Insulin glargine: Difference between revisions
Removed entire "comment" section; block had no citations; additionally, the study the author cited has not been published; un-cited personal comments are not appropriate in Wikepedia |
EMEA requires further studies |
||
| Line 44: | Line 44: | ||
</blockquote> |
</blockquote> |
||
The authors are careful to point out the limitations of the studies, and state categorically that "Lantus and other insulins do not cause cancer"<ref>http://www.diabetologia-journal.org/cancer.html</ref>. They have communicated their findings to the [[European Medicines Agency|European Medicines Agency (EMEA)]], which states that the results of the four studies were found to be inconsistent, and that a relationship between insulin glargine and cancer can neither be confirmed nor excluded. The Agency’s Committee for Medicinal Products for Human Use (CHMP) is to perform a detailed assessment of the studies’ results and any other relevant information, which will be communicated in due course.<ref>http://www.emea.europa.eu/humandocs/PDFs/EPAR/Lantus/40847409en.pdf</ref> |
|||
==Mechanism of action== |
==Mechanism of action== |
||
Revision as of 21:55, 30 June 2009
 |
| Clinical data | |
|---|---|
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number | |
| DrugBank | |
| CompTox Dashboard (EPA) | |
| ECHA InfoCard | 100.241.126 |
| Chemical and physical data | |
| Formula | C267H408N72O77S6 |
| Molar mass | 6063 g/mol g·mol−1 |
Insulin glargine, marketed by Sanofi-Aventis under the name Lantus, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. Its advantage is that it has a duration of action of 24 hours, with a "less peaked" profile than NPH. Thus, it more closely resembles the basal insulin secretion of the normal pancreatic beta cells. In type 2 diabetes and in combination with a short acting sulfonylurea (drugs which stimulate the pancreas to make more insulin), it can offer moderate control of serum glucose levels. In the absence of endogenous insulin (Type 1 diabetes or depleted type 2), Lantus needs the support of a fast acting insulin taken with food to reduce the effect of prandially derived glucose. It is fasting glucose elevation which more significantly affects HbA1c and thus determines the progression of the long-term complications of diabetes mellitus[citation needed].
The peakless profile of Lantus also enables the dose to be relatively higher than standard NPH insulin. Because standard NPH is normally administered at night, its peak of action tends to coincide with the lower serum glucose levels associated with nocturnal metabolism. This can induce nocturnal hypoglycaemia. Lantus offers the benefit of a more consistent pharmacological dynamic without nocturnal hypoglycaemia. The result of this is a patient who feels more confident and more comfortable with a lower pre-bed and pre-breakfast capillary glucose level.
Lantus is formulated at an acidic pH 4, where it is completely water soluble. After subcutaneous injection of the acidic solute ( which can cause discomfort and a stinging sensation and can be mitigated with the use of the I-port ), the body, at pH 7, slowly neutralizes the solution, causing insulin microcrystals to gradually precipitate from the insulin glargine solution, which then release insulin in biologically active form. This gradual process ensures that small amounts of Lantus are released into the body continuously, giving an almost peakless profile.
Cancer risk suspected
Information regarding an unpublished research paper implies that glargine may be associated with an increased risk for in certain populations. Press Release from Bristol University, UK, on June 26, 2009. Quote from the press release:
The European Association for the Study of Diabetes (EASD) today makes an urgent call for more research into a possible link between use of insulin glargine (an insulin analogue) and increased risk of cancer, following evidence from studies in Germany, Sweden and Scotland.
...The concerns about a possible link between use of Lantus insulin and increased cancer risk were raised by a German study of around 127,000 insulin-treated patients in an insurance database. The research identified a statistically significant link between patients who had used Lantus insulin and those who had been diagnosed with cancer...Of particular note in this study was the finding that the increased risk of cancer was dose-dependent.
...Professors Gale and Smith say...: “A large combined analysis of the best available databases worldwide is the best way forward, and EASD and sanofi-aventis are pledged to carry this investigation forward until we have either confirmed these preliminary observations or, more hopefully, finally put them to rest.”
The authors are careful to point out the limitations of the studies, and state categorically that "Lantus and other insulins do not cause cancer"[1]. They have communicated their findings to the European Medicines Agency (EMEA), which states that the results of the four studies were found to be inconsistent, and that a relationship between insulin glargine and cancer can neither be confirmed nor excluded. The Agency’s Committee for Medicinal Products for Human Use (CHMP) is to perform a detailed assessment of the studies’ results and any other relevant information, which will be communicated in due course.[2]
Mechanism of action
Insulin glargine have substitution of glycine for asparagine at A21 and two arginines added to the carboxy terminal of B chain. This allows insulin glargine to form a precipitate (hexamer) when injected subcutaneously into the patient. It can achieve a peakless level for at least 24 hours.
External links
- Insulin glargine - MedlinePlus
- Lantus website (Sanofi-Aventis)