Lipodissolve Injections: Critical study of blood values after subcutaneous administration of intravenous compounds

ASAL (January-May 2005): The study of gGT (gamma glutamyl transferasis) and bilirubin in 46 patients following lipodissolve injections was performed by ASAL consultant and faculty in 2005. Lipodissolve for aesthetic reasons per subcutaneous injections is well known in Europe and the U.S. since 2002. The aim of the examination was to detect possible changes in laboratory values following the subcutaneous injection of compounded for purposes of lipodissolve injection based on a critical theory posed by colleagues that the maximum recommended dosage could cause a possible risk of overload on the liver.

All the patients involved in the private study received the maximum recommended dose of 2500mg. All injections were given into the subcutaneous fat tissue. The gGt (gamma glutamyl tranferasis) and bilirubin values from venous blood was examined at different times of the treatment. Blood was taken on 5th day after first treatment, 8 weeks after first treatment and if there were more than one treatment sessions (maximum four), 8 weeks after the last series of injections.

All evaluated samples were within the normal range. The conclusion can be drawn that the lipids and compounds recommended for lipodissolve does not cause an increase of the evaluated blood values after subcutaneous application, such as proven after intravenous administration.

Background
Lipodissolve has been in widespread use in Europe and the USA since 2002 by doctors working in the field of aesthetics to achieve a reduction in the volume of smaller fat deposits by means of injections into the subcutaneous fatty tissue. The adipocytes burst (Hiroyuki Suszuki, Ronald L. Moy, Michael S.Kolodney, Division of Dermatology, Universitiy of Los Angeles (UCLA) , Dermatol. Surg. 2004;30:1001-1008, Ref.1) and lipases are released from the adipozytes by means of lipid transport and metabolism (MATHUR, BORN, MURTHY, FIELD, University of Iowa, Dept. of Internal Medicine, Biochem. Journal Great Britain 314, 569-575, Ref.2) that produce a local breakdown of fat which is then discharged via the liver in the form of gallic acids. One of the compounds used in Lipodissolve has been authorised for intravenous use in the prophylaxis and therapy of fat embolisms.

The subcutaneous application represents a so-called “off-label-use”, the use of a medicine for different purposes for which it has been licensed, under the full responsibility of the administering doctor and with the clear approval of the patient after an in-depth consultation session.
ASAL is a platform of consultant medical doctors who have made it their aim to investigate the scientific background to the functioning mechanism of lipolysis, to establish standardised guidelines and to set up a therapy surveillance of physician members reports.

Method of Examination and Results:
A total of 46 patients took part in the test. All the patients received the highest recommended dose of 2500 mg of compounded lipids and pharmaceutical agents per treatment injected into the subcutaneous fatty tissue as laid down by ASAL protocol.
The gGt (gamma glutamyl tranferasis) and bilirubin values from venous blood was examined. In the case of 12 patients the values were determined 5 days after the first injection session.
In the case of 14 patients the values were determined 8 weeks after the first injection session. And in the case of 20 patients the values were determined after several lipolysis injection sessions 8 weeks after the last series of injections. 5 days after the injection of 2500mg of phosphatidylcholine into the subcutaneous fatty tissue of 12 examinees, the following laboratory values were ascertained:

8 weeks after the first series of injections of 2500mg the laboratory values of 14 patients were determined as follows:

8 weeks after the last series of injections, 20 patients with several treatment sessions (maximum four) had the following values:

During the lipodissolve therapy, all the laboratory values determined in the 46 patients controlled remained, without exception, within the norm.
All the patients were treated with the highest recommended dose of 2500mg of total compounds per session contained lipids and pharmaceutical agents
administered subcutaneously into the fatty tissue.

After a repeated maximum of 4 individual treatment sessions each using 2500mg of compounds, venous blood samples were taken in different phases of the lipodissolve therapy, in other words, 5 days after the first series of injections, 8 weeks after the first series of injections and 8 weeks after the last series of injections.

Discussion:
For a final assessment whether there are still any unknown risks following the subcutaneous application of the medicine used for intravenous use, further studies are still necessary and are already on-going.

Conclusion:
The subcutaneous administering of the Lipodissolve compound showed no increase in the laboratory values determined in any of the volunteers. Because of the short time-span since the introduction of this therapy, long-term studies cannot be provided as yet. Despite the fact that doctors from around the world have successfully carried out 18.000 treatments without unexpected or adverse side-effects, lipodissolve treatments should only be carried out by specially trained doctors who should proceed with the required medical caution until long-term effects are established and the medications are licensed for subcutaneous use.

Refereneces:
1.) (Hiroyuki Suszuki, Ronald L. Moy, Michael S.Kolodney, Division of Dermatology, University of Los Angeles (UCLA), Dermatol. Surg. 2004;30:1001-1008 )
2.) (MATHUR, BORN, MURTHY, FIELD, University of Iowa, Dept. of Internal Medicine, Biochem.
Journal Great Britain 314, 569-575)