The Pharmaceutical Journal
Vol 277 No 7423 p473
21 October 2006

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Cochrane review questions value of pioglitazone

The value of pioglitazone (Actos) in the treatment of type 2 diabetes mellitus is questioned in a new Cochrane review.

The reviewers, led by Bernd Richter, department of endocrinology, diabetes and rheumatology at Heinrich-Heine University, Düsseldorf, Germany, examined data from 22 randomised controlled trials involving 6,200 patients. All trials included in the review had to last at least 24 weeks.

The researchers found that pioglitazone lowers HbA1c levels to a similar extent as other oral antidiabetic agents. “Probably the best comparison would be with metformin,” said Dr Richter, “where pioglitazone lowered HbA1c between 1.3 per cent and 1.4 per cent and metformin by 1.5 per cent.”

They also observed that pioglitazone is associated with an increased occurrence of oedema and conclude that published studies do “not provide convincing evidence that patient-oriented outcomes, like mortality, morbidity, adverse effects and health-related quality of life are positively influenced by this compound”. Dr Richter added that pioglitazone treatment should be restricted to patients who demonstrate a real benefit from therapy.

“Benefit should not be postulated on the basis of improvement of metabolic parameters like HbA1c reduction alone but should refer to patient-oriented outcomes such as fewer diabetic complications or better health-related quality of life,” he said.

Commenting on behalf of Takeda, manufacturer of Actos, Tony Barnett, professor of medicine, University of Birmingham, and head of diabetes services at the Heart of England NHS Foundation Trust, said: “The problem with the Cochrane review is that it is very long, over 90 pages, and most busy clinicians will not read this document in detail but rely on the abstract and summary, which I believe have a number of deficiencies.”

He pointed out that there was no mention within the summary of the beneficial effects of pioglitazone on traditional cardiovascular risk factors such as increasing high-density lipoprotein levels, the reduction of triglycerides and its overall effect on reducing blood pressure. “In addition, there are well documented reports of improvements in non-traditional CV risk factors,” he said.