Prescrire international
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Prescrire international · Nov 2015
Riociguat (Adempas). Chronic thromboembolic pulmonary hypertension with markedly restricted physical activity.
When pulmonary hypertension results in marked limitation in activities of daily living (functional class III), the first-choice vasodilator is bosentan, despite its limitations. There is no proven advantage of adding another vasodilator. The adverse effects of vasodilators outweigh their uncertain efficacy in patients with only a slight limitation of physical activity (class II). ⋯ Riociguat was teratogenic in experimental animals. In practice, in the absence of a better alternative, riociguat is an option for some patients with chronic thromboembolic pulmonary hypertension that markedly restricts their activities of daily living. It has no demonstrated advantage for other patients.
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Prescrire international · Nov 2015
Review Comparative StudyE-cigarettes and smoking cessation. Similar efficacy to other nicotine delivery devices, but many uncertainties.
E-cigarettes, marketed as an alternative to conventional cigarettes, are designed to transform a solution of variable composition, with or without nicotine, into an aerosol that the user inhales. How effective are e-cigarettes as an aid to smoking cessation, and what are their known adverse effects? To answer these questions, we conducted a review of the literature using the standard Prescrire methodology. A randomised trial involving 657 individuals who wanted to stop smoking compared e-cigarettes (with or without nicotine) with nicotine patches. ⋯ Apart from the effects of nicotine, there are few known adverse effects. However, there are many uncertainties as to the composition of the different e-liquids and the long-term effects of the substances when they are heated and inhaled. There is no reason to discourage smokers from substituting the proven, serious harms of tobacco smoke with the potential and poorly defined harms associated with e-cigarettes.
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Prescrire international · Nov 2015
Obstacles to transparency over pharmacovigilance data within the EMA.
In July and August 2014, the European Medicines Agency (EMA) organised two public consultations concerning European pharmacovigilance. These two consultations reveal a number of EMA proposals that are counterproductive to the objective of improving transparency over pharmacovigilance data. The EMA's proposals offer pharmaceutical companies an opportunity to participate in public hearings held by the European Pharmacovigilance Risk Assessment Committee (PRAC), in order to defend their drug. ⋯ The strings attached to the access that the EMA proposes to grant researchers to data contained in the centralised European pharmacovigilance database would allow the EMA to censor the publication of their findings. The EMA seems to regard pharmacovigilance data as commercially confidential information. Responding to these consultations provided an opportunity to remind the EMA that data about adverse effects are a public good, in the common interest, and that it is unacceptable to keep this information confidential.