[Kalpana]

• Roche tightens the string on diabetes drug aleglitazar
  

With budding competition every now and then and with strict FDA regulations Roche takes a strong step for the drug aleglitazar. Roche announced that the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to stop the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving aleglitazar. Aleglitazar is a peroxisome proliferator-activated receptor agonist. Other drugs which work with similar mechanism are GSK's Avandia (rosiglitazone) and Takeda's Actos (pioglitazone). In the pharma world its a second shock after serious notes on pioglitazone, many major companies have already stopped its production.

What went wrong with aleglitazar?

A product which started with a lot of praise and expectations and has already reached clinical phase-III trials is not moving forward, its quite a surprise!
Drug was proposed to be used for: Diabetes patients and cardiovascular diseases.
In the pan-world ALECARDIO trial of aleglitazar, 7228 patients with a recent acute coronary syndrome and type 2 diabetes were given a dose of aleglitazar 150 µg or placebo daily, in addition to the general medical therapy. Patients were basically from cardiology clinics, and the primary efficacy fail was indicated by: cardiovascular death, myocardial infarction, or stroke. Other symptopms like heart failure and changes in renal function.

Dr. Lincoff said news about bone fractures, heart failure, and gastrointestinal bleeding associated with aleglitazar was also there, and deterioration in renal function among some patients taking it was also seen, "but it was reversible, and we knew that based on other trials."
As full data is yet to be published he added, "We won't know until we analyze the data whether diabetes control is better in the aleglitazar arm."

This year has brought multiple bans on diabetes drugs, whether our drug administration has gone strict and is beneficial for patients or our diseases are getting extremely linked to each other, which is causing complications while treating the others? It has to be answered by experts. But all we can do is to wait for an effective and safe drug to the growing problem "Diabetes".

Check out following links for knowing more about it:
Pharmatimes
Clinical trials
Roche media release
Medscape