Saturday, June 12, 2010

ellaOne, the New Emergency Contraceptive Pill That Confuses the AP to No End

What is so complicate about the emergency contraceptive pill (ECP) that any MSM article about emergency contraception will invariably contain mistakes?

Take this example from a few months ago from the AP, New morning-after pill works for up to 5 days.

The article reports on a study that compared one type of ECP, ellaOne (30 mg ulipristal acetate), with another, NotPlan B (1.5 mg levonorgestrel). [I'll explain the reason for the made-up brand name in a moment.]

Briefly, ellaOne is an ECP from HRA Pharma containing 30 mg of ulipristal acetate, a progesterone receptor modulator that works primarily by delaying inhibiting ovulation. [It also works by delaying ovulation, but it's less effective, depending on the timing of administration.]

Here's what the AP article manages to get wrong (and why it matters):

ellaOne and NotPlan B

International researchers compared Plan B to the new drug ulipristal acetate, sold as ellaOne in Europe only with a doctor's prescription. The drug is not legally on the market elsewhere.

Experts tracked nearly 1,700 women aged 16 to 36 who received emergency contraception within three to five days of having unprotected sex. About half got Plan B while the rest got ellaOne.

So researchers compared Plan B with ellaOne, right? Wrong.

The researchers compared a single dose of 1.5 mg levonorgestrel with one of 30 mg ulipristal acetate. That is, they compared NotPlan B with ellaOne .

Plan B is a two-pill (two 0.75 mg levonorgestrel doses) regimen brand. [The other two-pill brand is Next Choice, the generic for Plan B.]

The one-pill (one 1.5 mg levonorgestrel dose) regimen brands are Plan B One-Step, the i-Pill / Nextime, and Levonelle One Step.

So why does it matter that the article confuses Plan B with Plan B One-Step? After all you can take both Plan B pills at the same time and, voila, one 1.5 mg dose. Two reasons.

First, medicine is not politics or religion. Facts and accuracy count especially when it comes to drug names, dosages, and regimens. A drug's efficacy and safety profile depend on the dosage and regimen. Just because you can use a drug on a modified regimen does not mean that Plan B magically transforms into Plan B One-Step.

Second, Plan B is no more. It has ceased to be. It's expired and gone to meet its maker. The manufacturer has discontinued Plan B and it's replacing it with Plan B One-Step.

On top of an incorrect report on what the researchers studied, the AP misses an opportunity to inform you of the rather important development that Plan B is no longer available. It also misses the opportunity to introduce Plan B One-Step, the replacement, and discuss how it differs from Plan B and what you need to know to use Plan B One-Step properly.

New morning-after [EC] pill works for up to 5 days...just like the old one

From the headline, New morning-after pill works for up to 5 days, to the key paragraph:

LONDON – A new type of morning-after pill is more effective than the most widely used drug at preventing pregnancies in women who had unprotected sex and also works longer, for up to five days, a new study says.

The report was published Friday in the British medical journal, Lancet.

Levonorgestrel, the most widely used emergency contraceptive pill, is only effective if women take it within three days of having sex.

So, the new ECP ellaOne works longer, for up to five days, than the older levonorgestrel brand which is only effective if women take it within three days of having sex, right? Once again, wrong!

First, the statement that levonorgestrel ECP brands are only effective if taken within three days of having unprotected intercourse is flat out wrong.

Both the two-pill regimen [1st pill taken as soon as possible after sex; 2nd dose 12 hrs later] and the one pill regimen [pill taken as soon as possible after sex] are effective if taken within 5 days of having unprotected intercourse.

It goes without saying that you shouldn't wait for 5 days to use ECPs. If you are sexually active and are not planning a pregnancy you should keep the i-Pill / Nextime handy because the sooner you use the ECP, the more effective it is. But since none of us live in Perfect, there will be instances when, for whatever reason, you're not able to take the ECP right after having unprotected intercourse.

It is important for you to know that you have up to 5 days to use ECPs to protect yourself, and it is irresponsible for the AP to give you the wrong information.

Second, the Lancet study did not show that the new ECP ellaOne is better than the levonorgestrel brands. Rather, what it did show was what the study was designed to show, namely that ellaOne was no worse than Plan B One-Step. This may seem like a distinction without a difference, but it's not.

It's quite likely that ellaOne is more effective than the levonorgestrel brands when taken 3 to 5 days after unprotected intercourse but that hasn't been established yet and you should know that when deciding if ellaOne is the best emergency contraceptive option for you.

And since I mentioned that ellaOne (ulipristal acetate, or UPA) might be more effective, here's a bit more detail on that:

The reason [30 mg UPA prevented significantly more pregnancies than did levonorgestrel in the 72-120 hour subgroup] seems to be that UPA can delay ovulation when taken closer to ovulation than can levonorgestrel. By the time the leading follicle reaches 15-17 mm, follicular rupture is prevented within 5 days no more often after levonorgestrel administration than after placebo administration. In contrast, when taken when the leading follicle reaches 18-20 mm (and ovulation should occur within 48 hours) and the probability of conception exceeds 30%, UPA prevents follicular rupture within 5 days of administration in 59% of cycles, compared with 0% in placebo cycles. Follicular rupture failed to occur within 5 days after treatment with UPA in all women treated before onset of the LH surge, in 79% of women treated after the onset of the LH surge but before the LH peak, and in 8% of women treated after the LH peak. Another study found that ulipristal acetate altered the endometrium, but whether this change would inhibit implantation is unknown.

Bottom line: The sooner you take ECP after unprotected intercourse the better. All dedicated ECP brands--Next Choice, Plan B One-Step, i-Pill/Nextime, Levonelle One Step, and ellaOne--work for up to 5 days after unprotected sex. It remains to be seen if ellaOne is more effective in the 3-5 days period. Last, but not least, when you read a MSM article on ECP just assume it's wrong and go form there.

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At 2:06 PM, Anonymous Anonymous said...

well I tried norlevo and it worked for me

At 8:17 AM, Anonymous Anonymous said...

Hi...i wish to know if Norlevo is taken once or you need to take multiple dosage!!


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