Author: Joseph Cusimano, et al.
Cusimano, J; et al..
Pass. WMF copyvio tool using TurnItIn: violation unlikely. The most similar phrases "Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform and ethyl acetate and insoluble in ether and n-hexane." and "Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation." were found in FDA drug approval documents, which constitutes Public Domain content and therefore does not constitute a copyright violation. --Steven Fruitsmaak (Reply) 18:32, 24 February 2018 (UTC)
Comments by Michaël R. Laurent, MD PhD
These comments were submitted on , and refer to this previous version of the article
This submission on the topic of Rabeprazole is based on the corresponding Wikipedia article to which the corresponding author has made substantial contributions. It is a generally well-written/accessible and exhaustive overview on a commonly prescribed medicine. I find it nicely illustrated, well structured and the abstract is clear. However I do have a few points to further improve this manuscript below.
I also made several changes to the text directly, please verify if you can support these changes!
Thank you for your review! I support the changes you have made to the article directly.
- My main suggestion is to make a more clear distinction throughout the text between the aspects which are generally applicable to PPIs, and which aspects are specific to Rabeprazole. For example I presume that most if not all of the side-effects are class effects and not specific to this one PPI, also the abstract and the text do not clearly make this distinction.
- Could you add more primary references to appropriate randomized trials (I am aware that it is debated whether or not this is appropriate under WP:MEDMOS, but for a review on a very specific topic like this one I think the key RCTs should be cited).
1. In the abstract,
- you start with indications from the rarest (Zollinger-Ellison) to the commonets (GERD), this order should be reversed I think.
Agreed. I wouldn't want people to think that ZE is the most common indication for rabeprazole!
- "Bone damage" and "dangerous rashes" should also be changed to "osteoporosis" and "allergic reactions" I think; even though this is a little higher reading level, it should above anything be accurate.
That's fair. I've changed "dangerous rashes" to "immune-mediated rashes," because eruptions like SJS are not quite "allergic reactions," but are mediated by the immune system. Thus, I've tried to be all encompassing with that term, though it doesn't reflect the terminology of my sources. I've changed "bone damage" to "osteoporosis."
- In the abstract it says "though this is unlikely in comparison to other proton pump inhibitors". What is meant exactly: that this is unlikely to be clinically significant, or that this is AS likely as with other PPIs? Please make this more clear.
Clarified to indicate that I'm talking about clinical significance, and noting that this significance is likely less than that of other PPIs.
- I would suggest to add the potential risk of different types of infections (a class effect of PPIs, e.g. risk of Clostridium) to the abstract.
Agreed. Added C. diff. and clarified that class effect ADR of osteoporosis.
- Why do you emphasize in the abstract that proton pumps are inhibited "permanently", the effect is still reversible no? Perhaps leave this part out (already repeats what is mentioned in the first sentence).
I emphasized the permanent nature of the proton pump inhibition to contrast with reversible inhibition of proton pumps. Albeit, the overall effect of irreversible proton pump inhibition (acid suppression) is still reversible, as you point out (as new proton pumps are produced, replacing those that are effectively "broken"). Nearly all currently available PPIs are irreversible inhibitors, but the new class of potassium-competitive (reversible) PPIs is a hot area of new research. E.g. vonoprazan and revaprazan.
2. Section on Medical uses:
- Has rabeprazole been specifically investigated in rare conditions such as Zollinger-Ellison or mastocytosis, and is it specifically approved for these indications? If not, perhaps this should be clarified and mentioned that this is, theoretically, off-label use!
The indication for Zolling-Ellison is explicitly mentioned in the FDA labeling. I believe that, technically, the use of rabeprazole would be on-label when used for these conditions because you're technically not treating the condition itself; rather, you're treating ulcerations associated with an underlying pathology. I couldn't find an explicit list of "pathological hypersecretory conditions" pertaining to the FDA labeling. I've emailed FDA Drug Info about this, and will update my response upon their reply.
- Thank you for responding to the above question. Perhaps I wasn't clear enough: I intended to ask, can you add any primary sources of randomized trials in specific populations like mastocytosis, or was this indication inferred from trials with other PPI's?
Thank you for clarifying. I've cited a trial in ZE, but there does not appear to be any trials of any PPI for the treatment of acid-related complaints 2/2 SM.
- Related to pregnancy, I would suggest adding the status of rabeprazole according to SafeFetus.com .
The entry for rabeprazole on this website is out of date. However, this made me realize that the article itself was out of date on this point, and I have therefore updated it with the most current package labeling and data from January 2018.
- "Kidney or liver problems", could you changes this to "insufficiency" or another appropriate wording?
Yes. I have updated the article to include more technical wording here.
3. Section on adverse effects:
- What do you mean exactly by "even up to 5 years after clinical trial follow-up": do you mean during 5 years of treatment, or 5 years after stopping the drug (which is how I interpret this, but that makes of course little sense).
The article was poorly worded. I have corrected it to more clearly refer to 5 years of treatment.
- Thank you for answering the above question. Could you add the info as a reference rather than as a footnote please? Thank you.
You're welcome. Yes--I've added the info as a reference as you've requested, and removed the footnote section.
- "Elevated serum gastrin may be associated with gastric cancer" : okay, but has the use of PPIs, and rabeprazole in particular, been associated with gastric cancer, or is gastrin associated with cancer even in subjects not taking PPIs?
Yes--PPIs have been associated with gastric cancer. Hypergastrinemia is also associated with cancer without the presence of PPIs. I've clarified the mechanism in greater detail in the article.
- I think there is also some evidence that gastric acid is required for the absorption of calcium and that this may be related to the increased risk of fractures?
That is one hypothesis, yes. I've added more detail to the MoA behind this ADR.
- Clostridium difficile infection is mentioned twice in this section. However other possible infections associated with PPIs include different types of pneumonia and also Salmonella and Campylobacter infection. Of course the evidence supporting these associations is weak but still I think you should expand this section and also discuss proposed mechanisms underlying these associations (although most of these mechanisms have not been proven either). To some extent of course, you may refer the reader to a more detailed discussion on some of these issues in another Wikipedia article e.g. the main PPI article.
I've expanded the infection risk section to include PNA and more info on enteric infections. I'll be updating in the future with another ADR from a French study I found.
4. Pharmacology section:
- Mechanism of action: something counterintuitive which should perhaps be clarified is that PPIs are formulated in an enteric-coated manner to pass the stomach and become absorbed in the smaller intestine. Then, through the bloodstream they again reach the parietal cells in the stomach and act there (if I am correct). Could you add this for clarity to the mechanism of action section?
Quite correct; I was referring only to the molecular MoA in the manuscript. I have clarified the MoA section to walk the reader through the mechanism, from the moment of po intake onward.
- Could you list the pKa of other commonly used PPIs for reference?
Yes! Completed. See Table 1.
- "compared to men in the United States": of course men in the US may also be of Japanese ancestry! Please correct.
Clarified. The people of "Japanese ancestry" were not US-Japanese, but Japanese people. The data set compared men from both countries. I've clarified the manuscript to make the source of the data more distinct.
5. Research section:
- "because two high quality clinical trials failed to demonstrate a benefit of rabeprazole-ER versus esomeprazole (another common PPI) for healing grade C or D erosive esophagitis,": could you add primary references to these two trials? Thanks.
First peer reviewer
Fabio Pace , Bolognini Hospital, ASST Bergamo Est, Bergamo (Italy) Division of Gastroenterology
This review was submitted on , and refers to this previous version of the article
Very thorough state-of-art on the subject
Thank you for your kind words and for your review. Let me know if you have any specific criticisms or suggestions for improvement.
Second peer reviewer
Ambavaram Vijaya Bhaskar Reddy , Universiti Teknologi Petronas
This review was submitted on , and refers to this previous version of the article
The present article on Rabeprazole majorly discussed the medical uses, contraindications, drug-drug interactions and its pharmacology in detail. However, a similar page ‘rabeprazole’ is already appears in Wikipedia that covered almost the same information mentioned in this article. I just wonder it is acceptable if its only the update to Wikipedia ‘rabeprazole’ article, otherwise there is nothing much to consider in this article. Assuming that it is an extension to existed Wikipedia ‘rabeprazole’ webpage, I suggest the following modifications to strengthen this article.
Thank you kindly for your thorough review and suggestions. I shall make the suggested changes, one-by-one.
- Abstract: the author can simplify the medical uses of rabeprazole instead lengthy sentences.
Shortened the sentence concerning the medical uses of rabeprazole.
- Ref: (rabeprazole has several medical uses: the management of conditions involving prolonged exposure to gastric acid (e.g. symptomatic gastroesophageal reflux disease), conditions that are worsened by gastric acid (e.g. ulcerations of the gastrointestinal tract), and conditions that involve excess gastric acid production (e.g. Zollinger–Ellison syndrome).
These uses are FDA-approved indications for the use of rabeprazole, and are cited by the package insert.
- Medical uses: please state the Proton pump inhibitors (PPIs), since the author mentioned the term as PPI thereafter in the whole article.
- Also please add some other PPI drugs in 1st line of the Medical uses “like other proton pump inhibitors such as omeprazole,” like esomeprazole and lansoprazole as they were compared with rabeprazole at the end of article.
- In the second paragraph of the Medical Uses “ Helicobacter Pylori” for more accuracy the author should abbreviate once as Helicobacter Pylori (H. pylori).
Thank you for these suggestions. The suggested changes have been made to the article.
- Available forms; Please re-arrange the sentence in this section, it lacks the meaning. Also, the authors stated the only available form is 20 mg.
- The above link shows 10 mg tablets were also available. Please consider the latest information on it.
- In Specific populations section under pregnancy: The author mentioned reference (12) is for the rats studies and the same reference is cited again for the rabbit studies. Please check.
- Adverse effects: in this section reference 28 is repeated consecutively. However, the authors can mention only once for both the sentences.
- Adverse effects in last paragraph “Please re-arrange the sentence “but there is no direct evidence that rabeprazole definitely caused these side effects”
- Overdose section: if possible please add few more references overdose studies.
- In Pharmacology section under Mechanism of action: “is taken by mouth looks improper” it could be replaced with ‘oral administration’.
- In Fig 3 and 4, it is recommended to present the structures of rabeprazole similarly.
- The authors can add some other properties of rabeprazole in addition to solubility under “physiochemical properties” section
- Although the references were appropriate, the authors can update few of them with latest/recent articles if possible.
Apart from the above all, the authors need to go through the entire article to rearrange the sentences that strengthen the language of this article.