Abstract
Background and objective: One of the problems associated with reaching the low-density lipoprotein cholesterol (LDL-C) target during statin treatment is the emergence of laboratory or clinical side effects. The aim of our study was to evaluate the prevalence of statin-associated adverse events in diabetic and non-diabetic patients affected by polygenic hypercholesterolemia or combined hyperlipidemia and the efficacy and tolerability of treatment with ezetimibe/simvastatin 10/10 mg/day on the same subjects experiencing the adverse events. Methods: Consecutively enrolment of patients affected by polygenic hypercholesterolemia or combined hyperlipidemia with or without type 2 diabetes mellitus. Each Centre used any of the available statins on the basis of current clinical judgement and monitored enrolled patients for adverse events during the following 2 years. Those patients with moderate adverse events suspended the current statin therapy for 1 month (washout period), and then were shifted to treatment with ezetimibe/simvastatin 10/10 mg/day and again monitored for adverse events in the following 6 months. We assessed body mass index, glycated haemoglobin, fasting plasma glucose, total cholesterol, LDL-C, high-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, creatinine phosphokinase and monitored adverse events such as asthenia and myalgia. Results and discussion: All 1170 Caucasian patients affected by polygenic hypercholesterolemia obtained a significant reduction in LDL-C during the observation period (P <0·05), while those with combined hyperlipidemia also showed a reduction in TG plasma level (P <0·05) and a significant increase in HDL-C (P <0·05). Patients affected by polygenic hypercholesterolemia experiencing adverse event under statin treatment obtained a significantly lower reduction than those tolerating the treatment (P <0·001). The prevalence of adverse events under statin treatment was 4·9% in non-diabetic patients with polygenic hypercholesterolemia, 8·6% in those with combined hyperlipidemia, 7·1% in diabetic patients with polygenic hypercholesterolemia and 7·6% in those with combined hyperlipidemia. Six months after the shift to treatment with ezetimibe/simvastatin 10/10 mg, all patients experienced a significant improvement in LDL-C, TG and HDL-C plasma level. No adverse event was registered during the ezetimibe/simvastatin 10/10 mg treatment period. It seems that previous side effects observed with statins did not re-appear with the administration of ezetimibe/simvastatin 10/10 mg/day. Conclusions: The efficacy and adverse effect profile of the ezetimibe and simvastatin combination appear to be good for both diabetic and non-diabetic patients, and in both conditions.
| Original language | English |
|---|---|
| Pages (from-to) | 267-276 |
| Number of pages | 10 |
| Journal | Journal of Clinical Pharmacy and Therapeutics |
| Volume | 34 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Jun 2009 |
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Keywords
- Combined hyperlipidemia
- Ezetimibe
- Poligenic hypercholesterolemia
- Simvastatin
- Type 2 diabetes mellitus
ASJC Scopus subject areas
- Pharmacology (medical)
- Pharmacology
Cite this
Efficacy and safety of ezetimibe/simvastatin association on non-diabetic and diabetic patients with polygenic hypercholesterolemia or combined hyperlipidemia and previously intolerant to standard statin treatment. / Derosa, G.; D'Angelo, A.; Franzetti, I. G.; Ragonesi, P. D.; Gadaleta, G.; Scalise, F.; Ciccarelli, L.; Piccinni, M. N.; Cicero, A. F G.
In: Journal of Clinical Pharmacy and Therapeutics, Vol. 34, No. 3, 06.2009, p. 267-276.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy and safety of ezetimibe/simvastatin association on non-diabetic and diabetic patients with polygenic hypercholesterolemia or combined hyperlipidemia and previously intolerant to standard statin treatment
AU - Derosa, G.
AU - D'Angelo, A.
AU - Franzetti, I. G.
AU - Ragonesi, P. D.
AU - Gadaleta, G.
AU - Scalise, F.
AU - Ciccarelli, L.
AU - Piccinni, M. N.
AU - Cicero, A. F G
PY - 2009/6
Y1 - 2009/6
N2 - Background and objective: One of the problems associated with reaching the low-density lipoprotein cholesterol (LDL-C) target during statin treatment is the emergence of laboratory or clinical side effects. The aim of our study was to evaluate the prevalence of statin-associated adverse events in diabetic and non-diabetic patients affected by polygenic hypercholesterolemia or combined hyperlipidemia and the efficacy and tolerability of treatment with ezetimibe/simvastatin 10/10 mg/day on the same subjects experiencing the adverse events. Methods: Consecutively enrolment of patients affected by polygenic hypercholesterolemia or combined hyperlipidemia with or without type 2 diabetes mellitus. Each Centre used any of the available statins on the basis of current clinical judgement and monitored enrolled patients for adverse events during the following 2 years. Those patients with moderate adverse events suspended the current statin therapy for 1 month (washout period), and then were shifted to treatment with ezetimibe/simvastatin 10/10 mg/day and again monitored for adverse events in the following 6 months. We assessed body mass index, glycated haemoglobin, fasting plasma glucose, total cholesterol, LDL-C, high-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, creatinine phosphokinase and monitored adverse events such as asthenia and myalgia. Results and discussion: All 1170 Caucasian patients affected by polygenic hypercholesterolemia obtained a significant reduction in LDL-C during the observation period (P <0·05), while those with combined hyperlipidemia also showed a reduction in TG plasma level (P <0·05) and a significant increase in HDL-C (P <0·05). Patients affected by polygenic hypercholesterolemia experiencing adverse event under statin treatment obtained a significantly lower reduction than those tolerating the treatment (P <0·001). The prevalence of adverse events under statin treatment was 4·9% in non-diabetic patients with polygenic hypercholesterolemia, 8·6% in those with combined hyperlipidemia, 7·1% in diabetic patients with polygenic hypercholesterolemia and 7·6% in those with combined hyperlipidemia. Six months after the shift to treatment with ezetimibe/simvastatin 10/10 mg, all patients experienced a significant improvement in LDL-C, TG and HDL-C plasma level. No adverse event was registered during the ezetimibe/simvastatin 10/10 mg treatment period. It seems that previous side effects observed with statins did not re-appear with the administration of ezetimibe/simvastatin 10/10 mg/day. Conclusions: The efficacy and adverse effect profile of the ezetimibe and simvastatin combination appear to be good for both diabetic and non-diabetic patients, and in both conditions.
AB - Background and objective: One of the problems associated with reaching the low-density lipoprotein cholesterol (LDL-C) target during statin treatment is the emergence of laboratory or clinical side effects. The aim of our study was to evaluate the prevalence of statin-associated adverse events in diabetic and non-diabetic patients affected by polygenic hypercholesterolemia or combined hyperlipidemia and the efficacy and tolerability of treatment with ezetimibe/simvastatin 10/10 mg/day on the same subjects experiencing the adverse events. Methods: Consecutively enrolment of patients affected by polygenic hypercholesterolemia or combined hyperlipidemia with or without type 2 diabetes mellitus. Each Centre used any of the available statins on the basis of current clinical judgement and monitored enrolled patients for adverse events during the following 2 years. Those patients with moderate adverse events suspended the current statin therapy for 1 month (washout period), and then were shifted to treatment with ezetimibe/simvastatin 10/10 mg/day and again monitored for adverse events in the following 6 months. We assessed body mass index, glycated haemoglobin, fasting plasma glucose, total cholesterol, LDL-C, high-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, creatinine phosphokinase and monitored adverse events such as asthenia and myalgia. Results and discussion: All 1170 Caucasian patients affected by polygenic hypercholesterolemia obtained a significant reduction in LDL-C during the observation period (P <0·05), while those with combined hyperlipidemia also showed a reduction in TG plasma level (P <0·05) and a significant increase in HDL-C (P <0·05). Patients affected by polygenic hypercholesterolemia experiencing adverse event under statin treatment obtained a significantly lower reduction than those tolerating the treatment (P <0·001). The prevalence of adverse events under statin treatment was 4·9% in non-diabetic patients with polygenic hypercholesterolemia, 8·6% in those with combined hyperlipidemia, 7·1% in diabetic patients with polygenic hypercholesterolemia and 7·6% in those with combined hyperlipidemia. Six months after the shift to treatment with ezetimibe/simvastatin 10/10 mg, all patients experienced a significant improvement in LDL-C, TG and HDL-C plasma level. No adverse event was registered during the ezetimibe/simvastatin 10/10 mg treatment period. It seems that previous side effects observed with statins did not re-appear with the administration of ezetimibe/simvastatin 10/10 mg/day. Conclusions: The efficacy and adverse effect profile of the ezetimibe and simvastatin combination appear to be good for both diabetic and non-diabetic patients, and in both conditions.
KW - Combined hyperlipidemia
KW - Ezetimibe
KW - Poligenic hypercholesterolemia
KW - Simvastatin
KW - Type 2 diabetes mellitus
UR - http://www.scopus.com/inward/record.url?scp=65549116534&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65549116534&partnerID=8YFLogxK
U2 - 10.1111/j.1365-2710.2008.01004.x
DO - 10.1111/j.1365-2710.2008.01004.x
M3 - Article
VL - 34
SP - 267
EP - 276
JO - Journal of Clinical Pharmacy and Therapeutics
JF - Journal of Clinical Pharmacy and Therapeutics
SN - 0269-4727
IS - 3
ER -