Frequently Asked Questions

Health Care Providers

 

Research & Efficacy

Is PreCardix® supported by clinical research?

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

Two clinical studies, 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 found that the unique bioactive marine peptides derived from hydrolyzed shrimp shells (Pandalus Borealis) found in PreCardix® have an ACE inhibiting action. The use of bioactive marine peptides in clinical trials resulted in a statistically significant effect blood on pressure health in over 89% of participants within eight weeks or less.

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®?

The clinically validated ACE inhibiting effect of PreCardix® bioactive marine peptides on blood pressure health is comparable to pharmaceutical ACE inhibitors. In the clinical trial, 89% of participants experienced a significant effect on their blood pressure health within eight weeks without significant side effects. The average reduction in systolic blood pressure was 9.5 mmHg and 4.2 mmHg in diastolic blood pressure. 43% of participants had a systolic blood pressure improvement over 10 mmHg, and 24% improved over 15 mmHg in systolic blood pressure. 

 

Were any studies conducted on renal or hepatic patients? Is it safe to use with those 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 participants without pre-existing conditions participate in clinical trials. In the PreCardix® study serum testing of CBC, glucose, creatinine, estimated glomerular filtration rate, sodium, potassium, chloride, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and bilirubin was performed at screening and 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 a pre-existing medical condition, such as kidney or liver 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.

 

In the future, will PreCardix® be considering morbidity/mortality evidence?

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 significant side effects in PreCardix® even though its ACE inhibiting mechanism of action is similar to 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. Some act as an ACEI and affect blood pressure health, while others 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 exert ACE-inhibiting properties. Each batch of PreCardix® must meet Marealis AS strict internal standards before it is released for commercial use to ensure the product will always meet the promised blood pressure-lowering attributes. 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 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, and also in the United States via Amazon.com. Distribution in Ghana, and the U.K. is in progress.

 

Is PreCardix® a ‘Certified B Corporation’?

Yes, PreCardix®‘s developing company Marealis AS 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 ACE inhibiting 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 MOA (mechanism of action) as ACEI medication 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 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 blood pressure lowering effects if discontinued prematurely blood pressure can rise to pre-treatment levels.

 

How soon can patients expect to see a reduction in blood pressure after starting PreCardix®?

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 taken daily to maintain results. Blood pressure may rise to pre-treatment levels if it is discontinued.

 

How long would you recommend using PreCardix® before moving to conventional medications to manage blood pressure?

Take PreCardix® daily as directed for a minimum of 8 weeks before determining clinical efficacy. In the clinical trial, 89% of participants experienced a significant reduction in blood pressure compared to baseline after eight weeks.

 

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

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 your health care provider’s discretion.

 

What is the dosage as an adjunct as compared to preventative or pre-diagnosed blood pressure treatment?

PreCardix® has not been studied in clinical research as an adjunct to antihypertensive medication. PreCardix® has been studied in a healthy adult population without co-morbidities or other medications 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 have used two tablets of PreCardix® daily, the same dose found to be effective in clinical research in unmedicated patients with mild-moderate 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 medication?

PreCardix® has not been directly studied in clinical trials in combination with anti-hypertensive medications. However, in-market research suggests that adding PreCardix® to an existing pharmaceutical protocol under healthcare practitioner supervision promotes further reduction in blood pressure.

There have been no reports of drug interactions or hypotension based on this in-market research. Patients who are on both PreCardix® and anti-hypertensive medications should be monitored by the prescribing physician for adverse effects including hypotension.

 

Could PreCardix® be used an adjunct treatment for patients not achieving blood control using ACE-inhibitors, or is it better to use as an adjunct with other antihypertensive classes?

In the clinical trial, PreCardix® was not studied in combination with any classes of antihypertensive medications. In-market research suggests that adding PreCardix® to an existing pharmaceutical protocol under healthcare practitioner supervision could further reduce blood pressure. No large-scale trials to confirm the efficacy and safety of this combination, or evidence to suggest one combination is superior to another. We advise using the same considerations you would apply when using other ACE-inhibitor pharmaceuticals.

 

What’s the difference between using this product as an adjunct vs using two ACEIs?

PreCardix® has a similar MOA as an ACEI pharmaceutical but is not associated with some of the serious side effects of ACEI medication.

PreCardix® reduced blood pressure with a comparable level to ACEI pharmaceuticals in the clinical trial but with no occurrences of dry cough, itching, edema, hypotension, hyperkalemia, or kidney impairment.

For patients who need additional blood pressure support but are experiencing side effects, PreCardix® may be a treatment to consider.

 

Are there interactions with Warfarin or any other drugs?

PreCardix® was not studied in combination with other medications or supplements. Interactions are inferred based on documented interactions with 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®. 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. We would also recommend close monitoring by the prescribing doctor 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® does not have any known significant side effects. It does not 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
  • Blood pressure >160/100 mmHg

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.

 

Is there any information on clearance from the body? Are there any problems with renal or liver dysfunction?

The PreCardix® clinical trial participants were a healthy baseline population with no co-morbidities. Patients with pre-existing medical conditions, including renal or liver dysfunction, were not studied. Patients with pre-existing co-morbidities should consult with their health care provider before starting PreCardix® and be closely monitored if they do begin taking it. A 24-hour collection of urine sodium, urine creatinine, and urine volume happened at baseline and week 8 of the clinical trial study. Serum testing including CBC, glucose, creatinine, an estimate of glomerular filtration rate, sodium, potassium, chloride, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, and bilirubin happened at screening and eight weeks. There were no clinically significant differences in the placebo and treatment groups. Pre-clinical toxicity trials on animal models (rats) found no resulting safety issues or hypotension when subjects received a daily dosage 100 times higher than that recommended.

 

Resource Materials

As well as the CPS insert, is there something that can go on our iPads? Is this going into our counter display unit?

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

· Patient handout

· Product monograph

· Training webinar modules

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

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