Prescrire international
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(1) New marketing authorizations continue to be granted for treatments of multiple myeloma, and new trials and meta-analyses continue to be published. This review re-examines our previous conclusions based on data published between 2003 and 2008. We again used the standard Prescrire methodology to review the latest data; (2) In patients who are symptomatic but who do not qualify for haematopoietic stem cell transplantation (especially people aged over 65), the results of five comparative trials suggest that adding thalidomide to the melphalan-prednisone combination delays myeloma progression by an additional 5 to 10 months. ⋯ Initial treatment with two successive transplantation procedures has a negative risk-benefit balance. (4) The optimal chemotherapy regimen prior to autologous stem cell transplantation is controversial. It is unclear which combination (vincristine + doxorubicin + dexamethasone, cyclophosphamide + dexamethasone, cyclophosphamide + dexamethasone, or bortezomib + dexamethasone, etc.) has a better risk-benefit balance in terms of survival and quality of life; (5) According to a meta-analysis of three clinical trials, thalidomide maintenance therapy appears to improve overall survival after Autologous stem cell transplantation; (6) Despite their inadequate evaluation, lenalidomide and pegylated liposomal doxorubicin are licensed for use in patients who relapse or who are refractory to initial treatment. In view of their major adverse effects, we consider that these drugs should only be used in clinical trials.
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Prescrire international · Oct 2009
Prasugrel: new drug. After angioplasty and stenting: continue to use aspirin + clopidogrel.
(1) For patients with acute coronary syndromes who have undergone percutaneous angioplasty and stenting, the best-assessed treatment for preventing relapses is a combination of aspirin and clopidogrel; (2) Prasugrel, an antiplatelet drug belonging the same chemical class as clopidogrel, is authorized in the EU for use in this indication; (3) Clinical evaluation is based on a randomized double-blind trial comparing prasugrel + aspirin versus clopidogrel + aspirin in 13 608 patients with acute coronary syndromes, half of whom were treated for at least 15 months. Prasugrel did not reduce overall mortality (about 3%) or the incidence of non-fatal stroke after 15 months (1% of patients). ⋯ Haemorrhages associated with revascularisation were also significantly more numerous with prasugrel (11.3% and 3.6%); (5) Subgroup analyses suggest that the risk-benefit balance of prasugrel is unfavourable in patients weighing less than 60 kg, patients over 75 years of age, and patients with a history of transient ischaemic attack or stroke; (6) The trial comparing prasugrel versus clopidogrel, as well as some animal studies, raise the possibility that prasugrel might increase the risk of cancer. In the main trial, prasugrel caused fewer cases of neutropenia than clopidogrel, but more cases of respiratory failure, hypotension and atrial flutter were observed; (7) In practice, for secondary prevention in patients with acute coronary syndromes treated with angioplasty and stenting, the risk-benefit balance of prasugrel, used in combination with aspirin, appears to be no better than that of clopidogrel + aspirin.
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Prescrire international · Oct 2009
Fentanyl effervescent buccal tablets: new formulation. For cancer patients with breakthrough pain: a second buccal formulation with minimal evaluation.
There is no firm evidence that patients with breakthrough cancer pain respond better to fentanyl effervescent buccal than to the "lollipop" formulation.