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Contraception. Key slides 2 Newer agents: Yasmin, Qlaira ▼ , Cerazette, Evra, NuvaRing ▼ , ellaOne ▼. Types of hormonal contraceptives (1). Combined hormonal contraceptives Combined oral contraceptive (COC): Usually ethinylestradiol combined with a progestogen (1/2/3/4 generation)

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contraception

Contraception

Key slides 2

Newer agents:

Yasmin, Qlaira▼, Cerazette, Evra, NuvaRing▼,

ellaOne▼

types of hormonal contraceptives 1
Types of hormonal contraceptives (1)

Combined hormonal contraceptives

Combined oral contraceptive (COC):

  • Usually ethinylestradiol combined with a progestogen (1/2/3/4 generation)

Transdermal preparation

  • ethinylestradiol with norelgestromin [an active metabolite of norgestimate] (Evra®)

Vaginal preparation

  • ethinylestradiol with etonogestrel (NuvaRing®▼)
types of hormonal contraceptives 2
Types of hormonal contraceptives (2)

Progestogen-only contraceptives

Progestogen-only pill (POP)

  • norethisterone (e.g. Micronor®), etynodiol diacetate (Femulen®), levonorgestrel (Norgeston ®), desogestrel (Cerazette®)
  • suitable when COCs unsuitable (e.g. predisposition to VTE)
  • higher failure rate than COCs

Parenteral progestogen-only contraceptive

  • Injection: medroxyprogesterone acetate (Depo-Provera®), norethisterone enantate (Noristerat®)
  • Implant: etonogestrel (Implanon®)

Progestogen-only intra-uterine device (IUD)

  • Levonorgestrel (Mirena®)

Emergency hormonal contraceptives

  • Levonorgestrel (Levonelle®)
  • Ulipristal acetate (ellaOne®▼)
do the newer cocs offer any advantages
Do the newer COCs offer any advantages?

Yasmin and Qlaira▼

  • No conclusive evidence of advantages over other COCs
  • Would seem to be little additional benefits for increased costs
yasmin
Yasmin

Yasmin® (ethinylestradiol 30microgram / drospirenone 3mg), £14.70 for 3 months (March 2010)

“Yasmin is an option for those women suitable for a COC. However, current evidence indicates that on a population level, Yasmin has no conclusive advantages over other standard strength COCs.”

MeReC Bulletin Volume 17, Number 2, November 2006

  • Not recommended for use within NHS Scotland
    • no evidence that Yasmin superior to other COCs on acne, pre-menstrual symptoms or well-being
    • statistically significant favourable weight change compared to standard COCs comes at substantially increased cost and no evidence that patients who discontinue COCs tolerate Yasmin any better
    • Yasmin is substantially more expensive than competitor products and provides little additional benefits for this additional cost

Scottish Medicines Consortium, March 2003

qlaira ukmi new medicines profile november 2009
Qlaira▼UKMI. New Medicines Profile. November 2009

Qlaira®▼ (estradiol valerate / dienogest in complex quadriphasic dosage regimen), £25.18 for 3 months (March 2010)

  • continuous 28-day cycle of 26 active tablets followed by 2 placebo tablets; missed pill advice is complex
  • Contraceptive effectiveness similar to other COCs
  • Side effects and tolerability comparable to other COCs
  • Fewer women had withdrawal bleeding with Qlaira than COC (advantage or disadvantage; ruling out pregnancy)
  • No long-term safety data
  • Not recommended for use within NHS Scotland
    • in the absence of a submission from the marketing authorisation holder

Scottish Medicines Consortium, September 2009

what did dtb say about qlaira dtb 2010 48 102 105
What did DTB say about Qlaira▼?DTB 2010;48:102-105
  • Concluded that they cannot recommend Qlaira for the following reasons:
    • Only one comparative study of Qlaira has been fully published, and this did not use contraceptive efficacy as a primary outcome measure, whilst the comparator COC in the trial did not contain the recommended starting dose of oestrogen
    • No advantages have been demonstrated for Qlaira over standard COCs in terms of efficacy or unwanted effects, and no long-term safety data are available for the drug
    • The dose regimen is potentially confusing and particularly complicated for dealing with missed pills
    • Qlaira is more expensive than other COCs
does the newer pop offer any advantage
Does the newer POP offer any advantage?

Cerazette

  • No conclusive evidence that more effective than standard POPs
  • Reserve for women who want POP but find strict 3-hour regimen of standard POPs difficult to keep
  • Parenteral and intra-uterine progestogen-only contraceptives also an option here
cerazette which pop rdtc drug update sep 2007
CerazetteWhich POP? RDTC. Drug Update. Sep 2007

Cerazette® (desogestrel 75 micrograms), £8.68 for 3 months (March 2010)

  • Inhibits ovulation: theoretical improved efficacy vs. standard POPs
  • Has 12-hour ‘missed pill’ window (unlike 3-hour with standard POPs)
  • Limited evidence comparing desogestrel vs. levonorgestrel suggests contraceptive efficacy NOT significantly different
    • desogestrel Pearl Index 0.41, levonorgestrel Pearl Index 1.55 (difference NS)

Cerazette. New Drug Evaluation. RDTC. May 2003

  • No published studies vs. COCs for efficacy / ovulatory inhibition

“As desogestrel is more expensive than standard POPs, reserve for women who find strict regimen of standard POPs difficult to keep to. Parenteral/intra-uterine progestogen-only contraceptives also option here”

what about the newer transdermal and vaginal combined hormonal products
What about the newer transdermal and vaginal combined hormonal products?

Evra and NuvaRing▼

  • Similar contraceptive effectiveness to COCs
    • Evra – possibly better compliance, but more discontinuations (due to adverse events) than COCs
    • NuvaRing – possibly better cycle control and less adverse events than COCs
  • Reserve for women dissatisfied with oral contraceptives, particularly if compliance a problem with COCs
  • Other options here include parenteral and intra-uterine progestogen-only contraceptives and non-hormonal methods of contraception
slide12
Evra
  • Evra® (transdermal patch releasing ethinylestradiol 33.9 micrograms and norelgestromin 203 micrograms per 24 hrs), £15.63 for 3 months (March 2010)
  • “Evra may be an option for some women who wish to use a reversible hormonal method of contraception and are experiencing compliance problems with COCs. However, routine prescribing of Evra in place of COCs is not supported by the evidence to date.”

MeReC Bulletin Volume 17, Number 2, November 2006

  • Recommended for restricted use within NHS Scotland
    • efficacy and adverse-effect profile similar to COCs
    • some evidence of improved overall compliance compared with COCs, but more expensive
    • Evra may be of benefit in women with substantial risk of poor compliance with COCs; restricted to this group

Scottish Medicines Consortium, September 2003

how does evra compare with cocs
How does Evra compare with COCs?
  • Contraceptive effectiveness similar with patch and COC (5RCTs)
  • More compliant cycles with patch than COC
  • More early discontinuations with patch than COC
  • More discontinuations due to adverse events with patch than COC
    • more breast discomfort, dysmenorrhoea, nausea and vomiting

Lopez LM, et al. Skin patch and vaginal ring versus COCs for contraception. Cochrane Database of Systematic Reviews 2010

  • Risk of VTE in users of Evra may be slightly increased compared with second generation COCs
    • Evra vs. COCs containing levonorgestrel

OR 1.4, 95%CI 0.9 to 2.3 (unpublished)

Drug Safety Update April 2008

slide14
NuvaRing▼London New Drugs Group. APC/DTC Briefing Document. March 2008Scottish Medicines Consortium, September 2009
  • NuvaRing®▼(vaginal ring delivering ethinylestradiol 15 micrograms and etonogestrel 120 micrograms per 24 hrs), £27.00 for 3 months (March 2009)
  • One ring inserted vaginally for 3-week duration, followed by 7-day ring-free break
  • Contraceptive efficacy similar to COCs
  • Possibly better cycle control with NuvaRing than COCs
  • Similar overall tolerability with NuvaRing and COCs, but
    • more device related problems with NuvaRing and less nausea
  • Accepted for use within NHS Scotland
    • for women dissatisfied with oral contraceptives, a second-line option along with other alternatives already available
    • other non-oral contraceptives available at lower cost
    • may be particularly suitable where compliance a problem with COC
how does nuvaring compare with cocs
How does NuvaRing compare with COCs?
  • Contraceptive effectiveness similar with vaginal ring and COCs (10 RCTs)
  • Cycle control similar or better with vaginal ring than COC
  • Generally similar discontinuation with vaginal ring and COC
  • Generally fewer adverse events with vaginal ring than COC
    • Less nausea, acne, irritability and depression with vaginal ring
    • More vaginitis and leukorrhoea with vaginal ring
    • Bleeding problems generally similar or less common with vaginal ring

Lopez LM, et al. Skin patch and vaginal ring versus COCs for contraception. Cochrane Database of Systematic Reviews 2010

  • Contraceptive efficacy with NuvaRing similar to COCs
    • NuvaRing Pearl Index 1.23, Microgynon 30 Pearl Index 1.19 (difference NS)
    • NuvaRing Pearl Index 0.25, Yasmin Pearl Index 0.99 (difference NS)

London New Drugs Group. APC/DTC Briefing Document. March 2008

what about the newer emergency hormonal contraceptive product ellaone
What about the newer emergency hormonal contraceptive product, ellaOne▼?
  • Levonelle® (levonorgestrel 1.5mg)
    • 1 tablet taken preferably within 12 hours of unprotected sex but no later than 72 hours
  • Non-hormonal IUD
    • Copper IUD can be inserted up to 120 hours (5 days) after unprotected sex
  • ellaOne®▼ (ulipristal acetate 30mg)
    • 1 tablet taken as soon as possible, but no later than 120 hours (5 days) after unprotected sex
slide17
ellaOne▼London New Drugs Group. APC/DTC Briefing Document. September 2009Scottish Medicines Consortium, January 2010

ellaOne®▼ (ulipristal acetate 30mg), £16.95 for 1 tablet (March 2010)

  • Ulipristal is a selective progesterone receptor modulator (SPRM) licensed for emergency contraception up to 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure
  • Primary mode of action thought to be inhibition of ovulation

Accepted for use within NHS Scotland

  • But other treatments are available at lower drug acquisition cost
  • Ulipristal at least as effective as levonorgestrel; similar side effect profile
  • Ulipristal licensed up to 120 hours
    • levonorgestrel up to 72 hours; IUD up to 120 hours, but low uptake
  • Ulipristal ‘POM’ only
    • levonorgestrel ‘POM’ and ‘P’ allowing supply through prescription, patient group direction or OTC sale
rct of ulipristal acetate vs levonorgestrel glasier af et al lancet 2010 375 555 62
RCT of ulipristal acetate vs. levonorgestrelGlasier AF, et al. Lancet 2010;375:555-62
  • Primary endpoint: pregnancy rate in women receiving EC within 72 hours
    • Ulipristal non-inferior to levonorgestrel
    • 1.8% with ulipristal vs. 2.6% with levonorgestrel

(OR 0.68, 95%CI 0.35 to 1.31)

  • In women who received EC 72 to 120 hours after unprotected sex, ulipristal prevented significantly more pregnancies (P=0.037)
summary 1
Summary (1)

Newer COCs: Yasmin and Qlaira▼

  • Little additional benefits for increased costs

Newer POP: Cerazette

  • No conclusive evidence that more effective than standard POPs
  • Reserve for women who want POP but find strict regimen difficult
  • Remember other options here (e.g. parenteral / intra-uterine progestogen-only contraceptives)
summary 2
Summary (2)

Newer non-oral combined hormonal contraceptives: Evra and NuvaRing▼

  • Similar contraceptive effectiveness to COCs
  • Reserve for women dissatisfied with oral contraceptives, particularly if compliance a problem with COCs
  • Remember other options here (e.g. parenteral/intra-uterine progestogen-only contraceptives and non-hormonal methods)

Newer EHC: ellaOne▼

  • Licensed for use for up to 5 days (120 hours) after unprotected sex
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