Manufacturer of the investigational cholesterol modifying agent anacetrapib (Merck) has released surprising early data from the drug’s cardiovascular outcomes study REVEAL that could potentially reinvigorate waning interest in HDL targeted therapies.
In a press release Merck said the late stage trial involving nearly 30,000 patients had met its primary endpoint, significantly reducing major coronary events such as coronary death, heart attack and coronary revascularisation in patients at high cardiovascular risk who are receiving effective LDL cholesterol-lowering therapy with atorvastatin, compared to placebo.
Dr Stephen Nicholls, cardiology professor at the South Australian Health and Medical Research Institute said the findings finally support the HDL-hypothesis and suggests that patients already receiving guideline-based therapies can continue to gain benefit by using the novel therapy.
“This is great news. We await seeing the details for both efficacy and safety when presented in full at the ESC meeting, but it does finally suggest that potent CETP inhibition – with both LDL lowering and HDL raising – has the potential to reduce residual risk in statin treated patients.
“The data will give us some sense for how anacetrapib may be used in clinical practice. Nevertheless, the early reports of REVEAL, on top of the positive news for CANTOS the week before and results of the FOURIER study presented earlier this year, are all good news for patients and drug development,” he told the limbic.
It’s a huge turnaround for the entire drug class, which has been plagued by trial setbacks and safety concerns. Those failures led to three other investigational drugs being pulled from the pipeline and sparked widespread scepticism about anacetrapib, the last CETP standing.
Full details about the findings won’t be made available until the European Society of Cardiology meeting in August but in its brief statement the company said its initial analysis of the study data found side effects were about the same as in earlier, smaller studies, with the most significant issue being that anacetrapib can accumulate and remain in fatty tissue years after taking the drug. Whether that is a safety issue is unknown but it has been reported previously, the company noted.
Despite announcing REVEAL’s apparent success the company remains cautious about applying for regulatory approval saying it will wait to ‘review the results of the trial with external experts’ before considering applying to regulatory bodies for approval.
You can access the full press release here.