Repeatedly Reported: Proton Pump Inhibitors (PPIs) cause “SILENT KIDNEY DAMAGE” & more...
Time has come to QUESTION ourselves if we really need to SUPRESS OUR ORGANS in the name of suppressing ACID?
Patients taking Proton pump inhibitors (PPIs) like Pantoprazole, Rabeprazole, Omeprazole, Esomeprazole, etc... may not be aware of a decline in kidney function.
A must see links
2. CLICK for compiled PPI side effects presentation
3. Youtube Video (Below)
Preface
The introduction of proton pump inhibitors (PPIs) into clinical practice has revolutionized the management of acid-related diseases. Twenty-five years after their introduction into clinical practice, PPIs remain the mainstay of the treatment of acid-related diseases, where their use in gastroesophageal reflux disease, eosinophilic esophagitis, Helicobacter pylori infection, peptic ulcer disease and bleeding as well as, and Zollinger–Ellison syndrome is appropriate. Prevention of gastroduodenal mucosal lesions (and symptoms) in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or antiplatelet therapies and carrying gastrointestinal risk factors also represents an appropriate indication.
After 25 years - The reality opens up
Studies in primary care and emergency settings suggest that PPIs are frequently prescribed for inappropriate indications or for indications where their use offers little benefit. Inappropriate PPI use is a matter of great concern, especially in the elderly, who are often affected by multiple comorbidities and are taking multiple medications, and are thus at an increased risk of long-term PPI-related adverse outcomes as well as drug-to-drug interactions.
Many say "I have been consuming, but nothing happened"
Arora et al. BMC Nephrology (2016) 17:112 mentioned clearly that in general, most patients with acute kidney injury are assumed to have acute tubular necrosis.
It is not surprising that AIN secondary to PPI use may also go undetected due to
- Awareness that PPIs can cause AIN may not be wide spread;
- The time interval from drug initiation to onset of clinical abnormalities is quite variable, ranging from 1 week to 9 months (median 9.9 weeks); and
- Typical features of hypersensitivity reaction are present in only a minority of cases.
What is the new study all about?
It is a new study (Published in Kidney International, 22nd Feb, 2017) evaluating the use of PPIs and KIDNEY DISEASE.
So whats the population / details about the new study?
The researchers - analysed data from the Department of Veterans Affairs databases on 125,596 new users of PPIs and 18,436 new users of other heartburn drugs referred to as H2 blockers. It was over five years of follow up.
What are the main findings in this new study of PPIs & H2RAs
More than half of patients (More than 50% of patients) who develop chronic kidney damage while taking the drugs do not experience acute kidney problems beforehand, meaning…“Patients may not be aware of a decline in kidney function. It's a silent disease, in the sense that it erodes kidney function very minimally and very gradually over time.”
The study also showed that among new users of H2 blockers, only 1.27 % developed end-stage renal disease. (H2RA known to cause less likely kidney problems)
PPI side effects were reported earlier or is it first time? WHat are the PPI alerts?
Several other studies have been published in the past in several eminent journals. This is the latest study. However, since PPIs are been in use since almost 2 decades, its hard to believe. But yet true. The following are the list of problems both in terms of MORBID & MORTAL cases that PPIs have been documented.
- PPIs & KIDNEY disease.
- PPIs & KIDNEY Progression ESRD, CKD etc.,
- PPIs & acute kidney injury & acute interstitial nephritis.
- PPIs and DEMENTIA
- Increased risk of Myocardial infarction (heart attack) associated with PPIs (even in general population)
- PPIs & ischemic cardiovascular events.
- PPIs and Endothelial AGING
- PPIs with ASPIRIN – Higher mortality rates.
- PPIs & Anaemia.
- PPIs & Clopidogrel.
- PPIs & Hyperparathyroidism.
- PPIs & Clostridium difficile associated GI infections.
- PPIs & Hypomagnesaemia.
- PPIs hampering absorption of Vit-B12, Iron, Calcium.
Are PPI really overused? even in India?
Recently in their edition of July – September issue, the journal “Pharmacy Practice” (2015 Jul-Sep;13(3):633) published. Studies emerged claiming up to 68% of hospital inpatients did not have appropriate indication for PPI therapy in developed countries such as US, Australia, New Zealand, Italy, and Ireland. Moreover, inappropriate PPI prescription noted (Hospitalized) are as below.
USA (65%), Australia (63%), New Zealand (40%), Italy (68%) and Ireland (33%)
A similar situation was also apparent in our setting, whereby 52.5% of all prophylactic PPIs prescribing were unnecessary according to guidelines used in this study. Trying to derive some unusual yet meaningful conclusions or inferences by correlating the market data, some of my observations are below. Before landing to some twisting facts, let me tell you which some of you industry personnel might already know.
Industry scenario - Every Indian Consumes
Out of all the categories in pharmaceuticals, it is an ANTI-ULCERANT brand that is the highest sold Pharmaceutical drugs in Indian market in terms of units. So…as per a representative figures (Sept’2015 IMS MAT figures) 1342039305 units (Strips) of antipeptic ulcerants are sold in India in a year.
Practically everyone takes a anti-peptic ulcerant.
Now, for a moment compare this with the population of the country as per the 2011 census. Practically everyone takes a antipeptic ulcerant. At the same time as per CMARC prescription data (CPR-Mar-Jun 2015) on a PPI, 52% of Pantoprazole prescription is for more than 7 days period.
Diabetes & Hypertension - Are they the apt indications to prescribe PPIs even if in adjunct therapy?
Diabetes and Hypertension which are chronic conditions feature in the TOP 7 most frequently prescribed indication for Pantoprazole (and even for most PPIs). Overtly, these two indications are not a prescribed/approved direct indication for PPIs. Moreover being long term conditions makes them more vulnerable that the international bodies do not feature them in a PPI indication lists directly.
Prescription wise, PPIs are prescribed for more than 15 day in Diabetic & hypertensive patients. 35% & more PPIs are prescribed in diabetes & hypertension.
CMARC also specifies that 35.9% PRESCRIPTIONS of Pantoprazole in Diabetes & 36.5% of PRESCRIPTIONS in Hypertension are for more than 15 days period. There arise some important questions and concerns, which we may not ascertain an answer right now.
Many times, even if doctors prescribe as per international guidelines for for 2 weeks, yet patient keep consuming without doctor's knowledge.
A considerable number of prescriptions are given in unapproved indications. How many patients follow it judiciously? How many patients self medicate further even after the completion of the course?
Whats the most important conclusion of the study published in Kidney International - FEB 2017?
Patients may not be aware of a decline in kidney function. It's a silent disease, in the sense that it erodes kidney function very minimally and very gradually over time. The results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure,
Whats the caution outlined?
Results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure. Doctors must pay careful attention to kidney function in their patients, who use PPIs, even when there are no signs of problems.
SUMMARY?
If at all the need is for long term acid suppression especially with chronic cases or drugs related to diabetes, hypertension, anti-platelets etc., then ideally should choose RANITIDINE (H2RA)
Always question the indication and risks of chronic PPI usage on a regular basis.
Avoid use of Long Term PPI.
Use PPI ideally for 15 days or 7 to 8 weeks in only severe cases.
A lifestyle modification is the best option especially for patients suffering from diabetes & hypertension with or without GERD.
If need be for long term, use a H2 receptor blockers instead of increasing the risks with PPIs in your patients.
__________________________________________________________
For further information contact
EMAIL: [email protected]
Twitter @pawankulkarni
___________________________________________________________________