GSK warn US doctors of possible association between fosamprenavir and heart attack

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Healthcare providers in the US have been notified of a possible connection between treatment with the protease inhibitor fosamprenavir (Lexiva in the US, Telzir in Europe) and heart attack. There is also a caution that therapy with the drug can cause increases in cholesterol.

GlaxoSmithKline (GSK), who make the drug, notified healthcare professionals that myocardial infarction (heart attack) and increases in cholesterol have been added to the list of possible side-effects on fosamprenavir’s product label.

The move comes after a French study (FHDH ANRS CO4) presented to the Conference on Retroviruses and Opportunistic Infections earlier this year showed that each year of therapy with the drug increased the risk of heart attack by 54%.

Glossary

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

myocardial infarction

Heart attack. Myocardial refers to the muscular tissue of the heart. An infarction is the obstruction of the blood supply to an organ or region of tissue.

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

diabetes

A group of diseases characterized by high levels of blood sugar (glucose). Type 1 diabetes occurs when the body fails to produce insulin, which is a hormone that regulates blood sugar. Type 2 diabetes occurs when the body either does not produce enough insulin or does not use insulin normally (insulin resistance). Common symptoms of diabetes include frequent urination, unusual thirst and extreme hunger. Some antiretroviral drugs may increase the risk of type 2 diabetes.

cardiovascular

Relating to the heart and blood vessels.

GSK are also reminding healthcare professionals of the importance of monitoring cholesterol and triglycerides before and during treatment with fosamprenavir. The company also recommends that other risk factors for cardiovascular disease, such as high blood pressure, diabetes and smoking should also be evaluated.

Results from the D:A:D study have previously identified therapy with protease inhibitors generally as a risk factor for heart attack. More recent results from this study group found an independent association between therapy with Kaletra (lopinavir/ritonavir) and myocardial infarction.

Neither fosamprenavir nor Kaletra are “preferred” options in the most recent US antiretroviral treatment guidelines for patients starting HIV therapy for the first time.