Your regular news update on what’s happening with fixed dose combination drugs (‘polypills’) for preventing cardiovascular events
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Group formed to improve access to polypill
The World Heart Federation has assembled a group of people—physicians, researchers, economists, policymakers, industry experts and others—who are aiming to make fixed dose combination drugs more available for preventing cardiovascular disease. The group will meet together at the World Congress of Cardiology and Cardiovascular Health in Mexico City on 8 June.
Work underway to get polypill onto WHO Essential Drugs List
WHO has twice turned down proposals to include polypills on the Essential Drugs List. A third proposal is being prepared for submission to the next meeting in December 2016 of the panel that decides which drugs are added to the list. The expert staff who service the panel are helping prepare the proposal.
Trial shows benefit of statin in those at intermediate risk of cardiovascular disease
The HOPE-3 trial in 12,705 participants in 21 countries was published in April and showed that “treatment with rosuvastatin at a dose of 10mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease.”
Polypill can improve adherence, blood pressure and LDL-cholesterol
The SPACE meta-analysis of randomized trials conducted in 3,140 patients in six countries showed that polypill therapy significantly improved adherence, systolic blood pressure and LDL-cholesterol in patients with cardiovascular disease or at high risk compared with usual care, especially among those who were under-treated at baseline.
FDA has formed the Combination Products Policy Council to rule on combination products
The US Food and Drug Administration (FDA), which has not yet licensed any polypills for preventing cardiovascular disease, has formed the Combination Products Policy Council to develop a unified FDA position on issues including evidentiary standards and data requirements and review limitations that can arise in applications for combination products. The council will gather input from external stakeholders on best practices for modernizing the combination review programme.
One set of polypills is now approved in 15 European countries
The polypills with the tradenames Trinomia, Sincronium, and Iltria are the result of a public/private collaboration between Centro Nacional de Investigaciones Cardiovasculares and the Spanish company Ferrer. The polypills, which contain aspirin (100mg), ramipril (in doses of 2.5, 5, or 10mg to allow for titration) and atorvastatin (20 mg), have been approved in 15 European countries (Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Rumania, Spain, Sweden) and Chile for use in secondary prevention of cardiovascular events.
The indication for these polypills is for the secondary prevention of cardiovascular events as substitution therapy in adult patients adequately controlled with the monocomponents given concomitantly at equivalent therapeutic dosages. Currently the polypills have been marketed in Spain, Portugal, Romania, Greece and Germany. The plan is to launch them in other European countries and worldwide.
Polypill available via the internet in the UK
No polypill has a full licence in the UK, but a four-component polypill is available via the internet and a special licence to those living in the UK. Those who are interested have to complete an online medical consultation and if deemed eligible then receive the polypills through the post for a charge. Patients have to complete a questionnaire asking about possible side effects before having the prescription renewed. (I have been using this service for several years.)
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