Anti-cancer drugs
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Multicenter Study Clinical Trial
Transdermal fentanyl: clinical development in the United States.
The first clinical experience in the United States of the transdermal therapeutic system (TTS) for delivery of fentanyl in cancer pain was a small study of five patients. Pain relief was established with intravenous (i.v.) fentanyl. A transdermal system was selected to deliver the same hourly dose while the i.v. infusion was tapered over 6 h. ⋯ The systems were used throughout a variety of concomitant complications of the cancer process. This experience demonstrated the safety and clinical effectiveness of TTS fentanyl in the treatment of chronic cancer pain. TTS fentanyl has been used widely in the USA since it was approved for marketing in 1990.
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The transdermal route of drug delivery has been used for the effective administration of therapeutic agents for more than a decade. The most important consideration in selecting a drug for transdermal delivery is the potential for improving therapeutic efficacy. The development of a transdermal fentanyl system provided an opportunity to add fentanyl to the armamentarium of strong opioids available for the treatment of cancer pain. ⋯ Steady state serum concentrations are reached by the second application. Clinical trials have established the efficacy and safety of transdermal fentanyl for the treatment of cancer pain. Transdermal fentanyl is not licensed for the treatment of acute pain, e.g. postoperative pain, and should not be prescribed for this purpose.
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In 1985 there were almost 5 million deaths from cancer, and it is estimated that in 2015 there will be over 9 million, of which almost three-quarters will be in developing countries. Seventy to eighty per cent of these patients will experience moderate or severe pain at some stage of their illness and at present most of these will die in pain. This is true in spite of the fact that there is substantial evidence which shows that in as many as 80% of patients with cancer pain it is possible to obtain complete relief with orally administered analgesics, either alone or supplemented with co-analgesic (adjuvant) drugs. ⋯ The most important advances in management have been the simplification and refinement of analgesic treatment which have made relief of cancer pain more widely accessible to patients. The introduction of controlled-release oral formulations of morphine has had a considerable impact because they are convenient and simple to use. The recent development of a long-acting non-invasive transdermal delivery system for strong opioid administration promises a further step forward in terms of flexibility and convenience for cancer patients.
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Clinical Trial
Transdermal fentanyl in combination with initial intravenous dose titration by patient-controlled analgesia.
Two studies including a total of 70 patients evaluated the efficacy and side effects of a combination of initial patient-controlled analgesia (PCA) for dose finding with transdermal fentanyl administration. Patients, requiring strong opioids for severe cancer pain, received intravenous (i.v.) fentanyl on an on-demand basis over a 24 h period. The amount of fentanyl administered was then used for selecting a suitable transdermal therapeutic system (TTS), which remained in place for 72 h. ⋯ A respiratory rate below 8 per minute was observed in three patients. Due to adequate symptomatic treatment, other moderate and severe symptoms were relatively rare. TTS fentanyl was shown to be an effective, safe and simple method for long-term pain relief in cancer patients and presents an interesting novel option in the treatment of cancer pain.
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Multicenter Study Clinical Trial Controlled Clinical Trial
Control of nausea and vomiting by Navoban (tropisetron) in 131 children receiving cytotoxic chemotherapy.
One hundred and thirty-one children with a median age of 5 years were administered Navoban (tropisetron), a selective antagonist of the serotonin receptor (5-HT3), dosed once daily at 0.2 mg/kg (with a maximum of 5 mg daily) in a study aimed at evaluating the prevention of nausea and vomiting induced by anti-cancer chemotherapy. The most common malignancy (in 49% of patients) was acute lymphocytic leukaemia. Patients received Navoban during one or more courses of emetogenic chemotherapy for a total of 455 courses administered intravenously or intravenously and intrathecally (IV + IT). ⋯ Ninety-six per cent of the intravenous chemotherapy group and 97% of the IV + IT chemotherapy group had a complete (70% and 55% respectively) or partial (26% and 42% respectively) response during the first 24-hour period of the first course in which Navoban was used. The second and subsequent courses yielded similar percentages. Delayed emesis was observed mainly during those courses employing the most emetogenic chemotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)