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Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies.
Curr Med Res Opin 2014; 30(5):775-84CM

Abstract

AIMS

Statin treatment may impair glucose homeostasis and increase the risk of new-onset diabetes mellitus, although this may depend on the statin, dose and patient population. We evaluated the effects of pitavastatin 4 mg/day on glucose homeostasis in patients with metabolic syndrome in the CAPITAIN trial. Findings were validated in a subset of patients enrolled in PREVAIL-US.

METHODS

Participants with a well defined metabolic syndrome phenotype were recruited to CAPITAIN to reduce the influence of confounding factors. Validation and comparison datasets were selected comprising phenotypically similar subsets of individuals enrolled in PREVAIL-US and treated with pitavastatin or pravastatin, respectively. Mean change from baseline in parameters of glucose homeostasis (fasting plasma glucose [FPG], glycated hemoglobin [HbA1c], insulin, quantitative insulin-sensitivity check index [QUICKI] and homeostasis model of assessment-insulin resistance [HOMA-IR]) and plasma lipid profile were assessed at 6 months (CAPITAIN) and 3 months (PREVAIL-US) after initiating treatment.

RESULTS

In CAPITAIN (n = 12), no significant differences from baseline in HbA1c, insulin, HOMA-IR and QUICKI were observed at day 180 in patients treated with pitavastatin. A small (4%) increase in FPG from baseline to day 180 (P < 0.05), was observed. In the validation dataset (n = 9), no significant differences from baseline in glycemic parameters were observed at day 84 (all comparisons P > 0.05). Similar results were observed for pravastatin in the comparison dataset (n = 14).

CONCLUSIONS

Other than a small change in FPG in the CAPITAIN study, neutral effects of pitavastatin on glucose homeostasis were observed in two cohorts of patients with metabolic syndrome, independent of its efficacy in reducing levels of atherogenic lipoproteins. The small number of patients and relatively short follow-up period represent limitations of the study. Nevertheless, these data suggest that statin-induced diabetogenesis may not represent a class effect.

Authors+Show Affiliations

Dyslipidemia and Atherosclerosis Research Unit, INSERM UMR-S939, Pitié-Salpêtrière University Hospital , Paris , France.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24328357

Citation

Chapman, M J., et al. "Effect of High-dose Pitavastatin On Glucose Homeostasis in Patients at Elevated Risk of New-onset Diabetes: Insights From the CAPITAIN and PREVAIL-US Studies." Current Medical Research and Opinion, vol. 30, no. 5, 2014, pp. 775-84.
Chapman MJ, Orsoni A, Robillard P, et al. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014;30(5):775-84.
Chapman, M. J., Orsoni, A., Robillard, P., Hounslow, N., Sponseller, C. A., & Giral, P. (2014). Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Current Medical Research and Opinion, 30(5), pp. 775-84. doi:10.1185/03007995.2013.874989.
Chapman MJ, et al. Effect of High-dose Pitavastatin On Glucose Homeostasis in Patients at Elevated Risk of New-onset Diabetes: Insights From the CAPITAIN and PREVAIL-US Studies. Curr Med Res Opin. 2014;30(5):775-84. PubMed PMID: 24328357.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. AU - Chapman,M J, AU - Orsoni,A, AU - Robillard,P, AU - Hounslow,N, AU - Sponseller,C A, AU - Giral,P, Y1 - 2014/01/10/ PY - 2013/12/17/entrez PY - 2013/12/18/pubmed PY - 2014/10/29/medline SP - 775 EP - 84 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 30 IS - 5 N2 - AIMS: Statin treatment may impair glucose homeostasis and increase the risk of new-onset diabetes mellitus, although this may depend on the statin, dose and patient population. We evaluated the effects of pitavastatin 4 mg/day on glucose homeostasis in patients with metabolic syndrome in the CAPITAIN trial. Findings were validated in a subset of patients enrolled in PREVAIL-US. METHODS: Participants with a well defined metabolic syndrome phenotype were recruited to CAPITAIN to reduce the influence of confounding factors. Validation and comparison datasets were selected comprising phenotypically similar subsets of individuals enrolled in PREVAIL-US and treated with pitavastatin or pravastatin, respectively. Mean change from baseline in parameters of glucose homeostasis (fasting plasma glucose [FPG], glycated hemoglobin [HbA1c], insulin, quantitative insulin-sensitivity check index [QUICKI] and homeostasis model of assessment-insulin resistance [HOMA-IR]) and plasma lipid profile were assessed at 6 months (CAPITAIN) and 3 months (PREVAIL-US) after initiating treatment. RESULTS: In CAPITAIN (n = 12), no significant differences from baseline in HbA1c, insulin, HOMA-IR and QUICKI were observed at day 180 in patients treated with pitavastatin. A small (4%) increase in FPG from baseline to day 180 (P < 0.05), was observed. In the validation dataset (n = 9), no significant differences from baseline in glycemic parameters were observed at day 84 (all comparisons P > 0.05). Similar results were observed for pravastatin in the comparison dataset (n = 14). CONCLUSIONS: Other than a small change in FPG in the CAPITAIN study, neutral effects of pitavastatin on glucose homeostasis were observed in two cohorts of patients with metabolic syndrome, independent of its efficacy in reducing levels of atherogenic lipoproteins. The small number of patients and relatively short follow-up period represent limitations of the study. Nevertheless, these data suggest that statin-induced diabetogenesis may not represent a class effect. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/24328357/Effect_of_high_dose_pitavastatin_on_glucose_homeostasis_in_patients_at_elevated_risk_of_new_onset_diabetes:_insights_from_the_CAPITAIN_and_PREVAIL_US_studies_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007995.2013.874989 DB - PRIME DP - Unbound Medicine ER -