Study looks at safety of contraceptive pills

Study looks at safety of contraceptive pills

- More than 85,000 women involved in study
- Blood clots a major study focus
- Similar risk of blood clots across all contraceptive pills studied, including Yaz and Yasmin 1

Auckland, November, 2014 - A new international study into the safety of oral contraceptive pills has found no significant difference in risk between different types of pill.1

This is good news for New Zealand women following suggestions that some contraceptive pills, such as Yaz and Yasmin, may increase risks of blood clots more than other contraceptive pills.2,3

The study, known as the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC), analysed data from more than 85,000 women in the United States and Europe.1

It is the largest study to date to investigate the safety of oral contraceptive pills and, importantly, to look at the number of venous blood clots also known as VTEs (venous thromboembolism) occurring on pills containing different progestins.

VTE is a rare and potential life threatening event. For women the risk of developing a VTE is dependent on a number of factors. Some of these include age, being overweight and obese, having given birth in the last few weeks or having a positive family history. Having major surgery or trauma, prolonged immobilisation or a long haul flight are also risk factors.4

In addition, it has been known for some time that taking the oral contraceptive pill increases the risk of VTE due to the oestrogen component. However, evidence has been conflicting as to whether different progestins in the pill confer different risks.

“We now have definitive evidence from this large, multicentre, prospective study that there is no difference in risk of thromboembolic events for the different progestins used in the combined oral contraceptives” said Dr Meyer, an Auckland gynaecologist and obstetrician.

“For women assessed to be appropriate candidates for the use of the combined oral contraceptive, it is reassuring to know that drospirenone-containing combined oral contraceptives can safely be given as an option.” Dr Meyer added.

ABOUT INAS-OC

The International Active Surveillance Study of Women Taking Oral Contraceptives investigated the general and cardiovascular risks of short- and long-term use of an extended 24-day regimen of drospirenone and ethinylestradiol compared to established oral contraceptives (OCs) in a routine clinical setting. It was designed as a large, transatlantic, controlled, prospective, observational, active surveillance study. Specific exclusion criteria were not applied due to the ‘non-interference’ approach – to achieve a study population that is representative of actual users of different pill types. All self-reported clinical outcomes of interest, e.g. VTE, were validated via attending physicians and relevant source documents. VTE events were verified by independent, blinded adjudication. The study was requested by the Federal Drug Administration and the European Medicines Agency and funded by Bayer, a manufacturer of hormonal contraceptives. The geographical region (USA or Europe) had no substantial impact on the relative risk estimates (despite large variances in mean weight and BMI, smoking levels and concomitant medication use).

Number of study centres 2,285 (USA, Austria, Croatia, Germany, Italy, Poland and Sweden)
Number of enrolled women 85,109
DRSP24d = 15,542 (18.3%)
DRSP21d = 9,377 (11.0%)
Non-DRSP = 60,190 (70.7%) of which LNG = 10,254 (12.0%)
Loss to follow-up 3.3% (low)
Duration of study 2-6 years
Woman years of observation 206,296

The results indicate that:
1. DRSP24d, DRSP21d, non-DRSP and LNG (levonorgestrel) OC* use showed similar incidence rates of venous and arterial thromboembolism (and other serious adverse events)
2. VTE incidence rates for DRSP24d, DRSP21d, non-DRSP and LNG were: 7.2, 9.4, 9.6 and 9.8 VTE/10,000 woman years (year of reproductive life) respectively
3. Adjusted hazard ratios for DRSP24d vs. non-DRSP and DRSP24d vs. LNG were 0.8 (95% confidence interval (CI) 0.5-1.3) and 0.8 (95% CI, 0.4-1.5)
4. Overall, the VTE risk for OC users was about three times higher (2.9) than that for non-pregnant non-users.

* DRSP24d Extended 24-day regimen of drospirenone and ethinyloestradiol; Marketed as YAZ® in New Zealand
DRSP 21d 21 day regimen of drospirenone and ethinylestradiol; Marketed as Yasmin® in New Zealand
Non-DRSP Oral contraceptives without drospirenone
LNG Oral contraceptives containing levonorgestrel; Marketed as Ava 30®, Levlen®, Microgynon 30®, Monofeme® in New Zealand

ENDS

Notes to editor: The International Active Surveillance Study of Women Taking Oral Contraceptives study was funded by Bayer, a manufacturer of hormonal contraceptives. The study was supervised by an Independent Safety Monitoring and Advisory Council with full authority over the study (including study protocol, protocol amendments, data analysis and stopping the study). The funder had no access to the source data and did not participate in designing the study or analysing the data.

Dr Lisa Meyer did not receive any remuneration nor honorarium in exchange for comment. Dr Meyer is a Specialist Obstetrician and Gynaecologist and current Director at Omnicare Women's Health and Sonelle Women's Ultrasound in Auckland.

Bayer: Science For A Better Life
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

REFERENCES:
1. Dinger J., Bardenheuer K. and Heinemann K. Cardiovascular and general safety of a 24-day regimen of drospirenone-containing combined oral contraceptives: final results from the International Active Surveillance Study of Women Taking Oral Contraceptives. Contraception. 2014; 89: 253 – 263.
2. Parkin L., Sharples K., Hernandez R., Jick S. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone and levonorgestrel: nested case-control study based on UK General Practice Research Database. British Medical Journal. 2011; 340: d2139.
3. Lidegaard O., Nielsen L., Skovlund C., Skjeldestad F., Lokkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different types of progestogens and oestrogen doses: Danish cohort study, 2001-9. British Medical Journal. 2011; 343: d6423.
4. Yaz Data Sheet. Access from www.medsafe.govt.nz on the 8th August 2014.

YAZ® The active tablets of YAZ contain 20 mcg ethinyloestradiol and 3 mg drospirenone. Use strictly as directed. YAZ is used as an oral contraceptive to prevent pregnancy. YAZ is also used for women with premenstrual dysphoric disorder (PMDD) and for women with moderate acne who also require oral contraception. YAZ is not to be used if you have, or have had a blood clot in the legs, lungs, heart, brain or any other part of the body. YAZ is not to be used if you have, or have had angina, a mini-stroke, liver tumours, severe liver disease, severe kidney disease, cancer of the breast or reproductive organs, migraine, pancreatitis, diabetes mellitus with blood vessel damage, unexplained vaginal bleeding, during pregnancy or where there may be an allergy to any of the ingredients of the preparation. Precaution is required when used in circulatory disorders, diabetes, increased blood potassium levels, Crohn’s disease, ulcerative colitis, hereditary angioedema, chloasma (yellowish-brown pigmentation of the skin), breast feeding and medical conditions known to deteriorate during pregnancy. It is important to discuss the possibility of rare but serious events such as a blood clot, with your doctor. Some of the risk factors for a blood clot include, cigarette smoking, age, obesity, high blood pressure, migraine, prolonged immobilisation, high cholesterol, surgery, heart valve disease, atrial fibrillation and a family history of blood clotting disorders. Common side effects are similar to other oral contraceptives and include headache, nausea, abdominal pain, weight gain, depressed or altered mood, breast pain or tenderness. Refer to pack for starting instructions and advice regarding missed tablets. YAZ has risks and benefits. Consult your doctor to see if this medicine is right for you. Always read the label and use only as directed. If symptoms persist or you have side effects, see your doctor. YAZ is an unfunded Prescription Medicine. A pharmacy charge, as well as normal Doctor’s visit fees will apply. Further information is available from the Consumer Medicine Information at www.medsafe.govt.nz or phone 0800 233 988, Bayer HealthCare Pharmaceuticals, Bayer New Zealand Limited PO Box 2825, Shortland Street, Auckland 1140.

YASMIN® The active tablets of YASMIN contain 30 mcg ethinyoestradiol and 3 mg drospirenone. Use strictly as directed. YASMIN is used as an oral contraceptive to prevent pregnancy. YASMIN is not to be used if you have, or have had a blood clot in the legs, lungs, heart, brain or any other part of the body. YASMIN is not to be used if you have, or have had angina, a mini-stroke, severe kidney disease, migraine, diabetes mellitus with blood vessel damage, pancreatitis, severe liver disease or liver tumours, cancer of the breast or reproductive organs, unexplained vaginal bleeding, during pregnancy or where there may be an allergy to any of the ingredients of the preparation. Precaution is required when used in circulatory disorders, diabetes, increased blood potassium levels, Crohn’s disease, ulcerative colitis, hereditary angio-oedema, chloasma (yellowish-brown pigmentation of the skin), breastfeeding and medical conditions known to deteriorate during pregnancy. It is important to discuss the possibility of rare but serious events such as a blood clot with your doctor. Some of the risk factors for a blood clot include, cigarette smoking, age, obesity, high blood pressure, high blood pressure, migraine, prolonged immobilisation, high cholesterol, surgery, heart valve disease, atrial fibrillation and a family history of blood clotting disorders. Common side effects are similar to other oral contraceptives and include headache, nausea, abdominal pain, weight gain, depressed or altered mood, breast pain or tenderness. Refer to pack for starting instructions and advice regarding missed tablets. YASMIN has risks and benefits. Consult your doctor to see if this medicine is right for you. Always read the label and use only as directed. If symptoms persist or you have side effects, see you doctor. YASMIN is an unfunded Prescription Medicine. A pharmacy charge, as well as normal doctor’s visit fees will apply. Further information is available from the Consumer Medicine Information at www.medsafe.govt .nz or phone 0800 233 988. Bayer HealthCare Pharmaceuticals, Bayer New Zealand Limited, PO Box 2825, Shortland Street, Auckland 1140.

TAPS NA7472, URTEX L.NZ.11.2014.0191

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