CORONA, the first prospective outcomes study examining the effect of adding a statin to optimised treatment for individuals with advanced heart failure, has shown that people taking rosuvastatin 10 mg (Crestor, Astra Zeneca) experienced an 8% reduction in the combined primary end point of CV death, MI or stroke (P=0.12). This reduction was primarily driven by a decrease in atherosclerotic events. CORONA also showed that significantly fewer hospitalisations occurred in individuals on rosuvastatin compared with placebo, whether due to any cause (P=0.007), CV causes (P<0.001), or for worsening heart failure (P=0.01).
Exubera marketing ceased
In October, Pfizer took the global decision to surrender the rights to market the inhaled insulin, Exubera, to the developer of the technology, Nektar Therapeutics. This means that Pfizer will cease production of Exubera and recommend that healthcare professionals do not start any new patients on Exubera. However, it should be highlighted that this was purely an economic decision and in no way a reflection of any safety concerns with the system.
‘We made an important decision regarding Exubera, a product for which we initially had high expectations,’ said Jeff Kindler, Chairman and Chief Executive Officer. ‘Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.’
Pfizer remains committed to working with physicians to transition individuals currently using Exubera to other treatment options in the next 3 months. Furthermore, the company will continue to invest significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines.
Prescribers with questions regarding Exubera’s withdrawal can contact the Pfizer Medical Information Line on 01304 616161.
UK launch of HumaPen Luxura HD for children
Eli Lilly & Company have launched a new insulin-delivery device, HumaPen Luxura HD, a reusable insulin pen that doses in half-unit increments from 1 to 30 units. Designed for ease of use, the pen enables carers, parents or children to administer insulin with the precision of half-unit dosing. In the case of over-dialling the number of units, the dose can be corrected with no loss of insulin.
To provide further support to children with diabetes and their families or caregivers, a series of information packs and education materials featuring the cartoon character Hu-Mee the Frog are supplied with the pen.
Januvia receives industry award
Sitagliptin (Januvia, Merck Sharp & Dohme), a treatment for type 2 diabetes, last week received the highly acclaimed 2007 Award for Best Pharmaceutical Agent at the Prix Galien USA Awards. The awards are internationally renowned and often considered the industry’s equivalent of the Nobel Prize. Sitagliptin was considered alongside 19 other compounds as part of the awards process.
Sitagliptin, the first in the new class of DPP-4 inhibitors, was licensed in the UK in April 2007 and has to date been prescribed in over one million people globally.
Launch of new blood glucose monitor Breeze 2
In September, Bayer Diabetes Care launched the Breeze 2 blood glucose monitor in the UK. This new meter uses no coding technology. Research suggests that miscoding is common with manually calibrated meters and can lead to significant errors in insulin dose in people actively managing their diabetes. For example, the probability of making an insulin dose error of 3 units is 24% for miscoded meters, compared with 0.49% when using a no coding meter.
The new Breeze 2 has a number of further features that include only needing to be loaded once for ten tests and results made available in 5 seconds from only 1ul of blood.
The meter also includes a 420-test memory, which means that people with diabetes can keep track of their blood glucose over longer periods and while on the move. People with diabetes can easily review 1-day, 7-day, 14-day and 30-day averages and data from the meter can be downloaded to a computer and analysed with a free software package, WinGlucofacts.
NICE confirms cost–effectiveness of Ezetrol
On 17 November 2007, NICE issued a Final Appraisal Determination recommending that ezetimibe (Ezetrol, MSD and Schering-Plough, UK), co-administered with a statin, is a cost-effective option for individuals whose serum total cholesterol or LDL-c is not appropriately controlled on the initial statin, which has been titrated appropriately, and who are being considered for an alternative statin.
NICE drew this conclusion after reviewing a meta-analysis that demonstrated that the absolute further reduction in LDL-c attributed to ezetimibe was approximately 22%. This compares with switching statins, which only yields an additional LDL-c reduction of 8%.
NICE also advocates the use of ezetimibe as monotherapy when statins are contraindicated, or if a person is intolerant of statins. In the appraisal, statin intolerance is defined as the presence of clinically significant adverse events that are considered to represent an unacceptable risk or may result in compromising compliance.
EMEA confirms positive risk–benefit balance for pioglitazone
After assessing all available data, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA concluded on October 18 that the benefits of pioglitazone (Actos, Takeda) in the treatment of type 2 diabetes continue to outweigh the risks.
Recently, the CHMP agreed that some information on a large CV outcome study (PROactive) could be included in the prescribing information: ‘Although the study failed regarding its primary end point, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding the use of pioglitazone’.
The CHMP also reviewed the concomitant use of pioglitazone and insulin and recommended not only the removal of the contraindication for use in combination with insulin but also to include combination therapy with insulin in the management of people with type 2 diabetes with insufficient glycaemic control on insulin for whom metformin is inappropriate.
Recently, the CHMP has also adopted a positive opinion for the combination of pioglitazone/metformin (Competact, Takeda) to recommend the deletion of the contraindication for its use in combination with insulin.
European license for vildagliptin
Vildagliptin (Galvus, Novartis) has been granted EU approval for use in treating people with type 2 diabetes in combination with the most common oral antihyperglycaemic agents (OHAs) – metformin, thiazolidinedioness or sulphonylureas.
Vildagliptin is a DPP-4 inhibitor and reduces blood glucose by targeting the dysfunction in the pancreatic islets that cause high blood glucose levels in people with type 2 diabetes.
In clinical trials, vildagliptin demonstrated an overall incidence of side effects similar to placebo. The most common side effects observed with vildagliptin use were stuffy nose, headaches, dizziness and upper respiratory tract infection.
The approval applies in all 27 countries of the EU as well as in Norway and Iceland.
Greater technology access needed
NICE has recommended making CGMS available to all children who have problems with persistent hypoglycaemic or hyperglycaemic episodes. Additionally, adults who have failed insulin therapy should be given access to insulin pumps. This raises funding concerns in many PCTs.
Attempts to achieve remission, or at least a substantial improvement in glycaemic control, should be the initial focus at type 2 diabetes diagnosis.
9 May 2024