Prescrire international
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Prescrire international · Oct 2004
Gefitinib: new preparation. Non small-cell lung cancer: stricter assessment needed.
(1) Platinum-based chemotherapy is generally used to treat advanced-stage non small-cell lung cancer (stages III and IV), but has only a modest impact on survival. There is no reference treatment. (2) Gefitinib inhibits the tyrosine kinase activity of the receptor for EGF (epidermal growth factor), which is thought to be involved in tumour growth. ⋯ The most frequent were gastrointestinal (diarrhea, nausea, vomiting) and cutaneous (rash, acne, dry skin, pruritus). (6) Interstitial pneumonitis occurred in about 1% of patients, and was fatal in about one-third of cases. (7) Gefitinib is metabolised by the cytochrome P450 isoenzyme CYP3A4, so carries a potentially high risk of interactions. (8) In practice, more thorough assessment of gefitinib is needed to determine whether this new drug is beneficial for patients with non small-cell lung cancer. Marketing authorisation is not currently justified.
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(1) Gastroschisis is a severe defect in the closure of the abdominal wall in newborns. The incidence seems to be increasing. (2) Three case-control studies have examined pseudoephedrine exposure among mothers of children born with gastroschisis. ⋯ In the most recent study, the risk of gastroschisis was increased 4.2-fold among women taking the pseudoephedrine-paracetamol combination (95% confidence interval 1.9-9.2). Paracetamol is not known to cause this malformation. (3) Pseudoephedrine is a sympathomimetic vasoconstrictor contained in many over-the-counter oral decongestants sold in France. (4) In practice, it is best to avoid prescribing, dispensing or using preparations containing pseudoephedrine during pregnancy.
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Prescrire international · Aug 2004
Comparative StudyRosuvastatin: new preparation. Opt for statins with evidence of efficacy on clinical outcome.
(1) Simvastatin and pravastatin are the two reference statins for type IIA and type IIB hypercholesterolaemia because they have the best-documented protective effect against cardiovascular events. Simvastatin and pravastatin are also the reference statins for familial heterozygous hypercholesterolaemia, though there is no evidence that they prevent cardiovascular events in this group. Statins are not very effective in familial homozygous hypercholesterolaemia. (2) Rosuvastatin is the sixth statin to arrive on the French market. ⋯ One trial showed it to be slightly more effective than atorvastatin on cholesterol levels. According to one trial, rosuvastatin does not appear to be more effective than atorvastatin in homozygous forms. (5) In clinical trials the adverse effects of rosuvastatin were similar to those of other statins, with the exception of renal adverse effects. We don't know whether rosuvastatin is more or less likely than other statins to cause rhabdomyolysis. (6) Clinical trials reported some cases of proteinuria and renal failure suggesting there is a need for more thorough assessment in long-term trials. (7) In practice, statins with the best-documented benefits (simvastatin and pravastatin) should be used first for cardiovascular prevention in patients with hypercholesterolaemia.
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Prescrire international · Jun 2004
Comparative StudyParecoxib: new preparation. A NSAID for postoperative pain: no proven advantage.
(1) Parecoxib is the second nonsteroidal antiinflammatory drug, after ketoprofen, to be marketed in France for the treatment of postoperative pain. (2) Another injectable NSAID, ketorolac, was marketed briefly in the 1990s. It was shown to be no more effective than ketoprofen, but was withdrawn from the French market because it provoked bleeding. (3) The clinical evaluation dossier on parecoxib contains no data from comparative trials with ketoprofen. ⋯ There is no evidence that this reduction translates into a lower risk of adverse reactions to opiates. (5) Parecoxib is marketed as "Cox-2-specific inhibitor", but follow-up is too short to show whether this property avoids the severe adverse effects seen with other NSAIDs, such as renal failure, gastrointestinal haemorrhage, and delayed wound healing. Parecoxib, like its principal metabolite valdecoxib, can cause severe hypersensitivity reactions. (6) Parecoxib is 10 times more expensive than injectable ketoprofen in France. (7) In practice, ketoprofen is still the best choice for parenteral NSAID-based pain relief in the postoperative setting.