Dr. Sasaki's data showed that elderly patients had decreased pain intensity and sleep disturbance with once-daily dosing of Kadian during a four-week treatment period. The results were based on the analysis of a population subset of 103 elderly patients who participated in the KRONUS-MSP (the Kadian: Response of Non-malignant, Under-treated Subjects with Moderate/Severe Pain) trial – the largest trial to date to examine the tolerability of a sustained-release opioid for the treatment of chronic, non-malignant pain. All of the patients enrolled in the trial had a history of unsuccessful pain management.
It is estimated that 85 percent of older adults suffer from significant health problems that predispose them to pain including vascular disease, neurological degenerative conditions, shingles, osteoarthritis and rheumatoid arthritis and osteoporosis. According to the National Institutes of Health, the elderly are prescribed medications about three times more frequently than the general population and have poorer compliance with directions for use . Additionally, age-related physiological changes in these adults make it difficult for physicians to predict the efficacy and safety of pain therapy.
"Complex dosing schedules are hard for the elderly to manage. Because Kadian can be administered only once a day and has a low incidence of side effects, it's an important option for treating elderly patients with chronic pain," said Dr. Sasaki, principal investigator of the study. "In this population, a safe option for chronic pain management is important and the convenience of the once-daily dosing that Kadian offers might help older adults comply with their treatment regimen."
KRONUS-MSP patients were given Kadian (morphine sulfate sustained-release capsules) once a day for four weeks, with the option of twice-daily dosing after week two. Pain and sleep assessments were measured using a Visual Numeric Scale on which patients rated the intensity of their pain or frequency of sleep disturbances on a scale that ranges from zero to 10 to display an increase in intensity. After a four-week period, elderly patients reported decreased pain intensity as well as sleep disturbances (decreasing 2.4 and 1.7 points, respectively). Dose adjustments were permitted; however the option to change from a once-daily dose was withheld until week two. A greater percentage of elderly patients (71.4 percent) remained on the once-daily dosing of Kadian than those under the age of 65 (55.6 percent). Patient and physician Global Assessment scores also improved with Kadian treatment. Charted on a scale from -4 (completely dissatisfied; uncontrolled pain, cannot function, disruptive dosing schedule) to +4 (completely satisfied; pain controlled, convenient dosing schedule, no side effects), improvements in global assessment scores with Kadian were 2.4 points for patients and 2.9 points for physicians.
Adverse events in this population of patients 65 and older included constipation (n=29 or 19.6 percent), nausea (n=14 or 9.5 percent), dizziness (n=11 or 7.4 percent), sedation (n=10 or 6.8 percent) and somnolence (n=9 or 6.1 percent). While treatment-related incidence of constipation in the elderly is expected to be higher than that of the 65 years or younger group, the overall incidence of constipation in the KRONUS-MSP trial is lower than that typically seen in trials of other opioids analgesics.
The KRONUS-MSP trial is the largest trial to date to examine the tolerability of a sustained-release opioid for the treatment of chronic non-malignant pain. The trial employed a community-based, prospective, randomized, open-label, blinded-endpoint design involving 1,418 patients with moderate to severe, chronic, non-malignant pain and a history of unsuccessful pain management.
Kadian is a Schedule II narcotic. As with other morphine-containing controlled substances, there is a potential risk of abuse with Kadian. Serious adverse reactions that may be associated with the use of Kadian are similar to those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension and/or shock.
Chronic pain is a condition marked by pain that persists for longer than the usual recovery time for an injury or longer than six months . It can be mild or extreme; continuous or periodic; and last for weeks, months or even years. It is estimated that between 10 and 20 percent of American adults suffer from non-malignant chronic pain, with almost half of them being over the age of 65 .
About Casa Colina Centers for Rehabilitation
Casa Colina was founded in 1936 as a rehabilitation center for children who had survived polio and other crippling diseases. Since then, Casa Colina has grown to provide medical and rehabilitation services for more then 6,000 adults and children a year with a broad range of diagnoses – from brain and spinal cord injury to tennis elbow and arthritis. In the last five years, Casa Colina has experienced dynamic growth and change, with the $78 million renovation of its 20-acre Pomona, Calif. campus and the construction of a new state-of-the-art rehabilitation hospital and outpatient surgery center to be completed in 2004.