OLBETAM ® Acipimox

OLBETAM ® is a drug based on Acipimox

THERAPEUTIC GROUP: Hypolipidemic - Synthetic analogue of nicotinic acid

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications OLBETAM ® Acipimox

OLBETAM ® is indicated in the treatment of primary and secondary dyslipidemias characterized by elevated blood levels of triglycerides and cholesterol.

OLBETAM ® should be preceded and combined with non-pharmacological therapeutic interventions, such as hypolipid diet and healthy lifestyle.

Mechanism of action OLBETAM ® Acipimox

Acipimox is a synthetic analogue of nicotinic acid (vitamin B3), with which it also shares the mechanism of action. Taken orally, it is rapidly and effectively absorbed in the gastrointestinal tract, reaching maximum plasma concentrations two hours after ingestion. Acipimox can reach the adipose tissue through the circulatory stream, separated from the bond with plasma proteins, where it prevents the release of free fatty acids.

The inhibition of lipolysis decreases the incoming flow of fatty acids at the liver level, with reduction of the substrate necessary for the synthesis of triglycerides. This event takes the form of a lower release of VLDL.

The effects described above result in a significant reduction in plasma concentrations of triglycerides, VLDL and LDL cholesterol. Furthermore, OLBETAM ® appears to be able to increase HDL cholesterol.

Following a rather short half-life, estimated at around 2 hours, over 90% of the active ingredient taken orally is found in the urine.

Studies carried out and clinical efficacy

DIFFERENCES BETWEEN ACIPIMOX AND NICOTINIC ACID

Although Acipimox shares the same chemical nature and the same mechanism of action with nicotinic acid, the results observed following treatment with both active ingredients - in patients with type 2b hyperlipidemia - have been decidedly different. The group treated with acipimox has in fact achieved decidedly more important results in terms of lipid-lowering action, without complaining about the side effects observed in the group treated with nicotinic acid (heartburn and skin rash).

2. THE EFFECTIVENESS OF ACIPRIMOX IN PRIMARY HYPERLIPIDEMIES

A dated study showing the efficacy of acipimox therapy at 750 mg / day for 60 days in hyperlipidemic patients. The results, very encouraging, show a reduction in total cholesterol levels from 10 to 23%, in triglycerides by 50%, and an increase in HDL cholesterol from 9 to 20%. Significant variability in treatment efficacy was observed between different hyperlipidemia groups.

3. THE EFFECTS OF ACIPIMOX ON THE METABOLISM OF GLUCOSE

It is known that the high concentration of fatty acids in the blood can significantly reduce insulin sensitivity, so that hypertriglyceridemia is often associated with insulin resistance. Acipimox, reducing lipolysis, consequently the levels of fatty acids in the blood, seems to be able to improve the peripheral utilization of glucose.

Method of use and dosage

OLBETAM ® capsules of 250mg of Acipimox: the suggested dosage is 2-3 capsules a day, divided into as many assumptions. The choice of the correct dosage should be made by the doctor based on the patient's medical history, the severity of the pathology in place and the objectives to be achieved.

A dose adjustment would also be necessary in case of reduced kidney function.

IN ANY CASE, BEFORE TAKING OLBETAM ® Acipimox - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.

Warnings OLBETAM ® Acipimox

Before starting treatment with OLBETAM ® it would be advisable to follow a hypolipid dietary plan and a correct lifestyle. In case of therapeutic pharmacological need, the intake of acipimox should however continue to associate with the aforementioned non-pharmacological strategies.

Before and during treatment with OLBETAM ® especially if continued for prolonged periods, it would be appropriate to check renal, hepatic and lipidemic features.

It would therefore be necessary to adjust the dosage in case of reduced renal function, discontinuing therapy when creatinine clearance levels fall below 30ml / min.

PREGNANCY AND BREASTFEEDING

The absence of studies concerning the safety of the acipimox on the health of the fetus, of the newborn and of the pregnant woman does not allow any form of judgment.

Therefore taking OLBETAM ® is not recommended during the entire period of pregnancy and breastfeeding.

Interactions

At present, no interactions with other drugs or molecules capable of significantly varying the therapeutic and pharmacokinetic properties of aciprimox are known.

Contraindications OLBETAM ® Acipimox

OLBETAM ® is contraindicated in patients with peptic ulcer and in case of hypersensitivity to one of its components.

Undesirable effects - Side effects

Both clinical trials and post-marketing findings did not record clinically significant adverse events, favoring the drug's good tolerability.

However OLBETAM ® especially during the first phase of treatment, can determine redness, sensation of heat and itching. These symptoms, due to its vasodilatory effect, tend to disappear with the continuation of the therapy.

Cases of heartburn, headache and asthenia have rarely been described, however not so severe as to require the suspension of treatment with OLBETAM ®

In case of manifest hypersensitivity reactions to the drug (hives, edema, rash, hypotension etc.) it is necessary to immediately stop the therapy.