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Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus.
Diabetes Metab. 1997 Apr; 23(2):131-6.DM

Abstract

A 16 week, randomized, double-blind, parallel, placebo-controlled study was designed to determine the effects of low-dose pravastatin on cholesterol concentrations in patients with mild hypercholesterolemia and non-insulin-dependent diabetes mellitus (NIDDM). Following a 6-to 8-week dietary run-in period, a mean serum total cholesterol (TC) level > 5.2 mmol/L (200 mg/dL), but < 7.8 mmol/L (300 mg/dL) was required for entry. Metabolic control of diabetes was determined by a hemoglobin Alc (HbAlc) level less than twice the upper limit of normal on two occasions. Eighty six (86) patients recruited in 5 French diabetic clinics, were randomized in a ratio of 1:1 (pravastatin 10 mg or placebo), and 74 completed the study. There were 12 discontinuations: 5 (11.6%) in the pravastatin group and 7 (16.3%) in the placebo group. Drop-out was due to an adverse event in 1 patient (2.3%) in the pravastatin group and in 5 patients (11.6%) in the placebo group. Thirty five (35) placebo patients and 14 pravastatin patients had their dose of treatment doubled at week 8: the dose of treatment was to be doubled at week 8 in the event of non-response to treatment (TC at week 7 > 5.2 mmol/L and TC decrease < 15% from baseline). At week 16, pravastatin lowered TC from 6.4 to 5.6 mmol/L (-13.8%, p < 0.001 versus placebo), low-density lipoprotein cholesterol (LDL-C) from 4.3 to 3.4 mmol/L (-20.4%, p < 0.001 versus placebo) and slightly increased high-density lipoprotein cholesterol (HDL-C) from 1.18 to 1.25 mmol/L (+6.7%). Side effects were similar in both groups. Blood glucose control was not altered as assessed by serial HbAlc measurements which were unchanged during treatment. This study demonstrated that low-dose pravastatin is effective in lowering cholesterol levels in patients with hypercholesterolemia and NIDDM.

Authors+Show Affiliations

Clinique d'Endocrinologie, Hôtel Dieu, Nantes, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

9137901

Citation

Krempf, M, et al. "Efficacy of Low-dose Pravastatin in Patients With Mild Hyperlipidemia Associated With Type II Diabetes Mellitus." Diabetes & Metabolism, vol. 23, no. 2, 1997, pp. 131-6.
Krempf M, Berthezène F, Wemeau JL, et al. Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus. Diabetes Metab. 1997;23(2):131-6.
Krempf, M., Berthezène, F., Wemeau, J. L., Moinade, S., Desriac, I., Amelineau, E., & Passa, P. (1997). Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus. Diabetes & Metabolism, 23(2), 131-6.
Krempf M, et al. Efficacy of Low-dose Pravastatin in Patients With Mild Hyperlipidemia Associated With Type II Diabetes Mellitus. Diabetes Metab. 1997;23(2):131-6. PubMed PMID: 9137901.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus. AU - Krempf,M, AU - Berthezène,F, AU - Wemeau,J L, AU - Moinade,S, AU - Desriac,I, AU - Amelineau,E, AU - Passa,P, PY - 1997/4/1/pubmed PY - 2000/3/11/medline PY - 1997/4/1/entrez SP - 131 EP - 6 JF - Diabetes & metabolism JO - Diabetes Metab. VL - 23 IS - 2 N2 - A 16 week, randomized, double-blind, parallel, placebo-controlled study was designed to determine the effects of low-dose pravastatin on cholesterol concentrations in patients with mild hypercholesterolemia and non-insulin-dependent diabetes mellitus (NIDDM). Following a 6-to 8-week dietary run-in period, a mean serum total cholesterol (TC) level > 5.2 mmol/L (200 mg/dL), but < 7.8 mmol/L (300 mg/dL) was required for entry. Metabolic control of diabetes was determined by a hemoglobin Alc (HbAlc) level less than twice the upper limit of normal on two occasions. Eighty six (86) patients recruited in 5 French diabetic clinics, were randomized in a ratio of 1:1 (pravastatin 10 mg or placebo), and 74 completed the study. There were 12 discontinuations: 5 (11.6%) in the pravastatin group and 7 (16.3%) in the placebo group. Drop-out was due to an adverse event in 1 patient (2.3%) in the pravastatin group and in 5 patients (11.6%) in the placebo group. Thirty five (35) placebo patients and 14 pravastatin patients had their dose of treatment doubled at week 8: the dose of treatment was to be doubled at week 8 in the event of non-response to treatment (TC at week 7 > 5.2 mmol/L and TC decrease < 15% from baseline). At week 16, pravastatin lowered TC from 6.4 to 5.6 mmol/L (-13.8%, p < 0.001 versus placebo), low-density lipoprotein cholesterol (LDL-C) from 4.3 to 3.4 mmol/L (-20.4%, p < 0.001 versus placebo) and slightly increased high-density lipoprotein cholesterol (HDL-C) from 1.18 to 1.25 mmol/L (+6.7%). Side effects were similar in both groups. Blood glucose control was not altered as assessed by serial HbAlc measurements which were unchanged during treatment. This study demonstrated that low-dose pravastatin is effective in lowering cholesterol levels in patients with hypercholesterolemia and NIDDM. SN - 1262-3636 UR - https://www.unboundmedicine.com/medline/citation/9137901/Efficacy_of_low_dose_pravastatin_in_patients_with_mild_hyperlipidemia_associated_with_type_II_diabetes_mellitus_ L2 - http://www.diseaseinfosearch.org/result/2236 DB - PRIME DP - Unbound Medicine ER -