An intrathecal (IT) combination of low doses of ziconotide and morphine allows safe and rapid control of oral opioid–refractory malignant pain.
- Patients with malignant pain refractory to high oral opioids doses with a mean visual analogue scale of pain intensity (VASPI) score of 70mm were enrolled.
- An IT combination therapy was administered: Ziconotide was started at a dose of 2.4μg/day, followed by increases of 1.2 μg/day at intervals of at least 7days, and an initial IT daily dose of morphine was calculated based on its oral daily dose.
- Percentage change in VASPI scores from baseline was calculated at 2days, at 7days, and weekly until the first 28days.
- The mean percentage change of VASPI score from baseline was used for efficacy assessment.
- Safety was monitored based on adverse events and routine laboratory values.
- Twenty patients were enrolled, with a mean daily VASPI score at rest of 90±7.
- All had a disseminated cancer with bone metastases involving the spine.
- The percentage changes in VASPI mean scores from baseline to 2days, 7days, and 28days were 39±13% (95% confidence interval [CI]=13.61–64.49, P<.001), 51±12% (95% CI=27.56–74.56, P<.001), and 62±13% (95% CI=36.03–87.89%, P<.001), respectively.
- Four patients experienced mild adverse events related to the study drugs.
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