Prescrire international
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Prescrire international · Aug 2001
Scopolamine: new preparations. Reference treatment for death rattle.
(1) The reference symptomatic drug treatment of death rattle is the use of atropinic agents such as scopolamine or atropine. (2) Marketing authorisation has now been granted in France for scopolamine in this indication, both for a subcutaneous preparation and a transdermal patch. (3) The clinical file on subcutaneous scopolamine delivery mainly comprises non comparative data on 200 patients studied prospectively and 196 patients studied retrospectively. (4) The assessment of transdermal scopolamine patches is limited to a few published cases. (5) Available data show the efficacy of scopolamine, when administered after aspiration of the back of the throat. (6) The main adverse effects are neuropsychological (excitation, hallucinations, delirium). (7) In practice, injectable scopolamine is the reference drug for symptomatic treatment of death rattle.
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Prescrire international · Aug 2001
Exemestane: new preparation. No tangible advance in metastatic breast cancer after tamoxifen failure.
(1) The reference second-line hormone treatment for breast cancer in postmenopausal women, after failure of anti-oestrogen therapy, is an aromatase inhibitor such as letrozole. (2) The clinical assessment file on exemestane, a new aromatase inhibitor licensed for this indication, contains no data from clinical trials versus letrozole or anastrozole, the other oral aromatase inhibitors. Data from non comparative trials fail to show whether cross-resistance between aromatase inhibitors exists. (3) In a double-blind trial involving 769 patients in whom tamoxifen had failed, the antitumour effect of exemestane appeared to be equivalent to that of the progestagen megestrol. (4) This trial showed that the adverse effect profile of exemestane was similar to that of other aromatase inhibitors, with mainly vasomotor flushes, nausea, fatigue and sweating. (5) In practice, the arrival of exemestane changes nothing in the hormone therapy of breast cancer in postmenopausal women, which should consist of tamoxifen (an anti-oestrogen) first; followed by the aromatase inhibitor letrozole if tamoxifen fails.
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Prescrire international · Apr 2001
Comparative StudyIrinotecan as first-line treatment of colorectal cancer: new indication. A modest advantage.
(1) The reference treatment for colorectal cancer is surgery. In advanced cases, the first-line drug regimen is fluorouracil combined with calcium folinate. (2) The indications for irinotecan, a cytotoxic agent, have recently been extended in France to cover first-line treatment of advanced-stage colorectal cancer, in combination with fluorouracil and calcium folinate. (3) The clinical file on irinotecan in this indication mainly contains two unblinded trials comparing irinotecan + fluorouracil + calcium folinate with fluorouracil + calcium folinate. Only one of these trials is interpretable. (4) In this trial adding irinotecan increased survival by 4.4 months and delayed deterioration of daily performance by 1.3 months (median values). (5) 44% of patients developed severe diarrhoea, 7% severe fatigue, 29% severe neutropenia and 20% severe leukopenia while on irinotecan. (6) In practice, the reference treatment in this setting remains fluorouracil. Combination with irinotecan should be discussed with the individual patient.
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Prescrire international · Dec 2000
Palivizumab in prevention of bronchiolitis: new preparation. Moderate efficacy in some infants.
(1) RSV infection, the main cause of bronchiolitis, can necessitate hospitalisation, especially of infants at risk, i.e. those with a history of prematurity or bronchodysplasia. No drug prevention has been available. (2) Palivizumab, a monoclonal antibody directed against respiratory syncytial virus (RSV), is now marketed for preventing respiratory tract infection by RSV in certain infants. (3) The evaluation dossier barely answers the questions raised by the use of this drug. (4) The results of six trials suggest that the optimal dose is 15 mg/kg palivizumab by monthly injection throughout the seasonal epidemic period. (5) A double-blind trial in 1 502 infants either aged less than 6 months and born prematurely (35 weeks of gestation or earlier), or aged under 2 years with a history of bronchopulmonary dysplasia, has shown that, relative to a placebo, palivizumab reduces the hospitalisation rates by 5% in absolute values. It does not influence mortality or the need for mechanical ventilation. (6) Given the lack of relevant trials, we do not know if palivizumab is effective in infants with immunodeficiency or congenital heart diseases. We do not know, either, whether the definition of groups at risk used in the only relevant trial is appropriate. (7) No serious adverse effects attributable to palivizumab were reported in clinical trials. (8) Treatment with palivizumab is costly.