Question 1

What was the clinical context of this study?

Accepted Answer

" . . we set out to estimate the comparative safety of these 3 categories of analgesics (nsNSAIDs, coxibs, and opioids) across a wide range of potential toxicities, including cardiovascular, gastrointestinal, fractures, and overall mortality." -lead author Daniel H. Solomon, MD, MPH, associate professor of medicine at Harvard Medical School and chief of clinical research, Division of Rheumatology, Brigham and Women's Hospital in Boston, Massachusetts, told Medscape Medical News. OTHER NOTES: In the United States, 1 in 5 adults received a prescription for an analgesic in 2006, accounting for 230 million prescriptions, but the comparative safety of the drugs is unclear. This is an observational cohort study using propensity score methods to balance baseline characteristics and to examine the comparative safety of the 3 most common types of analgesics using claims database data for healthcare use in Medicare beneficiaries.

Question 2

What were the clinical implications of this study?

Accepted Answer

Opioids compared with coxibs and nsNSAIDs are associated with higher risk for fractures and cardiovascular events, and coxibs are associated with lower risk for gastrointestinal bleeding but higher risk for cardiovascular events. Risk for hospitalization and all-cause mortality is highest with opioids vs coxibs and nsNSAIDs, and risk increases with duration of use.

Question 3

Who was included in the study?

Accepted Answer

Included were Medicare beneficiaries from 2 US states who qualified for pharmacy assistance in the period 1999 to 2005. Participants had recorded diagnoses for osteoarthritis or rheumatoid arthritis on 2 separate visits and entered the cohort at the time of their first analgesic prescribing (index date). The cohort had 12,840 members after propensity score matching. 85% of the participants were women, most were white, and mean age was 80 years.

Question 4

What were the safety events defined as in the study?

Accepted Answer

Safety events were defined as adverse events leading to a hospitalization, acute care hospitalization, death, or all-cause mortality.

Question 5

Users of which type of analgesics experienced the highest rates of adverse events?

Accepted Answer

Opioid Users Opioid users experienced higher rates of adverse events than the other 2 groups. The authors concluded that among the 3 types of analgesics used for osteoarthritis and rheumatoid arthritis, opioids carried the greatest and nsNSAIDs the lowest risk for adverse events and outcomes.

Question 6

What was the biggest limitation of the study?

Accepted Answer

According to the study's author: "The biggest [limitation] is that it is retrospective and based upon a Medicare claims database, not based upon actual hospital or doctors' office charts. Medical claims–based databases are large enough to generate the statistical power required to make important observations such as the ones in this study, but they can be biased both in the information they capture and in the information that they miss."

Question 7

Aside from the fact that the study was based on medical claims, what was another significant limitation of the study?

Accepted Answer

When asked about recommendations for additional research, Dr. Graf pointed out that this study did not look specifically at individual opioid medications or at their duration of use, and that it could not control for potentially confounding clinical information that may not have been captured in the Medicare claims database.

Question 8

For what adverse event was the greatest difference found among the 3 types of analgesics?

Accepted Answer

The difference was greatest for fractures, with a rate of 101 compared with 19 per 1000 person-years for opioid users compared with coxib users.

Question 9

What were the adverse effects found in the study regarding gastrointestinal bleeding?

Accepted Answer

The rate of gastrointestinal bleeding was reduced for coxib users vs users of nsNSAIDs (12 vs 21 per 100 person-years). Gastrointestinal track bleeding risk was 0.60 for coxib users compared with users of nsNSAIDs but was similar for opioid users compared with nsNSAID users.

Question 10

What were the findings regarding cardiovascular adverse events?

Accepted Answer

Compared with nsNSAIDs, coxibs (HR, 1.28) and opioids (HR, 1.77) were associated with higher cardiovascular adverse events.

Question 11

What were the risks for fractures found among use of the three types of analgesics?

Accepted Answer

Compared with nsNSAIDs, coxib use was associated with similar risk for fracture. However, opioid use was associated with increased risk for fracture compared with nsNSAID use (HR, 4.47).

Question 12

Were any increased risks of all-cause mortality found in the study for any of the 3 analgesic types?

Accepted Answer

There was also an increased risk for all-cause mortality (HR, 1.87) for opioid use compared with nsNSAID use, but not for coxib use vs nsNSAID use.

Question 13

What was found in the study regarding an increased risk of hospitalization events?

Accepted Answer

Use of opioids (HR, 1.68) — but not coxibs — compared with nsNSAIDs was associated with increased risk for hospitalization events.

Question 14

An 80-year-old woman with osteoarthritis requires analgesia for pain. Which of the following is likely to be associated with the lowest risk for gastrointestinal bleeding and no increased risk for fracture? A) Coxibs B) nsNSAIDs C) Opioids D) Risk similar for all 3

Accepted Answer

A) Coxibs Coxibs are associated with lower risk for gastrointestinal bleeding but higher risk for cardiovascular events

Opioids Study from 12/2010 Flashcards

Opioids Linked to More Adverse Events in Older Adults with Arthritis. From the results of a study reported in the December 13/27 issue of the Archives of Internal Medicine.

Brainscape's Knowledge GenomeTM

Opioids Study from 12/2010 Flashcards

Opioids Linked to More Adverse Events in Older Adults with Arthritis. From the results of a study reported in the December 13/27 issue of the Archives of Internal Medicine.

Brainscape's Knowledge Genome^TM