIOR ASSOCIATE EDITOR: Amy Faucard MANAGING EDITOR: Susie Wong ASSISTANT MANAGING EDITOR: Liz Donohue PRODUCTION COORDINATOR: Cheryl Brown EXECUTIVE DIRECTOR OF SALES: Gene Carbona FULFILLMENT & SYSTEMS MANAGER: Cristine Romatowski DIRECTOR OF MARKETING COMMUNICATIONS: Joanne F Valentino VICE PRESIDENT AND PUBLISHER: Yosef Wissner-Levy Founded in 1959 by Arthur Kallet and Harold Aaron, M.D Copyright and Disclaimer: The Medical Letter is an independent nonprofit organization that provides health care professionals with unbiased drug prescribing recommendations The editorial process 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as much as: a 5% b 20% c 40% d 80% Luliconazole Cream (Luzu) for Tinea Infections In the published trial, complete clearance of tinea pedis (clinical and mycological cure) weeks post-treatment with luliconazole occurred in about what percentage of patients? a 25% b 40% c 60% d 75% A 20-year-old college basketball player with tinea pedis and no health insurance has been given a sample tube and a prescription for Luzu cream but is concerned about the cost You could tell him that: a Luliconazole has been shown to be more effective than most other topical products for treatment of tinea pedis b Luliconazole is an imidazole antifungal, and this class of topical antifungals has been shown to be more effective than any other, but he could use a less expensive imidazole product c Luliconazole has been shown in clinical trials to be more effective than other imidazole antifungals d Cure rates have generally been similar with all topical antifungals used to treat tinea pedis, and there is no good reason to pay for an expensive brand name product for this condition Tobramycin Inhalation Solution (Bethkis) for Cystic Fibrosis Compared to the older tobramycin inhalation solution (Tobi), Bethkis: a is easier to administer b is more concentrated c has been shown to be more effective in eradicating Pseudomonas aeruginosa d all of the above Concomitant use of which of the following may antagonize the therapeutic effect of inhaled tobramycin? a inhaled albuterol b oral aztreonam c oral azithromycin d an inhaled anticholinergic ACPE UPN: Per Issue Exam: 0379-0000-14-445-H01-P; Release: June 23, 2014, Expire: June 23, 2015 Comprehensive Exam 70: 0379-0000-14-070-H01-P; Release: July 2014, Expire: July 2015 Over The Medical Letter® Continuing Medical Education Program medicalletter.org/cme Earn Up to 26 Category AMA PRA credits Choose CME from The Medical Letter in the format that’s right for you! Comprehensive Exam – Available online or in print to Medical Letter subscribers, this 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Call us at 800-211-2769 or 914-235-0500 or e-mail us at: custserv@medicalletter.org ... Copyright 2014 ISSN 1 523- 2859 The Medical Letter • Volume 56 • Issue 1445 • June 23, 2014 The Medical Letter ® Online Continuing Medical Education To take CME exams and earn credit, go to: medicalletter.org/CMEstatus... on controlled clinical trials, and on the opinions of its consultants The Medical Letter is supported solely by subscription fees and accepts no advertising, grants, or donations No part of the. .. information call: 800-211-2769 The Medical Letter ® On Drugs and Therapeutics Published by The Medical Letter, Inc • 145 Huguenot Street, New Rochelle, NY 10801 • A Nonprofit Publication Volume