2 NEWS JULY 2011 • CARDIOLOGY NEWS HEART OF THE MATTER Cardiology News AIM-HIGH and HDL President, IMNG Alan J. Imhoff

hen the National Heart, Lung, placebo group, in order to reach a target Editor in Chief Mary Jo M. Dales Executive Director, Operations Jim Chicca and Blood Institute announced LDL cholesterol level of less than 80 Executive Editors Denise Fulton, Kathy Scarbeck Director, Production/Manufacturing Yvonne Evans Struss that the Atherothrombosis In- mg/dL. This is somewhat ironic since Managing Editor Catherine Hackett W Production Manager Judi Sheffer Senior Editors Christina Chase, Kathryn tervention in Metabolic Syndrome With niacin plus statin was reported to be more Production Specialists Maria Aquino, Anthony DeMott, Jeff Evans, Lori Buckner Farmer, Low HDL/High Triglycerides: Impact on effective than ezetimibe plus statin in re- Draper, Rebecca Slebodnik Keith Haglund, Gina L. Henderson, Sally Koch Global Health (AIM-HIGH) trial was be- ducing carotid intima-media thickness in Kubetin, Teresa Lassman, Mark S. Lesney, Creative Director Louise A. Koenig ing terminated because of the futility of the ARBITER 6-HALTS study (N. Engl. J. Jane Salodof MacNeil, Renée Matthews, Design Supervisor Elizabeth Byrne Lobdell showing benefit, the study’s failure made Med. 2009;361:2113-22). Catherine Cooper Nellist, Amy Pfeiffer, Terry Senior Designers Sarah L.G. Breeden, Yenling Liu Rudd, Leanne Sullivan, Elizabeth Wood front page news. The National Lipid Association has rec- Designer Lisa M. Marfori The medical community, patient popu- ommended that physicians should wait Editorial Production Manager Carol Nicotera-Ward Photo Editor Catherine Harrell Associate Editors Felicia Rosenblatt Black, Web Production Engineer Jon Li lation, and interested public ask “why?” at until the full results of AIM-HIGH are re- Therese Borden, Lorinda Bullock, Jay C. Web Production Specialist Jennifer Calhoun this unexpected result of the study that ported before integrating the findings into Cherniak, Richard Franki, Virginia Ingram- compared extended-release niacin (Nias- their clinical practice, and that patients Wells, Jane Locastro, January W. Payne Sales Director, IMNG pan) plus simvastatin with should not stop taking niacin Reporters Chicago: Patrice Wendling; Denver: Mark E. Altier, 973-290-8220, placebo plus simvastatin. without the advice of their Bruce Jancin; Germany: Jennie Smith; [email protected] Miami: Damian McNamara; Mid-Atlantic: National Account Manager Michele G. Sullivan; New England: Diana Cardiologists and lipidolo- physician. Courtney Leonard, 973-290-8223, Mahoney; New York: Mary Ellen Schneider; gists may be better able to an- I agree with this recommen- [email protected] Philadelphia: Mitchel L. Zoler; San Diego: swer this question when the dation. It remains to be seen Doug Brunk; San Francisco: Sherry Boschert, Advertising Offices 60 Columbia Rd., full results are published. More whether we will ever know the Robert Finn; Washington: Alicia Ault, Frances Bldg. B, 2nd flr., Morristown, NJ 07960, information will certainly be full explanation for the futility Correa, Elizabeth Mechcatie, Naseem S. 973-290-8200, fax 973-290-8250 Miller, Heidi Splete, Miriam E. Tucker, Kerri Classified Sales Manager, IMNG required concerning the re- results of AIM-HIGH. We cer- Wachter Robert Zwick 973-290-8226, ported increase in stroke in the tainly will know much more Multimedia Producer Nick Piegari fax 973-290-8250, [email protected] niacin arm (28 vs 12). At this when the results are analyzed Contributing Writers Christine Kilgore, Classified Sales Representative stage, a hypothesis regarding and when HPS2-THRIVE is re- Mary Ann Moon Andrea LaMonica 800-381-0569, the lack of benefit must be ANTONIO M. ported. Project Manager Susan D. Hite fax 914-381-0573, GOTTO JR., M.D. [email protected] considered tentative at best. In the meantime, there are Assignments Manager Megan Evans However, the first thing that alternative ways of raising Reprints/Eprints Contact Wright’s Media 877-652-5295 comes to mind is whether the study was HDL currently being tested, including Editorial Offices 5635 Fishers Lane, Suite sufficiently powered. A clinical trial cur- with the cholesteryl ester transfer protein 6000, Rockville, MD 20852, 877-524-9335, Sr. Program Manager, Customized Programs rently underway at Oxford (England) Uni- (CETP) inhibitors anacetrapib and dal- [email protected] Malika Wicks versity, HPS2-THRIVE, is comparing ex- cetrapib, so the final results are far from Address Changes Fax change of address (with Audience Development Manager Barbara Cavallaro, 973-290-8253, [email protected] tended-release niacin and laropiprant (a complete concerning the benefit of rais- old mailing label) to 973-290-8245 or e-mail change to [email protected] Program/Marketing Manager Jennifer Eckert prostaglandin receptor antagonist to de- ing HDL cholesterol, particularly in pa- Business Controller Dennis Quirk Director of Information Technology Doug Adv. Services Manager Joan Friedman crease flushing approved in Europe but tients with low HDL cholesterol. AIM- Sullivan not the United States) against a back- HIGH does not disprove the theory that Credit Supervisor Patricia H. Ramsey Senior Systems Administrators Lee J. Unger, Manager, Administration/Conventions Lynne ground of simvastatin. HPS2-THRIVE raising HDL will be beneficial, and there Kreg M. Williams aims to enroll 25,000 subjects, so this dif- are abundant data showing that low HDL Kalish Systems Administrator/Application Support Receptionist Linda Wilson ference in size compared with AIM-HIGH increases cardiovascular risk. Peter Ayinde Accounts Payable Coordinator Daniela Silva must indicate large differences in expect- Hence, AIM-HIGH does not provide ed event rate. support for the “HDL hypothesis,” but CARDIOLOGY NEWS is an independent newspaper POSTMASTER Send changes of address (with One should also bear in mind that the neither does it drive the final nail in the that provides the practicing specialist with timely old mailing label) to CARDIOLOGY NEWS Circula- decrease in events reported with niacin in coffin. ■ and relevant news and commentary about clinical tion, 60 Columbia Rd., Bldg. B, 2nd flr., Morris- developments in the field and about the impact of town, NJ 07960. the Coronary Drug Project (J. Am. Coll. health care policy on the specialty and the CARDIOLOGY NEWS (ISSN 1544-8800) is published Cardiol. 1986;8:1245-55) was against a DR. GOTTO is the Stephen and Suzanne physician’s practice. monthly by International Medical News Group, background of placebo. Statins have set a Weiss Dean and Professor of Medicine at The ideas and opinions expressed in CARDIOLOGY LLC, an Elsevier company, 60 Columbia Rd., Bldg. nd very high bar for efficacy, and it can be dif- Weill Cornell Medical College, New York. He NEWS do not necessarily reflect those of the B, 2 flr., Morristown, NJ 07960, 973-290-8200, fax ficult to demonstrate incremental benefit is a consultant for AstraZeneca, KOWA, and Publisher. International Medical News Group, 973-290-8250. Subscription price is $114.00 per year. LLC, an Elsevier company, will not assume ©Copyright 2011, by Elsevier Inc. with an add-on to statin therapy, as was the Merck; sits on the Board of Directors for responsibility for damages, loss, or claims of any case in the ENHANCE trial with ezetim- Aegerion Pharmaceuticals and Arisaph kind arising from or related to the information ibe. In fact, there was substantial use of Pharmaceuticals; and is a member of contained in this publication, including any claims ezetimibe in the placebo group of AIM- advisory boards for DuPont and Vatera related to the products, drugs, or services INTERNATIONAL mentioned herein. MEDICAL NEWS HIGH, which therefore was not a true Capital. GROUP V I T A L SI G N S FDA Warns of Bladder Ca Risk With Lipid Regulators Were the Third–Best-Selling Type 2 Diabetes Drug Pioglitazone Drug Class in 2010

aking the type 2 diabetes drug piogli- 40% increase in the risk of bladder cancer. Oncologics $22.3 Ttazone for more than 1 year may in- Pioglitazone, marketed as Actos (Take- Respiratory agents $19.3 crease the risk of bladder cancer, the Food da), is also available in combination with Lipid regulators $18.8 and Drug Administration announced. metformin (Actoplus Met, Actoplus Met Antidiabetes agents $16.9 A review of the 5-year data from an on- XR) and with glimepiride (Duetact). The going 10-year epidemiologic study of al- FDA is recommending that pioglitazone Antipsychotics $16.1 most 200,000 patients with type 2 diabetes not be used in patients with active bladder Antiulcerants $11.9 found that overall, there was no increased cancer, and that it be used cautiously in pa- Antidepressants $11.6 EWS risk of bladder cancer pioglitazone users tients with a history of bladder cancer. N compared with never-users, after adjust- The FDA also plans to review the results Autoimmune agents $10.6 ment for age, sex, smoking, use of other di- of a French study that prompted French HIV antivirals $9.2 EDICAL M abetes medications, and other risk factors. authorities in June to suspend the use of Angiotensin II receptor $8.7 blockers

However, the risk did increase with higher the drug in France and German authori- LOBAL G doses and increasing duration of treat- ties to proscribe starting pioglitazone treat- Note: Figures represent U.S. wholesale revenue in billions. ment: Treatment with pioglitazone for ment in new patients. Source: IMS Institute for Healthcare Informatics LSEVIER more than 12 months was linked with a –Elizabeth Mechcatie E