MSD's cholesterol-lowering drug cuts atherosclerotic events in CKD patients

MANILA, Philippines - Global health care company MSD (known as Merck in the US and Canada) has good news for patients with chronic kidney disease (CKD).

In the study published in The Lancet last June 25 (Volume 377, Issue 9784), the cholesterol-lowering medicine ezetimibe 10 mg/simvastatin 20 mg reduced coronary revascularization and non-hemorrhagic strokes in patients with CKD.

The randomized controlled trial called SHARP (Study of Heart and Renal Protection) was conducted on a group of 9,270 patients with advanced CKD.

The group was divided in two, with 4,650 receiving ezetimibe 10 mg/simvastatin 20 mg and 4,620 receiving a placebo.

The results showed a statistically significant 17 percent reduction on first major atherosclerotic events — defined as cardiac death, non-fatal heart attack, non-hemorrhagic stroke or any revascularization procedure — in the group that received the active medicine compared to those who received the placebo.

Ezetimibe 10 mg/simvastatin 20 mg lowered bad cholesterol (or low density lipoprotein or LDL) by an average of 0.85 mmol/L compared to placebo. 

The researchers also found that there was no significant increase in the risk of hepatitis, gallstones, cancer or other non-vascular causes among the subjects of the experimental group compared to the placebo group.

Ezetimibe 10 mg/simvastatin 20 mg is a prescription medicine for which doctor’s advice should be sought. It has long been used for lowering bad cholesterol and raising good cholesterol (or high density lipoprotein or HDL) in the blood but the SHARP study is the first and only prospective clinical study in patients with CKD to show that an LDL cholesterol-lowering medicine reduced major vascular and atherosclerotic events.

Professor Colin Baigent, from the Clinical Trial Service Unit of the University of Oxford, who led the study said, “Over half of people with kidney disease will eventually be killed, not by their kidney disease but by cardiovascular disease.”

He added that it has been exceptionally difficult for doctors to manage cardiovascular disease among patients with CKD “because of fears that some drugs may turn out to be dangerous in people with damaged kidneys.”

In the Philippines, kidney disease is the 10th leading cause of death.

With the results of the SHARP study, MSD is now seeking regulatory approval for the use of ezetimibe 10 mg/simvastatin 20 mg in patients with CKD.