Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain.
Curr Med Res Opin. 2004 Sep; 20(9):1419-28.CM

Abstract

PURPOSE

To evaluate effectiveness and safety information of transdermal fentanyl (TDF) (Duragesic/Durogesic) and sustained-release oral morphine (SRM) in cancer pain (CP) and chronic non-cancer pain (NCP), a pooled analysis was conducted on datasets of published, open label, uncontrolled (no comparator group) and randomised controlled (with SRM as comparator) studies of TDF.

PATIENTS AND METHODS

Eight trials with treatment durations of at least 28 days met the inclusion criteria. The effectiveness analysis assessed changes in average pain and pain 'right now' scores between baseline and Day 28. The safety analysis evaluated the incidence of adverse events (AEs) reported within the first 28 days of treatment with TDF or SRM. Subgroup analyses included pain type, gender, age, weight, and body mass index.

RESULTS

Pooled efficacy data were available from 1220 patients; these showed that both TDF and SRM were effective in improving pain 'right now' scores (0-100 scale) from baseline to Day 28. The improvement was significantly more pronounced in the TDF treatment group (-26.7 +/- 31.3 for TDF, -18.7 +/- 30.9 for SRM, p = 0.002). This favourable effect of TDF was most apparent amongst patients with NCP. Data concerning AEs were available from over 2500 patients with CP (3 out of 10 patients) or chronic NCP (7 out of 10 patients). Significantly fewer patients in the TDF than in the SRM group reported any AE (72% vs. 87% respectively; p < 0.001), or an AE leading to the study drug being permanently discontinued (16% vs. 23% respectively; p < 0.001). Constipation and somnolence occurred considerably less frequently in the TDF than in the SRM treatment group. This difference was statistically significant in both the CP and NCP subgroups.

CONCLUSION

This pooled data analysis provides expanded insight into the safety and effectiveness profile of transdermal fentanyl in patients with chronic pain. It shows significantly improved pain relief with transdermal fentanyl compared with sustained-release oral morphine, and supports current evidence of favourable tolerability of transdermal fentanyl, particularly with regard to reduced constipation and somnolence.

Authors+Show Affiliations

Pain Management Unit, Dalhousie University, Halifax, NS, Canada. john.clark@cdha.nshealth.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15383190

Citation

Clark, A J., et al. "Efficacy and Safety of Transdermal Fentanyl and Sustained-release Oral Morphine in Patients With Cancer and Chronic Non-cancer Pain." Current Medical Research and Opinion, vol. 20, no. 9, 2004, pp. 1419-28.
Clark AJ, Ahmedzai SH, Allan LG, et al. Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. Curr Med Res Opin. 2004;20(9):1419-28.
Clark, A. J., Ahmedzai, S. H., Allan, L. G., Camacho, F., Horbay, G. L., Richarz, U., & Simpson, K. (2004). Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. Current Medical Research and Opinion, 20(9), 1419-28.
Clark AJ, et al. Efficacy and Safety of Transdermal Fentanyl and Sustained-release Oral Morphine in Patients With Cancer and Chronic Non-cancer Pain. Curr Med Res Opin. 2004;20(9):1419-28. PubMed PMID: 15383190.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. AU - Clark,A J, AU - Ahmedzai,S H, AU - Allan,L G, AU - Camacho,F, AU - Horbay,G L A, AU - Richarz,U, AU - Simpson,K, PY - 2004/9/24/pubmed PY - 2005/1/27/medline PY - 2004/9/24/entrez SP - 1419 EP - 28 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 20 IS - 9 N2 - PURPOSE: To evaluate effectiveness and safety information of transdermal fentanyl (TDF) (Duragesic/Durogesic) and sustained-release oral morphine (SRM) in cancer pain (CP) and chronic non-cancer pain (NCP), a pooled analysis was conducted on datasets of published, open label, uncontrolled (no comparator group) and randomised controlled (with SRM as comparator) studies of TDF. PATIENTS AND METHODS: Eight trials with treatment durations of at least 28 days met the inclusion criteria. The effectiveness analysis assessed changes in average pain and pain 'right now' scores between baseline and Day 28. The safety analysis evaluated the incidence of adverse events (AEs) reported within the first 28 days of treatment with TDF or SRM. Subgroup analyses included pain type, gender, age, weight, and body mass index. RESULTS: Pooled efficacy data were available from 1220 patients; these showed that both TDF and SRM were effective in improving pain 'right now' scores (0-100 scale) from baseline to Day 28. The improvement was significantly more pronounced in the TDF treatment group (-26.7 +/- 31.3 for TDF, -18.7 +/- 30.9 for SRM, p = 0.002). This favourable effect of TDF was most apparent amongst patients with NCP. Data concerning AEs were available from over 2500 patients with CP (3 out of 10 patients) or chronic NCP (7 out of 10 patients). Significantly fewer patients in the TDF than in the SRM group reported any AE (72% vs. 87% respectively; p < 0.001), or an AE leading to the study drug being permanently discontinued (16% vs. 23% respectively; p < 0.001). Constipation and somnolence occurred considerably less frequently in the TDF than in the SRM treatment group. This difference was statistically significant in both the CP and NCP subgroups. CONCLUSION: This pooled data analysis provides expanded insight into the safety and effectiveness profile of transdermal fentanyl in patients with chronic pain. It shows significantly improved pain relief with transdermal fentanyl compared with sustained-release oral morphine, and supports current evidence of favourable tolerability of transdermal fentanyl, particularly with regard to reduced constipation and somnolence. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/15383190/Efficacy_and_safety_of_transdermal_fentanyl_and_sustained_release_oral_morphine_in_patients_with_cancer_and_chronic_non_cancer_pain_ L2 - https://www.tandfonline.com/doi/full/10.1185/030079904X2114 DB - PRIME DP - Unbound Medicine ER -