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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
1997-5-30
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pubmed:abstractText |
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.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Anticholesteremic Agents,
http://linkedlifedata.com/resource/pubmed/chemical/Cholesterol,
http://linkedlifedata.com/resource/pubmed/chemical/Cholesterol, HDL,
http://linkedlifedata.com/resource/pubmed/chemical/Cholesterol, LDL,
http://linkedlifedata.com/resource/pubmed/chemical/Hemoglobin A, Glycosylated,
http://linkedlifedata.com/resource/pubmed/chemical/Placebos,
http://linkedlifedata.com/resource/pubmed/chemical/Pravastatin,
http://linkedlifedata.com/resource/pubmed/chemical/Triglycerides
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pubmed:status |
MEDLINE
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pubmed:month |
Apr
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pubmed:issn |
1262-3636
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
23
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
131-6
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pubmed:dateRevised |
2006-11-15
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pubmed:meshHeading |
pubmed-meshheading:9137901-Adult,
pubmed-meshheading:9137901-Aged,
pubmed-meshheading:9137901-Analysis of Variance,
pubmed-meshheading:9137901-Anticholesteremic Agents,
pubmed-meshheading:9137901-Cholesterol,
pubmed-meshheading:9137901-Cholesterol, HDL,
pubmed-meshheading:9137901-Cholesterol, LDL,
pubmed-meshheading:9137901-Diabetes Mellitus, Type 2,
pubmed-meshheading:9137901-Double-Blind Method,
pubmed-meshheading:9137901-Female,
pubmed-meshheading:9137901-Hemoglobin A, Glycosylated,
pubmed-meshheading:9137901-Humans,
pubmed-meshheading:9137901-Hyperlipidemias,
pubmed-meshheading:9137901-Male,
pubmed-meshheading:9137901-Middle Aged,
pubmed-meshheading:9137901-Placebos,
pubmed-meshheading:9137901-Pravastatin,
pubmed-meshheading:9137901-Triglycerides
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pubmed:year |
1997
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pubmed:articleTitle |
Efficacy of low-dose pravastatin in patients with mild hyperlipidemia associated with type II diabetes mellitus.
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pubmed:affiliation |
Clinique d'Endocrinologie, Hôtel Dieu, Nantes, France.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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