The Therapeutics Letter is only one of many independent bulletins in different countries that provide information to physicians, pharmacists and the public about drug treatments. In this Letter we present selected summaries published by a French drug bulletin, La Revue Prescrire (Prescrire). Like the Therapeutics Initiative, Prescrire is a member of the International Society of Independent Drug Bulletins (ISDB).
What is Prescrire?
Prescrireis a publication by a non-profit organization in France called Association Mieux Prescrire (AMP) (Association for Better Prescribing). Some articles from the French monthly bulletin, La Revue Prescrire, are published in a bi-monthly English version, Prescrire International.
AMP believes that health professionals need clear, reliable and independent information on which to base their medical care decisions.
The articles in Prescrire are written by health professionals who use standardized methods for literature searches, critical appraisal, and compilation of clinical trial evidence. Before publication each article is also reviewed by subject specialists in order to check the quality and relevance of the information.
Prescrire is financially independent from industry and government. Since 1992, subscriptions provide the sole source of financial support (presently about 30,000 to the French version and 800 to the English version).
The following are direct excerpts or translations from the Prescrire articles cited. We support the approach taken by Prescrire, but have not validated their conclusions.
Alendronate for secondary prevention of osteoporotic fractures (Dec 1997)
Alendronate for primary prevention of osteoporotic fractures (Jan 2000)
Three trials have shown that alendronate, 5 mg/day slows post-menopausal bone loss. However, this effect disappears on treatment cessation, and mineral bone density is only one risk factor for postmenopausal fractures. A placebo-controlled trial of primary prevention involving more than 4,000 patients showed no reduction in the risk of fracture after 4 years of treatment (alendronate 5 mg/day for 2 years and then 10 mg/day).
Risedronate for primary and secondary prevention of osteoporotic fractures (Sep 2001)
Alendronate 70 mg tablet (Apr 2003)
Risedronate 35 mg tablet (Nov 2003)
Osteoporotic fractures in men (Jun 2003)
Osteoporotic fractures also occur in men, but they are only half as frequent as in women. In men, the risk of hip fracture increases markedly after 75 years of age. Falls are the most frequent immediate cause of osteoporotic fracture. Fracture prevention in men with osteoporosis (as in women) is based on fall prevention, adequate calcium and vitamin D intake, and avoidance, when possible, of treatments reducing bone density. Evaluation of drug treatments for osteoporosis in men provides only weak evidence.9,10
Topiramate for migraine prevention: best avoided (May 2006)
The first-line drug for prevention of migraines is propranolol: it is the most thoroughly evaluated treatment, and thus far no other drug has been found to be more effective.
Topiramate, an antiepileptic drug, is now also approved for migraine prevention. Only 3 out of 4 double-blind placebocontrolled trials showed that topiramate 100 mg/day was effective: on average, 46% of patients had a reduction of at least 50% in the frequency of migraines, compared to 23% of patients on placebo. Increasing the dose to 200 mg/day did not lead to better efficacy.
A double-blind trial versus propranolol failed to show that topiramate was as effective or better than propranolol. Topiramate has numerous, frequent and sometimes serious adverse effects, mainly including neurosensory disorders (paraesthesias, language disorders, confusion) and gastrointestinal disturbances.
For the prevention of migraine attacks, it remains to be shown whether topiramate is as effective as propranolol. However, topiramate has more frequent and sometimes serious adverse effects. It is better to simply continue using propranolol.11,12
Tiotropium: just a me-too for COPD (May 2006)
Drug Safety Update from Prescrire
Neuroleptics: increased mortality in elderly patients (Jun 2005)
The US Food and Drug Administration (FDA) has issued a warning on the use of newer neuroleptics in elderly patients. The FDA warning is more comprehensive than similar warnings issued by the French and European regulatory agencies. Seventeen placebo-controlled trials have tested olanzapine, aripiprazole, risperidone and quetiapine in a total of 5106 elderly patients with dementia and behavioural disturbances.15
The trials lasted about 10 weeks. Mortality was higher in the neuroleptic groups (4.5%) than in the placebo groups (2.6%). The main causes of death were cardiovascular events (heart failure, sudden death) and infections (pneumonia).15 The doses used in these trials were not specified.
Other newer neuroleptics have not been tested in this patient population, but the FDA warning nonetheless includes the related neuroleptics clozapine and ziprasidone.
- Rev Prescrire. December 1997; 17(179):800-803.
- Prescrire Int. June 2000; 9(47)70.
- Rev Prescrire. January 2000; 20(202):10-13.
- Prescrire Int. June 2002; 11(59):94.
- Rev Prescrire. September 2001; 21(220):570-573.
- Prescrire Int. August 2003; 12(66)140.
- Rev Prescrire. April 2003; 23(238):248-249.
- Rev Prescrire. November 2003; 23(244):732-733.
- Prescrire Int. August 2003; 12(66):151.
- Rev Prescrire. June 2003; 23(240)455-459.
- Prescrire Int. August 2006; 15(84):132.
- Rev Prescrire. April 2006; 26(271):252-1/252-2.
- Prescrire Int. August 2006; 15(84):134.
- Rev Prescrire. May 2006; 26(272):325-327.
- US Food and Drug Administration. “FDA public health advisory. Deaths with antipsychotics in elderly patients with behavioral disturbances” 11 April 2005 http://www.fda.gov
- Prescrire Int. December 2005; 14(80):225.
- Rev Prescrire. June 2005; 25(262):432.
The Therapeutics Initiative presents critically appraised summary evidence primarily from controlled drug trials. Such evidence applies to patients similar to those involved in the trails, and may not be generalizable to every patient. We are committed to evaluate the effectiveness of our educational activities using the Pharmacare/PharmaNet databases without identifying individual physicians, pharmacies or patients. The Therapeutics Initiative is funded by the BC Ministry of Health through a grant to the University of BC. The Therapeutics Initiative provides evidence based advice about drug therapy, and is not responsible for formulating or adjudicating provincial drug policies.