On 2014 Jul 12, Jorge H Ramírez commented:

The overall quality of this randomized clinical trial is poor:

• Limited time of follow-up (12 weeks) to determine the safety and effectiveness of an active pharmacological principle or a fixed-dose combination (i.e., solifenacin plus tamsulosin).

• The study evaluates surrogate instead of definitive outcomes.

• No description of allocation concealment mechanisms.

• No description of methods used to generate the random sequence used in the randomization of patients to each study arms

• The article does not describe methods for the implementation of the random sequence.

• No appropriate description of blindings in the study.

• No intention-to-treat analysis

• Cardiovascular adverse events were not appropriately described in this article.

• Haemodynamic variables were not included as primary or secondary outcomes in this study.

Tamsulosin is a nonuroselective alpha blocker associated with severe hypotension in men.(1,2) Moreover, over three quarters of the studies with tamsulosin in humans are unpublished.(3)

A recent publication entitled "Solifenacin/tamsulosin FDC squeezes out competitors."(4) supports that this combination is cost-effective only based in the pharmacoeconomic analysis of this study (Neptune trial. van Kerrebroeck and colleagues. Eur Urol 2013).

I have the following open-question for anyone reading this comment:

What would happen with pharmacoeconomic evaluations involving solifenacin/tamsulosin in the treatment of lower urinary tract symptoms after considering the risk of severe hypotension and the results of unpublished studies?

Finally, I personally think that the title "Solifenacin/tamsulosin FDC squeezes out competitors." resembles more a pharmaceutical marketing campaign (a misleading one) than a serious paper reporting the results of a pharmacoeconomic analysis.

References

1. Bird Steven T, Delaney Joseph A C, Brophy James M, Etminan Mahyar, Skeldon Sean C, Hartzema Abraham G et al. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology BMJ 2013; 347:f6320 http://www.bmj.com/content/347/bmj.f6320

2. Ramirez Jorge. Severe hypotension associated with α blocker tamsulosin BMJ 2013; 347:f6492 http://www.bmj.com/content/347/bmj.f6492

3. Ramirez, Jorge H (2014): Expression of concern about tamsulosin: over three quarters of human studies are unpublished. figshare. http://dx.doi.org/10.6084/m9.figshare.1094338 URL:http://figshare.com/articles/Expression_of_concern_about_tamsulosin_over_three_quarters_of_human_studies_are_unpublished/1094338

4. Nazir, J. Solifenacin/tamsulosin FDC squeezes out competitors." PharmacoEconomics & Outcomes News 706 (2014): 10-5.

On 2014 Jul 12, Jorge H Ramírez commented:

The overall quality of this randomized clinical trial is poor:

• Limited time of follow-up (12 weeks) to determine the safety and effectiveness of an active pharmacological principle or a fixed-dose combination (i.e., solifenacin plus tamsulosin).

• The study evaluates surrogate instead of definitive outcomes.

• No description of allocation concealment mechanisms.

• No description of methods used to generate the random sequence used in the randomization of patients to each study arms

• The article does not describe methods for the implementation of the random sequence.

• No appropriate description of blindings in the study.

• No intention-to-treat analysis

• Cardiovascular adverse events were not appropriately described in this article.

• Haemodynamic variables were not included as primary or secondary outcomes in this study.

Tamsulosin is a nonuroselective alpha blocker associated with severe hypotension in men.(1,2) Moreover, over three quarters of the studies with tamsulosin in humans are unpublished.(3)

A recent publication entitled "Solifenacin/tamsulosin FDC squeezes out competitors."(4) supports that this combination is cost-effective only based in the pharmacoeconomic analysis of this study (Neptune trial. van Kerrebroeck and colleagues. Eur Urol 2013).

I have the following open-question for anyone reading this comment:

What would happen with pharmacoeconomic evaluations involving solifenacin/tamsulosin in the treatment of lower urinary tract symptoms after considering the risk of severe hypotension and the results of unpublished studies?

Finally, I personally think that the title "Solifenacin/tamsulosin FDC squeezes out competitors." resembles more a pharmaceutical marketing campaign (a misleading one) than a serious paper reporting the results of a pharmacoeconomic analysis.

References

1. Bird Steven T, Delaney Joseph A C, Brophy James M, Etminan Mahyar, Skeldon Sean C, Hartzema Abraham G et al. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology BMJ 2013; 347:f6320 http://www.bmj.com/content/347/bmj.f6320

2. Ramirez Jorge. Severe hypotension associated with α blocker tamsulosin BMJ 2013; 347:f6492 http://www.bmj.com/content/347/bmj.f6492

3. Ramirez, Jorge H (2014): Expression of concern about tamsulosin: over three quarters of human studies are unpublished. figshare. http://dx.doi.org/10.6084/m9.figshare.1094338 URL:http://figshare.com/articles/Expression_of_concern_about_tamsulosin_over_three_quarters_of_human_studies_are_unpublished/1094338

4. Nazir, J. Solifenacin/tamsulosin FDC squeezes out competitors." PharmacoEconomics & Outcomes News 706 (2014): 10-5.