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Pre-ipertensione: grafica con cuore e battito cardiaco
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Pre-hypertension: from Biofarma Group an innovative nutraceutical solution to counteract it

Data: 06_10_2022
Category: R&D Innovation

Growing importance attached to the general well-being of the organism and a greater concentration on the prevention of pathologies rather than on the subsequent treatment are the trends that today characterize the “health care” sector.

Biofarma Group has always considered prevention the best ally for the protection of health and often, through its products, focuses on supporting people in the preliminary stages of diseases to avoid the onset of the most advanced states, with all the consequences they entail. This is the case of Tensred plus®, an innovative clinically validated nutraceutical solution able to intervene in the pre-hypertension phase and thus counteract the progression of the condition to one of declared arterial hypertension.

Pre-ipertensione: tabella con i valori della pressione arteriosa

Pre-hypertension and arterial hypertension: definition, causes, and consequences

Pre-hypertension can be defined as the condition that occurs when a subject’s blood pressure is higher than usual but not at levels that are in a state of hypertension. This condition is recognized explicitly in the presence of systolic blood pressure between 130 and 139 and diastolic pressure between 85 and 89. Above these numbers, there is a clear situation of hypertension.

In 2017 the American Heart Association developed new guidelines relating to the definition of the disease, which consider a situation of “elevated blood pressure” already in the presence of values between 120 and 129 (PAS) and < 80 (PAD), demonstrating how important it is to keep pressure values under control to avoid cardiovascular risks.

Pre-ipertensione: illustrazione di confronto fra condizioni di elevata e normale pressione sanguigna

The consequences of high blood pressure are, in fact, innumerable. Among these is the possibility of developing pathologies such as coronary artery disease, heart failure, stroke, and peripheral vasculopathy. Hypertension is assumed to be responsible for 54% of all strokes and 47% of all ischemic heart disease worldwide. The condition also affects over a fourth of all adults and is the leading cause of death worldwide. It is estimated that over one billion people in the world are affected. 

Determining what causes hypertension is not easy. However, some factors are known that can contribute to increasing the chance of becoming hypertensive. These include non-modifiable factors, such as genetics and age, as well as factors that can be controlled, such as smoking, excessive consumption of alcoholic beverages, diet– especially if rich in calories and salt – and finally, a sedentary life. It is also believed that a situation of prolonged emotional stress over time can contribute to an increase in blood pressure.

Come curare l'ipertensione: illustrazione di cinque azioni per evitare una situazione di elevata pressione sanguigna

That is why prevention is fundamental. It is essential to support these subjects who are in pre-hypertension and about three times more likely to develop hypertension than other subjects. It has been estimated that 37% of the population with pre-hypertension will progress to hypertension in the following four years. In addition, compared to individuals with normal blood pressure, pre-hypertension is associated with a 27% increase in all causes of death and 66% in cardiovascular ones. 

This condition’s increasing incidence and global public awareness have led to significant demand for pharmaceuticals and solutions to treat the disease. As a result, market surveys have predicted a compound annual growth rate (CAGR) of 4.5% in recent years, accompanied by an increase in cases of high blood pressure by 60% between 2016 – 2025.

Care and remedies

What to do, then, in case of pre-hypertension?

Currently, the guidelines adopted for the treatment of hypertensive states prefer, up to the first stage, an initial intervention on lifestyle, particularly on those aspects that constitute risk factors. Specifically: weight loss, changes in diet (such as, for example, a reduction in sodium intake), a reasonable assumption of alcoholic beverages, and regular exercise can reduce blood pressure values effectively.

However, a radical lifestyle change is not easy to achieve, and even if you manage to do so, the results are often perceived only in the long run, discouraging patients. That is why, in a pre-hypertension phase, it can effectively support the path of elimination of risk factors with good nutraceutical support.

Meta-analyses of studies published in the literature have shown that numerous substances can induce significant drops in blood pressure. Some of these, however, require very high doses to produce effects, such as omega-3s. Others are too expensive, such as lactotripeptides, while others still involve side effects, such as garlic extracts. On the other hand, several substances have achieved positive results. For example, combining L-arginine with B vitamins has effectively counteracted blood pressure rise. Similar effects have been demonstrated for coenzyme Q10 and oral administration of Lactobacillus.

Biofarma Group has conducted a clinical study to observe the effects of a nutraceutical product containing a combination of these ingredients on blood pressure, thus demonstrating its effectiveness in supporting people in a pre-hypertension stage.

Tensred plus®: a supplement to counteract pre-hypertension

Biofarma Group, as part of its development of nutraceutical products complete with scientific dossiers available to out-licensed customers, has developed an innovative formula to combat pre-hypertension: Tensred plus®.

The formulation developed is supported by a proof of concept conducted by the Group, whose objective was to evaluate the effects of a nutraceutical containing ArginineLactobacillus Plantarum LPLDL®, Coenzyme Q10 and Vitamin B1 on systolic blood pressure (SBP) and diastolic (DBP) levels, in patients with pre-hypertension.

The observation was performed on a sample of 40 patients over 18 and of both sexes with pre-hypertension. They were asked to take the nutraceutical composition for several months, once a day at breakfast time. The main results obtained from the clinical study are as follows: a significant reduction in mean systolic blood pressure (SBP -4.1 mmHg, p= 0.041) and mean diastolic blood pressure (DBP -3.0 mmHg, p= 0.044) was observed, the focus of the investigation. Although these values can suggest a result that is not particularly significant if we consider that the object of the observation is a nutraceutical product used on substantially still healthy subjects who are only in a situation at risk of developing the disease. In addition, a significant reduction in total cholesterol (CT -13.5 mg/dl) and low-density lipoproteins, more commonly known as “bad cholesterol” (LDL-C -11.4 mg/dl), was also observed.

In conclusion, you can say that the clinical trial demonstrated the efficacy of the identified nutraceutical compound to support patients with pre-hypertension, reducing blood pressure values and counteracting the progression of the state toward one of the hypertension arteries a. This is a significant result, especially if we consider that this is one of the few, if not, the only pilot study which evaluated subjects in a state of pre-hypertension, consistent with the increasing importance attributed by the medical community to timely intervention in this preliminary phase of the disease.

From these results, Tensred plus® was born, whose effectiveness is therefore given by the synergy of four mechanisms of action: L-arginine, an amino acid considered vasodilator;  Vitamin B1 (thiamine) that contributes to the normal functioning of the heart (EFSA authorized claim); L. Plantarum LPLDL®, which improves blood pressure through mechanisms that include improving total cholesterol and low-density lipoprotein cholesterol levels, reducing blood glucose level and insulin resistance; in fine Coenzyme Q10, antioxidant able to act on both systolic and diastolic pressure and whose deficiency is therefore associated with cardiovascular diseases.

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Figure 1. Systolic and diastolic blood pressure variation during the study with the nutraceutical (*p < 0.05 vs. baseline)

Figure 2. Lipid profile variation during the study with the nutraceutical (*p < 0.05 vs. baseline)

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The effectiveness of this synergistic mix of natural ingredients is also given by the galenic form chosen for administration: a triple-layer tablet. It is a technology for the oral administration – in a single product – of formulations with active ingredients or mixtures of active ingredients with diversified, prolonged, and controlled release for greater effectiveness on the body. The advantages guaranteed by this technology, which is among those developed by Biofarma Group, are different:

  • the prevention of incompatibility between active substances and excipients, which remain separate and distinct until taken;

  • the administration of identical or different ingredients, with a diversified spread and with a direct and diversified action on the area to be treated;

  • the ease of intake. The use of distinct layers and different colors differentiates the product from other tablets and confirms the presence of different groups of ingredients.

Therefore, advanced technology, effective formulation, and solid scientific experience are the assets of Tensred plus®. A nutraceutical product that can accompany and support subjects suffering from pre-hypertension in the healing path of modification of their lifestyle, aimed at avoiding the risks of developing declared arterial hypertension.


Edited by:

  • Arianna Vanelli: R&D Manager

  • Stefania Murzilli: Scientific Specialist


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