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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

Kakis G
Bay Centre for Birth Control, University of Toronto, Ontario, Canada.
Powell M
No affiliation info available
Marshall A
No affiliation info available
Woutersz TB
No affiliation info available
Steiner G
No affiliation info available

MeSH

AdolescentAdultApolipoprotein A-IApolipoproteins BCholesterolCholesterol, HDLCholesterol, LDLContraceptives, Oral, CombinedContraceptives, Oral, HormonalContraceptives, Oral, SyntheticDrug CombinationsEthinyl EstradiolEthinyl Estradiol-Norgestrel CombinationFemaleHumansLipidsLipoproteinsLipoproteins, LDLLipoproteins, VLDLNorethindroneNorgestrelRisk FactorsTriglycerides

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 -