Peer Review History

Original SubmissionJune 29, 2021
Decision Letter - Masaki Mogi, Editor
Transfer Alert

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PONE-D-21-21296

Consumption of single products versus fixed-dose combination medicines for hypertension and hyperlipidemia during 2015-2019 in South Korea

PLOS ONE

Dear Dr. Kim,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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The manuscript has to be revised according to the Reviewers' suggestion.

See the comments carefully and respond them appropriately.

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Kind regards,

Masaki Mogi

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: No

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The manuscript is well written and clear to the reader.

Only two remarks:

• In "Use by drug classification" chapter, paragraph 5, line 2, after "...carvedilol (4.8 DIDs, 67 million USD", it needs a parenthesis ")";

• In "Discussion" chapter, paragraph 1, line 9, it is "...followed by C08 (CCB), with 70.7 DIDs".

Reviewer #2: The present study is a retrospective study based on the Korean national health insurance claims database, describing the trends in consumption of fixed-dose combinations of lipid-lowering and antihypertensive drugs. The study is of interest and the following comments should be taken into account to improve its quality.

-The available data regarding triple combinations (e.g. 2 antihypertensive drugs+statin or 1 antihypertensive drug+statin+ezetimibe) should be reported.

-The results of large meta-analyses in the field should be discussed.

-Pharmacokinetic/pharmacodynamic data regarding potential interactions should be elaborated in the Discussion section.

-Figure 1, despite being comprehensive, is complicated. An additional figure is suggested showing the consumption trends of the most common antihypertensive drugs and combinations, presenting the name of the class (e.g. Diuretics) and not the drug codes in order to be easily interpretable by clinicians.

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6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

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Reviewer #1: Yes: Artur Mendes Moura

Reviewer #2: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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Attachments
Attachment
Submitted filename: Revision manuscript PlosOne.docx
Revision 1

Consumption of single products versus fixed-dose combination medicines for hypertension and hyperlipidemia during 2015-2019 in South Korea

Response to reviews’ comments

Dear Masaki Mogi

We appreciate the opportunity to revise our manuscript (manuscript ID PONE-D-21-21296), based on your comments in an e-mail that was dated August 13, 2021. The manuscript has been revised based on the comments that were provided.

We have enclosed the revised manuscript with the changes highlighted as well as a response to the reviewers comment (below). Also, we revised the reference list.

Thank you for your ongoing consideration, and we look forward to hearing from you.

Sincerely,

Dong-Sook Kim

Response to the reviewer #1’s comment

We would like to thank the reviewer for improving the manuscript.

The manuscript is well written and clear to the reader.

Only two remarks:

In "Use by drug classification" chapter, paragraph 5, line 2, after "...carvedilol (4.8 DIDs, 67 million USD", it needs a parenthesis ")";

In "Discussion" chapter, paragraph 1, line 9, it is "...followed by C08 (CCB), with 70.7 DIDs".

Author’s Response: Thank you for the time and effort you invested in thoroughly reviewing this manuscript. According to your comment, we revised.

Response to the reviewer #2’s comment

We would like to thank the reviewer for improving the manuscript.

The present study is a retrospective study based on the Korean national health insurance claims database, describing the trends in consumption of fixed-dose combinations of lipid-lowering and antihypertensive drugs. The study is of interest and the following comments should be taken into account to improve its quality.

-The available data regarding triple combinations (e.g. 2 antihypertensive drugs+statin or 1 antihypertensive drug+statin+ezetimibe) should be reported.

Author’s Response: Thank you for your comment.

The unit of analysis of this study was to medicine. We analyzed the characteristics of patients who use fixed dose combination (FDC). However, multiple use of hypertension and hyperlipidemia combinations in the patient unit was not analyzed.

-The results of large meta-analyses in the field should be discussed.

-Pharmacokinetic/pharmacodynamic data regarding potential interactions should be elaborated in the Discussion section.

Author’s Response: Thank you for these helpful comments. However pharmaceutical company must submit approval data to Food and Drug Administration, so doctors might prefer to prescribe fixed dose combination (FDC) of hypertensive drugs or hyperlipidemia rather than to combine each drug. Therefore, we did not consider regarding potential interactions because this study examined the pattern or trend of combination drugs. Also, we mentioned the large meta-analyses of fixed-dose combination drugs and changed the Discussion section as follows:

According to several meta-analysis studies, the FDC treatment is associated with a significant improvement in adherence and persistence in comparison with single therapy or FECs, thereby increase of BP control effect, so these strategies have been preferred compared with conventional therapies.

-Figure 1, despite being comprehensive, is complicated. An additional figure is suggested showing the consumption trends of the most common antihypertensive drugs and combinations, presenting the name of the class (e.g. Diuretics) and not the drug codes in order to be easily interpretable by clinicians.

Author’s Response: Thank you for your suggestion. According to your comment, we revised.

Attachments
Attachment
Submitted filename: Response to reviewer.docx
Decision Letter - Masaki Mogi, Editor

Consumption of single products versus fixed-dose combination medicines for hypertension and hyperlipidemia during 2015-2019 in South Korea

PONE-D-21-21296R1

Dear Dr. Kim,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Masaki Mogi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

No further comment.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: (No Response)

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #2: The authors have adequately revised their manuscript; therefore, it can be accepted for publication.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Artur Mendes Moura

Reviewer #2: No

Formally Accepted
Acceptance Letter - Masaki Mogi, Editor

PONE-D-21-21296R1

Consumption of single products versus fixed-dose combination medicines for hypertension and hyperlipidemia during 2015-2019 in South Korea

Dear Dr. Kim:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

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Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Masaki Mogi

Academic Editor

PLOS ONE

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