Titre du document / Document title

Effects of simvastatin 20 mg/d on serum lipid profiles in Japanese hyperlipidemic patients : A prospective, open-label pilot study

Auteur(s) / Author(s)

YOSHIDA Hiroshi ^{(1 2)} ; YANAI Hidekatsu ⁽¹⁾ ; SHODA Toru ⁽²⁾ ; FURUTANI Nobuyuki ⁽¹⁾ ; SATO Noriko ⁽¹⁾ ; TADA Norio ⁽¹⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Division of General Medicine, Department of Internal Medicine, Kashiwa Hospital, Jikei University School of Medicine, Kashiwa, JAPON
⁽²⁾ Department of Laboratory Medicine, Kashiwa Hospital, Jikei University School of Medicine, Kashiwa, JAPON

Résumé / Abstract

Background: Hyperlipidemia is a major risk factor for ischemic heart disease. Hydroxymethylglutaryl coenzyme A reductase inhibitors ("statins") (eg, simvastatin) are considered first-line cholesterol-lowering therapy because they are effective and well tolerated, even at high doses. Based on a literature search, no studies have been published concerning the effects of simvastatin 20 mg/d in Japanese patients who had not previously received lipid-lowering treatment. Objective: The aim of this study was to assess the clinical tolerability and effectiveness of simvastatin 20 mg/d in achieving the target lipid concentrations recommended in the 2002 Japan Atherosclerosis Society (JAS) guidelines in Japanese patients with hyperlipidemia. Methods: This prospective, open-label pilot study was conducted at Kashiwa Hospital, Jikei University School of Medicine, Kashiwa, Japan. Male and postmenopausal female patients aged ≥18 to 70 years with hyperlipidemia (total cholesterol [TC], ≥220 mg/dL; triglycerides [TG], 150-400 mg/dL) who had not received lipid-lowering medications for at least 6 months before the study were enrolled. Patients received simvastatin 20 mg PO QD for 4 weeks. Effectiveness was assessed using serum concentrations of TC, low-density lipoprotein cholesterol (LDL-C), TG, and lipid peroxide, measured at 0 (baseline) and 4 weeks. Target serum TC and LDL-C concentrations as outlined by the JAS were as follows: category A, TC <240 mg/dL and LDL-C <160 mg/dL; category B1 and B2, TC <220 mg/dL and LDL-C <140 mg/dL; and category C, TC <200 mg/dL and LDL-C <120 mg/dL. A subanalysis of the correlation between baseline high-density lipoprotein cholesterol (HDL-C) and target achievement rates was conducted by baseline HDL-C concentration (<50 or ≥50 mg/dL). Tolerability was assessed using spontaneous reporting of adverse events and laboratory analysis, including liver function tests. Results: Twenty-two patients participated in the study (16 women, 6 men; mean [SD] age, 56.0 [8.0] years; mean [SD] body mass index, 23.6 [3.4] kg/m2). Mean serum TC, LDL-C, TG, and lipid peroxide concentrations significantly decreased from baseline (changes, -28.6%, -40.4%, -24.0%, and -14.5%, respectively; P < 0.001, <0.001, <0.001, and <0.01, respectively). The mean HDL-C concentration significantly increased from baseline (change, 7.2%; P < 0.001); the mean increase was significantly greater in patients with baseline HDL-C <50 mg/dL compared with those with baseline HDL-C a50 mg/dL (changes, 11.3% vs 4.4%; P < 0.05). Target TC and LDL-C concentrations were achieved in 90.9% of patients. No serious adverse events were observed, and liver enzyme and creatine kinase concentrations did not increase to above-normal values. Conclusions: The results of this study suggest that simvastatin 20 mg/d might be useful in the clinical treatment of hyperlipidemia in Japanese patients. The study drug was well tolerated.

Revue / Journal Title

Current therapeutic research   ISSN 0011-393X   CODEN CTCEA9 

Source / Source

2005, vol. 66, n^o6, pp. 613-629 [17 page(s) (article)] (50 ref.)

Langue / Language

Anglais

Editeur / Publisher

Excerpta medica, Belle Mead, NJ, ETATS-UNIS  (1959) (Revue)

Mots-clés anglais / English Keywords

Vascular disease ; Cardiovascular disease ; Dyslipemia ; Metabolic diseases ; Statin derivative ; Enzyme inhibitor ; Enzyme ; Oxidoreductases ; Hydroxymethylglutaryl-CoA reductase ; Asia ; Antilipemic agent ; Recommendation ; Atherosclerosis ; Cholesterol HDL ; Lipoprotein LDL ; Prospective ; Human ; Hyperlipemia ; Japan ; Lipids ; Serum ; Simvastatin ;

Mots-clés français / French Keywords

Inhibiteur HMG-CoA reductase ; Vaisseau sanguin pathologie ; Appareil circulatoire pathologie ; Dyslipémie ; Métabolisme pathologie ; Statine dérivé ; Inhibiteur enzyme ; Enzyme ; Oxidoreductases ; Hydroxymethylglutaryl-CoA reductase ; Asie ; Hypolipémiant ; Recommandation ; Athérosclérose ; Cholestérol HDL ; Lipoprotéine LDL ; Prospective ; Homme ; Hyperlipémie ; Japon ; Lipide ; Sérum ; Simvastatine ;

Mots-clés espagnols / Spanish Keywords

Vaso sanguíneo patología ; Aparato circulatorio patología ; Dislipemia ; Metabolismo patología ; Statina derivado ; Inhibidor enzima ; Enzima ; Oxidoreductases ; Hydroxymethylglutaryl-CoA reductase ; Asia ; Hipolipemiante ; Recomendación ; Ateroesclerosis ; Colesterol HDL ; Lipoproteína LDL ; Prospectiva ; Hombre ; Hiperlipemia ; Japón ; Lípido ; Suero ; Simvastatina ;

Mots-clés d'auteur / Author Keywords

simvastatin 20 mg ; low high-density lipoprotein cholesterol ; 2002 Japanese Atherosclerosis Society guideline ; lipid goal ; Japanese hyperlipidemic patients ;

Localisation / Location

INIST-CNRS, Cote INIST : 9560, 35400013317657.0110