Research Activities, July 2011: Patient Safety and Quality: Studies examine safety of pain killers among older adults

Research Activities, July 2011: Patient Safety and Quality: Studies examine safety of pain killers among older adults: "Patient Safety and Quality
Studies examine safety of pain killers among older adults

Older patients with arthritis and their physicians have to consider differences in comparative safety between nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs), selective cyclooxygenase-2 inhibitors (coxibs), and opioids when deciding on medication for non-cancer-related pain, according to a new study. Specifically, opioid use is associated with increased relative risk for a number of safety events compared with nsNSAIDs, the researchers found. A companion study by the same researchers also reports major differences in comparative safety among five opioid drugs commonly used to treat non-cancer-related pain. Although prescription painkillers account for 230 million prescription purchases annually, little is known about the comparative safety of these drugs, except for the cardiovascular safety of nsNSAIDs and coxibs, note the researchers.

In both studies, they used 7 years of combined data (1999�2005) for Medicare beneficiaries from two Middle Atlantic States, who qualified for pharmaceutical assistance programs, to look at the relative risk for a specific cardiovascular event, (heart attack, stroke, heart failure, revascularization, and out-of-hospital cardiac death), a gastrointestinal (GI) event (upper or lower bleeding, or bowel obstruction), acute kidney injury, liver toxicity, bone fractures, and three composite safety measures (cardiovascular event, fracture, and GI tract bleeding).

The studies were funded by a contract from the Agency for Healthcare Research and Quality (Contract No. 290-05-0016) to Brigham and Children's Hospital in Boston, as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program. They are briefly described here.

Solomon, D. H., Rassen, J. A., Glynn, R. J., and others. 'The comparative safety of analgesics in older adults with arthritis' (2010, December). Archives of Internal Medicine 170(22), pp. 1968-1978.

This study compared nsNSAIDs as the reference treatment with coxibs and opioids in 12,840 Medicare patients with osteoarthritis or rheumatoid arthritis (4,280 for each drug category). Compared with patients taking nsNSAIDs, those prescribed coxibs or opioids appeared to have increased risk of cardiovascular events (by 28 percent and 77 percent, respectively). GI bleeding risk was observed to reduce by 40 percent for coxib users, but for opioid users was similar to the risk for patients on nsNSAIDs. Patients taking coxibs and nsNSAIDs seemed to have similar risk of fractures, but the risk for those on opioids was elevated more than fourfold. Opioids (but not coxibs) were associated with an increased risk (by 68 percent) of safety events requiring hospitalization and an 87 percent increase in all-cause mortality.

Solomon, D. H., Rassen, J. A., Glynn, R. J., and others. 'The comparative safety of opioids for nonmalignant pain in older adults' (2010, December). Archives of Internal Medicine 170(22), pp. 1979-1986.

The researchers compared five different opioid drugs (hydrocodone bitartrate, codeine phosphate, oxycodone hydrochloride, propoxyphene hydrochloride, and tramadol hydrochloride), using hydrocodone as the reference medicine among 31,375 Medicare patients (6,275 patients for each opioid drug). The risk of cardiovascular events appeared to be similar across the opioid groups for the first 30 days after the beginning of therapy, but was elevated by 62 percent for codeine compared with hydrocodone after 180 days. Tramadol was associated with a reduction in risk of fracture by 79 percent after 30 days of use, while propoxyphene reduced this risk by 46 percent after the same period of time. All of the opioids studied had similar risks of GI bleeding. Both oxycodone and codeine were associated with substantially increased risk of all-cause mortality (by 143 percent and 105 percent, respectively) after 30 days of use compared with hydrocodone.

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