Showing papers by "Robert L. Reid published in 2010"

Oral Contraceptives and Venous Thromboembolism: Consensus Opinion from an International Workshop held in Berlin, Germany in December 2009

Abstract: This document provides the consensus opinion from an international workshop regarding oral contraceptives and the risk of venous thromboembolism (VTE). It discusses the background and purpose of the workshop the benefits and risks of oral contraceptives describes the serious complication of VTE and assesses the VTE risks of new oral contraceptive products. It also includes information on recently published studies focused on oral contraceptives and VTE.

Oral Contraceptives and the Risk of Venous Thromboembolism: An Update

Abstract: Objective To provide current and emerging evidence on oral contraceptives and the risk of venous thromboembolism. Evidence Articles published in English from 2005 were retrieved through searches of PubMed and Medline, using the following terms: venous thromboembolism, VTE, contraception, oral contraceptives, hormonal contraception. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis and incorporated in the guideline to May 2010. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The quality of evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table). Summary Statements 1.Modern oral contraceptives offer highly effective contraception and a range of non-contraceptive benefits. (I) 2.Venous thromboembolism, although rare, remains one of the serious adverse consequences of hormonal contraception. Best evidence indicates that venous thromboembolism rates in non-users of reproductive age approximate 4–5/10 000 women per year; rates in oral contraceptive users are in the range of 9–10/10 000 women per year. For comparison, venous thromboembolism rates in pregnancy approach 29/10 000 overall and may reach 300–400/10 000 in the immediate postpartum period. (II-1) 3.Research demonstrates that oral contraceptives with ≤ 35 μg of ethinyl estradiol carry a lower risk of venous thromboembolism than oral contraceptives with 50 μg. (II-2) Although preliminary data suggest a possible further reduction in venous thromboembolism with oral contraceptives with 4.Recent contradictory evidence and the ensuing media coverage of the venous thromboembolism risk attributed to the progestin component of certain newer oral contraceptive products have led to fear and confusion about the safety of oral contraceptives in general and drospirenone-containing oral contraceptives in particular. "Pill scares" of this nature have occurred in the past, with panic stopping of the pill, increased rates of unplanned pregnancy, and no subsequent decrease in venous thromboembolism rates. (II-3) 5.Two high quality research studies that addressed the venous thromboembolism risk associated with various oral contraceptives found comparable venous thromboembolism rates with drospirenone-containing oral contraceptives and other approved products. (II-1) 6.Two reports suggesting an increased risk of venous thromboembolism with drospirenone-containing oral contraceptives have significant methodological flaws that render their conclusions suspect. It seems likely that residual confounding could have distorted both the results and the conclusions of these reports. (II-3)

Original research article Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada ☆,☆☆

Abstract: Background: The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg. Study Design: Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events. Results: Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively. Conclusions: Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting.