Looking for a winning strategy to reduce statin dosage? Berberol® is the answer
Statins are important drugs because of their effectiveness in lowering cholesterol. However, some people may experience adverse effects during the treatment, particularly when taking high dosages.
Berberol® can help in controlling high LDL cholesterol and may be recommended as complementary approach to statin therapy, to reduce the dosage by half while maintaining an optimal lipid level.
Statins: pro, cons and possible add-on strategy
No doubt, statins are an important class of medication with a significant role in reducing high LDL cholesterol and associated cardiovascular risk, but while they are generally effective and widely prescribed, they do have some potential disadvantages or cons.
Especially at high dosages, statins can cause well-known side effects, such as: muscle pain, fatigue, altered liver parameters, and rhabdomyolysis in very severe cases.
Because of these side effects, a percentage of patients taking statins become poorly adherent to the drug treatment and are forced to decrease the statin dosage or discontinue it. This condition is defined as statin-intolerance.
For statin-intolerant patients the choice of a safe and effective nutraceutical, to be used alongside the drugs or as standalone treatment, can become crucial to keep low lipid levels and help patients meeting their therapeutic target.
The prime candidate to fill this role is Berberol®, a patented combination of two plant extracts obtained from Berberis aristata and Silybum marianum that can provide the patient with a measurable clinical benefit.
Berberol® for statin-intolerant patients: clinical evidence
The Italian study Clinical role of fixed combination of standardized Berberis aristata and Silybum marianum extracts in diabetic and hypercholesterolemic patients intolerant to statins tested the efficacy of Berberol® in diabetic and hypercholesterolemic patients, all diagnosed with statin intolerance.
The enrolled patients, aged 18 to 80 years, were divided into three groups to evaluate Berberol® (2 tablets per day) as monotherapy, in combination with statin, and in combination with ezetimibe.
At the end of the period of observation, results were as follows:
- 25% reduction in LDL-C with Berberol® used as monotherapy;
- 33% reduction in LDL-C with Berberol® used as add-on to ezetimibe;
- 28% reduction in LDL-C with Berberol® used as add-on to statin.
The study shows that Berberol® significantly reduces LDL cholesterol in statin-intolerant patients, both as add-on and as monotherapy. Furthermore, throughout the duration of the study, no patient had altered blood safety parameters (CPK and transaminases) or showed side effects attributable to the treatment.
These results were confirmed by a larger study, the double-blind, randomized, placebo-controlled study titled Berberis aristata combined with Silybum marianum on lipid profile in patients not tolerating statins at high dose, published in the important journal Atherosclerosis.
137 dyslipidemic subjects, with previous adverse events to statins at high doses, were enrolled.
After 1-month wash-out period from the high-dosage statin treatment, patients were randomized into two groups:
- A group receiving Berberol® (2 tablets per day) + halved dosage of statin
- The other group receiving placebo + halved dosage of statin
After 6 months of treatment, optimal lipid level was maintained in the group that used Berberol® as add-on to the reduced dosage of statin, while lipid profile significantly worsened in the placebo group.
The results thus demonstrate the efficacy of Berberol® in compensating for statin halving while maintaining appropriate levels of LDL. Furthermore, also in this study, the treatment did not cause alteration in liver and muscle function parameters.
Why should patients choose Berberol®?
Berberol® is a unique formula that exploits the potential of Silymarin from Silybum marianum to enhance the bioavailability of Berberine which is in turn responsible for the beneficial effect on lipid profile thanks to these two proven synergistic mechanisms of action:
- inhibition of PCSK9, a key protein that induces the degradation of LDL receptors
- increase of LDL receptor expression that promotes the clearance of LDL cholesterol from the blood, leading to lower LDL-C levels.
The efficacy of Berberol® has been validated in more than 10 clinical trials on more than 1,000 subjects including several kinds of patients, e.g.: dyslipidemic patients not meeting the target or showing residual risk (high triglycerides) despite taking hypolipidemic drugs; diabetic patients on metformin who developed gastrointestinal intolerance; diabetic patients on insulin or other drugs whose dosage need to be reduced; and patients with metabolic syndrome.
