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The use of a large-scale surveillance system in Planned Parenthood Federation of America clinics to monitor cardiovascular events in users of combination oral contraceptives.
International Journal of Fertility and Women's Medicine. 1999 Jan-Feb; 44(1):19-30.In response to studies reporting an excess of thrombotic events in women who used oral contraceptives (OCs) containing third-generation progestins, the Planned Parenthood Federation of America (PPFA) launched a retrospective review of clients at all PPFA-affiliated centers during 1993-95. During the 3-year study period, 2,265,087 woman-years of OC use were recorded in clinic drug sale records. All OCs prescribed in this period contained 30 or 35 mcg of estrogen and either norgestimate (21.0%), desogestrel (8.9%), norethindrone (46.6%), or levonorgestrel (23.6%) as the progestin. 70 major thrombotic events among clients using OCs (3 vascular complications per 100,000 woman-years of OC use) were reported to PPFA's risk management division during 1993-95; these included 25 cases of deep vein thrombosis, 20 cases of pulmonary embolism, 22 cerebrovascular accidents, and 3 myocardial infarctions. There were 5 deaths (0.22/100,000 woman-years of use), all from pulmonary emboli. The thrombotic event rates were calculated as the relative risk of complication, comparing the risk of each event for one progestin relative to the other three classes of progestins. The overall risk varied from a low of 1.895 events/100,000 woman-years for norgestimate OC users to a high of 3.969 events/100,000 woman-years for desogestrel OC users, but these differences were not statistically significant. In the progestin comparison, desogestrel users showed elevated risks for pulmonary emboli and fatalities, norgestrel use was associated with an increased risk of deep vein thrombosis, and norgestimate an increased risk of deep vein thrombosis and pulmonary embolism. Generally, these four groups of low-dose OCs appear safer than any previously published study has indicated. In part, this may reflect PPFA's careful prescribing guidelines. In addition to following US Food and Drug Administration contraindications, PPFA affiliates do not provide OCs to women over 35 years of age who smoke more than 15 cigarettes a day.
WHO Scientific Group Meeting on Cardiovascular Disease and Steroid Hormone Contraceptives. Reunion du Groupe scientifique OMS sur les maladies cardio-vasculaires et les contraceptifs hormonaux steroidiens.
WEEKLY EPIDEMIOLOGICAL RECORD. 1997 Nov 28; 72(48):361-3.More than 100 million women worldwide are thought to use steroid hormone contraceptive methods, with an estimated 93 million women using combined oral contraceptives (COCs). The composition and use of these contraceptive preparations, especially those of COCs, have changed dramatically over the years. The World Health Organization (WHO) convened a Scientific Group Meeting on Cardiovascular Disease and Steroid Hormone Contraception during November 3-7, 1997, to review current scientific data on the use of steroid hormone contraception as they relate to the risk of myocardial infarction, ischemic and hemorrhagic stroke, and venous thromboembolic disease. The group also reviewed the incidence of cardiovascular disease among women of reproductive age in general, how the effect of risk factors for cardiovascular disease may be changed using hormonal contraceptives, and whether different compositions of COCs have different cardiovascular risk profiles. The group was comprised of the authors of background papers prepared for the meeting and experts from around the world. The scientific group's conclusions are presented. The incidence and mortality rates of all cardiovascular diseases are very low among reproductive-age women. For women who do not smoke, who have their blood pressure checked, and who do not have hypertension or diabetes, the risk of myocardial infarction in COC users is not increased regardless of age. While current users of COCs have a low absolute risk of venous thromboembolism, their risk is still 3-6 times greater than that of nonusers, with the risk probably being highest during the first year of use.
[Sexual abstinence or thrombosis? Comment on the controversy regarding the "third generation pill"] Enthaltsamkeit oder Thrombose? Stellungnahme zur Kontroverse um "Pille der dritten Generation".
FORTSCHRITTE DER MEDIZIN. 1995 Nov 30; 113(33):18, 20.In October 1995 the WHO published the alarming results of an international study about oral contraceptives (OCs) and the risk of venous thrombosis stating that with the use of the third generation of OCs or micropills containing gestodene and desogestrel the risk increases twofold compared with OCs containing other gestagens. However, the Zurich discussion group, composed of German and Swiss hormone researchers, declared that this statement should be taken with a grain of salt. The study reported that 3 cases of thrombosis occur for 100,000 woman years when no OCs are used. When OCs without the above two gestagens are used the incidence of thrombosis increases to 8 cases/100,000 woman years. With the use of these micropills the incidence rose to 17 cases/100,000. The experts interpretation of the differentials was that the common risk factors for thrombosis (obesity, smoking, age, and duration of OC use) were not sufficiently taken into consideration. The original higher dose OCs already produced side effects early on, such as thrombosis, stroke, and heart infarction. Therefore, in the late 1980s the introduction of the new generation of OCs with lower doses seemed to be a welcome solution. The micropill, Femovan by Schering, was put on the market containing .03 mg of ethinyl estradiol (EE) and .075 mg of gestodene, a synthetic, very effective gestagen. The Organon Company introduced another preparation (Marvelon) that contained the same dose of EE and .15 mg of desogestrel. The considerable attention to the putative higher risk of thrombosis posed by these agents was not shared by the European Drug Commission, which did not see any reason for removal of these OCs from the market. The third generation OCs also provide benefits: reduction of bleeding anomalies and cardioprotective effects. Even the increased thrombosis risk is significantly lower than the thrombosis risk posed by pregnancy, delivery, and puerperium.
ADVANCES IN CONTRACEPTION. 1990 Sep; 6(3):169-76.Clinical trials of vaginal rings containing progestins or ethinyl estradiol and progestins by WHO, the Population Council and private firms are reviewed. Contraceptive steroids can be formulated into Silastic vaginal rings because they are released continuously from this material (zero-order kinetics). Vaginal rings have the advantage of avoiding the 1st pass effect on the liver, as well as self- administration, unrelated to the timing of coitus and regulation of withdrawal bleeding with removal for 7 days per cycle. The shell vaginal ring, with an inert core, a layer of Silastic containing the progestogen, and an outer Silastic layer is designed to regulate release by the thickness of the outer layer. The WHO tested rings releasing 200 mcg norethisterone/day resulting in too many menstrual side effects; and 50 mcg/day with too high a failure rate. A ring releasing 20 mcg levonorgestrel is expected to perform well. The Population Council designed rings releasing 152 mcg ethinyl estradiol and 252 mcg levonorgestrel, and 183 mcg ethinyl estradiol and 293 mcg levonorgestrel. These resulted in pregnancy rates of 2/100 woman years, and continuation rates of 50%, but unacceptably adverse lipid effects. Women discontinued for vaginal symptoms. Compared to a similar combined oral pill, the rings offered no advantage. WHO subsequently introduced a ring releasing 20 mcg levonorgestrel: efficacy was 3.8 and continuation over 50%. A new segmented ring with desogestrel is causing fewer androgenic effects and bleeding complaints. Another ring in current trials gives off 120 mcg desogestrel and 30 mcg ethinyl estradiol with no pregnancies and good acceptability in 100 women to date. Availability of Silastic material and quality control in manufacture are seen as obstacles to overcome for mass production of these vaginal rings.