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/>                                                                            Updated August 4, 2017

Treatment protocols such as Inflammation Therapy resolve chronic inflammatory symptoms by stimulating the immune system to eliminate persistent pathogens. The resulting cellular death provokes Jarisch-Herxheimer reactions (i.e., immunopathology) which often cause hormonal, endocrine, and blood count changes.

The kidneys may be affected by subclinical chronic inflammation, and must function well enough to eliminate additional toxins released as a result of the bacterial die-off. Mildly abnormal kidney function during treatment is common and not a cause for concern. However, because treatment often requires many years of immune system stimulation to resolve inflammation, it's vital that medical practitioners regularly monitor kidney function (BUN, creatinine, eGFR, proteinuria, electrolytes, B/P, 24 hour urine, cystatin C, etc.) to ensure these markers of health don't stray too far from normal and aren't continuing to trend in the wrong direction.

Kidney function lab results that are seriously out of range should not be ignored nor should they be considered a normal part of the healing process. Seriously out of range kidney function tests do indicate renal stress that could result in permanent organ damage if waste products are allowed to accumulate. Anecdotal case reports include patients who have had to discontinue the treatment protocol in order to avoid dialysis.

However, the medical professionals at CIR have learned that reducing immunostimulation (i.e., upregulation of vitamin D receptor transcription of antimicrobial peptides) by decreasing the dose of Benicar (olmesartan) is an effective strategy to improve worrisome kidney function so patients can safely continue Inflammation Therapy. See Benicar Dose.

Updated September 9, 2014

ScienceDaily (Dec.16, 2010) — There is burgeoning public interest in possible wide-ranging health benefits from vitamin D, including cardiovascular health. In a study published in the December 2010 issue of The American Journal of Medicine, investigators found that there was no independent association between serum levels of vitamin D or parathyroid hormone and cardiovascular mortality. This prospective study was the first in a population of older community-dwelling adults with a low prevalence of vitamin D deficiency and a broad range of kidney function.

Researchers collected data from the Rancho Bernardo study, which was established in 1972. Between 1997 and 1999, 1091 participants attended a follow-up visit where blood samples were collected, along with detailed surveys of medical history, medications, cigarette smoking, alcohol consumption, and exercise; serum levels of 25-hydroxyvitamin D (25[OH]D) (mean 42 ng/mL), 1,25-dihydroxyvitamin D (1,25[OH]2D) (median 29 pg/mL), and intact parathyroid hormone (median 46 pg/mL) were measured; mean estimated glomerular filtration rate (eGFR) was 74 mL/min/1.73 m2. Using data from 1073 participants who qualified for this study, these people were followed for a median of 6.8 years (maximum 10.7 years). During this period, there were 266 deaths, including 111 cardiovascular deaths. Of those 111, 71 had normal kidney function (eGFR > 60 mL/min/1.73 m2) and 40 had reduced kidney function (eGFR < 60 mL/min/1.73 m2).

In populations with chronic kidney disease, low levels of 25(OH)D and 1,25[OH]2D, and high levels of intact parathyroid hormone have been suggested to explain the association between chronic kidney disease and cardiovascular mortality. Even in people with intact kidney function, there are multiple mechanisms that could link Vitamin D and cardiovascular disease.

"To our knowledge, this is the first prospective study to investigate the role of serum 25[OH]D, 1,25[OH]2D, and intact parathyroid hormone in the prediction of cardiovascular mortality in a population of older community-dwelling adults with a low prevalence of vitamin D deficiency and a broad range of kidney function," commented Lead investigator Simerjot K. Jassal, MD, Division of General Internal Medicine and Geriatrics, Department of Medicine, University of California, San Diego, and VA San Diego Healthcare System, La Jolla.

Dr. Jassal continued, "After adjusting for age alone, there was no independent association between serum levels of 25(OH)D, 1,25(OH)2D, or intact parathyroid hormone and cardiovascular mortality. Prior published literature in community-dwelling adults suggests an increased risk of cardiovascular mortality only in individuals with vitamin D levels lower than levels observed here. Our null results may mean that only larger disruptions in levels of 25(OH)D and 1,25(OH)2D contribute to cardiovascular mortality. These null findings are also compatible with results from randomized clinical trials in which vitamin D supplementation has failed to prevent cardiovascular outcomes, although the doses of vitamin D in these trials may have been too low."

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Elsevier Health Sciences, via EurekAlert!, a service of AAAS.

Journal Reference:

1. Simerjot K. Jassal, Michel Chonchol, Denise von Mühlen, Gerard Smits, Elizabeth Barrett-Connor. Vitamin D, Parathyroid Hormone, and Cardiovascular Mortality in Older Adults: The Rancho Bernardo Study. The American Journal of Medicine, 2010; DOI: 10.1016/j.amjmed.2010.07.013

 

 

 

Page reviewed May 14, 2011

Benicar-HTN

Cardiovascular risk

Two studies have prompted safety reviews of olmesartan (Benicar), but hypertension experts attending the European Society of Hypertension (ESH) European Meeting on Hypertension in June 2010 did not appear to be particularly concerned about possible risk of cardiac death. See ROADMAP presented; hypertension experts react to FDA review of olmesartan safety. (You may be asked to register for free access to the story about ROADMAP study.)

Hypertension experts thought the supposed increased risk of cardiac death from olmesartan in the ROADMAP and ORIENT studies could be due to chance. They noted that the drug has proven no real danger since it went on the market in 2002. The FDA is evaluating data from the two studies.

The FDA's ongoing safety review of Benicar and cardiovascular events states:

"Do not stop your treatment with Benicar unless told to do so by your healthcare professional."

4/14/11 safety review update: FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events

The results of this well-powered 2013 study do not raise concerns for the risk of SCD or death from all causes among olmesartan users in comparison with users of other ARBs or ACE inhibitors:
Cardiac mortality in users of olmesartan, other angiotensin-receptor blockers and angiotensin-converting enzyme inhibitors

06/26/2014 The U.S. Food and Drug Administration (FDA) has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. As a result, recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same. Patients should discuss any questions they have with their health care professionals. It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional. This safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non–fatal heart attack was lower in the olmesartan–treated patients. The collective evidence available at this time does not support changing recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes.

FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required
This information is in follow-up to the FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events.

Cancer riskBenicar_Safety

The US FDA also announced this month that it will be conducting a safety review of olmesartan after a paper about a meta-analysis, published in Lancet Oncology, suggested that angiotensin receptor blockers, as a class of drugs, may be linked to a small increase in cancer risk. There was no increased risk of death from cancer.

Most patients included in the meta-analysis, 86 percent, were taking telmisartan (Micardis), so the applicability of this analysis to other or all ARBs is not known. The data analyzed was limited to only four FDA-approved ARBs (telmisartan, losartan, valsartan, and candesartan), and none of the data was based on use of olmesartan, irbesartan or eprosartan.

The German drug maker of Micardis noted that the meta-analysis relied mainly on data from a combination of Micardis with an angoitensin-converting enzyme (ACE) inhibitor called ramipril. The manufacturer of Micardis does not recommend this combination. The drug maker also pointed out that no analysis was provided for the available data from the trial arms using each compound separately.

In its safety alert, the FDA says it has "not concluded that ARBs increase the risk of cancer." The agency is reviewing information related to this safety concern and will update the public when additional information is available. At this time, FDA believes the benefits of ARBs continue to outweigh their potential risks.

The European Medicines Agency has announced plans to review the possible risk of cancer in patients taking angiotensin-receptor blockers (ARBs), based on a meta-analysis in the June 2010 issue of Lancet Oncology, which suggested a "modest but significant" link between ARBs and cancer.

This article states:

"data analysed in the study was limited to 3 out of 7 US Food and Drug Administration-approved ARBs (telmisartan, losartan, and candesartan), so it is unknown if valsartan, irbesartan, olmesartan, and eprosartan are linked to a higher risk of new cancer incidence."

At the same time, hypertension experts are up in arms about the paper, calling it deeply flawed. See EMA to review ARBs and cancer, infuriating experts, who point to missing data and adverse consequences.

The FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks. See Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk.

Editorial: Meta-Analysis Concludes Angiotensin Receptor Blocker Use Increases the Risk of Developing Cancer: Concerns About the Science and the Message.

"In conclusion, we think that this situation highlights the need for us to better educate the mass media about levels of evidence. The fact that the publication of this finding from a study with a low weight of evidence was given such widespread national attention is troubling. According to well-established rules of evidence-based medicine, studies such as this should never dictate clinical care and should remain hypothesis-generating. Perhaps the American Society of Hypertension (ASH) should develop a panel of experts that could be available to help the media appropriately evaluate the strength and significance of publications related to hypertension.

We feel that based on the evidence presented to date, there is no need for physicians to change their prescribing of ARBs or for any regulatory change to occur at this time. We do recommend the following steps be taken to clarify the issue of a potential link between ARBs and incident cancer: (1) a better-designed patient level meta-analysis of all relevant ARB studies, including VALUE, be performed; (2) administrative claims databases such as those available from the Veterans Administration (VA) should be examined to determine whether there is an association between ARB use and incident cancer; (3) any clinical investigators with cancer-related data and ARB use should contact the authors of the present study so they can perform an updated meta-analysis (submitted as a Letter to the Editor of Lancet Oncology); and (4) future trials using ARBs should collect cancer data as a pre-specified end point of interest. Societies such as ASH need to work with the media to properly position and explain the results"

This study states "In conclusion, long-term use of ARBs is associated with a lower incidence of cancer occurrence, thereby suggesting that ARBs may prevent cancer development."
Angiotensin II Receptor Blockers and Risk of Cancer in Patients With Systemic Hypertension.

Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed
FDA's meta-analysis of 31 randomized controlled trials comparing ARBs to other treatment found no evidence of an increased risk of incident cancer, cancer-related death, breast cancer, lung cancer, or prostate cancer in patients receiving ARBs.

Renal risk

The concern about kidney damage while taking Benicar with an NSAID is unfounded. This only refers to the angiotensin receptor blockers that are combined with a diuretic (e.g., olmesartan with hydrochlorothiazide). These combination products are often prescribed to treat high blood pressure. Inflammation Therapy uses only single ingredient Benicar.

See: Concurrent use of diuretics, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers with non-steroidal anti-inflammatory drugs and risk of acute kidney injury: nested case-control study

Long-term safety of high-dose angiotensin receptor blocker therapy in hypertensive patients with chronic kidney disease.

Sprue-like enteropathy risk

Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)

The sprue-like enteropathy recently associated with Benicar involves severe and protracted diarrhea. This puzzling sundrome has been experienced by only a small subset of users and we've not seen it in any patients on Inflammation Therapy.

Stearates are used in many drugs (including Benicar), as a lubricant and stabilizer. In sensitive individuals, stearates could coat the lining of the intestines and prevent proper digestive actions from taking place, thus causing gastroenteritis.

Sprue-like enteropathy

Benicar (olmesartan medoxomil) has recently been linked with development of sprue-like enteropathy in a small subset of users. The gastrointestinal symptoms are not celiac disease because a gluten-free diet did not affect them, the patients did not have the usual antibodies and their symptoms resolved when olmesartan was discontinued. Benicar's prodrug activity occurs in the small bowel but the etiology of this phenomenon is unknown. It could be a consequence of the prodrug action, the infectious theory of systemic inflammation (i.e., Herxheimer reaction) or inactive ingredients in the formulated medication.

Anyone who is experiencing severe and protracted diarrhea should discuss with their doctor the possibility it being caused by Benicar.

This September 2014 study concluded:
"Our findings suggest that neither olmesartan nor other ARBs were associated with diarrhea among patients undergoing endoscopy. The spruelike enteropathy recently associated with olmesartan is likely a rare adverse effect and milder presentations are unlikely."
Olmesartan, Other Antihypertensives, and Chronic Diarrhea Among Patients Undergoing Endoscopic Procedures: A Case-Control Study.

---oOo---

See also Lies, Damned Lies, and Medical Science.

Updated September 7, 2014

ScienceDaily (Mar.18, 2009) — A lack of Vitamin D, due to reduced sunlight, has been linked to depression and the symptoms of Seasonal Affective Disorder (SAD), but research by the University of Warwick shows there is no clear link between the levels of vitamin D in the blood and depression.

Exposure to sunlight stimulates vitamin D in the skin and a shortage of sunlight in the winter has been put forward as one possible cause of SAD. However Warwick Medical School researchers, led by Dr Oscar Franco, have discovered low levels of vitamin D in the blood may not be connected to depression.

In a study published in the Journal of Affective Disorders, the team recruited more than 3,000 people and tested levels of vitamin D (25-hydroxyvitamin D) in the blood. They then carried out a questionnaire with the participants to assess the prevalence of depressive symptoms.

Vitamin D deficiency exists when the concentration of 25-hydroxy-vitamin D (25-OH-D) in the blood serum occurs at 12ng/ml (nanograms/millilitre) or less. The normal concentration of 25-hydroxy-vitamin D in the blood serum is 25-50ng/ml.

The researchers found there was no clear association between depressive symptoms and the concentration of vitamin D in the blood.

Dr Oscar Franco, Assistant Clinical Professor in Public Health, said: "Few studies have explored the association between blood 25-hydroxyvitamin D concentrations and depression in the general population. A deficiency of vitamin D has also been attributed to several chronic diseases, including osteoporosis, common cancers, autoimmune and cardiovascular diseases."

This study was carried out in collaboration with colleagues from the Institute for Nutritional Sciences, Chinese Academy of Sciences in China.

The team recruited 3,262 community residents aged 50-70 from Beijing and Shanghai in China as part of the Nutrition and Health of Aging Population in China (NHAPC) project.

Dr Franco said his study did not evaluate whether the depressive symptoms were seasonal and suggested more studies needed to be done.

Dr Franco said: "Previous studies into the effects of vitamin D supplementation have produced mixed results. More studies are still needed to evaluate whether vitamin D is associated with seasonal affective disorders, but our study does raise questions about the effects of taking more vitamin D to combat depressive symptoms."

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by University of Warwick.

Journal Reference:

1. An Pan, Ling Lu, Oscar H. Franco, Zhijie Yu, Huaixing Li, Xu Lin. Association between depressive symptoms and 25-hydroxyvitamin D in middle-aged and elderly Chinese. Journal of Affective Disorders, 2009; DOI: 10.1016/j.jad.2009.02.002

Page reviewed April 4, 2015