An analysis of data from the ‘CLEAR Outcomes’ trial has revealed that statin-intolerant patients taking bempedoic acid had a reduced risk of experiencing a major cardiac event, compared with those on placebo.
Data from the trial, which enrolled 13,970 statin-intolerant patients, have showed that the lowered risk level was comparable to that seen on statins for the same extent of low-density lipoprotein cholesterol (LDL-C) reduction.
Patients treated with statins are known to experience a reduced risk of cardiovascular events, such as heart attack or stroke, that is proportional to how much the drugs lower their LDL-C levels.
However, although bempedoic acid is known to lower LDL-C to a similar extent, until now it was not clear whether that was accompanied by a comparable cardiovascular benefit.
Michael Lincoff, vice chair for research at the department of cardiovascular medicine at the Cleveland Clinic in Ohio, and lead author of the study presented the results at ‘ENDO 2023’ — the Endocrine Society’s annual meeting in Chicago, Illinois, on 16 June 2023.
Results from the study — supported by Esperion Therapeutics, which manufactures bempedoic acid — also indicate that these benefits increase in proportion to how much LDL-C is lowered and how long patients have been taking the medicine, just like with statins.
As a benchmark, the study used data from previous meta-analyses of statin trials that showed that every 1 mmol/L reduction in LDL-C was associated with a 22% reduction in major vascular events.
Data from ‘CLEAR Outcomes’ show that the treatment of statin-intolerant patients with bempedoic acid was associated with a 21% decrease in LDL-C, compared with placebo.
Lincoff said: “Our findings indicate bempedoic acid may be a valuable therapy for patients who cannot tolerate adequate doses of statins or who need to further lower their LDL cholesterol levels.
The comparability of these benefits was not a given: previous research, published in February 2022, has indicated that different diabetes medicines can have varying effects on cardiovascular health, even when they improve blood sugar levels by a similar amount.
Commenting on the study, Paul Wright, lead cardiac pharmacist at Barts Heart Centre in London, said: “Whilst the relative effectiveness in outcome is comparable when adjusted to achieving a reduction in LDL-C by 1 mmol, we need to bear in mind that the LDL-C reductions seen with statins are larger.
“You expect around a 21% reduction of LDL-C with bempedoic acid but even with a ‘low dose statin’ — using atorvastatin 20 mg — you would expect a 43% reduction.”