Phosphatidylcholine in the treatment of localized fat

Journal of Drugs in Dermatology, Oct, 2003 by Doris Hexsel, Marcio Serra, Rosemari Mazzuco, Taciana Dal'Forno, Debora Zechmeister

Highly purified phosphatidylcholine extracts from lecithins contained in egg yolk and soybean are used to prepare the oily parenteral nutrition emulsion (16). It has been described that in an infusion containing 1.2% phosphatidylcholine extract from egg yolk and 55% glucose (1 ml/kg/min) given to cats, there was a low incidence of side effects. Therefore, phosphatidylcholine was considered non-toxic for parenteral use (16).

The first reports of cardiological use of phosphatidylcholine (Lipostabi[R] by Aventis Pharma) are from the 70s. The drug was administered orally and parenterally, mainly by Italian and Russian physicians (17,18). The capacity of phosphatidylcholine to reduce blood cholesterol as well as high and low lipoprotein levels was reported (7,17). Klimov et al. compared the efficacy of Lipostabil[R] with that of nicotinic acid for the treatment of patients with hyperlipoproteinemia. They found that while both medicines reduced the intensity and incidence of angina pectoris, only phosphatidylcholine offered an effective treatment with minimum side effects (19).

Laboratorio Magistral, a Brazilian company which manufactured and distributed phosphatidylcholine among Brazilian physicians, claimed there was no acute or subchronic toxicity with doses up to 25 times the maximum. However, no studies were presented to corroborate this claim.

Commercial Presentations

Phosphatidylcholine is presented in two forms: the commercial product (Lipostabil[R] or Essentiale[R] (Natterman International GMBH), approved for cardiological use in some countries in Europe), and the manipulated medication, prepared under medical prescription. The latter should meet the quality and safety criteria established by competent authorities, regarding formulation described in Law 344, RDC 33 (when manufactured in Brazil) or competent bodies in other countries (15,20-22).

Materials and Methods

In the patient selection, the presence of certain physical conditions that could contribute to the occurrence of side effects was investigated. The exclusion criteria included the following: allergic antecedents to one of the components of the formula, pregnancy and lactation, active kidney or hepatic disease, mellitus diabetes or thyroid disease, obesity (assessed by the body mass index, BMI), moderate to severe loose skin or flaccidity, previous surgeries, and the presence of fibrosis or adherence in the areas to be treated.

From July 2001 to December 2002, the total number of treated patients was 213, of which 8 patients were HIV/AIDS positive.

Two hundred and five patients with different patterns of localized fat deposits on the body (thighs, hips, abdomen, flanks) and/or face (chin region) were submitted to treatment with phosphatidylcholine.

The patients were submitted to 1 to 5 treatment sessions with an average interval of 15 days between each session. The medication administered (250 mg/ml phosphatidylcholine, manufactured by the Laboratorio Magistral) was injected pure or diluted in saline solution (0.9%), depending on the extension of the area to be treated. The injections were made in the subcutaneous tissue using 30 G needles and 3 ml syringes. The depth of the application was 1 to 2 cm below the cutaneous surface and 0.2 ml was applied at each point with a distance of 2 cm between the points. The total volume of phosphatidylcholine injected varied according to the quantity of localized fat deposits in each patient, but in all cases no more than two vials (10 ml) were applied per session.