1. seuraavan sukupolven pikainsuliini Eurooppaan.
Eräs haaste diabeteksen hoidossa on insuliinin hidas vaikutusaika. Joskus insuliini unohtuu pistää ennen ruokailua ja verensokeri nousee turhan korkealle aterian jälkeen, koska pikainsuliini vaikuttaa hitaasti. Lääkealan yritykset kehittelevät seuraavan sukupolven ultranopeaita ateriainsuliineja. Ensimmäinen niistä on hyväksytty Euroopan ja Kanadan markkinoille.
Novo Nordisk:in uusi ultranopea pikainsuliini Fiasp®(fast-acting insulin aspart) , hyväksyttiin lääkekäyttöön Euroopassa tammikuussa 2017.
Fiasp vaikuttaa yhtä tehokkaasti 20 minuuttia aterian jälkeen pistettynä kuin Novorapid® , ennen ateriaa pistettynä. Tunti ruokailun jälkeen Fiasp®laskee verensokeria 1-2 m/mol enemmän kuin Novorapid®, samassa ajassa.
Edit:
Fiaspin on todettu tehoavan 4-kertaa tehokkaammin 15 minuuttia pistoksesta ja 2-kertaa tehokkaammin 30 minuuttia pistoksesta kuin Novorapid samassa ajassa. Tämä Iso-Britannian testien perusteella.
Fiasp®on samaa pikavaikutteista Aspart-insuliinia kuin NovoRapid®, mutta siihen on lisätty 2 "lisäainetta", jotka nopeuttavat(/tehostavat?) ateriainsuliinin vaikutusta.
Lääkeyhtiön varajohtaja Krogsgaard tiedotteessa totesi , että kyseessä on yhtä suuri muutos kuin reilu vuosikymmen sitten siirtyminen ihmisperäisistä insuliineista geenimuokattuihin lääkkeisiin.
yli 2000 diabeetikon tutkimuksessa Fiasp® laski pitkääsokeria (HbA1c) ja se laski aterianjälkeisiä verensokeritasoja , yhtä turvallisesti kuin nykyinen Aspart-insuliini NovoRapid®.
Lääkeyhtiön mukaan Fiasp® saapuu markkinoille vuoden 2017 aikana.
Sitä milloin Fiaspia Suomessa saa?
Ja milloin se on Kelakorvattavien insuliinien joukossa? Ei varmaan kukaan osaa arvata.
Odotan mielenkiinnolla tosielämän kokemuksia, niin arjessa kuin juhlissa.
-Jan
Tim, (UK) on jo testailemassa.
https://m.facebook.com/?_rdr#!/photo.php?fbid=10154300262170703&id=512055702&set=gm.1442913342405610&source=57&refid=18&__tn__=E
Tutkimus uuden Aspart-insuliinin vaikutuksesta verensokerinlaskemiseen aterian jälkeen.
"
Fiasp® is insulin aspart (NovoRapid®) in a new formulation, in which two new excipients have been added to ensure earlier, greater and faster absorption, thereby providing earlier insulin action. The review of Fiasp® was based on the onset programme, a phase 3 clinical programme comprising of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.
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"Fiasp is a faster formulation of insulin aspart (Novolog/NovoRapid). It is able to provide “earlier, greater and faster absorption, thereby providing earlier insulin action.”
The executive vice president and chief science officer of Novo Nordisk, Mads Krogsgaard said in the press release that, “The incremental benefits with Fiasp® are comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago.”----------------------------------
Krogsgaard is referring to how faster insulin analogs were introduced a little over a decade ago and we saw a great improvement in blood sugar management surrounding meals over the older Regular human insulin. Now it looks like the age of ultra-fast rapid-acting insulin is upon us and bringing another potential improvement in blood sugar management."
https://diatribe.org/fiasp-faster-acting-mealtime-insulin-approved-europe
"Fiasp, a new “next-generation,” faster-acting mealtime insulin, recently received approval from the European Medicine’s Agency (EMA), Europe’s equivalent of the US FDA. Fiasp is a more rapid-acting version of Novo Nordisk’s currently available NovoRapid insulin (known as NovoLog in the US).
The new insulin is expected to become available in Europe in the first half of 2017. Novo Nordisk will sell it in vials, refillable PenFill pens, and pre-filled disposable FlexTouch pens. Pricing information for Fiasp is not yet available – diaTribe would imagine that when it’s approved in the US, it will be at least a little more expensive than Novo Nordisk’s Novolog, but in the EMA, it may be lower (this is pure speculation).
In the US, Fiasp is expected to be resubmitted to the FDA in Spring 2017, with an approval hopefully expected by the end of the year. Last fall, the FDA requested further safety information about the drug. As diaTribe understands it, Novo Nordisk’s recent meetings with with the FDA have been highly constructive, and the company committed to sending all the information needed to the FDA by May 6. diaTribe also looks forward to hearing what people with diabetes think of the new insulin when they try it – even if the changes are small, current insulins have many potential areas of improvement.
Perhaps most exciting is that Fiasp taken 20 minutes after the start of a meal has been shown to manage blood glucose levels as well as NovoRapid taken just before mealtime – a meaningful convenience win for those “I forgot to take my insulin!” moments. Taking Fiasp before meals is still the recommended option, but according to many people with diabetes with whom diaTribe speaks, “life happens”, and this dosing flexibility is a welcome feature, all else equal.
Compared to those using NovoRapid, Fiasp users also saw slight A1c improvements in studies, without a higher likelihood of severe hypoglycemia. Moreover, blood glucose levels an hour after mealtime averaged about 10 mg/dl lower in people taking Fiasp than in those taking NovoRapid. This probably equates to overall better “time in zone” and better “outcomes beyond A1c” – diaTribe looks forward to seeing this real-world data."
European public assessment report