Oral Contraceptives: Risks, Benefits & New Regimes

August 3, 2011

ORAL CONTRACEPTIVES: . Objectives . Know the risks, benefits and side effects of oral contraceptives . Utilize basic concepts in OC prescribing . Know how to modify regiments to manage side effects .Objectives .Know the risks, benefits and side effects of oral contraceptives .Utilize basic concepts in OC prescribing .Know how to modify regiments to manage side effects


Oral Contraceptives:


Risks, Benefits & New
Regimes

B. Norman Barwin



ORAL CONTRACEPTIVES:
.
Objectives
.
Know the risks, benefits and side effects of
oral contraceptives
.
Utilize basic concepts in OC prescribing
.
Know how to modify regiments to manage
side effects
.Objectives
.Know the risks, benefits and side effects of
oral contraceptives
.Utilize basic concepts in OC prescribing
.Know how to modify regiments to manage
side effects






ORAL CONTRACEPTIVES

.Low Failure Rate
.Percentage experiencing an accidental
pregnancy in the 1st year of continuous
use:
. Lowest expected 0.1%
. Typical 3.0%




ORAL CONTRACEPTIVES


.Low Incidence of Intolerable Side Effects
. Especially compared to progestin only
methods (irregular bleeding, acne,
weight gain)
. Most side effects resolve in the first 1 to 3  months of use
. Counseling is CRITICAL




ORAL CONTRACEPTIVES

.Serious complications are RARE in healthy
non- smokers
. No increase in stroke/myocardial infarction
. Morbidity increases in the presence of
underlying risk factors: SMOKING, hypertension,
hyperlipidemias, morbid obesity, diabetes
. 3 to 4 fold increase in thrombeombolic events



ORAL CONTRACEPTIVES

.Simple to initiate/Simple to discontinue




ORAL
CONTRACEPTIVES


.Few Contraindications
. Past history of or current
thrombophlebitis or thromboembolic disorders
. Cerebrovascular or coronary artery disease
. Known or suspected carcinoma of the
breast, endometrium, or other
estrogen dependent neoplasia



ORAL
CONTRACEPTIVES

.Few Contraindications
. Undiagnosed abnormal genital bleeding
. Cholestatic jaundice of pregnancy or
jaundice with prior pill use
. Hepatic adenomas or carcinomas
. Known or suspected pregnancy



ORAL CONTRACEPTIVES


.Few Contraindications
. “Warnings” listed in package insert
. Cigarette smoking
. Hypertension
. Hyperlipidemia
. Morbid obesity
. Diabetes




ORAL CONTRACEPTIVES


.Noncontraceptive USES/BENEFITS
. The majority of women are unaware of
most benefits of OC use
. Healthcare providers often neglect to
discuss noncontraceptive benefits




ORAL CONTRACEPTIVES


.Noncontraceptive USES/BENEFITS
. Menstrual cycle symptom control
. Protection of fallopian tube function
. Beneficial effects on the breasts
. Treatment of androgen excess disorders
. Cancer prevention
. Reduction in gynecologic procedures
. Perimenopausal benefits/uses




ORAL CONTRCEPTIVES

.Reduction in Healthcare Costs
. For the patient:
.Less tampons, pads, pain meds, office visits,
procedures
. For the HMO Insurance Company:
.Less visits and procedures
. For the employer:
.Less absenteeism




ORAL CONTRCEPTIVES

.SUMMARY
. Low failure rate
. Low incidence of side effects
. Serious complications are rare
. Simple to initiate and discontinue
. Few absolute contraindications
. Numerous non contraceptive uses/benefits
. Reduction in healthcare costs




ORAL
CONTRACEPTIVES

.SUMMARY
. LONG-TERM USE OF OC’s recommended
because:
. No additional risks with long-term use
. Added benefits with long-term use
. Prevention of gynecological problems with OC’s is
more effective than treatment with OC’s
. Many gynecological problems develop, worsen,
and are less tolerated in the second half of the
reproductive years




REASONS OC’s NOT USED

. Contraindications
. Side effects
. Compliance problems
. Fear/Concern



NEW REGIMENS TO MANAGE
SIDE EFFECTS AND IMPROVE
COMPLIANCE



The Standard 28 Day Regime

.21 Active / 7 Hormone Free
.Until recently, all formulations were a 28 day cycle
. 21 active / 7 hormone free

.Rationale
.To mimic the natural menstrual cycle by inducing
monthly withdrawal bleeding
.Low incidence of breakthrough bleeding

.Drawback
. Monthly withdrawal symptoms



Symptoms During the Pill Free
Interval



Hormonal Withdrawal Symptoms
In Oral Contraceptive Users

.Objective
. Measure the frequency and severity of
symptoms during the pill free interval
compared to the active pill interval



Hormone Withdrawal Symptoms In
Oral Contraceptive Users


.Study Design
. Prospective study of OC users
. 69 new starts: No OC use in last 3
months
. 193 current users: OC use 12 months




Hormone Withdrawal Symptoms In
Oral Contraceptive Users

.Data Collection
. Demographics
. Daily calendars to subjectively record
headaches, pelvic pain, bleeding,
analgesic use, and other
symptomatology




Hormone Withdrawal Symptoms In
Oral Contraceptive Users

.Headaches
.Pelvic Pain
.Bloating and Swelling
.Breast Tenderness



Reasons To Modify The Standard
21/7 OC Regime

.Common estrogen withdrawal symptoms during
the hormone free interval
.Medical disorders:
. Anemia, endometriosis, catamenial,
seizures, etc.
.Convenience/”Forgetability”




Changing The Standard OC
Regime: Current/Future Ideas


.Shorten the hormone free interval from 7 days to
3 to 5 days to provide greater ovarian
suppression and decrease the incidence/severity
of hormone withdrawal symptoms
.Extend the # of days of active OC’s to greater
than 21 days
.Add estrogen during the hormone free interval




Extending The Duration Of Active
Oral Contraceptive Pills to Manage
Hormone Withdrawal Symptoms

.Objective
.Test the hypothesis that extending the number
of consecutive active OC’s will decrease the
frequency of menstrual related problems




Extending The Duration Of Active
Oral Contraceptive Pills to Manage
Hormone Withdrawal Symptoms

.Method
. Prospective analysis of 50 patients on
OC’s who experience hormone withdrawal
symptoms during the pill free interval
and were allowed to extend the number of
consecutive active OC’s




Method of Extending Number of
Active Weeks

.Instructed to take 6 consecutive weeks of active
OC’s followed by a hormone free week
.The interval of active pills was increased by 3
weeks each consecutive cycle (6 wks, 12 wks)
followed by a hormone free week
.If a patient experienced intolerable side effects,
she remained on the regimen that worked best
for her




Study Results Of The 50 Patients*


.37 patients (74%) stabilized on an extended regimen
.6 week 8
. 9 week 13
.12 week 16

.13 patients (26%) not stabilized on an extended
regimen
. Most common reasons
.Breakthrough bleeding
.Breakthrough spotting
.Headaches




Extended OC Regime:

.If initiating OC’s, begin with the standard
regimen for 2 months because of high incidence
of BTB/BTS and other side effects
.Have patient return during the 3rd cycle to
assess compliance/side effects




Extended OC Regime:

.If patient having withdrawal symptoms during
the hormone free interval or wants to delay
menses, discuss extending the active pills
.Instruct to extend pills till BTB/BTS occurs,
take a 4 to 7 day hormone free interval, and
restart (re label pack to correct day of week if
necessary)




Extended OC Regime:

.Warn the patient that she can go off the “real”
pill for less than 7 days but never more than 7
days!!
.Make sure your patient understands and is
comfortable with this extended regimen; if not,
use standard regimen




Extended OC Regime:


.Increases counseling time in the office; your
patient must understand how to extend
.Side effects?? - no extensive data; studies
underway




Extended OC Regime:

.Increased OC cost because more active weeks
per year and potentially more trips to the
pharmacy (prescribe 3 months at a time)
.But, less tampons/pads/analgesics/ migraine
medications, etc.




Extended OC Regime:

.Increased lifetime steroid use, but no theoretical
reason to anticipate increased complications
(i.e.. DVT, MI, stroke, etc.); no extensive data
.No reported increase in complications through
extended regimes used for decades in patients
with endometriosis




What can you do if a patient can’t
or doesn’t want to extend, but has
estrogen withdrawal symptoms
during the hormone free interval?

. ? Add Estrogen ?






CONCLUSION


.Menstrual disorders are common: dysmenorrhea,
menorrhagia, irregular menses, menstrual migraines
.Menstrual disorders are less common in patients on
OC’s, but they still occur in a significant percentage
and can affect compliance
.Modifications of the standard 21 day active / 7 day
hormone free interval and newer formulations will
improve the quality of life for many of our patients