Prescrire Int [JOURNAL]
Sun
200 papers
Mepolizumab (Nucala°) in asthma.
Prescrire Int · 2017 Feb · PMID 30726627
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Sacubitril + valsartan (Entresto°) in chronic heart failure.
Prescrire Int · 2017 Feb · PMID 30726626
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Taking missing data into account in everyday practice.
Prescrire Int · 2017 Jan · PMID 30730643
Ideally, health professionals would have all the necessary information at their disposal for making healthcare decisions, but in reality they lack a great deal of clinically relevant data. Some of these missing data simp...
Ideally, health professionals would have all the necessary information at their disposal for making healthcare decisions, but in reality they lack a great deal of clinically relevant data. Some of these missing data simply cannot, or cannot yet, exist. In other cases, the data are missing because the healthcare professional was unable to find them even though they are available, because they have not been generated even though they could have been, because they have not been published, or because they have been concealed. In most cases, when data on medi- cal interventions are suspected or known to be missing, this can be taken into account by assuming that the supposed benefits of the interven- tion are overestimated, while its harms are underestimated. When several drugs appear to have a similar harm-benefit balance, it is better to choose those for which fewer data are missing, or those which have the longest clinical use.
Hypertension Targeting 120 mmHg: survival benefit after 3 years, but high renal risk.
Prescrire Int · 2017 Jan · PMID 30730642
In a randomised trial, reducing the systolic blood pressure target to around 120 mmHg led to a reduction in all-cause mortality compared to a tar- get of around 135 mmHg: after about 3 years, 3.3% of patients in the "int...
In a randomised trial, reducing the systolic blood pressure target to around 120 mmHg led to a reduction in all-cause mortality compared to a tar- get of around 135 mmHg: after about 3 years, 3.3% of patients in the "inten- sive" treatment group had died versus 4.5% in the "standard" treatment group. The trial was not blinded, however.The patients included were aged 50 years or older, at high risk of cardiovascular events, often overweight but not dia- betic, and had no history of stroke or symptomatic heart failure. This survival benefit was accompan- ied by a twofold increase in serious adverse effects, in particular renal effects, and cannot be extrapolated to the majority of hypertensive patients.
Pseudoephedrine: ischaemic colitis.
Prescrire Int · 2017 Jan · PMID 30730641
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Keppra° oral solutions of levetiracetam: cases of overdose.
Prescrire Int · 2017 Jan · PMID 30730640
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Statins: increased risk of type 2 diabetes.
Prescrire Int · 2017 Jan · PMID 30730639
Five meta-analyses of double-blind randomised comparative clinical trials have shown a small but statistically significant increase in the risk of type 2 diabetes in statin users. The relative risk was about 1.1. One add...
Five meta-analyses of double-blind randomised comparative clinical trials have shown a small but statistically significant increase in the risk of type 2 diabetes in statin users. The relative risk was about 1.1. One add- itional case of diabetes occurred for approximately every 255 patients treated with a statin for 4 years. The risk is dose-dependent. It was observed with all the statins studied, including pravastatin, simvastatin, atorvastatin and rosuvastatin. In practice, the risk of diabetes is not a reason for choosing one statin rather than another. When statin ther- apy is justified, pravastatin and simva- statin remain the statins of choice.
Benzodiazepines: dementia in the elderly?
Prescrire Int · 2017 Jan · PMID 30730638
About twenty benzodiazepines and related drugs, such as zolpidem and zopiclone, are used to treat sleep dis- orders and anxiety, and also as anti- convulsants.Their short-term adverse effects include confusion and cogni-...
About twenty benzodiazepines and related drugs, such as zolpidem and zopiclone, are used to treat sleep dis- orders and anxiety, and also as anti- convulsants.Their short-term adverse effects include confusion and cogni- tive disorders that regress only slow- ly after treatment withdrawal, especial- ly in elderly patients. Questions have been raised as to persistent cognitive effects in case of long-term benzo- diazepine exposure. A case-control study of 1796 patients over 66 years of age showed that benzodiazepine exposure 5 to 10 years previously was statistically significant- ly more frequent among those who developed Alzheimer's disease. Five other epidemiological studies provided similar results. However, some studies showed no relation with the duration of exposure or the cumu- lative dose; this is an argument against a causal relationship between benzodiazepine use and dementia. These studies provide only weak evidence and thus fail to establish a causal relationship. In addition, early symptoms of dementia can cause anx- iety, which may lead to benzodiazepine prescription in the period preceding diagnosis.The results of these studies do not, however, rule out a long-term risk of persistent cognitive impair- ment. In practice, the known adverse effects of benzodiazepines are a suf- ficient reason to avoid these drugs, especially in elderly patients. The pos- sibility of irreversible cognitive impair- ment is another reason not to pre- scribe them.
Sonidegib (Odomzo°) and extensive basal cell carcinoma.
Prescrire Int · 2017 Jan · PMID 30730637
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Edoxaban (Lixiana°).
Prescrire Int · 2017 Jan · PMID 30730636
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INN Common stem: -relin.
Prescrire Int · 2017 Jan · PMID 30730635
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Olaparib (LYNPARZAO) Ovarian cancer: spare patients who are in remission.
Prescrire Int · 2017 Jan · PMID 30730634
Standard post-surgical (adjuvant) chemotherapy for ovarian cancer is based on a platinum salt, and may be repeated if relapse occurs more than six months after the end of chemo- therapy. Olaparib inhibits enzymes involve...
Standard post-surgical (adjuvant) chemotherapy for ovarian cancer is based on a platinum salt, and may be repeated if relapse occurs more than six months after the end of chemo- therapy. Olaparib inhibits enzymes involved in DNA repair. It is claimed to have an antitumour effect, especially in the presence of deleterious BRCA muta- tions. Olaparib has been authorised in the EU for continuous single-agent therapy after the end of platinum-based chemotherapy in patients with "plati- num-sensitive" BRCA-positive ovarian cancer who have already received at least two lines of platinum-based che- motherapy and entered complete or partial remission after the last course of treatment. Clinical evaluation of olaparib is based on a randomised, double-blind, placebo-controlled trial in 265 patients who were recruited regardless of their BRCA status. After a median follow-up of 37 months, patients treated with olaparib showed no survival advan- tage, whether or not their tumour harboured BRCA mutations. The time to radiological progression was pro- longed by several months. An inher- ently unreliable post hoc analysis suggested that olaparib delayed the need for further chemotherapy. Olaparib exposes these patients in remission to frequent adverse effects, including nausea, vomiting, and impaired haematopoiesis. Olaparib can also cause life-threatening myelo- dysplastic syndrome, acute myeloid leukaemia, and haemorrhage. Olaparib is metabolised in the liver, mainly by cytochrome P450 isoenzymes CYP3A4 and CYP3A5. It is also a P-glycoprotein substrate and is likely to inhibit CYP3A4, P-glycopro- tein and other carrier proteins. Multiple pharmacokinetic interactions are also likely. Treatment with olaparib requires patients to take eight capsules twice a day, between meals. In practice, in early 2016, expectations of patients with ovarian cancer who have received at least two lines of chemotherapy are high, as they have short life expectancy and no sat- isfactory treatment options. Yet treat- ment with olaparib after the end of platinum-based chemotherapy still has an unfavourable harm-benefit bal- ance: patients derive no proven ben- efit, but adverse effects are frequent and sometimes fatal.
RTS,S/AS01E malaria vaccine (MoSQUIRIX*) Children living in malaria-endemic regions: little efficacy, poorly documented harms.
Prescrire Int · 2017 Jan · PMID 30730633
Malaria remains a major public health problem in most tropical coun- tries. Plasmodium falciparum infection can be life-threatening, especially in children. Insecticide-treated bed nets have been shown to reduce deaths d...
Malaria remains a major public health problem in most tropical coun- tries. Plasmodium falciparum infection can be life-threatening, especially in children. Insecticide-treated bed nets have been shown to reduce deaths due to malaria among young children. A malaria vaccine (RTS,S/AS01E) containing two adjuvants has been assessed for its ability to prevent P. falciparum malaria among young children living in endemic areas. The clinical data have been analysed by the European Medicines Agency (EMA) in conjunction with the World Health Organization (WHO). Efficacy has been evaluated in sub-Saharan African countries. Two trials including a total of more than 16 000 children aged 6 weeks to 17 months compared the malaria vac- cine with a rabies vaccine or a menin- gococcal vaccine. Most of the children were healthy, had ready access to healthcare, and were protected with bed nets. In these trials, three injections of the malaria vaccine one month apart did not reduce overall mortality or malaria mortality in low-mortality settings. In the year following vaccina- tion, the risk of malaria episodes was reduced by about 30% among children aged 6 to 12 weeks and by about 50% among those aged 5 to 17 months.The incidence of severe malaria was only reduced in the older age group. Vac- cine efficacy waned rapidly over time, even with a booster dose at 18 months. During clinical trials, reactions at the injection site and systemic reac- tions were more frequent with the malaria vaccine than with the compara- tor vaccines. Febrile seizures during the days following vaccination were 2 to 5 times more frequent with the malaria vaccine among children aged 5 to 17 months. The malaria vaccine may also carry a risk of meningitis, as well as a risk of pneumonia among HIV-infected children and premature infants.
Out of the frying pan, into the fire.
Prescrire Int · 2017 Jan · PMID 30730632
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Patients want to be heard.
Prescrire Int · 2016 Dec · PMID 30758930
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Prescrire's Médicaments en Questions: First results of a practice improvement programme.
Prescrire Int · 2016 Dec · PMID 30758929
In 2014, Prescrire launched a new distance-learning practice improve- ment programme for subscribers to our French edition, called M6dicaments en Questions (Medicines in Question).The aim of this programme is to help hea...
In 2014, Prescrire launched a new distance-learning practice improve- ment programme for subscribers to our French edition, called M6dicaments en Questions (Medicines in Question).The aim of this programme is to help healthcare professionals take greater account of the harmful effects of drug treatments in their daily practice, manage adverse effects better, and help to reduce their inci- dence and severity. This programme is based on a reflexive approach: participants describe, analyse and compare their practices; update and improve their knowledge base; exchange ideas with other health professionals; and devel- op strategies for improvement. The results of the first session (2014-2015) have been encouraging: participants took greater account of adverse effects, exposed fewer patients to the harms of drugs that have an unfavourable harm-benefit balance, communicated better with other healthcare professionals, found it easier to discuss adverse effects with patients, and were encouraged to report adverse effects to the public pharmacovigilance system.
Pneumococcal vaccination in persons at high risk.
Prescrire Int · 2016 Dec · PMID 30758928
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Resectable non-small cell lung cancer Adjuvant chemotherapy: slightly longer survival.
Prescrire Int · 2016 Dec · PMID 30758927
About one-quarter of cases of non- small cell lung cancer are diagnosed sufficiently early, i.e. at stages I to lIlA, to envisage surgical resection. Despite this surgery, the prognosis remains poor. In 2016, what is the...
About one-quarter of cases of non- small cell lung cancer are diagnosed sufficiently early, i.e. at stages I to lIlA, to envisage surgical resection. Despite this surgery, the prognosis remains poor. In 2016, what is the harm-benefit balance of chemotherapy in addition to surgical resection of early-stage non-small cell lung cancer? We con- ducted a review of the literature using the standard Prescrire methodology. In 38 trials including about 11 000 patients, the 5-year survival rate rose from 60% to 64% when surgery was followed by chemotherapy in patients who mainly had stage IB or I disease, and from 29% to 33% in patients with mainly stage Ill disease who also received radiation therapy. The chemo- therapy regimens used in most of these trials consisted of cisplatin plus a vinca alkaloid such as vinorelbine. In 15 trials including more than 2000 patients, most of whom had resectable stage IB, IIB or lIlA disease, platinum-based chemotherapy given before surgery raised the 5-year sur- vival rate from 40% without chemo- therapy to 45%. There are too few data to assess the impact of chemotherapy on sur- vival among patients who undergo surgery for stage IA disease. About two-thirds of patients who receive platinum-based chemotherapy experience serious adverse effects, and at least 1% of patients die from toxicity. The most common adverse effects are haematological disorders. Tyrosine kinase inhibitors and angiogenesis inhibitors have not been shown to improve survival among patients with resectable non-small cell lung cancer. Clinical guidelines published since 2010 recommend cisplatin-based chemotherapy for patients with resect- able stage IIB or lIlA disease. There is some disagreement concerning stage IB and IIA disease. In practice, clinical trials show that adjuvant chemotherapy improves the 5-year survival rate by a few percent- age points among patients who under- go surgical resection for non-small cell lung cancer. Adjuvant chemother- apy with cisplatin and a vinca alkaloid is thus a reasonable choice for surgi- cal patients (except those with a local- ised tumour measuring ≤ 3 cm), who accept its toxicity, with the hope of a slightly longer survival. It is also a reasonable option for patients to forgo chemotherapy.
Diethylstilbestrol (DES): also harms the third generation.
Prescrire Int · 2016 Dec · PMID 30758926
Diethylstilbestrol(DES) is a synthet- ic nonsteroidal oestrogen and endo- crine disruptor that was used in the 1950s-1970s to prevent spontaneous abortion, despite its lack of proven efficacy. Millions of women worldwide...
Diethylstilbestrol(DES) is a synthet- ic nonsteroidal oestrogen and endo- crine disruptor that was used in the 1950s-1970s to prevent spontaneous abortion, despite its lack of proven efficacy. Millions of women worldwide took DES during pregnancy. In France, between 1951 and 1981, about 160 000 children were exposed to DES during the first trimester of their intrauterine life, and in some cases almost throughout the entire pregnancy. They are referred to as "DES daughters" and "DES sons". In 2010, in France, about 25 000 DES daughters were aged 33 to 40 years: pregnancies among these women are foreseeable until about 2020. In utero exposure to DES can have harmful effects. In particular, DES daughters have an increased risk of cancer and structural abnormalities of the uterus that can adversely affect their pregnancies. What are the consequences of tak- ing DES during pregnancy for the third generation, i.e. the children of DES children? To answer this question, we reviewed the available data in mid- 2016 using the standard Prescrire methodology. According to a retrospective study conducted in France by Réseau DES France, published in 2016, which included 4409 DES grandchildren (2228 girls and 2181 boys) and about 6000 controls, about one-quarter of DES grandchildren are born prematurely. Preterm delivery exposes neonates to serious neonatal complications, including neurosensory disorders, disabilities and increased neonatal mor- tality. The more premature the baby, the greater the risk of complications. In the Réseau DES France study, cerebral palsy was more frequent in the DES grandchildren group: 59/10 000, versus 6/10 000 in the control group. A study conducted in the United States in about 4500 DES daughters found that preterm delivery occurred at a frequency of about 26%, much higher than that reported in controls. Neonatal mortality was 8 times higher among DES grandchildren, and the risk of stillbirth was twice as high. Other smaller studies have also shown an increased risk of preterm birth. A cohort study conducted in about 5000 DES grandchildren found that the risk of malformations of any type was higher than in the unexposed control group. Epidemiological studies, conduct- ed in several countries, found an increased frequency of hypospadias in DES grandsons. The relative risk was about 5 in the largest study. Other, less robust studies found no statistically significant difference. Several studies in several countries have shown a twofold increase in the risk of oesophageal atresia or tracheo- oesophageal fistula in DES grandchildren. The data on congenital heart defects or musculoskeletal malformations are limited and uninformative. Epidemiological studies have not identified a significant increase in the risk of gynaecological anomalies or cancers in DES granddaughters. Limited data are available on the risk of malformations in the children of DES sons. The data obtained in rodents exposed to DES (and other endocrine disruptors) make it entirely plausible that in utero exposure to DES, in humans too, provokes epigenetic effects that are passed on to future generations not directly exposed to DES. In practice, these data should be discussed with DES daughters, their partners and healthcare teams so that appropriate monitoring, clinical man- agement and follow-up can be arranged for both mother and baby. The harms of taking DES during pregnancy last for decades and affect future generations.
Cometinib (Cotellic°) and metastic melanoma.
Prescrire Int · 2016 Dec · PMID 30758925
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