Pharmacy & Therapeutics - February 2008 - (Page 85)

NEW DRUGS continued from page 76 DRUG NEWS hydrochlorothiazide (Tekturna HCT, Novartis/Speedel) is now available as a single tablet containing two drugs for high blood pressure. Aliskiren is the first approved direct renin inhibitor. In clinical trials, the combination resulted in significant additional reductions in blood pressure compared with either drug alone. Aliskiren should be used after other medications have been tried. The tablets are scheduled to be available in Februar y in strengths of 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/ 12.5 mg, and 300 mg/25 mg. The long-term potential of aliskiren and direct renin inhibition is being studied in ASPIRE HIGHER, a program that focuses on cardiovascular and kidney disease. Tekturna is known as Rasilez outside the U.S. Aliskiren is the subject of this month’s Drug Forecast column on page 92. (Sources: Novartis/Speedel, January 21, 2008; www.tekturnahct.com.) to-severe chronic plaque psoriasis. The approval was based on two pivotal trials—REVEAL and CHAMPION— involving more than 1,400 adults. In these trials, nearly 75% of treated patients achieved 75% clearance or better at the 16th week, compared with those receiving placebo. Adalimumab was approved to treat moderate-to-severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderateto-severe Crohn’s disease in 2007. (Sources: Am Acad Dermatol, January 2008; Br J Dermatol online.) mg/dL, or hypertriglyceridemia-induced pancreatitis. It can increase ser um triglyceride levels, particularly when it is used with sulfonylureas or insulin. Caution should be used for patients with triglyceride levels exceeding 300 mg/dL. Patients should take vitamins A, D, E, and K at least four hours before taking this drug. (Sources: FDA, Daiichi Sankyo, January 18, 2008.) Natalizumab (Tysabri) For Crohn’s Disease Natalizumab (Tysabri, Biogen Idec/ Elan) has been used since 2006 to treat some forms of multiple sclerosis. It is now approved for treating moderate-tosevere Crohn’s disease in patients with inflammation who have not responded to or who cannot tolerate conventional therapies for Crohn’s disease. This drug must be infused by trained professionals. Patients, prescribers, pharmacies, and infusion centers must be enrolled in the Crohn’s Disease–Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program and must agree to comply with strict monitoring guidelines. If there is no improvement after three months, treatment should be discontinued. The label carries a boxed warning about progressive multifocal leuko encephalopathy, an opportunistic viral infection that affects the brain. Patients who are taking steroids for Crohn’s disease should begin tapering steroid doses while taking natalizumab. Treatment should be discontinued if steroids cannot be fully tapered within six months. (Source: FDA, January 14, 2008.) Colesevelam (Welchol) For Glucose Control In Type-2 Diabetes Colesevelam HCl (Welchol, Daiichi Sankyo) is now approved to help improve glycemic control (glycosylated hemoglobin, or HbA1c) in adults with type-2 diabetes when it is used alone or with other antidiabetic agents such as metformin (Glucophage, Bristol-Myers Squibb) and insulin. This is the first medication approved to reduce both glucose levels and low-density lipoproteincholesterol levels (LDL-C) when compared with placebo. Since 2000, this bile acid sequestrant has been used alone or with a statin to lower elevated LDL-C levels in patients with primary hypercholesterolemia. Unlike most other cholesterol-lowering drugs, such as statins, it is eliminated without traveling to the liver or kidneys; therefore, it is not expected to have drug interactions via the cytochrome P450 pathway. Colesevelam has also had beneficial effects on HDL-C and apolipoprotein-B levels. Colesevelam should not be used in combination with fenofibrate, and it is not indicated for patients with type-1 diabetes, diabetic ketoacidosis, with bowel obstruction, triglyceride levels above 500 NEW DOSAGES Lisdexamfetamine (Vyvanse): More Doses for ADHD Three new dosage strengths have been approved for Shire’s lisdexamfetamine dimesylate (Vyvanse), which is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). The added strengths of 20 mg, 40 mg, and 60 mg are expected to be available in the second quarter of 2008. Current strengths are 30 mg, 50 mg, and 70 mg. Vyvanse is currently approved in the U.S. for use in children 6 to 12 years of age. The FDA is reviewing an sNDA for treating ADHD in adults. Although Vyvanse was generally well tolerated in clinical studies, it should not be taken if a child has arteriosclerosis, symptomatic hear t disease, hyper tension, hyperthyroidism, an allergy to sympathomimetic amines, seizures, glaucoma, problems with alcohol or drugs, or NEW FORMULATION Aliskiren (Tekturna) HCT For Hypertension Aliskiren combined with the diuretic Vol. 33 No. 2 • February 2008 • P&T® 85 http://www.tekturnahct.com

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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