BMJ  2005;331:235-236 (23 July), doi:10.1136/bmj.331.7510.235-b

Letter

Perindopril monotherapy and PROGRESS in Europe

EDITOR—Perindopril has been registered in Poland as monotherapy for the prevention of recurrent stroke. The perindopril protection against recurrent stroke study (PROGRESS) is given as the only supporting evidence for this new indication, which is difficult to reconcile with the trialists' admission in the text of the publication that treatment with perindopril alone showed no discernible reduction in the risk of stroke.¹

Promotion of the new indication for perindopril is ongoing in Poland. Full page advertisements have run in Medycyna Praktyczna (issues 7-8/2004), announcing this "NEW INDICATION FOR USE," the capitalised words situated above a cartoon brain. Below the brain we read: "Secondary prevention of cerebrovascular incidents. THE ONLY ACEI registered for secondary prevention of cerebrovascular incidents in patients regardless of their age." Prominently displayed is the familiar PROGRESS logo.

No mention of indapamide is made in the prescribing instructions. No mention is made in the registration information that risk reduction in PROGRESS was seen only if indapamide was given in combination with perindopril.

In Italy, based on PROGRESS, perindopril (4 mg/day) has been granted a similar extended indication as monotherapy for the prevention of recurrent stroke. The Italian advertising inserts ignore the critical role of indapamide in PROGRESS.² Yet in their BMJ commentary, the PROGRESS trialists admit that perindopril in monotherapy at 4 mg/day provided no detectable benefits for prevention of recurrent stroke.³

It is unclear how these registration mistakes may have arisen. Both perindopril and indapamide are manufactured by Servier, a sponsor of the PROGRESS trial (perindopril is currently under patent protection; indapamide is no longer protected by patent). It is possible that the promoters of perindopril in these countries have misunderstood the findings of the PROGRESS trial. Whatever the origins of the mistakes, they are problematic sequelae of the ambiguously reported clinical trial data.⁴

Richard.Wennberg{at}uhn.on.ca
University of Toronto, University Health Network, Toronto, Canada M5T 2S8

University of Toronto, University Health Network, Toronto, Canada M5T 2S8

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Competing interests: None declared.

References

1. PROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6,105 individuals with a previous stroke or transient ischaemic attack. Lancet 2001;358: 1033-41.[CrossRef][Web of Science][Medline]
2. Bobbio M, Della Penna V, Tarascio A. Inchiesta sull'indicazione terapeutica del perindopril. Dall'evidence based medicine all'advertisment based medicine. Occhio Clinico 2005;3: 6.
3. MacMahon S, Neal B, Rodgers A, Chalmers J. Commentary. The PROGRESS trial three years later: time for more action, less distraction. BMJ 2004;329: 970-1.[Free Full Text]
4. Wennberg R, Zimmermann C. The PROGRESS trial three years later: time for a balanced report of effectiveness. BMJ 2004;329: 968-70.[Free Full Text]

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