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Heart Patients Safely Combine Plavix, Heartburn Pills

By jeremyc | August 31, 2009

Heart patients can safely take drugs to prevent blood clots from forming with pills to protect the stomach against heartburn and ulcers, a study found.

The results should ease concerns that mixing the medications may reduce the effectiveness of Bristol-Myers Squibb Co. and Sanofi-Aventis SA’s Plavix blood thinner, used daily by millions of people to prevent deadly clots from forming. Reports in the past year suggested that giving ulcer medicines like AstraZeneca Plc’s Nexium could negate the benefit of Plavix.

About 2 million people worldwide undergo procedures to clear heart arteries each year, then take aspirin plus Plavix or Effient from Eli Lilly & Co. and Daiichi Sankyo Co. to prevent re-clogging. Doctors routinely prescribed pills to reduce patients’ stomach acid at the same time, since the other medications can cause gastrointestinal trouble.

“The current findings provide some reassurance to clinicians,” said Michelle O’Donoghue, an investigator from Brigham and Women’s Hospital in Boston who presented the data at the European Society of Cardiology meeting in Barcelona today.

The ulcer drugs, known as proton pump inhibitors, are often given to sicker patients, which may explain why they seem to do more poorly than others, O’Donoghue said in an e-mailed response to questions. In their analysis, the researchers adjusted for those differences, she said.

Proton pump inhibitors include Nexium, AstraZeneca’s biggest seller with more than $5.2 billion in revenue last year, and rivals such as Prilosec; Eisai Co.’s Aciphex; Wyeth’s Protonix; and Prevacid, sold by Takeda Pharmaceutical Co.

No Differences

Researchers analyzed the effect of ulcer drugs on patients who took either Plavix or Effient. In the key trial used to get approval of Effient, there were no differences in deaths, heart attacks or strokes regardless of whether patients were taking the ulcer drugs.

In another analysis, the researchers examined how the ulcer medications affected Plavix and Effient in laboratory tests. The combination did reduce the anti-platelet activity that prevents blood from clotting, with a more powerful effect in Plavix patients. The effect didn’t have an effect on how patients fared, the study found.

The results aren’t definitive because they don’t come from a study designed specifically to compare patients on the drug cocktail to those who didn’t get the ulcer medications, said Jonathan Halperin, director of clinical cardiology services at Mount Sinai Medical Center in New York. While some patients may be fine, others may not, he said.

‘Getting Away With It’

“Doctors have a way of sniffing out what they can get away with,” Halperin said in an interview. “We know that there is this phenomenon. Physicians and patients need to be alert to it, but we are learning some patients can get away with it for reasons we don’t entirely understand.”

Another study may be able to answer the question when it’s presented at a medical meeting later this month. The trial, dubbed Cogent, looks at patients given Plavix plus the generic ulcer drug omeprazole, sold as Prilosec, compared to those given Plavix alone. The goal of the study is to reduce bleeding in the stomach and ulcers in patients who are also taking aspirin.

Deepak Bhatt, chief of cardiology at the VA Boston Healthcare System, will present the findings at the Transcatheter Cardiovascular Therapeutics conference in San Francisco next month. Cogentus Pharmaceuticals, a closely held company based in Menlo Park, California, funded the study.

Company Studies

Bristol-Myers and Sanofi have agreed to conduct new studies to better understand how the medicines and heredity affect how well Plavix works, the Food and Drug Administration said in a notice posted Jan. 26 on its Web site.

Today’s findings contradict those of a review of Medco Health Solutions Inc.’s database of 19 million prescription drug users. In that report, released last November, one-third of those who got artery-clearing surgery and then took the blood thinners and the ulcer medicines suffered serious complications within a year.

Overall, proton pump inhibitors were associated with a 50 percent increase in the risk of heart attack, stroke, bypass surgery and cardiac-related death for Plavix users, the Medco study found. People who took anti-clotting drugs alone had problems a fifth of the time.

A separate study that tracked 8,205 patients with chest pain or mild heart attacks given Plavix after being discharged from Veterans Affairs hospitals from October 2003 to January 2006 found Plavix patients were 25 percent more likely to die or be readmitted to a hospital if they also took the ulcer drugs. The study was published in the Journal of the American Medical Association in March.

Topics: | Aciphex, Effient, Nexium, Plavix, Prevacid, Prilosec, Protonix |

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