Rx update 12-02

R x U p d a t e
Drugs recently approved or pending approval AVANDAMET
(n = 269) received Roferon-A 3 MIU thrice weekly, Pegasys 90 µg GlaxoSmithKline of Research Triangle Park, NC, received ap- once weekly, or Pegasys 180 µg once weekly. In all 3 studies, treat- proval from the US Food and Drug Administration (FDA) to ment with Pegasys 180 µg resulted in significantly more respond- market Avandamet (rosiglitazone maleate and metformin hy- ing patients, compared with treatment with Roferon-A. Pegasys drochloride) tablets to improve glycemic control in patients is contraindicated in neonates and infants and in patients with with type 2 diabetes mellitus already treated with rosiglitazone hypersensitivity to any of its components, autoimmune hepatitis, and metformin as separate tablets or who are inadequately or decompensated hepatic disease. The most common adverse controlled on a metformin-only regimen. No clinical efficacy tri- effects of the drug include headache, fatigue, myalgia, pyrexia, als have been conducted with Avandamet; however, studies rigors, and psychiatric reactions (eg, depression, irritability).
using the separate components have established safety and effi- The recommended dosage of Pegasys is 180 µg once weekly for cacy. In a 26-week, randomized, double-blind, placebo/active- 48 weeks by sc administration in the abdomen or thigh.
controlled study, 339 patients with type 2 diabetes mellitus whowere inadequately controlled on 2.5 g/day of metformin ran- SUBOXONE AND SUBUTEX
domly received rosiglitazone 4 mg once daily, rosiglitazone 8 mg The FDA has approved marketing of Suboxone (buprenor- once daily, or placebo in addition to metformin. A statistically phine hydrochloride/naloxone hydrochloride) and Subutex significant improvement in fasting plasma glucose and hemo- (buprenorphine hydrochloride) sublingual tablets by Reckitt globin A was shown in patients treated with either combination Benckiser Pharmaceuticals, Inc, of Richmond, VA, for the treat- of metformin and rosiglitazone versus patients continued on ment of opioid dependence. Efficacy of the drugs was evaluated metformin alone. Avandamet is contraindicated in patients with by a double-blind, placebo- and active-controlled study in which bility while not exceeding the maximum recommended daily urine samples that were negative for nonstudy opioids was sta- dose of rosiglitazone 8 mg/metformin 2000 mg.
tistically higher for patients in both the Suboxone and Subutexgroups than in the placebo group. Both drugs are contraindi- cated in patients with known hypersensitivity. The most com- The FDA granted approval to Hoffmann-La Roche Inc of Nut- monly reported adverse effects are headache, withdrawal syn- ley, NJ, to market Pegasys (peginterferon alfa-2a) for the treat- drome, pain, nausea, and sweating. When taken sublingually, ment of adults with chronic hepatitis C virus (HCV) infection Suboxone and Subutex have similar clinical effects and are inter- who have compensated liver disease and have not previously changeable. Subutex is preferred for induction and Suboxane received interferon alfa. The drug’s safety and efficacy were for maintenance. The recommended target dose of Suboxone assessed in 3 randomized, open-label, active-controlled clinical is 16 mg daily. The drugs can be prescribed by office-based studies involving treatment-naive adults with compensated liver physicians who complete a mandatory 8-hour (minimum) disease and detectable HCV. All patients received therapy by training session and obtain a waiver allowing them to prescribe subcutaneous (sc) injection for 48 weeks and were followed for an additional 24 weeks. In study 1, patients (n = 630) receivedeither Roferon-A (interferon alfa-2a) 3 MIU thrice weekly,Pegasys 135 µg once weekly, or Pegasys 180 µg once weekly. Instudy 2, patients (n = 526) received either Roferon-A 6 MIU Compiled from press reports and pharmaceutical company press releases. For more thrice weekly for 12 weeks and then 3 MIU thrice weekly for information, contact Jennifer M. Lehr, Hospital Physician, 125 Strafford Avenue, 36 weeks or Pegasys 180 µg once weekly. In study 3, patients Copyright 2002 by Turner White Communications Inc., Wayne, PA. All rights reserved.
12 Hospital Physician December 2002
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Source: http://www.turner-white.com/pdf/hp_dec02_drugs.pdf