Emerging drugs for cancer-related pain

Mercadante, Sebastiano

doi:10.1007/s00520-011-1281-y

Cited by 9 publications

(8 citation statements)

References 43 publications

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“…World Health Organization (WHO) Step III opioid analgesics (e.g., morphine) are often used for moderate to severe cancer pain management [1–3]. The level of pain relief achieved with opioid analgesics varies from patient to patient [1], and many patients (approximately 10–30 %) with cancer-related pain do not achieve adequate analgesia with opioids [4].…”

Section: Introductionmentioning

confidence: 99%

Ready Conversion of Patients with Well-Controlled, Moderate to Severe, Chronic Malignant Tumor–related Pain on Other Opioids to Tapentadol Extended Release

Imanaka¹,

Tominaga²,

Etropolski

et al. 2014

Clin Drug Investig

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Background and ObjectivesThe effectiveness and tolerability of tapentadol extended release (ER), a centrally acting analgesic with μ-opioid receptor agonist and norepinephrine (noradrenaline) reuptake inhibitor activities, have been demonstrated in patients with chronic pain, including those switching directly from prior opioid therapy. The objective of the current study was to evaluate the effectiveness and safety of conversion to oral tapentadol ER (50–250 mg twice daily) from previous around-the-clock strong opioid therapy in patients with moderate to severe, chronic malignant tumor–related cancer pain that was well-controlled.MethodsThis randomized, open-label, phase III study, which was conducted in Japan, included a 1- to 2-week screening period (on previous opioid) and an 8-week, open-label treatment period. Eligible patients, who were taking a strong opioid analgesic and had a mean pain intensity score <4 during the 3 days prior to randomization (adequate pain control on previous strong opioid), were randomized (1:1) to receive twice-daily treatment with tapentadol ER (100–500 mg/day) or morphine sustained release (SR; 20–140 mg/day; reference for assay sensitivity). Initial doses were estimated based on the conversion ratio of tapentadol ER:oxycodone:morphine:fentanyl = 10:2:3:0.03. The primary effectiveness endpoint was the proportion of patients who maintained pain control [change from baseline in mean pain intensity (11-point numerical rating scale) less than +1.5 for 3 consecutive days and no more than two doses of rescue medication per day for 3 consecutive days) during the first week of open-label treatment.ResultsIn the tapentadol ER group (n = 50), 84.0 % of patients (42/50; 95 % CI, 70.89–92.83) maintained pain control during Week 1. On the Patient Global Impression of Change, 2.1 % (1/48), 2.1 % (1/48), 22.9 % (11/48), and 50.0 % (24/48) of patients in the tapentadol ER group reported that their overall condition was “very much improved,” “much improved,” “minimally improved,” and “not changed,” respectively, at Week 1 compared with 0 %, 10.7 % (3/28), 28.6 % (8/28), and 53.6 % (15/28) reporting these ratings at Week 8. The sensitivity of effectiveness analyses was validated based on results using morphine SR; 98.0 % (49/50; 95 % CI, 89.35–99.95) of patients in the morphine SR group maintained pain control after 1 week of treatment. The overall safety profile was similar to that demonstrated in previous studies; tapentadol ER was associated with a lower incidence of gastrointestinal treatment-emergent adverse events than morphine SR [38.0 % (19/50) vs. 54.0 % (27/50)], including constipation [12.0 % (6/50) vs. 20.0 % (10/50)] and vomiting [6.0 % (3/50) vs. 26.0 % (13/50)].ConclusionsOverall, results indicate that conversion from previous strong opioids to tapentadol ER (50–250 mg twice daily) was successful and resulted in safe and effective pain control with improved gastrointestinal tolerability versus morphine SR in patients with moderate to severe cancer-related pain that was well-controlle...

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Section: Introductionmentioning

confidence: 99%

Ready Conversion of Patients with Well-Controlled, Moderate to Severe, Chronic Malignant Tumor–related Pain on Other Opioids to Tapentadol Extended Release

Imanaka¹,

Tominaga²,

Etropolski

et al. 2014

Clin Drug Investig

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“…Moderate to severe, chronic pain is one of the most common symptoms of cancer and affects an estimated 70% to 90% of patients with advanced disease 1,2 . The management of associated chronic pain is recognized as one of the central challenges in the overall care of cancer patients, due in part to the high prevalence of cancer pain and its detrimental effect on patient wellbeing 3 .…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain

Imanaka¹,

Tominaga²,

Etropolski

et al. 2013

Current Medical Research and Opinion

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“…When an exogen mu-opioid agonist binds to these receptors, the release of various neurotransmitters is inhibited, interrupting the coordinate rhythmic contractions required for intestinal motility and reduces mucosal secretions [3]. Different from many opioid-related adverse effects which occur at the beginning of treatment and which tend to disappear over time, constipation constantly persists and may represent a relevant problem during the chronic treatment with opioids [4]. The physical consequences of constipation demand consideration.…”

Section: Introductionmentioning

confidence: 99%

Combined oral prolonged-release oxycodone and naloxone in chronic pain management

Mercadante

Giarratano

2012

Expert Opinion on Investigational Drugs

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Emerging drugs for cancer-related pain

Cited by 9 publications

References 43 publications

Ready Conversion of Patients with Well-Controlled, Moderate to Severe, Chronic Malignant Tumor–related Pain on Other Opioids to Tapentadol Extended Release

Ready Conversion of Patients with Well-Controlled, Moderate to Severe, Chronic Malignant Tumor–related Pain on Other Opioids to Tapentadol Extended Release

Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain

Combined oral prolonged-release oxycodone and naloxone in chronic pain management

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