The content of this page is intended for health care providers, not for consumers. Consumers should always contact their health care provider before making any changes to their blood pressure management plan. 

 

Research & Efficacy

Is PreCardix^® supported by clinical research?

PreCardix^® is the result of over a decade of research and development dedicated to finding an effective, sustainable, and evidence-based natural product to support blood pressure health. 

Two clinical studies, the Mare-study (preliminary clinical trial) and Marealis 13TBHM (peer-reviewed, double-blind, placebo-controlled, multicentre clinical trial), were conducted on the bioactive marine peptides (RSPC) in PreCardix^® between 2012 and 2015 on over two hundred and twenty male and female participants aged 30 – 75. 

Clinical research has found that the unique bioactive marine peptides derived from hydrolyzed shrimp shells (Pandalus borealis) found in PreCardix^® have a natural ACE-inhibiting mechanism of action. The use of bioactive marine peptides in clinical trials resulted in a statistically significant effect on blood pressure. Over 89% of clinical trial participants saw a significant impact on blood pressure within eight weeks or less compared to baseline levels.

Read the entire clinical trial published in the International Journal of Hypertension here.

 

What is the anticipated blood pressure effect patients can expect with the use of PreCardix^®?

In the clinical trial, 89% of participants experienced a significant effect on their blood pressure health within eight weeks or less without serious side effects. The average reduction in systolic blood pressure was 6.7 mmHg, and 1.7 mmHg reduction in diastolic blood pressure after 8 weeks compared to baseline¹. 43% of participants experienced over 10 mmHg improvement in systolic blood pressure, and 24% of participants experienced over 15 mmHg in systolic blood pressure, compared to baseline.

¹ Musa-Veloso K, Paulionis L, Pelipyagina T, Evans M. A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure. Int J Hypertens. 2019;2019:2345042. Published 2019 Aug 5. doi:10.1155/2019/2345042. Ref. table 4.

Have any studies been conducted on patients with renal or hepatic concerns? Is PreCardix^® safe to use in these patients?           

Patients with pre-existing medical conditions, including renal or hepatic concerns, did not participate in the PreCardix^® bioactive marine peptides clinical trial. Only healthy and unmedicated adults without pre-existing conditions participated. In the clinical trial, serum testing of CBC, glucose, creatinine, estimated glomerular filtration rate, sodium, potassium, chloride, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and bilirubin was completed at screening and at eight weeks. There were no clinically significant differences in any of these parameters in the placebo and treatment groups at baseline or study end. All individuals, including those with pre-existing medical conditions, including renal and hepatic issues, must consult with their health care provider before initiating PreCardix^®.

 

Can PreCardix^® provide any protection to end organ damage?

Existing clinical research has not looked at the potential for PreCardix^® to protect against end-organ damage. There were no changes to kidney or liver markers between baseline and eight weeks in the clinical trial participants.

 

Will research be conducted investigating the impact of PreCardix^® on morbidity/mortality outcomes?

Research on the impact PreCardix^® bioactive marine peptides may have on morbidity and mortality will likely be conducted in the future. Upcoming research will study the potential mechanism behind the lack of serious side effects of PreCardix^® despite its proven ACE inhibiting mechanism of action similar to that of ACE inhibiting pharmaceuticals. We will test the current hypothesis set forth by our research and development team that the unique peptides within PreCardix^® work synergistically, with some acting as an ACEI, while others may prevent unwanted side effects.

 

Manufacturing Standards

How does PreCardix^® maintain consistency in the active ingredient in the manufacturing process?

Each 1,200 mg dose (2 tablets) of PreCardix^® consists of approximately 25,000 unique bioactive peptides that have a natural ACE-inhibiting mechanism of action. Each batch of PreCardix^® must meet Marealis’ strict internal standards before it is released for commercial use to ensure the product will always meet the expected effect on blood pressure health seen in clinical trials. This consistency and efficacy are ensured by testing the product for bioactivity and ACE-inhibiting attributes before and after the product is manufactured in tablet form.

 

What are the ingredients in PreCardix^®?

Each tablet of PreCardix^® contains 600 mg of protein hydrolysate from cold water shrimp (Pandalus borealis) shell. The active medicinal ingredient is Refined Shrimp Peptide Concentrate (RSPC) made up of peptides 2-7 amino acids long which pass unmodified into the bloodstream. These unique bioactive peptides work synergistically to produce ACE-inhibiting effects. Some peptides exert direct ACE-inhibition and two of the most potent constituents in PreCardix^® have been patented. 

The non-medicinal ingredients required for tablet manufacturing and palatability are: microcystalline cellulose, croscarmelose sodium, magnesium stearate, silicon dioxide, polyethelene glycol, talc (less than 20mg of USP-NF talc in the tablet’s coating), polyvinyl alcohol, titanium dioxide.

 

Is PreCardix^® derived from just shrimp, or shrimp and shellfish?

PreCardix^® is derived from the shells of cold-water Arctic prawns (Pandalus Borealis). No other shellfish or species are used to produce PreCardix^®.

 

Can the dose (1,200 mg) be quantified in the number of shrimp shells?

The shells of 1 kg of shrimp, when extracted and refined through our proprietary controlled enzymatic hydrolysis process, provide the active ingredient equaling approximately a 1-month dosage of PreCardix^®. The shrimp proteins are refined through a proprietary enzymatic hydrolysis process to produce the ACE-inhibiting attributes associated with the peptides in the final product. Shells contain in-tact proteins and would not have the same effect on blood pressure.

 

Does PreCardix^® contain a significant amount of iodine?

The iodine content of PreCardix^® has been analyzed in a laboratory setting and determined to be 0.048 mg of iodine in a daily dose of PreCardix^®.

 

Is PreCardix^® only available in Canada?

PreCardix^® is currently available in Canada, as well as in the United States via Amazon.com. Distribution in Ghana and the U.K. is in progress.

 

Is PreCardix^® a ‘Certified B Corporation’?

PreCardix^®‘s developing company Marealis is a Certified B Corporation. Certified B Corporations (B Corps) are businesses that meet the highest standard of social and environmental performance, public transparency, and legal accountability to balance profit and purpose. B Corps are crucial in facilitating and accelerating a global culture shift to redefine success in business and build a more inclusive and sustainable economy.

 

Mechanism of Action and Clinical Pharmacology 

How does PreCardix^® work?

PreCardix^® bioactive marine peptides have a clinically documented, natural ACE-inhibiting mechanism of action. ACE inhibitors affect blood pressure by preventing ACE (angiotensin-converting enzyme) from converting angiotensin 1 to angiotensin 2. Angiotensin 2 increases blood pressure in several ways, including stimulating sodium and fluid retention, and constricting blood vessels. Inhibiting excess levels of ACE reduces angiotensin 2.

 

How does PreCardix^® have the same mechanism of action as ACEI pharmaceuticals but not the same side effect profile?

PreCardix^®is a unique composition of thousands of bioactive marine peptides derived from the shells of arctic cold-water shrimp. These short-chain peptides are isolated through a proprietary hydrolysis process. It is hypothesized by the PreCardix^® research and development team that this unique combination of peptides mitigates the adverse effects seen with single-molecule ACE-inhibitors. It should be noted that this is a theory and further research on peptide-specific mechanisms of action is being conducted. 

 

Can PreCardix^® cause an overdose reaction if over 2 tablets are taken daily?

In clinical trials, PreCardix^® did not cause hypotension in any of the subjects. Once blood pressure reached healthy levels, blood pressure numbers stabilized without decreasing further. These results are consistent with the in-market data. In animal studies (rats), doses 100x the recommended daily dose did not cause hypotension or other overdose reactions.

Reference: Aluko, R., 2018. Food protein-derived peptides: Production, isolation, and purification. Proteins in Food Processing, [online] pp.389-412

 

Dosing and Administration

How should I prescribe PreCardix^® to my patients?

The recommended dose of PreCardix^® is 2 tablets (1,200 mg of the active ingredient) a day. Ideally, the tablets should be taken together before noon and away from other medications, natural health products, caffeinated drinks, and food. Patients should take PreCardix^® for a minimum of 8 weeks before determining if the treatment is effective. This timeline is based on clinical research, in which 89% of participants saw a significant reduction in blood pressure after 8 weeks compared to baseline. 

PreCardix^® should be taken on an ongoing basis to maintain its effect on blood pressure health. If discontinued prematurely, blood pressure may rise to pre-treatment levels. Patients taking PreCardix^® should regularly measure and monitor their blood pressure levels at home and with their health care provider to confirm safety and effectiveness, as with any treatment.

 

How soon can patients expect to see an effect on blood pressure levels after starting PreCardix^®?

Patients may see an effect on blood pressure levels within 2-8 weeks, however, patients should take PreCardix^® for a minimum of 8 weeks before determining the efficacy of treatment. In clinical trials, 31% of participants experienced a significant effect on their blood pressure health after just 2 weeks and by week 8, 89% of participants experienced a significant effect on in their blood pressure health compared to baseline. 

PreCardix^® should be continued to be taken daily to maintain results. Blood pressure may rise to pre-treatment levels if it is discontinued.

 

Other than blood pressure, are there any recommended monitoring parameters for patients who choose PreCardix^®?

We advise patients to continue to work closely with their health care providers so that appropriate parameters specific to the patient’s current health situation are monitored and assessed. Patients taking PreCardix^® should measure and monitor their blood pressure levels at home and with their health care provider to confirm safety and effectiveness, as with any treatment. 

PreCardix^® did not impact serum potassium or kidney function in clinical research. Considering PreCardix^® bioactive marine peptides have a natural ACE-inhibiting action, monitoring these parameters along with blood sugars at baseline and throughout treatment may be warranted at the health care provider’s discretion. 

 

Is the recommended dosage of PreCardix^® different when used as an adjunct compared to a sole treatment?

PreCardix^® has not been studied in clinical research as an adjunct to antihypertensive medication or any other medications. PreCardix^® has been studied in an unmedicated, healthy adult population without co-morbidities and in the dose of 1,200mg a day, only. 

In-market reports from customers who have added PreCardix^® alongside antihypertensive medication under the direction and guidance of their physician, they have used two tablets of PreCardix^® daily, the same dose found to be effective in clinical research in unmedicated patients with mild-moderately elevated blood pressure at baseline.

 

What are the storage instructions for PreCardix^®?

PreCardix^® should be stored at room temperature. It does not need to be refrigerated.

 

Co-administration with Medications

Can you combine PreCardix^® with anti-hypertensive medications?

PreCardix^® has not been directly studied in clinical trials in combination with anti-hypertensive medications. In-market reports suggest that adding PreCardix^® to an existing pharmaceutical protocol under health care provider direction and supervision may provide additional support in attaining healthy blood pressure levels. 

There have been no reports of drug interactions or hypotension based on in-market data collected to date, however, patients who are on both PreCardix^® and anti-hypertensive medications should be monitored by the prescribing physician for adverse effects including hypotension.

 

Does PreCardix® interact with medications, including Warfarin?

PreCardix^® was not studied in combination with other medications or supplements in clinical research. Interactions listed below are inferred based on documented interactions of common ACE inhibiting drugs. Other interactions may also occur.

• The effect of PreCardix^® on blood pressure may be augmented by other blood pressure medication or natural health products and cause low blood pressure. This effect has been well-documented with individuals combining alpha-blocking medication and ACE inhibitors after the first dose. Monitor for this potential effect.
• PreCardix^® bioactive marine peptides did not increase potassium levels in the clinical trial. However, due to the ACE inhibiting action, potassium levels should be monitored frequently, particularly with agents that increase serum potassium, such as potassium-sparing diuretics, potassium supplements, and potassium-containing salts.
• A possible causal relationship between ACE inhibitor treatments and allopurinol (a pharmaceutical treatment for gout) may lead to hypersensitivity. PreCardix^® should be used cautiously with allopurinol until further research establishes safety.
• The use of NSAIDs (such as Ibuprofen) may reduce the effect of ACE inhibiting medication. Monitor blood pressure regularly if you are taking NSAIDs with PreCardix^®.
• Intravenous iron infusion should be administered cautiously in individuals using PreCardix^®. ACE inhibitors may augment the systemic effects of IV iron. Oral iron supplementation is not a concern.
• Individuals taking lithium should have lithium levels monitored frequently. ACE inhibitors may decrease renal elimination of lithium, leading to lithium toxicity (CNS symptoms, ECG changes, renal failure). PreCardix^® was not studied along-side lithium medication

 

Is there a guideline that directs physicians on how to wean off pharmaceuticals and replace with PreCardix^®?

At this time there is no specific protocol for coming off blood pressure medications to replace them with PreCardix^®. PreCardix^® is not a substitute for medication. Due to the high degree of interpersonal variability, we can not advise a medication weaning schedule that would cover all of these complexities. Furthermore, we can’t definitively comment on the safety of combining pharmaceuticals with PreCardix^® as there are no pre-clinical or clinical trials on this combination. We do however have case reports and in-market research that show the successful combination of blood pressure medication with PreCardix^®. When adding PreCardix^® to a patient’s blood pressure management plan, follow the same principals as additive therapy or when switching medications. Close monitoring by the prescribing doctor is important as there is a theoretical risk of hypotension when combining PreCardix^® with blood pressure lowering medication, although this interaction has not been reported in any of the case reports or in-market data we have received. 

 

Side Effects & Contraindications

Can someone with a shellfish allergy take PreCardix^®?

PreCardix^® should not be used in patients with known shellfish allergies. The active ACE-inhibiting peptides in PreCardix^® are derived from the shells of arctic cold-water shrimp.

 

What are the potential side effects of PreCardix^®?

PreCardix^® had no serious side effects reported in the study. It has not been found to cause side effects sometimes associated with ACE inhibitor medication such as dry cough, itching, edema (swelling), high potassium levels, or hypotension (low blood pressure).

PreCardix^® may cause moderate nausea. One case of mild; euphoric mood, fatigue, upper abdominal pain, and headache occurred during the clinical trial.

 

Is PreCardix^® safe in pregnancy and breastfeeding?

PreCardix^® has not been studied in pregnancy or breastfeeding and should be avoided throughout the entire gestational period due to the potential teratogen effects of ACE inhibitors. Women who are breastfeeding should not take PreCardix^®.

 

Are there any patients who should avoid taking PreCardix^®?

PreCardix^® is not appropriate for or during: 

• Pregnancy or while breast-feeding
• Children under 18 years old
• Individuals with a shellfish allergy
• Patients who have a history of angioedema related to the use of ACEI medication
• Patients with renal artery stenosis

Patients who are on medications or who have pre-exisiting health conditions should always consult with their health care provider before initiating PreCardix^®. Never stop or change your medication without consulting with your health care provider. PreCardix^® is not a substitute for medication.

 

How do I report suspected side effects?

Any suspected side effects associated with the use of PreCardix^® should be reported to Health Canada. For more information regarding reporting online, by mail or fax, visit their Adverse Reaction Reporting website here, or call toll-free at 1-866-234-2345.

 

Resource Materials

What resource materials are available to learn more about PreCardix^®?

The following materials are also available online at precardix.ca/resources.

· Patient handout (Proper use of PreCardix^®)

· Product monograph

· Training webinar modules

Additional patient resources, including how to measure blood pressure at home, are available at precardix.ca/blog.

If you require an alternative format or to request printed copies, please email support@precardix.ca.