Safety of olmesartan (Benicar)

Some patients and healthcare providers have expressed concerns about the safety of higher than typical doses of olmesartan (Benicar).

Ample research supports the fact that olmesartanMedication taken regularly by patients on the Marshall Protocol for its ability to activate the Vitamin D Receptor. Also known by the trade name Benicar. is one of the safest and has the most gentle side effects profiles of almost any drug on the market – as opposed to Benicar HCT, which contains a thiazide and is harmful.

I feel there are simply no adverse reactions or negative side effects that I need to worry about while taking the Marshall ProtocolA curative medical treatment for chronic inflammatory disease. Based on the Marshall Pathogenesis. medications. It is an extremely safe approach. Personally, I believe overtreating this condition is preferable than undertreating as the side effects of both antibiotics and Benicar are so minimal compared to the risk of [disease] recurrence.

Greg Blaney, M.D.

Although they do so for many other drugs, the U.S. Food and Drug Administration has set no unsafe upper limit for olmesartan. The FDA bases its safety data on “post-marketing experience” - how many dose-related adverse events have been linked to the drug – and for olmesartan, they are negligible. The FDA has consequently set no unsafe dosage level for Olmesartan.

In fact, the FDA guidelines for olmesartan, state:

• The guidelines allow a dosage of “40 mg Q6hr” (the dose used by patients on the MP).
• Olmesartan dosing must be individualized.
• The overall frequency of adverse events is not dose-related.

A 2001 study published in the Journal of of Pharmacology found olmesartan to be safe and well tolerated at doses of up to 160 mg/day.¹

CS-866 [olmesartan] was safe and well tolerated at doses of up to 160 mg/day…. [Olmesartan] has no serious adverse effects.

Lee R. Schwocho, PhD and Harvey N. Masonson, MD ²

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 label for olmesartan states that the drug is well-tolerated. Adverse events were similar to those experienced by the placebo group – a group of patients who were not given the drug at all. Adverse events were generally “mild, transient and not related to dose.” The frequency of adverse events also had no relationship to the dose of olmesartan.

In placebo-controlled trials, the only side effect that occurred in more than 1 percent of olmesartan-treated patients vs. placebo-treated patients was dizziness (3 percent vs. 1 percent). The label does state that olmesartan should not be used during pregnancy or breast-feeding, but since pregnant women are not allowed to do the Marshall Protocol, the warning is of little concern for those using the medicine to recover from Th1 disease.

According to the report:

In the dose-finding study, 792 patients were randomized to olmesartan (2.5-80 mg) or placebo once daily…. The results of the clinical studies in >3000 patients receiving olmesartan showed that the frequency and profile of adverse events with olmesartan were generally similar to those with placebo; the frequency of adverse events was not dose related. Olmesartan, with or without hydrochlorothiazide, was well tolerated over two years of treatment.

Hans R. Brunner, MD ³

In April 2007, the staff of Autoimmunity Research FoundationNon-profit foundation dedicated to exploring a pathogenesis and therapy for chronic disease. had a high-level meeting at the FDA in Maryland. One of the topics on the agenda was how to put an end to concerns physicians express about the safety of olmesartan.

Those present included the head of CDER's Cardio-Renal Drug Products Division at the time olmesartan was approved, Dr. Robert Temple.

He [Dr. Temple] is expert on the drug’s behavior and is currently the medical director at the Food and Drug Administration division that evaluates drugs. He made it clear that the hypotensive effect of olmesartan is already in full effect at a low dose (less than 40 mg) and there is a graph in the package insert showing that beyond that 40mg the dose really doesn’t affect BP any more. Second, he pointed out that the FDA has set no toxic level for olmesartan, because its safety is not in question, and certainly not at the levels we are using.

Trevor Marshall, PhD

Additional papers on the general safety of olmesartan state:

Frequency of adverse events is not dose related.⁴

Peak plasma concentrations of olmesartan occur 1-3 hours after administration, after which concentrations decrease with an elimination half-life of 10-15 hours… Frequencies of adverse events during treatment with olmesartan medoxomil and placebo are similar, with no evidence of a dose response. There are no clinically significant effects on laboratory parameters, and the drug-interaction potential of olmesartan medoxomil is low.⁵

High-dose ARB treatment in patients with chronic renal disease is not associated with any clinically significant long-term negative effects on serum creatinine or potassium and is thus an important therapeutic modality with which to achieve further reductions in urinary protein excretion.⁶

The results of this pilot study suggest that supramaximal doses of ARBs are safe and well tolerated in patients with chronic kidney disease, while reducing both blood pressure and proteinuria.⁷

Olmesartan medoxomil has minimal adverse effects with no clinically important drug interactions. Animal studies have shown that olmesartan medoxomil provides a wide range of organ protection. Olmesartan medoxomil ameliorated atherosclerosis in hyperlipidemic animals and ameliorated cardiac remodeling and improved survival in rats with myocardial infarction. Olmesartan medoxomil has renoprotective effects in a remnant kidney model and type 2 diabetes models.⁸

Just as some patients mistakenly assume they're allergic to MP antibiotics, patients mistake certain symptoms brought about by olmesartan use for harmful side effects.

The most common reason that patients who begin the Marshall Protocol incorrectly assume that they are suffering from side effects of olmesartan is that they mistakenly attribute the hormonal adjustments that accompany the onset of a olmesartan blockade to side effects of the drug. These hormonal changes occur because in most patients with Th1 disease, the body has become accustomed to a higher than normal level of the hormone 1,25-DPrimary biologically active vitamin D hormone. Activates the vitamin D nuclear receptor. Produced by hydroxylation of 25-D. Also known as 1,25-dihydroxycholecalciferol, 1,25-hydroxyvitamin D and calcitirol., which rises as part of the immune system’s reaction to bacteria.

But the olmesartan blockade quickly and dramatically lowers 1,25-D - by as much as half in just two weeks. Since 1,25-D is a powerful hormone that affects nearly every cell in the body, and interacts with all the body’s major hormones, myriad other hormones are forced to adjust their levels according to the new lower level of 1,25-D. This often causes temporary neurological-type symptoms such as (but not limited to) fatigue, dizziness, headache, photosensitivityAbnormal sensitivity to sunlight and bright lights. Also referred to as "sun flare" or "light flare.", irritability, sleep disturbances, brain fog, etc. As the body adjusts to this hormonal shift these symptoms dissipate, usually in a week or two.

Patients should not confuse the rise in symptoms that occurs due to immunopathology with side effects of olmesartan. Immunopathology is absolutely necessary to make progress on the MP.

The ability to accept and tolerate a certain level of immunopathologyA temporary increase in disease symptoms experienced by Marshall Protocol patients that results from the release of cytokines and endotoxins as disease-causing bacteria are killed. is a requisite of continuing with the Marshall Protocol and is not always predictable. Usually symptoms wax and wane, but they can also be constant for varying periods of time. Immnopathology-generated symptoms often mimic a patient’s disease symptoms but they can also be surprisingly new, pointing to areas of previously undetected inflammationThe complex biological response of vascular tissues to harmful stimuli such as pathogens or damaged cells. It is a protective attempt by the organism to remove the injurious stimuli as well as initiate the healing process for the tissue..

Meg Mangin

Olmesartan has a number of protective effects. For one, it's a potent anti-inflammatory. Since the anti-inflammatory actions of olmesartan actually protect organs, the medication will reduce damage to the body from immunopathology.

Olmesartan is designed to reduce the impact on the tissues of the inflammatory substances released by the immune system as part of the immunopathological reactionA temporary increase in disease symptoms experiences by Marshall Protocol patients that results from the release of cytokines and endotoxins as disease-causing bacteria are killed..

Other protective effects include:

• reduction and amelioration of kidney disease
• prevent migraines⁹
• inhibit liver fibrosis and aid liver healing¹⁰
• protect the kidneys in diabetic nephropathy¹¹
• reduce insulin resistance¹²
• complete review of protective effects…