Prescrire international
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Prescrire international · Jun 2003
Comparative StudyOral oxycodone: new preparation. No better than oral morphine.
(1) For the treatment of cancer pain resistant to WHO step I and II analgesics, several oral morphine preparations are available, in immediate-release and sustained-release formulations. (2) A sustained-release form of oxycodone, an old opiate, was marketed in France in 2002 for oral treatment of cancer pain, in two daily doses. (3) The results of three comparative double-blind trials suggest that 1 mg oxycodone is similarly effective to 1.5 mg of morphine. According to another comparative double-blind trial, 1 mg oxycodone has about the same analgesic efficacy as 0.25 mg of hydromorphone. (4) Oxycodone has the usual opiate side effects including constipation, sedation, nausea and vomiting, and pruritus. (5) Oxycodone has not been tested in comparative trials in patients in whom morphine is ineffective or poorly tolerated. (6) The available product range of sustained-release oxycodone does not allow the dose to be adjusted rapidly at the outset of treatment, and is poorly suited to patients who have difficulty swallowing. (7) In practice, oral morphine remains the reference treatment for cancer pain resistant to WHO step I and II analgesics.
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Prescrire international · Jun 2003
Comparative StudyRofecoxib in rheumatoid arthritis: new indication. No better that other NSAIDS.
(1) For symptoms of rheumatoid arthritis (pain, joint stiffness), the reference treatment is a nonsteroidal antiinflammatory drug (NSAID) such as diclofenac or ibuprofen. Celecoxib, a coxib NSAID, has no proven advantages over these other NSAIDs. (2) Rofecoxib is the second coxib to be approved in this indication. The clinical evaluation file shows that the optimal daily dose is 25 mg. (3) A comparative trial in more than 8 000 patients, showed that rofecoxib was no more effective than 1 g/day of naproxen. ⋯ During postmarketing follow up in the United States, a number of deaths due to gastrointestinal complications on rofecoxib were reported. Rofecoxib carries the same renal risk as other NSAIDs. An excess risk of cardiovascular events cannot be ruled out. (5) In practice, the advent of rofecoxib in no way influences the choice of NSAID for symptomatic treatment of rheumatoid arthritis.
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Prescrire international · Apr 2003
Comparative StudyDrotrecogin alfa: new preparation. For some cases of severe sepsis?
(1) Severe sepsis is fatal in 30-50% of cases, despite antibiotic therapy and intensive care. (2) The first specific treatment to be marketed in France was HA-IA monoclonal antibodies, in 1991. However, marketing approval was granted precipitously, on the basis of a single, controversial comparative trial, and the product was withdrawn after a second trial gave negative results. (3) Marketing authorization for drotrecogin alfa (recombinant activated protein C) was granted in 2002 for this indication. (4) The product was approved after a single comparative double-blind placebo-controlled trial in 1 690 patients. ⋯ The manufacturing process was also changed, making it difficult to interpret the results of this trial. (5) The trial found that drotrecogin alfa reduced mortality (by 6% in absolute values: 25% versus 31%), but also increased the risk of severe haemorrhage, the main adverse effect (3.5% versus 2%). (6) Retrospective subgroup analyses identified patients most likely to benefit from drotrecogin alfa, and also patients who would be needlessly exposed to an additional risk. (7) Drotrecogin alfa is a very expensive drug. (8) In practice, this clinical trial should be considered preliminary. Other, strictly designed and conducted trials are therefore required.
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Prescrire international · Dec 2002
Review Comparative StudyTreatment of postherpetic neuralgia: tricyclic antidepressants still the reference.
(1) Pain generally disappears when herpes zoster lesions have healed, but the risk of postherpetic neuralgia, though it is low, increases with age. (2) Antivirals prescribed during the acute phase do not reduce the risk of postherpetic neuralgia, but they do reduce its duration. (3) Common non specific analgesics such as paracetamol seem inadequate against postherpetic neuralgia. Amitriptyline and desipramine, despite their limited efficacy, are the reference. Gabapentin, although somewhat less effective, is a possible second line option. It is unclear how long treatment should last.