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EDITORIALS: G Karthikeyan and John W Eikelboom Treatment of intermittent claudication BMJ 2009; 338: b46 [Full text]

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Further key points from the work of De Backer, et al.

John Urquhart, Palo Alto, CA 94301 USA   (21 April 2009)

Further key points from the work of De Backer, et al. 21 April 2009
John Urquhart, Prof of Biopharmaceutical Sciences, UCSF; prof (ret) of pharmaco-epidemiology, Maastricht University 975 Hamilton Ave, Palo Alto, CA 94301 USA Send response to journal: Re: Further key points from the work of De Backer, et al.	Several additional points may be added to the editorial on the findings of De Backer, et al. (1) re the use of 'naftidrofuryl' for intermittent claudication. First is the matter of chemical nomenclature: the proper name of the agent is 'naftidrofuryl oxalate'. This point may seem picky in an era in which the terms 'sodium' and 'potassium' are widely mis-used as synonyms for the chloride salt of each, for these terms could as well imply other salts of the respective cations, or even their native metals. Different salts of the same cation can have distinctively different biological actions, as the findings in (2) foretold. Second, the editorial concerns the content, but not the process, of the work by De Backer, et al. (1), whose study pioneers a process of gaining access to the studies carried out during the drug's original clinical development. It is a form of 'pharmaco-archeology', which creates a valuable precedent in the evaluation of drugs that have passed from the ownership of their original developer, and have entered the public domain as generic agents with multiple manufacturers. Satisfactory archiving of such data is an unmet need, as generic drugs are the real orphans in today's pharmaceutical marketplace: their manufacturers have no commercial interest in their comparative evaluation against other drugs, nor in their further clinical development, with the infrequent exceptions when novel, patentable formulations can substantively change a drug’s clinical pharmacology (3). Third, the proven therapeutic value of exercise in both type II diabetes and chronic heart failure suggests that any therapeutic maneuver which removes an obstacle to exercise, e.g., intermittent claudication, opens the way for patients with these prevalent diseases to reap the benefits of exercise, if they can maintain a suitable regimen (4). References: 1. De Backer T, et al. Naftidrofuryl for intermittent claudication: meta- analysis based on individual patient data. BMJ 2009;338:b603 doi:10.1136/bmj.b603. 2. Kurtz TW, et al. "Salt-sensitive" essential hypertension in men. Is the sodium ion alone important? N Engl J Med 1987;317:1043-8. 3. Urquhart J. Controlled drug delivery: pharmacologic and therapeutic aspects. J Internal Med 2000;248:357-76. 4. Coats AJS, et al. Effects of physical training in chronic heart failure. Lancet 1990;335:63-6. Competing interests: None declared