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Clin Drug Investig. 1998;16(1):1-7. doi: 10.2165/00044011-199816010-00001.

Gemfibrozil treatment in patients with elevated lipoprotein a: a pilot study.

Clinical drug investigation

A G Fereshetian, M Davidson, H Haber, D M Black

Affiliations

  1. Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan, USA.

PMID: 18370512 DOI: 10.2165/00044011-199816010-00001

Abstract

OBJECTIVE: This pilot study investigated the efficacy of high-dose gemfibrozil (2400 mg/day) in treating patients with elevated lipoprotein (a) [Lp(a)]. Lp(a) has been shown to be an independent risk factor for the development of coronary heart disease (CHD).

PATIENTS: Eleven patients with serum Lp(a) >/=45 mg/dl participated in this 12-week study. Initially, all patients received oral gemfibrozil 600mg twice daily. At 4-week intervals, the dose was increased by 600mg for patients able to tolerate the increase up to a maximum of 2400 mg/day.

RESULTS: Eight patients completed the study. Three of these patients met the predetermined criterion of a clinically meaningful Lp(a) reduction of 33%. The mean percentage change in Lp(a) was not statistically significant with values of -18.3 +/- 15.4% (p = 0.14, 1-tailed). All patients demonstrated a significant decrease in plasma triglycerides. The mean percentage change was -62.5 +/- 1.8% (p < 0.001, 1-tailed). The mean percentage change in total cholesterol was -12.4 +/- 3.8% (p = 0.007, 1-tailed). Gemfibrozil was considered suspect in five of 16 adverse events reported, but only one of these (dyspepsia) caused withdrawal from the study. For all patients participating in the study no adverse event was characterised as severe.

CONCLUSION: While the small number of patients does not allow any definitive conclusion on effectiveness to be drawn, the results suggest that further randomised studies utilising larger patient numbers appear warranted.

References

  1. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):713-9 - PubMed
  2. Biochem J. 1994 Nov 15;304 ( Pt 1):27-30 - PubMed
  3. Am J Cardiol. 1991 May 15;67(13):1039-145 - PubMed
  4. Clin Chem. 1986 Jan;32(1 Pt 1):63-6 - PubMed
  5. Circulation. 1997 Jan 21;95(2):295-6 - PubMed
  6. Monogr Atheroscler. 1986;14:145-9 - PubMed
  7. Arterioscler Thromb Vasc Biol. 1996 Mar;16(3):471-8 - PubMed
  8. Circulation. 1994 Oct;90(4):1688-95 - PubMed
  9. J Lipid Res. 1996 Jun;37(6):1298-308 - PubMed
  10. Clin Chem. 1984 Mar;30(3):352-6 - PubMed
  11. JAMA. 1992 Feb 26;267(8):1109-12 - PubMed
  12. Ann Pharmacother. 1994 Mar;28(3):343-51 - PubMed
  13. Arterioscler Thromb Vasc Biol. 1996 Dec;16(12):1568-72 - PubMed
  14. JAMA. 1994 Apr 6;271(13):999-1003 - PubMed
  15. Cardiovasc Drugs Ther. 1995 Apr;9(2):347-50 - PubMed
  16. Circulation. 1995 Feb 15;91(4):948-50 - PubMed
  17. Arterioscler Thromb Vasc Biol. 1995 Jul;15(7):850-5 - PubMed
  18. Clin Chem. 1983 Dec;29(12):2026-30 - PubMed
  19. Arch Intern Med. 1997 Jun 9;157(11):1170-6 - PubMed
  20. Atherosclerosis. 1996 Jul;124 Suppl:S75-81 - PubMed
  21. J Lipid Res. 1995 Jun;36(6):1294-304 - PubMed
  22. JAMA. 1992 Jun 24;267(24):3326-9 - PubMed
  23. JAMA. 1996 Aug 21;276(7):544-8 - PubMed
  24. Eur J Clin Invest. 1994 Jul;24(7):444-53 - PubMed
  25. Arch Intern Med. 1997 Jun 9;157(11):1161-2 - PubMed

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