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| |  Morphine Extended Release Capsules Improve Pain Relief and Other Symptoms in Patients With Arthritis and Fibromyalgia Pain SAN ANTONIO, T.X. -- May 4, 2006 -- Kadian(R) (morphine sulphate extended-release capsules) improves pain scores and pain symptoms in arthritis and fibromyalgia syndrome (FMS) patients to the same degree as patients with other moderate to severe chronic non-malignant pain states, according to two supplemental analyses presented at the 25th Annual Scientific Meeting of the American Pain Society. "Opioid use in this patient population may be considered after first-line treatment has failed and these data further support this conclusion," said study investigator Bruce Nicholson, MD, Director, Pain Specialists of Greater Lehigh Valley, Inc. "Kadian demonstrated efficacy and safety in these patient groups." These sub-analyses are from a large, demographically diverse, community-based study population. A total of 1,428 patients were enrolled by investigators at 202 community-based pain centers. Of these, 1,418 non-malignant pain patients were included in the safety population, and 1,150 patients were included in the ITT population. The mean age of the patient population was 47.9 plus or minus 12.5 years (range, 19-89 years). Overall, 60.3% of the patients were women, and 89.6% were white (7.4% black, 2.0% Hispanic, 0.5% Asian, and 0.5% other).(1) In the first sub-analysis patients whose moderate-to-severe chronic pain had been undertreated were given Kadian for four weeks. These patients were compared with patients with other non-malignant pain states (OP). Arthritis patients (n=98; 89 osteoarthritis, 9 rheumatoid) taking Kadian experienced a 25% improvement in pain scores and a 19% improvement in sleep scores (P <.001). The arthritis pain patients had similar results to the OP patients in the study. Additionally, patients saw a significant improvement in patient and physician assessment of therapy and quality of life scores.(2) In the second sub-analysis, Kadian significantly improved moderate-to- severe chronic pain symptoms in patients with a diagnosis of fibromyalgia syndrome (FMS) who had been previously undertreated. Eighty-one FMS patients who had participated in the larger study (n=1428) and used Kadian were compared with data on patients with other pain types after four weeks. Patients began once-daily dosing, with dose adjustments after one or two weeks, and could switch to twice-daily dosing after two weeks, if needed. Patients taking Kadian experienced a 24% improvement in pain scores and a 15% improvement in sleep scores (P <.05). Patients with FMS initially reported lower scores in their overall quality-of-life (QoL) scales than those with non-malignant pain, but by week four both patient groups showed similar improvements in QoL.(3) The most common adverse events in both analyses were constipation and nausea. In the arthritis pain sub-analysis, constipation was reported by 17% of arthritis patients and 12% of OP patients; nausea was reported by 11% and 8% of patients, respectively.(4) In the FMS arm, constipation was reported by 14% and 12% of FMS and OP patients; nausea was reported by 10% and 10% of patients, respectively.(5) This full study and these sub-analyses were supported by Alpharma Branded Products Division Inc., formerly known as Faulding Laboratories Inc. Alpharma Branded Products Division has a growing franchise in the chronic pain market with Kadian (morphine sulfate extended-release) Capsules. Kadian is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Kadian capsules contain an opioid agonist which is a Schedule II controlled substance. Kadian has an abuse liability similar to other opioid analgesics. This should be considered when prescribing or dispensing Kadian in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Serious adverse reactions that may be associated with Kadian therapy in clinical use are those observed with other oral opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. Patients who do not have a proven tolerance to opioids should be started only on the 20 mg strength, and usually increased at a rate not greater than 20 mg every other day. Kadian 100 mg capsules are for use in opioid- tolerant patients only. Kadian capsules are to be swallowed whole and are not to be chewed, dissolved, or crushed. Taking chewed, dissolved, or crushed Kadian capsules or pellets leads to rapid release and absorption of a potentially fatal dose of morphine. Patients must not consume alcoholic beverages while on Kadian therapy. The use of alcohol while taking Kadian may result in a significant increase in the release rate and absorption of a potentially fatal dose of morphine. REFERENCES
SOURCE: Pain Specialists of Greater Lehigh Valley PC
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