1. Choosing a combination OCP: Comparing risks of PE, MI, & CVA
Andrea Dotson
Lauren Bauer
August 23, 2017

2. Schedule for Today 5 min - Introduction, background
35 min - Group work
10 min - Reporting from groups
5 min - EBM pearl
5 min - Questions, comments
1 min - Evaluation

3. “Mona”
Your patient is a 36 year old female with an unremarkable medical history who presents to discuss birth control with combination (estrogen/progestin) contraceptive pills (COC). She has no previous history of HTN, DM, Cancer, CAD, CVA, or PE. She does not smoke tobacco.
She read about a case in France of a woman who had a stroke after starting a 3rd generation OCP with gestodene (GSD) and ethinyl-estradiol (EE). She wants you to prescribe a COC with the lowest risk of causing CVA, MI, or PE.

4. Background
“In December 2012, a young French woman sued a drug company and the head of the French drug regulatory Agency (ANSM) after she had a stroke with major sequellae when using a third-generation pill containing gestodene (GSD) and ethinyl-estradiol (EE). This case, which received extensive media coverage, has provoked alarm in France (1, 2). Subsequently, contraceptive practices have changed. This case highlighted the risks of vascular thromboembolic diseases associated with pills and, in particular, with the use of newer pills.”
Justine Hugon-Rodin,
Anne Gompel,
and Geneviève Plu-Bureau
MECHANISMS IN ENDOCRINOLOGY: Epidemiology of hormonal contraceptives-related venous thromboembolism Eur J Endocrinol 171 (6) R221-R230, doi: /EJE First published online 10 July 2014

5. Epidemiology
Combined oral contraceptive pills (COCs) are the most common form of reversible birth control in developing countries
Over 100 million women worldwide
COCs are known to increase coagulation factors, triglycerides, LDL, insulin, and decrease glucose tolerance all known risk factors for CVD
Cochrane Review showed 1.6 increased risk of arterial thrombosis among women using COCs compared to those who did not

6. COC Options Estrogen dosing Progestin types
– higher doses increase risk of PE
Formulations from 20 to 50 micrograms
Progestin types
Norethisterone
Levonorgestrel
Desogestrel
Gestoden
Norgestrel

7. Objectives
Formulate a clinically relevant question and identify population, exposure, comparison, outcome, and type of study (PICOT) to address patient question
Find research study to address this question (thank you AFP May 1, 2017)
What are the results of the study
Are the results valid
Apply these results to your patient
AFP May 1 issue mentioned this article as one of the 20 research studies of 2016 for primary care physicians!!

8. Now… Materials distributed Split into 3 groups
Formulate PICOT (5 minutes)
Review abstract, methods, results (10 min)
Complete critical appraisal (20 min)
Report (10 min)
EBM pearl (5 min)
Questions (5 min)
Complete evaluation (1 min)

9. COCs We Prescribe Ethinyl estradiol (mcg) Brand Names Progestin Type
20 mcgm
Alesse, Levlite, Aviane, Lutera, Aubra
levonorgestrel
Yaz, Vestura, Nikki
drospirenone
Microgestin Fe, Loestrin 21 1/20
norethindrone acetate
25 mcgm
Ortho Tri-Cyclen Lo
norgestimate
Cyclessa
desogestrel
30 mcgm
Yasmin, Zarah
Desogen, Reclipsen
Levlen, Levora, Nordette
Seasonale (continuous), Seasonique
35 mcgm
Ortho-Cyclen, MonoNessa, Sprintec
Ortho-Tri-Cyclen, TriNessa
50 mcgm
Norinyl
Ethynodiol diacetate

10. EBM Pearl: OR or RR
Relative risk (RR) is the probability that a member of an exposed group will develop a disease relative to the probability that a member of an unexposed group will develop that same disease
Odds ratio (OR) is the odds of disease among exposed individuals divided by the odds of disease among unexposed
Remember: “Odds” is the probability that the event WILL occur to the probability that the event will NOT occur

11. Calculating Relative Risk Odds Ratio
Ex: The absolute risks of sexual dysfunction w/ venlafaxine and placebo are 20.0% and 8.33%, respectively. RR=20.0/8.33=2.40
Ex: The odds of developing sexual dysfunction with venlafaxine are 8:32 (i.e. 8/32 or 0.25) and the odd of developing sexual dysfunction with placebo are 3:33 (i.e. 3/33 or 0.091). The OR is 8:32/3:33 or 2.75.

12. Interpreting OR and RR RR or OR = 1 RR or OR >1 RR or OR <1
Risk in exposed = risk in non-exposed (RR)
Exposure is not related to disease (OR)
No association
RR or OR >1
Risk in exposed > risk in non-exposed (RR)
Exposure is positively related to disease (OR)
Positive association, ? causal
RR or OR <1
Risk in exposed < risk in non-exposed (RR)
Exposure is negatively related to disease (OR)
Negative association, ? protective

13. When to Use Relative Risk (need incidence) Odds Ratio Cohort study
Randomized controlled trial
Cohort Study
Case Control Study

14. Questions?