Cardiovascular Business - November/December 2008 - (Page 32)

PersPeCtive: PHArMA 25.0– 22.5– 20.0– sales of Oral Anti-Diabetes Drugs soar sales $ Billions 17.5– 15.0– 12.5– 10.0– 7.5– 5.0– 2.5– 0– 1992 Oral Anti-Diabetic Drugs Human insulins and Analogues as the rate of diabetes increases, sales of oral anti-diabetic drugs will continue to outstrip sales of insulin. source: iMs therapy Forecaster 2002 2010 From clinical to practical David Nathan, MD, chief of the diabetes unit at Massachusetts General Hospital, says that there was a trend of moving away from prescribing TZDs, specifically Avandia, even before the publication of the ACCORD and ADVANCE trials. “While those studies didn’t point the fi nger at TZDs, they did not exonerated them either,” he says. Nathan suggests that the popularity once appreciated by Avandia may have shifted to Actos. “The data that exist—which are far from conclusive—could potentially support that there is a benefit of pioglitazone,” he says. Avandia’s sluggish sales over the past few market quarters also indicate its unfavorable trend in prescriptions. In highlighting his drug of choice, Patel notes that in ADVANCE, almost all intensive group patients received gliclazide-MR, compared to none in the standard care group, so it “appears to be an agent with a good safety profile. But again, major conclusions about overall efficacy and safety must be ascribed to the strategy as a whole, which included gliclazide-MR in all patients.” Singh says that his first choice is metformin (Glucophage, Bristol-Myers Squibb) due to its long-standing positive outcomes data. Metformin is currently the most popular anti-diabetic drug in the U.S. and one of the most prescribed drugs in the country overall, with nearly 35 million prescriptions filled in 2006 for generic metformin alone (Drug Topics, March 2007). However, the diabetes drugs in the U.S. have no cardiovascular outcomes data on their label, Singh notes. Due to the adverse events linked with Avandia, an FDA panel voted in July to recommend that pharmaceutical companies conduct long-term studies—up to five years—to produce evidence that would rule out an unacceptable level of CV risk. The panel considered, but rejected, to require the diabetes drugs to show CV benefit. The proposed FDA conditions could slow down the process of newer oral agents entering the U.S. market. Even with the myriad new drugs that are emerging, the consensus for the treatment of type 2 diabetes is to use older drugs, use them more aggressively and use insulin earlier, Nathan says. He adds that the newer drugs tend to be more expensive since they are all brand names, and they tend to be less powerful than sonal singh, Md, an the older drugs. The trend also is to assistant professor of move away from a glucose-centric internal medicine at Wake Forest university school approach and more toward a cardio- of Medicine, questions the vascular risk reduction approach that rationale for leaving avandia involves aspirin, blood-pressure low- on the u.s. market. ering drugs and other drugs as well. While there is a trend toward transitioning to an insulin regimen earlier, Singh notes that oral agents are more convenient and often, less costly. He also adds that the pressure for physicians to achieve the ADA target hemoglobin A1c level of 6.5 percent or lower may not be appropriate for certain patients with CV disease, as shown by the ACCORD trial. For those patients with type 2 diabetes who continue to be treated with oral agents, they often are taking eight to 10 pills on average just for the diabetes and diabetes-related problems alone. One goal is to have an approach that reduces the number of pills patients must take. “It remains a major burden on our patients, and one that we have not dealt with effectively in the overall management of our patients,” Nathan concludes. 32 Cardiovascular Business November/December 2008

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Cardiovascular Business - November/December 2008 Contents First Word Cover Story: Practice Management Software Moves Beyond Bean Counting The Death of CME as We Know It? Clinical Study Digets: Triple-Antiplatelet Therapy; Ex-Vioxx Users Beware Shockwaves Subside from the FDA's Echo Contract Warning Burning Question: Does Laser Heart Therapy for Angina Really Work? Advanced Visualization Adds New Practive Dimension Coronary Calcium Scoring Program Reaps Dividends Interventionalists Get Pumped Up About Mechanical Chest Compression Trials Force Physicians to Re-Examine Oral Anti-Diabetic Drug Protocols News & Views Calendar Reader Resources The ACC Corner

Cardiovascular Business - November/December 2008

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