Efficacy and Safety of Etelcalcetide in Hemodialysis Patients with Moderate to Severe Secondary Hyperparathyroidism
, Eliana Fasulo, Michela Frittoli, Chiara Leotta, Hoang Nhat Pham, Andrea Stucchi, Paola Ciceri, Andrea Galassi and Mario Cozzolino *Round 1
Reviewer 1 Report
Dear Authors,
I appreciate your paper regarding a topic of interest for the Nephrology community. However, I think the small number of patients constitutes the main limitation of this study. In particular, I believe that univariate and multivariate analyses are of scarce significance if referred to so few events (for example, only 7 patients reached the target of PTH reduction > 40%). This limitation should be recognized by the authors. Consequently, the conclusions should be more cautious, especially when the authors indicate the level of PTH 1300 pg/ml as a sort of cut-off.
In addition, I think it could be interesting that in the Discussion the authors further underline and explain the meaning and mechanisms of tertiary HP (probably present in the patients of Group B).
Author Response
Comments to the Author
I appreciate your paper regarding a topic of interest for the Nephrology community. However, I think the small number of patients constitutes the main limitation of this study. In particular, I believe that univariate and multivariate analyses are of scarce significance if referred to so few events (for example, only 7 patients reached the target of PTH reduction > 40%). This limitation should be recognized by the authors. Consequently, the conclusions should be more cautious, especially when the authors indicate the level of PTH 1300 pg/ml as a sort of cut-off. In addition, I think it could be interesting that in the Discussion the authors further underline and explain the meaning and mechanisms of tertiary HP (probably present in the patients of Group B).
We are grateful to the reviewer for his/her kind words and for giving us the chance to improve our manuscript.
We recognized the limitations of our study, trying to be more cautious in the Conclusions. Also, we add a paragraph on tertiary HP in the Discussion
Reviewer 2 Report
The authors reported that efficacy and safety of etelcalcetide in 16 hemodialysis patients with moderate to severe secondary hyperparathyroidism. The findings of this manuscript might include some clinically significant contents, but there are some concerns on this case report.
1. In Table 1, the authors should describe sex and the cause of end stage renal disease of enrolled patients, such as diabetic kidney disease, glomerulonephritis, renal sclerosis, etc.
2. In Figure 1, the authors should show group A and B separately for the changes in etelcalcetide dosage.
3. The authors showed the changes in concomitant therapies with chelating agents and vitamin D in the two groups in Figure 2 as bar graphs. However, those should be described as a Table.
4. Conclusion is too long. Some of the sentences in conclusion should transfer to discussion appropriately.
Author Response
Reviewer: 2
Comments to the Author
The authors reported that efficacy and safety of etelcalcetide in 16 hemodialysis patients with moderate to severe secondary hyperparathyroidism. The findings of this manuscript might include some clinically significant contents, but there are some concerns on this case report.
We would like to sincerely thank the reviewer for his/her rewarding words.
- In Table 1, the authors should describe sex and the cause of end stage renal disease of enrolled patients, such as diabetic kidney disease, glomerulonephritis, renal sclerosis, etc.
We did so for gender.
- In Figure 1, the authors should show group A and B separately for the changes in etelcalcetide dosage.
We believe that in this way it is clear to read the figure.
- The authors showed the changes in concomitant therapies with chelating agents and vitamin D in the two groups in Figure 2 as bar graphs. However, those should be described as a Table.
We believe that with the figure can be clear the use of Ca-free P binders. Also, we already have 8 tables.
- Conclusion is too long. Some of the sentences in conclusion should transfer to discussion appropriately.
We shortened the discussion.
Round 2
Reviewer 1 Report
Dear Authors, I think the paper is acceptable for publication in the current form.
Author Response
Thank you
Reviewer 2 Report
The manuscript is improved by the revision. However, conclusion is still too long. The limitation should be moved to transfer to discussion appropriately.
Author Response
We modified the conclusions
