ADA 2006: Lilly and Amylin Tout Benefits of Byetta

Lilly and Amylin Play Four Aces

• The companies presented data from a study of 233 patients, which demonstrated that Byetta injection lowered the blood glucose levels in patients with type 2 diabetes who had failed to achieve target glucose control with the use of the popular thiazolidinedione (TZD) class of diabetes drugs, with or without metformin. In this study, participants who received Byetta treatment received a five microgram dose twice a day for the first four weeks, then 10 micrograms twice a day for the remainder of the study. The key findings from this study were that:
• Byetta led to a significant 0.8% reduction in A1C from baseline, compared to a 0.1% increase in the control group;
• patients treated with Byetta demonstrated much improved glucose control over the control group;
• the study also showed that patients treated with Byetta experienced an important average weight reduction of 3.3 pounds, compared to a reduction of 0.4 pounds among the control group; and
• rates of mild and moderate hypoglycaemia were similar between Byetta and placebo treatment.
  
  
• Lilly and Amylin also announced the results of a two-year study showing that patients treated with Byetta sustained improvements in blood glucose control and progressive weight loss after two years. The study demonstrated that patients who completed two years of Byetta treatment in this open-label extension trial experienced an average reduction in their haemoglobin A1C values of 1.1% from baseline. This demonstrates the sustained efficacy of the drug, since after the initial 30-day clinical study, patients also experienced an average AC1 value of 1.1%. However, importantly, this study demonstrated that the weight loss among patients continued to improve, with patients in the extension trial achieving an average loss of 10 pounds, compared to the five pounds observed in the initial study.
  
  
• In a further presentation, Lilly and Amylin presented data showing the efficacy and safety of their once-a-week long-acting release (LAR) formulation of Byetta. In this study – involving 45 patients - the LAR formulation of Byetta improved both glycaemic and weight control, and was well tolerated as a combination therapy with metformin or on its own with diet and exercise. In patients administered with 0.8mg or 2.0mg of exenatide LAR, 33% and 86% respectively achieved A1C levels of 7% or less, while none of the subjects who were treated with placebo reached this target.
  
  
• As well as presenting studies that demonstrate the clinical benefits of Byetta and the sustained weight loss improvements enjoyed by many patients undergoing treatment, Lilly and Amylin aimed to drive home the benefits of Byetta to physicians attending the ADA by presenting data from a study entitled ‘Short Term Economic Impact of Weight Change Amongst Patients with Type 2 Diabetes’. This study, which was funded by Lilly and Amylin, analysed data from an health maintenance organisation (HMO) claims database between 1997 and 2005, finding that patients who experienced an extremely moderate 1% weight loss decreased their average healthcare costs by around 3.6% over the 12-month period following their weight loss; this translated into an average saving of US$256. The study also showed that savings made by patients considered to be obese who achieved a similar weight loss were even greater, at around US$408 per person, or a 5.6% decrease in their total healthcare costs.

Outlook and Implications:

The key messages that Lilly and Amylin appear to have been targeting in their presentations at the ADA were:

• firstly, the safety and efficacy of Byetta; in all of these studies, Byetta did achieve impressive improvements in patients' glucose control.
  
  
• secondly, that the use of Byetta is linked to significant sustained average weight loss among patients;
  
  
• thirdly, and extremely importantly, that these improvements can be achieved over the long term; this is of particular clinical benefit, since achieving long-term glucose control and sustained weight reduction would represent a great clinical benefit for many patients with type 2 diabetes;
  
  
• finally, Lilly and Amylin have presented data that show demonstrable economic benefits from the use of Byetta, and patients' weight loss associated with its use.

This final piece of the jigsaw is particularly important, since not only is a reduction in weight extremely desirable for many patients with type 2 diabetes, but the fact that this can lead to savings in other parts of their healthcare spending is likely to lead to more health insurers covering the drug on their health benefits. Such pharmacoeconomic studies are an extremely hot topic across the pharmaceutical industry at the moment, and Lilly and Amylin will hope that this study will be extremely influential, as they aim to position Byetta against other drugs for the treatment of type 2 diabetes, which have been shown to be associated with weight gain.

Related Articles:

• United States: 21 April 2006: New Products Drive 13% Increase in Eli Lilly's Q1 Earnings
• United States: 3 March 2006: Eli Lilly and Amylin Seek to Expand Use of Byetta
• United States: 2 May 2005: Amylin and Eli Lilly Get FDA Clearance for New Diabetes Treatment