A randomised controlled trial with prolonged‐release oral oxycodone and naloxone to prevent and reverse opioid‐induced constipation

Meißner, Winfried; Leyendecker, Petra; Mueller–Lissner, Stefan; Nadstawek, J.; Hopp, Michael; Ruckes, Christian; Wirz, Stefan; Fleischer, Wolfgang; Reimer, Karen

doi:10.1016/j.ejpain.2008.06.012

Cited by 231 publications

(188 citation statements)

References 21 publications

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“…In patients with chronic pain, oral naloxone improved symptoms of laxation (24), but because of its very narrow therapeutic index, doses that reverse gut symptoms can often cause reversal of analgesia (25). However, there has been a resurgence of interest in naloxone in a prolonged-release preparation, which shows evidence of analgesic efficacy and safety when used in combination with oxycodone (prolonged release) for moderate-to-severe chronic pain (26) and improved bowel function when compared with oral oxycodone (prolonged release) alone (27). This effiacy continues for up to 52 weeks in patients with non-cancer chronic pain (28).…”

Section: Naloxonementioning

confidence: 99%

Opioid Induced Constipation

Aurilio¹,

Pace²,

Pota³

et al. 2012

Constipation - Causes, Diagnosis and Treatment

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Section: Naloxonementioning

confidence: 99%

Opioid Induced Constipation

Aurilio¹,

Pace²,

Pota³

et al. 2012

Constipation - Causes, Diagnosis and Treatment

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“…The optimal ratio was 2:1. Only a minimal number of patients had cancer pain [24]. Thus, it is important to have more data in the cancer population who are at higher risk of constipation due to the large number of contributing factors [6].…”

Section: New Opioid Formulationsmentioning

confidence: 99%

Emerging drugs for cancer-related pain

Mercadante

2011

Support Care Cancer

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“…13 After oral administration naloxone has a low oral bioavailability of <2% due to its high first-pass metabolism. 12 Prior to its hepatic metabolism, however, naloxone acts locally in the gut to block gut opioid receptors. 3 By this mechanism of action, oral naloxone improves OIBD.…”

Section: Oxycodone and Naloxone: A Novel Mode Of Actionmentioning

confidence: 99%

“…A 202 patient randomised, double-blind study evaluated the analgesic efficacy of the oxycodone/ naloxone combination and its impact on OIBD in patients with severe, chronic, mainly non-cancer pain. 12 Patients having stable oral oxycodone therapy (40, 60 or 80mg/day) were randomised to receive naloxone (10,20 or 40mg/ day) or placebo. After a four-week maintenance phase, patients then received oxycodone alone for two weeks.…”

Section: Efficacy Of the Oxycodone/naloxone Combinationmentioning

confidence: 99%

Prolonged‐release oxycodone/naloxone for chronic pain

O'Connell¹,

Simpson

2009

Future Prescriber

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Chronic pain is common, and opioid therapy is often required for pain management. Unfortunately, opioid-induced bowel dysfunction (OIBD) is a frequent and debilitating side-effect of opioid use. A new prolonged-release (PR) preparation of oxycodone/naloxone has been developed for moderate-to-severe pain that reduces OIBD in patients. In this article, we consider the mode of action and efficacy of this combination opioid therapy for chronic pain. C hronic pain, which can be defined as pain that persists or progresses over a prolonged period, 1 is a widespread problem affecting 19% of adults across Europe. 2 In a large-scale telephone sur vey involving 46 394 respondents in 15 European countries and Israel, the most common source of chronic pain was low back pain (24%), which was most often due to osteoarthritis (34%). 2 More in-depth interviews took place with 4839 of those who had reported chronic pain. This showed that 66% had moderate pain assessed by a Visual Analogue Score (VAS) of 5-7 (rating 1 as being no pain and 10 as the worst pain imaginable), 34% had severe pain (VAS of 8-10), 46% had constant pain and 54% had intermittent pain. 2 For many people, the duration of pain was prolonged: 59% had pain for 2-15 years, while 21% had pain for more than 20 years. CHRONIC PAIN AND USE OF OPIOIDSNonsteroidal anti-inflammator y drugs (NSAIDs), anticonvulsants, antidepressants, membrane stabilisers and opioids are all used to treat chronic pain. Careful dose titration and management of side-effects are essential for optimal pharmacotherapy. The World Health Organization (WHO) recommends opioids for managing moderate-tosevere cancer pain, but the role of opioids in chronic non-cancer pain is less established; they are increasingly being used to treat chronic non-cancer pain. 3 Breivik et al found that only 5% of those taking prescription medications for pain were taking a strong opioid. 2 There may be a need to optimise opioid use for those patients who do not respond to other analgesic regimens including pharmacological and non-drug therapies. Opioids may be useful for neuropathic and nociceptive pain if other strategies fail to provide adequate analgesia within a reasonable time. 4 Opioids are an important treatment option but they must be carefully prescribed and their use managed appropriately.A large meta-analysis of 41 randomised trials involving 6019 patients with nociceptive pain (osteoarthritis, rheumatoid arthritis or back pain), neuropathic pain Prolonged-release oxycodone/ naloxone for chronic pain Naloxone binds selectively to intestinal opioid receptors, without blocking the analgesic effect of oxycodone. SCIENCE PHOTO LIBRARY

show abstract

A randomised controlled trial with prolonged‐release oral oxycodone and naloxone to prevent and reverse opioid‐induced constipation

Abstract: Co-administration of PR oral naloxone and PR oral oxycodone is associated with a significant improvement in bowel function compared with PR oral oxycodone alone, with no reduction in the analgesic efficacy of oxycodone.

Cited by 231 publications

References 21 publications

Opioid Induced Constipation

Opioid Induced Constipation

Emerging drugs for cancer-related pain

Prolonged‐release oxycodone/naloxone for chronic pain

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