Novel medicine significantly reduces cholesterol in patients
Novel medicine significantly reduces cholesterol in patients with high cholesterol – five trials confirm and extend findings of previous studies
May 2014, University of Cape Town – The results of five trials of evolocumab, a potential new drug for patients with high cholesterol, were presented at the recent congress of the American College of Cardiology (ACC) held in Washington in April 2014. Evolocumab has been previously shown to significantly reduce cholesterol levels in patients with high cholesterol in relatively small and short studies. In the largest and longest study of evolocumab reported to date, the drug reduced ‘bad cholesterol’ (LDLC) by a further 57% when compared to placebo. The drug was generally very well tolerated with no safety concerns identified, say the authors in a paper recently published in the New England Journal of Medicine.
“This is a significant finding, as this international multi-centre study was the largest and longest study of evolocumab thus far, and conducted at 88 trial sites across South Africa, Europe, Canada, US and Australia,” says first author and University of Cape Town (UCT) investigator Dr Dirk Blom of Groote Schuur Hospital’s (GSH) Division of Lipidology. Dr Blom collaborated with other South African researchers at Tygerberg Hospital, Paarl Research and Unitas Hospital (Gauteng).
The study enrolled patients with high cholesterol. These patients all received standard cholesterol lowering medication in the initial phase to make sure their cholesterol reached the recommended level. Patients were then randomly allocated to the study drug (evolocumab) or placebo injections. Patients received injections once every four weeks under the skin (similar to insulin for diabetics). The main outcome measures were cholesterol reduction and safety. This study is significant because it showed that the drug works as well after 52 weeks as after 12 weeks – there was no loss of efficacy. As the biggest study thus far it also provided substantial amount of information about safety.
Evolocumab has been mainly studied when given in addition to standard cholesterol lowering medication, but as two other studies presented at the ACC meeting showed it is also effective when given on its own and is well tolerated by patients who are intolerant of standard cholesterol lowering medications (statins). Evolocumab, developed by US pharmaceutical company Amgen, is still in clinical development and has not been approved for use in patients outside the clinical trial setting anywhere.
Head of the Department of Medicine at UCT and GSH, Prof Bongani Mayosi, says: “We are very proud that one of our colleagues published this study as a first author. This is a very big accomplishment in the life of an academic, with many of us still aspiring to achieve such an honour. It is reserved for those who are involved with research that may change clinical practice!”