Medical DevicesEuropean Medicines Agency Update On Safety Of Insulin Glargine
The European Medicines Agency (EMEA) is looking into four recently
published registry studies investigating a possible relationship between
insulin analogues, in particular insulin glargine, and the risk of
cancer. The studies were published on the Diabetologia website on 26
June 2009.
Insulin glargine is a long-acting insulin analogue, authorised in the
European Union (EU) as Lantus and Optisulin, for the treatment of
adults, adolescents and children aged six years or above with diabetes,
when treatment with insulin is required.
The results of the four studies were found to be inconsistent. In two
studies (Scottish Diabetes Research Network Epidemiology Group and
Jonasson et al) an association between breast cancer was found in a
group of patients taking insulin glargine as monotherapy, but not in
another group of patients using insulin glargine together with other
types of insulin. For other cancers, no association was found. In these
two studies dose-dependency was not evaluated. The third study (Hemkens
et al) reported a dose-dependent association between use of insulin
glargine and malignancies. However, no information is available on the
types of cancer found in this study. In the fourth study (Currie et al),
no association between cancer (either breast, colorectal, pancreatic or
prostate cancer) and the use of insulin glargine, or any other insulin,
was found.
On the basis of the currently available data, a relationship between
insulin glargine and cancer cannot be confirmed nor excluded. However,
the concerns raised by the four studies require further in-depth
evaluation.
The Agency"s Committee for Medicinal Products for Human Use (CHMP) will
perform a detailed assessment of the studies" results and any other
relevant information. This review will also address issues, such as
dose-response effects, the implications of the relatively short duration
of the studies and influence of other factors on the risk of breast
cancer and other cancers (e.g. age, body mass index (BMI), menopausal
status, parity, socioeconomic status).
The Marketing Authorisation Holder for Lantus and Optisulin,
Sanofi-Aventis, has been asked to comment on this potential safety
concern.
Patients being treated with insulin glargine are advised to continue
their treatment as normal. At this time there is no recommendation that
patients should change their current treatment. In case of any concerns,
patients should consult their doctor.
Further information will be provided once the CHMP has concluded its
review.
Notes
1. The articles are available online
here.
2. Insulin analogues, such as insulin glargine, are substances that
are similar to human insulin, but with some modifications that change
properties such as the way the insulin is absorbed after injection or
its duration of action.
3. Lantus and Optisulin have been authorised in the European Union
since June 2000. They are marketed in all 27 EU Member States.
4. More information on Lantus and Optisulin is available in the
European Public Assessment Report EPAR. For Lantus, please see here; For
Optisulin, please see here.
European Medicines Agency