12th Annual Abracadabra Diabetes Nursing Conference
24th February 2012, The Renaissance Manchester Hotel, Manchester
Progression of type 2 diabetes: Managing your patients appropriately at different stages
12th March 2012, Belstead Brook Hotel, Ipswich
Progression of type 2 diabetes: Managing your patients appropriately at different stages
13th March 2012, Holiday Inn, Brent Cross
Progression of type 2 diabetes: Managing your patients appropriately at different stages
14th March 2012, Ramada Belfast Shaws Bridge, Belfast
The money that was collected for Children in Need at the PCDS National meeting in Birmingham on Friday 18th November totalled £845.00. The PCDS would like to thank all delegates for their generosity.
As the committee of the Primary Care Diabetes Society, we welcome the recent statement from the European Medicines Agency (EMA), which has reviewed pioglitazone-containing medicines following concerns over the occurrence of bladder cancer (EMA, 2011). While finding that the treatments are associated with a small increased risk of bladder cancer, the Agency concluded that they remain a valid treatment option for certain people with type 2 diabetes.
When considering starting pioglitazone:
- People with diabetes should make an informed decision about the drug, which should include a discussion on risks and benefits.
- These medicines should not be used in people with current, or a history of, bladder cancer, or in patients with uninvestigated haematuria. The risk factors for bladder cancer should be considered before initiating treatment with pioglitazone, particularly smoking.
- In people with diabetes in later life the lowest therapeutic dose should be chosen.
When considering patients already using pioglitazone:
- Existing users of pioglitazone who are receiving or have previously received treatment for bladder cancer, or have uninvestigated haematuria, should have their pioglitazone treatment stopped.
- Existing users of pioglitazone should be informed of the slightly increased risk of bladder cancer, as their medicine is reviewed, so that they can make an informed decision. We would suggest that this risk is put in the context of the possible benefit in cardiovascular risk reduction from the drug.
- Prescribers should review the treatment of patients on pioglitazone after 3 to 6 months (and regularly afterwards), to ensure that only patients who are deriving sufficient benefit continue to take it.
Importantly, long-term pioglitazone studies are ongoing, with a commitment to report at regular intervals (Takeda Pharmaceutical Company Limited, 2011). Specifically, the manufacturer of the drug has been asked to conduct a pan-European epidemiological study that will examine the risk characteristics, in particular the risk period and risk with increasing age, to inform the evidence-base for risk minimisation measures. The committee of the Primary Care Diabetes Society await the publication of these studies, and commit to keep members informed of any important emerging data or changes to prescribing information.
There are significant numbers of patients for whom pioglitazone is an effective and beneficial treatment in their struggle with type 2 diabetes. As healthcare professionals, our responsibility is to ensure that each individual is offered the treatment that is best for them, and that regular reviews ensure that any medication is only continued while it is effective. Thus, with pioglitazone we can maximise the benefits for patients while minimising any risks.
Baum C (2011) Direct healthcare professional communication on pioglitazone and a small increased risk of urinary bladder cancer. Available at: http://tiny.cc/10yu8 (accessed 05.08.2011)
Dormandy JA, Charbonnel B, Eckland DJ et al (2005) Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet 366: 1279–89
European Medicines Agency (2011) European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer.
Lewis JD, Ferrara A, Peng T et al (2011) Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care 34: 916–22
Takeda Pharmaceutical Company Limited (2011) European Medicines Agency Recommends Revised Labeling and Guidance for Pioglitazone-Containing Products.
PCDS notes the Europe-wide withdrawal of rosiglitazone in all formulations (Avandia®andAvandamet® in the UK). Prescribers should no longer prescribe rosiglitazone in any formulation either as an acute item or as a repeat prescription. PCDS suggests that rosiglitazone prescriptions be changed at the earliest time convenient to the person with type 2 diabetes, but preferably within the next 2 months.
For people with well-controlled diabetes and without evident heart failure or significant risk of fracture, a direct switch to pioglitazone (Actos®) – 4 mg rosiglitazone to 30 mg pioglitazone, or 8 mg rosiglitazone to 45 mg pioglitazone – would be appropriate. There are three formulations of the combination product Avandamet®: 2 mg rosiglitazone with either 500 mg or 1 g metformin, and 4 mg rosiglitazone with 1 g metformin. There is, however, only one preparation of pioglitazone with metformin (Competact®): 15 mg pioglitazone with 850 mg metformin. The table below gives some advice on changing Avandamet® to Competact® in those people whose type 2 diabetes is well controlled and without contraindications to the use of a thiazolidinediones (TZDs). Please remember that such a change of medication has the potential to increase the risk of hypoglycaemic episodes.
For those not well controlled with TZDs, or with relative contraindications to TZDs, this time should be used as an opportunity to review overall care and consider other therapeutic options in accordance with the NICE guidelines.
