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5/21/2001

Patients Prefer Fentanyl Patch to Oral Morphine

Kate Traynor

Patients who use opioids to control chronic pain benefit more from applying a transdermal fentanyl patch than swallowing extended-release morphine tablets, researchers say.

In a study involving adults with chronic pain not caused by cancer, 65 percent of the participants preferred the patch over the oral drug. Twenty-eight percent said they liked oral morphine better than transdermal fentanyl, and 15 percent had no preference.

Overall scores on a standard test measuring quality of life were higher when the patients used fentanyl than when they tried morphine, the researchers said. Scores on four of the eight quality-of-life measures were significantly better during fentanyl use.

According to the researchers, whose findings were reported in the May 12 BMJ (PDF), the main reason patients preferred the fentanyl patch was that it gave better pain relief than oral morphine. Thirty-five percent of the patients said the patch gave "good" or "very good" pain control. This level of pain relief was achieved with oral morphine by 23 percent of the patients.

Study participants were recruited from pain management clinics in Europe, Canada, and South Africa. Eligible patients had used a "potent" opioid for at least six weeks before entry into the study and had achieved "moderate" pain control with a stable amount of the drug product during the week before the study. Morphine was the most common of the 18 opioids used by the study participants at baseline.

Each patient was examined 24 hours before the first scheduled dose of oral morphine or transdermal fentanyl to confirm that an opioid was needed for pain relief. A total of 130 patients were assigned to receive morphine for four weeks and then fentanyl for four weeks, and 126 other patients were to use the drugs in the opposite sequence.

Morphine treatment consisted of an individualized regimen of extended-release morphine tablets ranging in strength from 10 to 200 mg each, with half of the daily dose given every 12 hours. Fentanyl was administered using 25- to 100-mcg transdermal patches, with the dosage based on each patient’s need at baseline for an opioid.

The researchers evaluated the safety and efficacy of the drug regimens at days 7, 16, and 28 during each four-week treatment period. A total of 196 patients completed both parts of the study.

Each patient received a prescription for 5-mg immediate-release morphine tablets to control breakthrough pain. Patients who needed more than 60 mg of this rescue medication over two days while using the patch or more than 10 mg/day while taking extended-release morphine received a higher dosage of their study drug. Fentanyl users requested more rescue medication than morphine users did.

Adverse events prompted 10 percent of the patients to withdraw from the study while using fentanyl and 5 percent to drop out while taking morphine. None of the patients died during the study, although one participant’s breathing became abnormal while taking morphine.

Except for constipation, which was less common during fentanyl use, the overall frequency of adverse events was similar during the two treatment periods. Nearly half of the study participants reported constipation while taking morphine, but less than a third did while using fentanyl. Erythema at the site where the patch was applied was reported by 41 percent of fentanyl users, making this the most common adverse event noted during fentanyl use.

Funding for this study was provided by the Janssen Research Foundation, a division of fentanyl-patch manufacturer Janssen Pharmaceutica. Two of the seven authors of the article have received funding or other support from Janssen, and one has also received support from Napp Laboratories Ltd., which manufactures an extended-release morphine product.