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home:protocol:olmesartan:safety [04.10.2020] – [Safety of olmesartan (Benicar)] sallieq | home:protocol:olmesartan:safety [09.14.2022] (current) – external edit 127.0.0.1 | ||
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===== FDA safety guidelines ===== | ===== FDA safety guidelines ===== | ||
- | Although they do so for many other drugs, the [[http:// | + | Although they do so for many other drugs, the [[https:// |
- | According to the [[http:// | + | According to the [[https:// |
* "The overall frequency of adverse reactions was not dose-related." | * "The overall frequency of adverse reactions was not dose-related." | ||
* " | * " | ||
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===== Data supporting the safety of higher than typical dosing frequencies ===== | ===== Data supporting the safety of higher than typical dosing frequencies ===== | ||
- | A 2001 study published in the //Journal of of Pharmacology// | + | A 2001 study published in the //Journal of of Pharmacology// |
< | < | ||
- | //**Lee R. Schwocho, PhD** and **Harvey N. Masonson, MD**// (({{pubmed> | + | //**Lee R. Schwocho, PhD** and **Harvey N. Masonson, MD**// (({{pmid> |
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Animal studies in mice, with olmesartan doses up to 480 times the human dose of 40 mg per day (relative to body weight), showed that olmesartan is not carcinogenic. | Animal studies in mice, with olmesartan doses up to 480 times the human dose of 40 mg per day (relative to body weight), showed that olmesartan is not carcinogenic. | ||
- | The [[http:// | + | The [[https:// |
From a MPStudySite topic | From a MPStudySite topic | ||
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< | < | ||
- | //**Hans R. Brunner, MD**// (({{pubmed> | + | //**Hans R. Brunner, MD**// (({{pmid> |
==== Results of FDA meeting ==== | ==== Results of FDA meeting ==== | ||
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Additional papers on the general safety of olmesartan state: | Additional papers on the general safety of olmesartan state: | ||
- | < | + | < |
</ | </ | ||
- | < | + | < |
- | < | + | < |
- | < | + | < |
- | < | + | < |
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Other protective effects include: | Other protective effects include: | ||
* [[home: | * [[home: | ||
- | * prevent migraines(({{pubmed> | + | * prevent migraines(({{pmid> |
- | * inhibit liver fibrosis and aid liver healing(({{pubmed> | + | * inhibit liver fibrosis and aid liver healing(({{pmid> |
- | * protect the kidneys in diabetic nephropathy | + | * protect the kidneys in diabetic nephropathy |
- | * reduce insulin resistance(({{pubmed> | + | * reduce insulin resistance(({{pmid> |
* // | * // | ||
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===== Recent research ===== | ===== Recent research ===== | ||
- | olmesartan reduced angiotensin II and aldosterone levels more effectively than azilsartan, resulting in a stable antihypertensive effect. Olmesartan also had an inhibitory effect on cardiac hypertrophy. Accordingly, | + | olmesartan reduced angiotensin II and aldosterone levels more effectively than azilsartan, resulting in a stable antihypertensive effect. Olmesartan also had an inhibitory effect on cardiac hypertrophy. Accordingly, |
- | [[http:// | + | [[https:// |
- | With the halt of reimbursement of olmesartan, there was a decrease in the prescription of ARB in France. When olmersartan was replaced by another ARB, a worse blood pressure control was observed in treated hypertensive patients. | + | With the halt of reimbursement of olmesartan, there was a decrease in the prescription of ARB in France. When olmersartan was replaced by another ARB, a worse blood pressure control was observed in treated hypertensive patients. |
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The incidence of this adverse drug reaction is not entirely clear, although it is thought to be rare. | The incidence of this adverse drug reaction is not entirely clear, although it is thought to be rare. | ||
- | (({{pubmed> | + | (({{pmid> |
- | Seven cases (2.8%) reported recurrence of symptoms after restarting olmesartan (({{pubmed> | + | Seven cases (2.8%) reported recurrence of symptoms after restarting olmesartan (({{pmid> |
Although enteropathy is rare, clinicians should remain vigilant of this potential adverse event even years after medication initiation. | Although enteropathy is rare, clinicians should remain vigilant of this potential adverse event even years after medication initiation. | ||
- | (({{pubmed> | + | (({{pmid> |
- | results suggest that SMEEDS formulation improves dissolution and oral bioavailability of OM while reducing adverse effects (celiac-like enteropathy or diarrhea ). (({{pubmed> | + | results suggest that SMEEDS formulation improves dissolution and oral bioavailability of OM while reducing adverse effects (celiac-like enteropathy or diarrhea ). (({{pmid> |
==== Collagenous enteritis, a genetic problem? ==== | ==== Collagenous enteritis, a genetic problem? ==== | ||
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Collagenous enteritis is an uncommon small intestinal injury pattern with unclear pathogenesis. | Collagenous enteritis is an uncommon small intestinal injury pattern with unclear pathogenesis. | ||
- | All subjects with biopsy-proven collagenous enteritis diagnosed between 2002 and 2015 were identified from 2 tertiary care medical centers. Human leukocyte antigen (HLA)-DQ genotyping was performed by polymerase chain reaction on archived tissue. Celiac disease serology, past medical history, medications, | + | All subjects with biopsy-proven collagenous enteritis diagnosed between 2002 and 2015 were identified from 2 tertiary care medical centers. Human leukocyte antigen (HLA)-DQ genotyping was performed by polymerase chain reaction on archived tissue. Celiac disease serology, past medical history, medications, |
- | Olmesartan was not associated with intestinal malabsorption or significant body weight loss in the general Korean population. | + | Olmesartan was not associated with intestinal malabsorption or significant body weight loss in the general Korean population. |
+ | < | ||
===== Notes and comments ===== | ===== Notes and comments ===== | ||
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**FDA Finds Olmesartan Does Not Cause Cardiovascular Events** | **FDA Finds Olmesartan Does Not Cause Cardiovascular Events** | ||
- | http:// | + | https:// |
- | http:// | + | https:// |
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- | [[http:// | + | [[https:// |
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- | http:// | + | https:// |
..Trevor.. | ..Trevor.. | ||
</ | </ | ||
- | ===== References ===== | + | ===== References =====</ |