By Jonathan Springston, Assistant Editor, AHC Media
In a recently published study, investigators sought to determine if combining two proven cholesterol-lowering drugs would produce even better outcomes than if they were to treat patients with each drug separately. Surprisingly, when they combined the two drugs, the researchers found their study subjects recorded the lowest low-density lipoprotein (LDL) cholesterol readings ever notched during a major trial of cholesterol-lowering drugs.
Working with 968 patients presenting for coronary angiography at 137 academic and community hospitals around the world, researchers randomized 484 patients to receive 420 mg of a PCSK9 inhibitor called evolocumab monthly, combined with a regular course of statins. The other 484 patients received statins alone. In the group receiving only statins without evolocumab, patients recorded a 93 mg/dL average LDL reading, while patients who received the combination recorded a 36.6 mg/dL average reading. Further, 64% of patients who received the drug combination demonstrated a reduction in coronary plaque buildup, as opposed to 47% of statin-only patients.
“Statins are already the gold standard for lowering cholesterol, but we wanted to find out if we could do better,” said Steven Nissen, MD, chair of cardiovascular medicine at the Cleveland Clinic and one of the study’s lead authors. “These findings demonstrate significant regression of coronary disease can be achieved by adding a PCSK9 inhibitor to statins to drive cholesterol to incredibly low levels never previously studied.”
Some study subjects presented with LDL cholesterol levels at < 70 mg/dL, which is below any current global recommendations. Eighty-one percent of these patients received the drug combination and also demonstrated a reduction in coronary plaque, some exhibiting LDL levels as low as 20 mg/dL. The authors noted there were no safety issues in patients registering such low readings.
“These findings suggest that the large clinical outcome trials currently underway are likely to show major benefits from combination therapy using a PCSK9 inhibitor and a statin compared with a statin alone,” said Stephen Nicholls, MBBS, PhD, professor at the South Australian Health and Medical Research Institute, cardiologist at Royal Adelaide Hospital, and another lead author. “However, it is important to keep in mind that this combination therapy may not be for everybody, and in this study we only looked at high-risk heart patients.”
For more on this study and all the critical analysis of the latest clinical research in cardiovascular medicine, be sure to check out Clinical Cardiology Alert.