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Clinical Trial
Comparative Study
English Abstract
Journal Article
[Tapentadol prolonged release improves analgesia, functional impairment and quality of life in patients with chronic pain who have previously received oxycodone/naloxone].
MMW Fortschritte der Medizin 2014 July 25
STUDY OBJECTIVE: This subgroup analysis of a prospective, non-interventional study involving general practitioners and internists investigated the administration of tapentadol prolonged release (tapentadol PR; Palexia retard) for the treatment of patients who have previously received oxycodone/naloxone.
METHODS: From the overall effectiveness sample (n = 5,002) data of all patients who were previously treated with oxycodone/naloxone in a fixed combination (n = 382) were included in this analysis. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, functional impairment, and tolerability of tapentadol PR. Health related quality of life was documented at baseline and at the end of observation by patients using the SF-12 questionnaire.
RESULTS: Back pain was the most common cause of pain. Including all pain diagnoses, mixed type of pain (nociceptive and neuropathic) predominated. The oxycodone/naloxone pretreatment was multifold combined with strong opioids (10.2%), weak opioids (29.3%), non- opioids (78.3%), co-analgesics (56.0%) and analgesic rescue medication (26.9%). Switching to tapentadol PR resulted in a mean pain reduction of 3.41 points from 7.29 ± 1.40 at baseline to 3.88 ± 1.86 at end of observation (NRS 11, 11-point pain scale; descriptive p value ≤ 0.001; n = 373), using a final average daily dosage of 252.9 mg tapentadol PR. In all four categories assessing the pain-related functional impairment, significant improvements have been achieved. In addition to significantly reduced pain-related impairments of everyday activities patients' data documented significant improvements in physical and mental SF-12 total scores, which initially were already at critically low range. A good tolerability of tapentadol PR therapy was reported.
CONCLUSIONS: Patients, who were previously treated with oxycodone/naloxone, benefit from a tapentadol PR therapy as well: data analysis shows a clinically relevant improvement of analgesia, functionality and quality of life. Furthermore, the previous analgesic "co"-medication could be reduced during tapentadol PR therapy.
METHODS: From the overall effectiveness sample (n = 5,002) data of all patients who were previously treated with oxycodone/naloxone in a fixed combination (n = 382) were included in this analysis. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, functional impairment, and tolerability of tapentadol PR. Health related quality of life was documented at baseline and at the end of observation by patients using the SF-12 questionnaire.
RESULTS: Back pain was the most common cause of pain. Including all pain diagnoses, mixed type of pain (nociceptive and neuropathic) predominated. The oxycodone/naloxone pretreatment was multifold combined with strong opioids (10.2%), weak opioids (29.3%), non- opioids (78.3%), co-analgesics (56.0%) and analgesic rescue medication (26.9%). Switching to tapentadol PR resulted in a mean pain reduction of 3.41 points from 7.29 ± 1.40 at baseline to 3.88 ± 1.86 at end of observation (NRS 11, 11-point pain scale; descriptive p value ≤ 0.001; n = 373), using a final average daily dosage of 252.9 mg tapentadol PR. In all four categories assessing the pain-related functional impairment, significant improvements have been achieved. In addition to significantly reduced pain-related impairments of everyday activities patients' data documented significant improvements in physical and mental SF-12 total scores, which initially were already at critically low range. A good tolerability of tapentadol PR therapy was reported.
CONCLUSIONS: Patients, who were previously treated with oxycodone/naloxone, benefit from a tapentadol PR therapy as well: data analysis shows a clinically relevant improvement of analgesia, functionality and quality of life. Furthermore, the previous analgesic "co"-medication could be reduced during tapentadol PR therapy.
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