{"title":"HPV vaccines: too soon to detect an impact on mortality.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 176","pages":"268"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36937550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In late 2014, the epidemiological data available on the human papilloma- virus (HPV) 6/11/16/18 vaccine and the HPV 16/18 vaccine, derived from several million vaccinated girls or young women, showed no link between HPV vaccination and the development of autoimmune diseases or central or peripheral neurological disorders. A few cohort studies have called these results into question. The detailed results of a large French cohort study focused on 14 types of conditions in girls aged 13 to 16 years, 842 120 of whom received an HPV vaccine. Eleven of these conditions were no more common than in the unvaccinated girls. A statistically significant association was identified between Guillain-Barré syndrome and HPV vaccine: 1 to 2 additional cases per year per 100 000 vaccinees. A link between Guillain-Barr6 syndrome and other vaccines has already been observed, making a causal link plausible, despite the lack of an established causal mechanism. The statistical link between inflammatory bowel disease and HPV vaccines is weak. The statistical association reported in the French study between thyroiditis and the HPV 16/18 vaccine constitutes low-level evidence, but it is consistent with some other weak evidence. As of early 2016, no significant link has been found between thyroiditis and the HPV 6/11/16/18 vaccine. In practice, in view of the uncertainties, healthcare professionals must present the options to girls and their families in a balanced manner. Girls are faced with a choice between a plausible risk of a very rare event (Guillain-Barré syndrome) in the weeks following vaccination, and the risk of a much less rare event (cervical cancer), which is probably reduced by vaccination but occurs many years later. As of early 2016, it is reasonable that some girls will choose to be vaccinated in the hope of reducing their risk of cancer. It is also reasonable that others will choose not to be vaccinated due to the risk of Guillain-Barré syndrome, despite its rarity.
{"title":"Human papillomavirus vaccines and Guillain-Barré syndrome: managing uncertainties.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In late 2014, the epidemiological data available on the human papilloma- virus (HPV) 6/11/16/18 vaccine and the HPV 16/18 vaccine, derived from several million vaccinated girls or young women, showed no link between HPV vaccination and the development of autoimmune diseases or central or peripheral neurological disorders. A few cohort studies have called these results into question. The detailed results of a large French cohort study focused on 14 types of conditions in girls aged 13 to 16 years, 842 120 of whom received an HPV vaccine. Eleven of these conditions were no more common than in the unvaccinated girls. A statistically significant association was identified between Guillain-Barré syndrome and HPV vaccine: 1 to 2 additional cases per year per 100 000 vaccinees. A link between Guillain-Barr6 syndrome and other vaccines has already been observed, making a causal link plausible, despite the lack of an established causal mechanism. The statistical link between inflammatory bowel disease and HPV vaccines is weak. The statistical association reported in the French study between thyroiditis and the HPV 16/18 vaccine constitutes low-level evidence, but it is consistent with some other weak evidence. As of early 2016, no significant link has been found between thyroiditis and the HPV 6/11/16/18 vaccine. In practice, in view of the uncertainties, healthcare professionals must present the options to girls and their families in a balanced manner. Girls are faced with a choice between a plausible risk of a very rare event (Guillain-Barré syndrome) in the weeks following vaccination, and the risk of a much less rare event (cervical cancer), which is probably reduced by vaccination but occurs many years later. As of early 2016, it is reasonable that some girls will choose to be vaccinated in the hope of reducing their risk of cancer. It is also reasonable that others will choose not to be vaccinated due to the risk of Guillain-Barré syndrome, despite its rarity.</p>","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 176","pages":"265-268"},"PeriodicalIF":0.0,"publicationDate":"2016-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36974178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
After an acute coronary syndrome, the 6-year results of the "IMPROVE-IT" randomized trial showed a 1.6% reduction in the number of nonfatal myocardial infarctions with the ezetimibe + simvastatin combination compared with simvastatin alone, but no reduction in mortality.
{"title":"Ezetimibe + statin: insufficient benefit.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>After an acute coronary syndrome, the 6-year results of the \"IMPROVE-IT\" randomized trial showed a 1.6% reduction in the number of nonfatal myocardial infarctions with the ezetimibe + simvastatin combination compared with simvastatin alone, but no reduction in mortality.</p>","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 175","pages":"245-246"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36909554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The only available trial, a non-comparative study with 63 patients, failed to determine the efficacy of ibrutinib. In contrast, adverse effects are numerous and sometimes severe, including haematological disorders. Further evaluation of ibrutinib in this setting is necessary.
{"title":"ibrutinib (IMBRUVICA°) and Waldenström's macroglobulinaemia.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The only available trial, a non-comparative study with 63 patients, failed to determine the efficacy of ibrutinib. In contrast, adverse effects are numerous and sometimes severe, including haematological disorders. Further evaluation of ibrutinib in this setting is necessary.</p>","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 175","pages":"232"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36855058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Nicorandil: so much needless suffering.","authors":"Émilie Beslin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 175","pages":"241"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36855060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Doping in East Germany: drugs as a geopolitical tool.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 175","pages":"251"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36909558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The results of two large epidemiological studies on the association between domperidone and ventricular arrhythmia or sudden cardiac death were published in 2015; one study was conducted in Taiwan and the other in the United Kingdom. They also examined metoclopramide. Both studies demonstrated an increased risk of sudden cardiac death and ventricular arrhythmia with metoclopramide, similar to the risk associated with domperidone. The results concerning domperidone were consistent with those of previous studies. In particular, they showed that the risk was higher with doses greater than 30 mg per day or with concomitant use of inhibitors of the cytochrome P450 isoenzyme CYP3A4, which reduce domperidone clearance. In practice, metoclopramide has a marginal role in patient care, with minor efficacy. Domperidone should not be used at all; its efficacy at the approved dose, beyond a placebo effect, is uncertain.
{"title":"Metoclopramide, domperidone: sudden cardiac death, ventricular arrhythmia.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The results of two large epidemiological studies on the association between domperidone and ventricular arrhythmia or sudden cardiac death were published in 2015; one study was conducted in Taiwan and the other in the United Kingdom. They also examined metoclopramide. Both studies demonstrated an increased risk of sudden cardiac death and ventricular arrhythmia with metoclopramide, similar to the risk associated with domperidone. The results concerning domperidone were consistent with those of previous studies. In particular, they showed that the risk was higher with doses greater than 30 mg per day or with concomitant use of inhibitors of the cytochrome P450 isoenzyme CYP3A4, which reduce domperidone clearance. In practice, metoclopramide has a marginal role in patient care, with minor efficacy. Domperidone should not be used at all; its efficacy at the approved dose, beyond a placebo effect, is uncertain.</p>","PeriodicalId":35983,"journal":{"name":"Prescrire International","volume":"25 175","pages":"238-240"},"PeriodicalIF":0.0,"publicationDate":"2016-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36855062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}