Fentanyl Buccal Tablet May Provide More Rapid Relief of Cancer Pain

Dr. Sebastiano Mercadante MD Director, Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit La Maddalena Cancer Center, Palermo, ItalyMedicalResearch.com Interview with:
Dr. Sebastiano Mercadante MD

Director, Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit
La Maddalena Cancer Center, Palermo, Italy

Medical Research: What is the background for this study? What are the main findings?

Dr. Mercadante:  Breakthrough cancer pain (BTcP) has been defined as a transitory increase in pain intensity that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background (1). Breakthrough cancer pain is a common problem in patients with cancer and is associated with significant morbidity. In a recent report in which a pragmatic definition of breakthrough cancer pain was used (2), the prevalence of BTcP was 75% (3).

Oral morphine (OM) has been traditionally offered as a breakthrough cancer pain medication in doses of about 1/6 of the daily opioid regimen for years, although this approach has never been supported by any evidence. Different technologies have been developed to provide a rapid onset of effect with potent opioid drugs such as fentanyl (rapid onset opioids, ROOs) delivered by non-invasive routes. Fentanyl products have been shown to be significantly superior to oral opioids, but it has been suggested that the dose of fentanyl should be individually titrated in order to enable effective analgesia to be delivered while minimizing the risk of clinically significant adverse effects. The need of dose titration with rapid onset opioids has never been appropriately assessed and this statement is derived by a series of weaknesses of papers published for regulatory issues. Indeed, the only existing study comparing dose titration and proportional doses, reported that proportional doses of (Fentanyl buccal tablet) FBT are more effective and safe over dose titration method. NICE guidelines did not provide evidence for that, at least at certain time intervals after administration.

To scientifically compare rapid onset opioids and oral morphine, we used a similar approach and made a strict selection of patients, according to a more specific algorithm for a diagnosis o fbreakthrough cancer pain. Thus, patients were randomized to receive in a crossover design Fentanyl buccal tablet and oral morphine, both given in doses proportional to opioid daily doses, for the management of breakthrough cancer pain.

This comparative study has shown that, when giving the drugs for breakthrough cancer pain in doses proportional to the opioid regimen for background pain, Fentanyl was clearly superior for efficacy and rapidity in comparison with oral morphine. The analgesic effect was more intense either at 15 and 30 minutes after study medications were given. A larger number of episodes treated with Fentanyl buccal tablet  presented a decrease in pain intensity of ≥33% and ≥50% in comparison with episodes treated with oral morphine, and a relevant difference in SPID30 was reported. Of interest, adverse effects commonly observed in patients receiving opioids were not severe and did not differ between the treatments, suggesting that the use of proportional doses of both drugs are safe, reflecting what is derived by the long-lasting experience with oral morphine.  

Medical Research: What should clinicians and patients take away from your report?

Dr. Mercadante: Clinicians should be aware that rapid onset opioids can be more effectively used in doses proportional to basal opioid regimen, confirming in a more robust way a clear superiority over oral morphine in the first 30 minutes, the approximate target for a timely intervention required to a breakthrough cancer pain medication.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Mercadante: Although it is expected that fentanyl products provide a similar effects over oral morphine, as observed in some open-label studies, further studies should confirm that all rapid onset opioids can be more effectively used in doses proportional to basal opioid regimen, without particular risks of adverse effects.

Citation:

Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study.

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Dr. Sebastiano Mercadante MD (2015). Fentanyl Buccal Tablet May Provide More Rapid Relief of Cancer Pain 

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