Effect of ezetimibe in patients who cannot tolerate statins or cannot get to the low density lipoprotein cholesterol target despite taking a statin

Background: Recent guidelines underline the need for high-risk patients to reach strict low density lipoprotein cholesterol (LDL-C) targets (1.8-2.6 mmol/L; 70-100 mg/dL), and specifically mention the possible use of combination therapy (e.g. statin + ezetimibe) to achieve these goals. Methods: A retrospective case-note audit was carried out to assess the response to administering ezetimibe in patients unable to tolerate statins (Group 1), or high dose of statins (Group 2) and patients who cannot achieve the LDL-C target (2.6 mmol/L; 100 mg/dL) despite taking a statin (Group 3). Results: Ezetimibe lowered LDL-C levels by 20-29% across the 3 patient groups after 2-3 months of treatment. High density lipoprotein cholesterol (HDL-C) levels tended to remain unchanged, although there was a consistent trend for a fall if baseline values were 'high'. However, the LDLC/HDL-C ratio changed significantly and favourably in all groups. The fall in fasting triglyceride levels in all groups was greater (reaching 19-25%) when baseline levels were >= 1.5 or 1.7 mmol/L (136-150 mg/dL). There were no marked abnormalities in liver function tests or creatine kinase activity. In Group 3 there was a significant trend for a fall in serum creatinine levels across the tertiles of baseline creatinine values. Limitations of the present study include the small sample size (especially in Groups 1 and 2), its short-term duration and the absence of event-based end-points. Therefore, the results are hypothesis-generating rather than conclusive. Conclusions: When used alone or added to a statin, ezetimibe favourably altered the LDL-C/HDL-C ratio and lowered triglyceride levels. Ezetimibe was well tolerated in patients with statin intolerance and was associated with a 26% fall in LDL-C. An additional action may be some degree of improved renal function. Further studies are needed to confirm these findings.