A PD BE study comparing tiotropium DPI inhalers: Gx Tiova (Cipla) vs. Spiriva (BI)
March 14, 2016
There's a journal most of you probably have not heard of: the Saudi Pharmaceutical Journal, part of the Elsevier stables. I have been subscribing to this journal for a while, mostly out of curiosity. There is in the current issue and article a few of you will find of interest. Good news: it's an open access article.
Yunes Panahi et al. published a PD BE study on the comparison of a generic tiotropium DPI (Tiova made by Cipla and marketed in India) vs. Spiriva HandiHaler. The study was performed on 79 patients, in a randomised double blind way. Both the HandiHaler and Rotahaler were used in the study, for their respective products; these are fundamentally different devices. FEV1, FVC and a host of quality of life indices according to SGRQ were also measured.
This sort of article is a type one would like to see more often: actual PD BE results. Of course it falls short of proving full BE, but it is a fair attempt at a complex subject from a relatively unknown research group. Their BE justification is not standard, and does not rely on confidence intervals analysis, and therefore falls short of accepted norms. From the data presented, it is fair to say that Tiova shows some effectiveness in treating the symptoms of COPD. This is not surprising since tiotropium is known to be a useful molecule in the treatment of COPD. A relative efficacy combined with the price difference (USD 0.64-0.89 per dose for Tiova vs. USD 0.94 to 3.90 for Spiriva HH) between test and reference could well convince some countries to recommend the use of Tiova.
Is Tiova really equivalent to Spiriva HH? ... well I certainly would not rush to replace my current medicine if I used any. I shall leave you to make your own judgment.
Here are some questions to ask about the article:
-What would the BE tests look like if the data was analysed in a rationalised statistical way?
-What does the in vitro data look like? The fact that there are 18 mcg of tiotropium in both the reference and test products is certainly not an indication that the same amount of tiotropium reaches the lungs
-Is the population representative? 92.7% of the subjects were male. This probably reflects a cultural or sociological trait of Iran.
You can find the full text of the study at:
Investigation of the efficacy of generic and brand-name tiotropium bromide in the management of chronic obstructive pulmonary disease: A randomized comparative trial
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