Results of a study to determine the effects of three oral contraceptives on serum lipoprotein levels.

A multicenter, double-blind investigation with random allocations of subjects to Ortho-Novum 1/50 tablets, Ortho-Novum 1/35 tablets, or Modicon tablets (Ortho Pharmaceutical Corporation, Raritan, NJ) was conducted. Each subject remained on the same oral contraceptive (OC) for at least four cycles. Serum high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglyceride, and cholesterol were measured prior to the initiation of OC therapy and were repeated after treatment cycles 2 and 4. There were no significant changes in HDL, LDL, or serum cholesterol levels. Triglyceride levels increased but remained significant only with the lowest dose product. These were no significant differences among the three drugs for the four parameters studied.

Oral contraceptive exposure of amenorrheic women with and without prolactinomas.

The purpose of this study was to determine the extent of oral contraceptive (OC) exposure of women with secondary amenorrhea of hypothalamic-pituitary etiology. In 93 of 126 women with secondary amenorrhea sufficient data were obtained regarding menstrual history and OC exposure: 26 patients had evidence of a prolactinoma, an additional 26 patients had idiopathic hyperprolactinemia without evidence of a pituitary tumor, and 41 had "pure" dysfunction hypothalamic-pituitary amenorrhea. After stratification by age at diagnosis and parity the estimated odds ratio for past oral contraceptive usage showed no differences among the three groups (odds ratios between 0.74 and 1.48). Using the chi-square test the proportion of subjects who had regular menses before oral contraceptive intake and developed anovulation immediately after discontinuance ("post pill amenorrhea") in the three groups also showed no difference (x2 = 0.60, P = 0.74). These data indicate that non-ovulatory patients are likely to have been exposed to OC, and do not indicate that patients with prolactinomas differ in the extent of their OC exposure from other specified groups of patients with secondary.

A statistical methodology for postmarketing surveillance of adverse drug reaction reports.

This paper presents a statistically optimal exact hypothesis testing procedure for detecting changes in sales adjusted adverse drug reaction (ADR) rates between historical and current periods, with a computer program that implements this test appended. We provide discussions and illustrations on how to monitor ADR rates for product lines that consist of several pharmacologically equivalent dosage forms.

Measures of association between disease and genotype.

This paper is concerned with the statistical aspects of the phenomenon of disease occurring more frequently in individuals with some genotypes than in individuals with others. A correlation coefficient is defined to quantify association between disease and genotype. A distinction is made between the concepts of independence of allele and disease and independence of genotype and disease. This distinction is used to define two components of association which describe separate aspects of association of disease with genotype. One component is a measure of the association of disease with allele; the other a measure of the effect of allele interaction on association of disease and genotype. One aspect of the usefulness of the partition into components which is discussed is in expressing the recurrence risk of disease for a relative of an affected individual. A chi-squared analysis is provided to test hypotheses about the components of association and other hypotheses of genetic interest. This analysis is illustrated using a study done to determine the effect of the sex-linked dwarfing gene in male chickens on resistance to E. coli infection. This analysis shows a significant allele interaction effect on resistance to disease but no association of disease with alleles. In conclusion, some extensions and limitations of the proposed concepts and procedures are discussed.