Eicosapentaenoic acid effect on hyperlipidemia in menopausal Japanese women

doi:10.1016/S0029-7844(00)00988-1

Obstetrics & Gynecology

Volume 96, Issue 4, October 2000, Pages 521-528

https://doi.org/10.1016/S0029-7844(00)00988-1 Get rights and content

Abstract

Objective: To assess the efficacy and safety of eicosapentaenoic acid for the treatment of hyperlipidemia in symptomatic menopausal Japanese women.

Methods: We performed a prospective observational 48-week study in hyperlipidemic menopausal women. We randomly assigned 141 women, whose levels of serum total cholesterol were 220 to 280 mg/dL or whose serum triglycerides were 150 to 400 mg/dL at baseline to groups treated with estriol (E3) 2 mg daily (control group, n = 72) or ethyl icosapentate 1800 mg daily and E3 2 mg (eicosapentaenoic acid group, n = 69).

Results: Serum levels of total cholesterol decreased significantly from 249.4 to 238.6 mg/dL (−4.3%, P = .003) in the control group and from 252.3 to 234.0 mg/dL (−7.3%, P = .001) in the study group at week 48 in the women whose total cholesterol was not less than 220 mg/dL at baseline. Serum levels of triglycerides decreased significantly from 194.5 to 141.5 mg/dL (−27.2%, P = .001) in the study group but increased slightly from 192.9 to 207.4 mg/dL (+7.5%) in the control group at week 48 in the women whose level of triglycerides was not less than 150 mg/dL. There were significant differences between these two groups at weeks 12, 24, and 48. Serum levels of total cholesterol and triglycerides were significantly decreased at week 48 in the study group regardless of whether the women were obese. There were no severe adverse effects.

Conclusion: Combination therapy with eicosapentaenoic acid and E3 was effective and safe for menopausal women with hypertriglyceridemia.

Section snippets

Materials and methods

We studied 141 women, 23 premenopausal and 118 postmenopausal, who had menopausal symptoms and hyperlipidemia, 46 to 62 years of age, between June 1996 and March 1999, at 33 health institutions in Niigata, Japan. Hyperlipidemia was defined as a serum total cholesterol concentration of 220–280 mg/dL or a serum triglyceride concentration of 150–400 mg/dL. Women with severe hyperlipidemia (serum total cholesterol greater than 280 mg/dL or serum triglycerides greater than 400 mg/dL) were considered

Results

There were no significant differences in clinical background of the women allocated to the two groups (Table 1). The proportion of patients who took all medication prescribed was 87.5% in the control group and 88.8% in the eicosapentaenoic acid group at week 12, 84.7% and 81.2% at week 24, and 75.0% and 68.1% at week 48, respectively. The changes in serum levels of total cholesterol, triglycerides, HDL, and LDL cholesterol from baseline to week 48 for premenopausal and postmenopausal women were

Discussion

We prospectively studied the effects of eicosapentaenoic acid on lipid metabolism in hyperlipidemic women with menopausal symptoms. The postmenopausal hypoestrogen state could cause osteopenia and hyperlipidemia, which is associated with coronary heart disease and brain embolism. The most important finding of this study was that combination therapy with eicosapentaenoic acid and E3 significantly decreased the serum triglycerides level compared with E3 alone. Eicosapentaenoic acid has an

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^☆: This research was supported by an educational grant from Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.

¹: The clinical investigators comprising the Niigata Epadel Study Group are: Akira Honda, MD, Tetsuro Yahata, MD, Masatoshi Tomita, MD, Hiroshi Matsushita, MD, Takashi Miida, MD, Minoru Nakamura, MD, Norihito Sudo, MD, Kouichi Tanaka, MD, Kiyoshi Yamada, MD, Ichiro Yamazaki, MD, Masahiro Yasuda, MD, Masaaki Takahashi, MD, Takeshi Takahashi, MD, Michihito Endo, MD, Takeshi Hirohashi, MD, Masami Kato, MD, Isao Hataya, MD, Naoki Motani, MD, Susumu Abe, MD, Hiroshi Watanabe, MD, Shigeru Arai, MD, Hideo Yuzawa, MD, Susumu Ozaki, MD, Shiro Ishii, MD, Kunio Tanaka, MD, Toshio Nishiyama, MD, Masaharu Hirokawa, MD, Akira Tohyama, MD, Takao Terashima, MD, Yasuo Adachi, MD, Akiteru Tokunaga, MD, Yoshiya Tojo, MD, Takaaki Suzuki, MD, Yoshiki Kazama, MD, Norio Nishimura, MD, Yuuetsu Sudo, MD, Toshihiro Maruhashi, MD, Akira Goto, MD, Akira Higuchi, MD, Ayako Sasaki, MD, Yusuke Minagawa, MD, Kazushige Suzuki, MD, Miwako Ishii, MD, Toru Yanase, MD, Takashi Fujimaki, MD, Shigeko Takagi, MD, Masaki Tamura, MD, Tetsuo Tomita, MD, and Syuji Honda, MD.

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Eicosapentaenoic acid effect on hyperlipidemia in menopausal Japanese women☆

Abstract

Section snippets

Materials and methods

Results

Discussion

Atherosclerosis

Am J Cardiol

Am Heart J

Lancet

Atherosclerosis

Metabolism

Am J Med

Am J Clin Nutr

Lancet

J Lipid Res

Thromb Res

Curr Ther Res

Eur J Pharmacol

Eur J Pharmacol

Atherosclerosis

Atherosclerosis

Maturitas

Lancet

Menopause and risk factors for coronary heart disease

N Engl J Med

Differences in low density lipoprotein subfractions and apolipoproteins in premenopausal and postmenopausal women

J Clin Endocrinol Metab

Plasma lipoprotein levels as predictors of cardiovascular deaths in women

Arch Intern Med

Plasminogen activator and plasminogen activator inhibitor activities in men with coronary artery disease

J Lab Clin Med