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A two-year clinical study of the effects of two triphasic oral contraceptives on plasma lipids.
Int J Fertil Menopausal Stud. 1994 Sep-Oct; 39(5):283-91.IJ

Abstract

OBJECTIVE

Oral contraceptive formulations can alter plasma lipid and lipoprotein levels; however, lower-dose triphasic tablets show only minimal metabolic effects during 6 or 12 cycles of use. Involvement of lipids in chronic cardiovascular conditions, plus long-term use of oral contraceptive tablets, prompted this first 24-cycle study of the effect of triphasic formulations on young women.

METHODS

69 women assigned randomly to an ethinyl estradiol/levonorgestrel formulation (Triphasil) or an ethinyl estradiol/norethindrone formulation (Ortho 7/7/7) and 25 control women (no hormonal contraception) had blood sampled for lipids and lipoproteins pre-trial, and at 3- or 6-cycle intervals for 24 cycles.

RESULTS

At cycle 24, control women experienced no significant change from baseline in any variable except apolipoprotein B (apo B). Plasma apo B increased 42% (P < .01), reflecting the LDL apo B increase (42%, P < .01). Both combination formulations significantly increased apo B (plasma, VLDL, IDL and LDL); the increases ranged between 47% and 84%. Plasma apo A1 rose (15%, P < .001) in the Ortho 7/7/7 group only. Plasma and LDL triglycerides were increased significantly (P < .001) by the norethindrone product, 43% and 81%, respectively, and plasma and LDL cholesterol, 14% and 28%, respectively. Cholesterol decreased in all other subfractions, including HDL (11%, P < .01). HDL cholesterol decreased significantly in the Triphasil group (8%, P < .05); no other cholesterol subfractions changed significantly. All cycle-24 lipid and lipoprotein values remained well within respective normal ranges.

CONCLUSION

Although 2-year exposure to the triphasic oral contraceptive formulations changed the lipid risk factors for cardiovascular disease only within normal ranges, there remains potential for long-term health effects when compounded with other risk factors.

Authors+Show Affiliations

Bay Centre for Birth Control, University of Toronto, Ontario, Canada.No 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

7820162

Citation

Kakis, G, et al. "A Two-year Clinical Study of the Effects of Two Triphasic Oral Contraceptives On Plasma Lipids." International Journal of Fertility and Menopausal Studies, vol. 39, no. 5, 1994, pp. 283-91.
Kakis G, Powell M, Marshall A, et al. A two-year clinical study of the effects of two triphasic oral contraceptives on plasma lipids. Int J Fertil Menopausal Stud. 1994;39(5):283-91.
Kakis, G., Powell, M., Marshall, A., Woutersz, T. B., & Steiner, G. (1994). A two-year clinical study of the effects of two triphasic oral contraceptives on plasma lipids. International Journal of Fertility and Menopausal Studies, 39(5), 283-91.
Kakis G, et al. A Two-year Clinical Study of the Effects of Two Triphasic Oral Contraceptives On Plasma Lipids. Int J Fertil Menopausal Stud. 1994 Sep-Oct;39(5):283-91. PubMed PMID: 7820162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A two-year clinical study of the effects of two triphasic oral contraceptives on plasma lipids. AU - Kakis,G, AU - Powell,M, AU - Marshall,A, AU - Woutersz,T B, AU - Steiner,G, PY - 1994/9/1/pubmed PY - 1994/9/1/medline PY - 1994/9/1/entrez KW - Americas KW - Biology KW - Canada KW - Cardiovascular Effects KW - Cholesterol KW - Clinical Research KW - Comparative Studies KW - Contraception KW - Contraceptive Agents, Estrogen--pharmacodynamics KW - Contraceptive Agents, Female--pharmacodynamics KW - Contraceptive Agents, Progestin--pharmacodynamics KW - Contraceptive Agents--pharmacodynamics KW - Contraceptive Methods--administraction and dosage KW - Developed Countries KW - Ethinyl Estradiol--pharmacodynamics KW - Family Planning KW - Levonorgestrel--pharmacodynamics KW - Lipid Metabolic Effects KW - Lipids KW - Norethindrone--pharmacodynamics KW - Norgestrel--pharmacodynamics KW - North America KW - Northern America KW - Oral Contraceptives, Combined--administraction and dosage KW - Oral Contraceptives, Phasic--administraction and dosage KW - Oral Contraceptives--administraction and dosage KW - Physiology KW - Research Report KW - Risk Factors KW - Studies SP - 283 EP - 91 JF - International journal of fertility and menopausal studies JO - Int J Fertil Menopausal Stud VL - 39 IS - 5 N2 - OBJECTIVE: Oral contraceptive formulations can alter plasma lipid and lipoprotein levels; however, lower-dose triphasic tablets show only minimal metabolic effects during 6 or 12 cycles of use. Involvement of lipids in chronic cardiovascular conditions, plus long-term use of oral contraceptive tablets, prompted this first 24-cycle study of the effect of triphasic formulations on young women. METHODS: 69 women assigned randomly to an ethinyl estradiol/levonorgestrel formulation (Triphasil) or an ethinyl estradiol/norethindrone formulation (Ortho 7/7/7) and 25 control women (no hormonal contraception) had blood sampled for lipids and lipoproteins pre-trial, and at 3- or 6-cycle intervals for 24 cycles. RESULTS: At cycle 24, control women experienced no significant change from baseline in any variable except apolipoprotein B (apo B). Plasma apo B increased 42% (P < .01), reflecting the LDL apo B increase (42%, P < .01). Both combination formulations significantly increased apo B (plasma, VLDL, IDL and LDL); the increases ranged between 47% and 84%. Plasma apo A1 rose (15%, P < .001) in the Ortho 7/7/7 group only. Plasma and LDL triglycerides were increased significantly (P < .001) by the norethindrone product, 43% and 81%, respectively, and plasma and LDL cholesterol, 14% and 28%, respectively. Cholesterol decreased in all other subfractions, including HDL (11%, P < .01). HDL cholesterol decreased significantly in the Triphasil group (8%, P < .05); no other cholesterol subfractions changed significantly. All cycle-24 lipid and lipoprotein values remained well within respective normal ranges. CONCLUSION: Although 2-year exposure to the triphasic oral contraceptive formulations changed the lipid risk factors for cardiovascular disease only within normal ranges, there remains potential for long-term health effects when compounded with other risk factors. SN - 1069-3130 UR - https://www.unboundmedicine.com/medline/citation/7820162/A_two_year_clinical_study_of_the_effects_of_two_triphasic_oral_contraceptives_on_plasma_lipids_ DB - PRIME DP - Unbound Medicine ER -