Title: Clinical Characteristics and Management of Patients with Nonalcoholic Steatohepatitis
in a Real-World Setting: Analysis of the Ipsos NASH Therapy Monitor Database
Version: 2 Date: 13 Jan 2023
Reviewer:  Harishankar Gopakumar
Reviewer's report:
Dear Authors,
It was a pleasure to read your work titled “Clinical Characteristics and Management of Patients
with Nonalcoholic Steatohepatitis in the Real-World Setting: Analysis of the Ipsos NASH
Therapy Monitor Database"
This is overall a well written study and I commend the authors on their very relevant work in the
field of NASH and NAFLD that is increasing prevalence globally. There is need for awareness
and ongoing education on the latest recommendations of diagnosis and management of NAFLD/
NASH in non-academic community practice and this study highlights this.
There are a few concerns that I have outlined below.
# 1
The authors find that the biopsy rates were broadly similar among PCPs, endocrinologists,
gastroenterologists, and hepatologists (72%-74% across all four diagnosing physician
specialties). This I find to be very different from what is "real-world". It is much more likely
that a primary care physician or endocrinologist would refer a patient to a gastroenterologist
or hepatologist for evaluation rather than ordering the liver biopsy themselves. As the authors
have mentioned, the liver biopsy rates in this study are also higher than what is usually reported.
The results of this study hence seem to not actually be a representation of real-world practice
of these specialists.
# 2
This study seems to reflect practice of physicians who manage NASH regularly given the high
percentage of liver biopsies and use of Vitamin E and Pioglitazone which are the two medications
that have been shown to reverse steatohepatitis (PIVENS Trial).
# 3
In sentence 287, the authors mention that vitamin E is the only drug "shown to have
any histological efficacy in randomized clinical trials". This is an inaccurate statement as
Pioglitazone was also shown to have histological efficacy with reduction in lobular inflammation
and steatosis as in PIVENS trial although it did not meet the primary endpoint.
# 4
In keeping with the above, the readers, I believe would be curious to know what constitutes the
Ipsos NASH database and what patients/hospitals/physicians contribute to it.
# 5 The authors of this study conclude that physicians prescribed statins and vitamin E primarily
for weight loss. Statins have been in use for many decades now and its indications are well known
to most physicians. Patients with NAFLD and NASH frequently have coexisting metabolic
syndrome including hypercholesterolemia for which statins are often prescribed. Hence it will
be very important to clarify how this was ascertained that statins were prescribed primarily for
weight loss.
# 6
I am afraid this study also suffers from lack of novelty as the subject of knowledge gap and
the divergence of community practice from guidelines in NAFLD/NASH are previously studied
and published.
Title: Clinical Characteristics and Management of Patients with Nonalcoholic Steatohepatitis
in a Real-World Setting: Analysis of the Ipsos NASH Therapy Monitor Database
Version: 2 Date: 13 Jan 2023
Reviewer:  Harishankar Gopakumar
Reviewer's report:
Dear Authors,
It was a pleasure to read your work titled “Clinical Characteristics and Management of Patients
with Nonalcoholic Steatohepatitis in the Real-World Setting: Analysis of the Ipsos NASH
Therapy Monitor Database"
This is overall a well written study and I commend the authors on their very relevant work in the
field of NASH and NAFLD that is increasing prevalence globally. There is need for awareness
and ongoing education on the latest recommendations of diagnosis and management of NAFLD/
NASH in non-academic community practice and this study highlights this.
There are a few concerns that I have outlined below.
# 1
The authors find that the biopsy rates were broadly similar among PCPs, endocrinologists,
gastroenterologists, and hepatologists (72%-74% across all four diagnosing physician
specialties). This I find to be very different from what is "real-world". It is much more likely
that a primary care physician or endocrinologist would refer a patient to a gastroenterologist
or hepatologist for evaluation rather than ordering the liver biopsy themselves. As the authors
have mentioned, the liver biopsy rates in this study are also higher than what is usually reported.
The results of this study hence seem to not actually be a representation of real-world practice
of these specialists.
# 2
This study seems to reflect practice of physicians who manage NASH regularly given the high
percentage of liver biopsies and use of Vitamin E and Pioglitazone which are the two medications
that have been shown to reverse steatohepatitis (PIVENS Trial).
# 3
In sentence 287, the authors mention that vitamin E is the only drug "shown to have
any histological efficacy in randomized clinical trials". This is an inaccurate statement as
Pioglitazone was also shown to have histological efficacy with reduction in lobular inflammation
and steatosis as in PIVENS trial although it did not meet the primary endpoint.
# 4
In keeping with the above, the readers, I believe would be curious to know what constitutes the
Ipsos NASH database and what patients/hospitals/physicians contribute to it.
# 5 The authors of this study conclude that physicians prescribed statins and vitamin E primarily
for weight loss. Statins have been in use for many decades now and its indications are well known
to most physicians. Patients with NAFLD and NASH frequently have coexisting metabolic
syndrome including hypercholesterolemia for which statins are often prescribed. Hence it will
be very important to clarify how this was ascertained that statins were prescribed primarily for
weight loss.
# 6
I am afraid this study also suffers from lack of novelty as the subject of knowledge gap and
the divergence of community practice from guidelines in NAFLD/NASH are previously studied
and published.
Please review this paper.
user
Title: Clinical Characteristics and Management of Patients with Nonalcoholic Steatohepatitis
in a Real-World Setting: Analysis of the Ipsos NASH Therapy Monitor Database
Version: 2 Date: 13 Jan 2023
Reviewer:  Harishankar Gopakumar
Reviewer's report:
Dear Authors,
It was a pleasure to read your work titled “Clinical Characteristics and Management of Patients
with Nonalcoholic Steatohepatitis in the Real-World Setting: Analysis of the Ipsos NASH
Therapy Monitor Database"
This is overall a well written study and I commend the authors on their very relevant work in the
field of NASH and NAFLD that is increasing prevalence globally. There is need for awareness
and ongoing education on the latest recommendations of diagnosis and management of NAFLD/
NASH in non-academic community practice and this study highlights this.
There are a few concerns that I have outlined below.
# 1
The authors find that the biopsy rates were broadly similar among PCPs, endocrinologists,
gastroenterologists, and hepatologists (72%-74% across all four diagnosing physician
specialties). This I find to be very different from what is "real-world". It is much more likely
that a primary care physician or endocrinologist would refer a patient to a gastroenterologist
or hepatologist for evaluation rather than ordering the liver biopsy themselves. As the authors
have mentioned, the liver biopsy rates in this study are also higher than what is usually reported.
The results of this study hence seem to not actually be a representation of real-world practice
of these specialists.
# 2
This study seems to reflect practice of physicians who manage NASH regularly given the high
percentage of liver biopsies and use of Vitamin E and Pioglitazone which are the two medications
that have been shown to reverse steatohepatitis (PIVENS Trial).
# 3
In sentence 287, the authors mention that vitamin E is the only drug "shown to have
any histological efficacy in randomized clinical trials". This is an inaccurate statement as
Pioglitazone was also shown to have histological efficacy with reduction in lobular inflammation
and steatosis as in PIVENS trial although it did not meet the primary endpoint.
# 4
In keeping with the above, the readers, I believe would be curious to know what constitutes the
Ipsos NASH database and what patients/hospitals/physicians contribute to it.
# 5 The authors of this study conclude that physicians prescribed statins and vitamin E primarily
for weight loss. Statins have been in use for many decades now and its indications are well known
to most physicians. Patients with NAFLD and NASH frequently have coexisting metabolic
syndrome including hypercholesterolemia for which statins are often prescribed. Hence it will
be very important to clarify how this was ascertained that statins were prescribed primarily for
weight loss.
# 6
I am afraid this study also suffers from lack of novelty as the subject of knowledge gap and
the divergence of community practice from guidelines in NAFLD/NASH are previously studied
and published.
assistant