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Lower-intensity statin combination potential alternative to monotherapy
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High-risk patients who cannot tolerate or do not respond to statins may benefit from lower-intensity statin combination therapy with ezetimibe or a bile acid sequestrant, according to a new report.
However, clinicians should use this strategy with caution because there is a lack of data on long-term outcomes and adverse events, researchers said.
The researchers performed a systematic review of 36 randomized controlled trials that assessed the effects of combination therapy with a lower-intensity statin and a non-statin medication vs. statin monotherapy among adult patients at high risk for atherosclerotic CVD. The studies were collected from the Embase database and the Cochrane Central Register of Controlled Trials through July 2013, and from the MEDLINE database through November 2013. The primary outcomes of concern were LDL cholesterol and long-term clinical outcomes, including mortality, cerebrovascular and acute coronary events, and revascularization.
Across four studies covering 288 patients with hyperlipidemia, combination therapy with a low-intensity statin and bile acid sequestrant reduced LDL cholesterol more than monotherapy with a mid-intensity statin, with a treatment difference ranging from 0% to 14%. A mid-intensity statin administered with ezetimibe (Zetia, Merck) was associated with a more pronounced decrease in LDL cholesterol compared with high-intensity statin monotherapy, both among patients with atherosclerotic CVD (5% to 15% difference range among 11 studies and one subgroup analysis) and diabetes (3% to 21% difference range among seven studies and four subgroup analyses).
Data on long-term outcomes and treatment adherence were insufficient for all evaluated treatment regimens, and the majority of studies with data on adverse events lasted fewer than 20 weeks and had very low or no event incidence. The researchers also noted a lack of sufficient evidence available to assess the efficacy of a statin administered in combination with fibrates, niacin or omega-3 fatty acids.
“Lower-intensity statin combined with bile acid sequestrant or ezetimibe may be alternatives to higher-intensity statin monotherapy among high-risk patients who are statin intolerant or who have a less than anticipated LDL cholesterol response,” the researchers wrote. “… However, clinicians should use these strategies with caution and counsel their patients, given the lack of evidence regarding [atherosclerotic CVD] risk reduction benefits and limited data on adverse events.”
Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.
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