Older arthritis treatments taken in combination with a heartburn drug may be easier on the stomach than medications such as the recalled painkiller Vioxx that were touted as causing fewer stomach problems, researchers in a drugmaker-sponsored review said Wednesday.
Arthritis sufferers who had taken Merck & Co.’s Vioxx and a similar drug withdrawn by Pfizer Inc. are switching to a mix of older, anti-inflammatory medications taken in combination with a popular heartburn drug to prevent stomach damage.
Taken alone, nonsteroidal anti-inflammatory drugs (NSAIDS) are blamed for up to 16,000 deaths from gastrointestinal bleeding in the United States. Cox-2 inhibitors, which include Vioxx and Pfizer’s withdrawn Bextra, were designed to ease pain as effectively as older, nonprescription drugs while being easier on the stomach.
NSAIDS include ibuprofen and naproxen and are sold under brand names such as Advil and Aleve.
The study of the drugs taken in combination, presented at the Digestive Disease Week conference in Chicago and funded by heartburn drug maker TAP Pharmaceuticals, looked at side effects of upset stomachs, but did not look at the more serious problem of gastrointestinal bleeding.
The authors said upset stomach and heartburn are much more common complications of NSAIDs and a significant cost driver.
The broad analysis of data from 32 studies found that the drug combination lessened the risk of upset stomach, versus taking just a Cox-2 inhibitor.
The older arthritis drugs have the added benefit of being cheaper, researchers said.
“In the end it is mostly a cost issue,” said Dr. Brennan Spiegel, a study author and physician at the Veteran’s Affairs Greater Los Angeles Healthcare System.
“It is also a quality of life issue if ongoing (upset stomach) is not well treated,” he said.
But Larry Sasich, a pharmacist at consumer advocacy group Public Citizen, said upset stomach was a weak side effect to examine because it is stomach bleeding that makes the older painkillers risky.
“The issue is protecting people from going to the hospital or dying from gastrointestinal bleeding,” he said.
TAP Pharmaceuticals, which funded the study, is a joint venture between Abbott Laboratories Inc. and Japan’s Takeda Pharmaceutical Co. Ltd., which sells the heartburn drug Prevacid.
Because there are few trials directly comparing Cox-2 drugs with the heartburn and arthritis combination, authors used a statistical approach called meta-analysis to combine the findings of 32 studies.
Merck pulled Vioxx from the market last September after it was found to increase the risk of stroke and heart attack. Pfizer later withdrew Bextra at the request of the U.S. Food and Drug Administration after the agency said risk of a life-threatening skin allergy outweighed the drug’s benefits.
One major medication in the class, Pfizer’s Celebrex, remains on the market.
Since Vioxx was recalled, use of heartburn drugs like AstraZeneca Plc’s Prilosec and TAP’s Prevacid combined with over-the-counter arthritis drugs has risen.
