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Theory alone is obviously surpassed by clinical evidence

I was interested to read the response from Toby Capstick and colleagues at the UK Clinical Pharmacy Association Respiratory Group (PJ, 7 June 2014, p576) to my previous letter (PJ, 10/17 May 2014, p506).

I would like to make clear that I take no issue with the proactive identification of potential safety concerns, as suggested by the UKCPA group. The opening sentence in my letter should have made that clear. I also did not comment against the theoretical basis of their argument, which is entirely sound. My own position was simply that theory alone is obviously surpassed by clinical evidence. Practically speaking, it seems to me that converting corticosteroid potencies from fluticasone furoate to fluticasone propionate in order to then convert to beclometasone is unlikely to provide an accurate reflection of relevant potencies because inaccuracies in the conversion ratios will be amplified by the sequential nature of this calculation. What is required then is a dedicated study of fluticasone furoate to beclometasone potency and close analysis of post-marketing safety data for Relvar Ellipta. My main concern was the confusion that the group’s letter may cause about the place of the drug in therapy. I do not believe this is an unreasonable concern given the language used in the group’s original letter, warning specifically of “dosing errors”. Presumably the group thinks that these errors may arise from use of the drug within its licence, otherwise why else would it raise the issue?

I fail to see how this will not lead to confusion and the result I fear is inappropriate off-licence use, which would confound post-marketing safety data analysis and actually have the effect of making it more difficult to prove whether or not the group’s concerns are valid.

The group also questions why I did not comment on the issue of the name “Relvar” or the blue colour. I did not do so because I entirely agree with its concerns here and believe it said all that needed to be said.

Michael Charvonia also responds (PJ, 7 June 2014, p577), questioning my assumption that a once-daily inhaler would improve compliance over twice-daily inhalers. I agree reasons for non-compliance with inhalers are multiple, but Mr Charvonia may like to see the following interesting studies that provide good evidence to support my claim.1,2,3

Stuart Hill



Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065351

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