This cookie is set by GDPR Cookie Consent plugin. These cookies ensure basic functionalities and security features of the website, anonymously. in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,įor study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.Necessary cookies are absolutely essential for the website to function properly.Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.Įstablished atherosclerotic cardiovascular disease. in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,.Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: Primary hypercholesterolaemia and mixed dyslipidaemia What are the risks associated with Praluent? In a study involving over 18,000 patients who had established heart disease, less than 10% of patients given Praluent had a cardiovascular event (meaning death, heart attack, stroke, chest pain due to problems with the blood flow to the heart leading to hospitalisation) during the study compared with over 11% of patients given placebo. When given on top of standard treatment or on its own, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe. These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment. Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for hypercholesterolaemia (ezetimibe). Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins. Praluent has been studied in 10 main studies involving over 5,000 adult patients with hypercholesterolaemia (including patients with heterozygous familial disease) and mixed dyslipidaemia. Hypercholesterolaemia and mixed dyslipidaemia For more information about using Praluent, see the package leaflet or contact your doctor or pharmacist. Patients or their carers can inject the medicine once they have been trained by a healthcare professional. If the desired response is not achieved after 4 to 8 weeks of treatment, the doctor can increase or decrease the dose. The dose of Praluent is adjusted based on the levels of fats in blood and response to the medicine. The usual starting dose is 75 mg every two weeks, but patients requiring bigger reductions of blood fat levels may start with 150 mg every two weeks or 300 mg every 4 weeks. The injection is given under the skin of the abdomen, thigh or upper arm. Praluent is available as a solution for injection in a pre-filled syringe or pre-filled pen (75 mg, 150 mg and 300 mg). The medicine can only be obtained with a prescription. Before starting treatment with Praluent, other causes of excess cholesterol and abnormal fat levels in the blood should be excluded.
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