Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Voluven (Pharmatel Fresenius Kabi)
6% solution for intravenous infusion
Approved indication: hypovolaemia

The optimum solution for expanding plasma volume is uncertain. There is debate about whether patients given colloid solutions, such as albumin, have worse outcomes than patients given crystalloid solutions.1 To address some of the concerns synthetic colloids have been developed.

Pentastarch is derived from amylopectin. To slow down its metabolism by amylase, hydroxyethyl groups are added to the molecule. After this formulation is infused the expansion in intravascular volume lasts for 4-6 hours.

This formulation has been compared with other colloids in relatively small numbers of patients. Some of these comparisons have been with similar products containing a different ratio of hydroxyethyl groups.

In cardiac surgery there was no difference in efficacy between the new formulation and a similar product with a higher molecular weight.2 A study in orthopaedic surgery had a similar result and found that the new formulation may have less effect on some coagulation factors.3

Patients may develop hypersensitivity reactions, including anaphylaxis, to pentastarch. Itching is common. There may be confusion about pancreatitis as amylase concentrations rise in patients given pentastarch.

While pentastarch is effective, many factors including cost and physicians' opinions will determine whether it is used in preference to other volume expanders.1

manufacturer provided the product information

The Transparency Score ( ) is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.

References

  1. Miletin MS, Stewart TE, Norton PG. Influences on physicians' choices of intravenous colloids. Intensive Care Med 2002;28:917-24.
  2. Gallandat Huet RC, Siemons AW, Baus D, van Rooyen-Butijn WT, Haagenaars JA, van Oeveren W, et al. A novel hydroxyethyl starch (Voluven) for effective perioperative plasma volume substitution in cardiac surgery. Can J Anesth 2000;47:1207-15.
  3. Langeron O, Doelberg M, Ang E-T, Bonnet F, Capdevila X, Coriat P. Voluven, a lower substituted novel hydroxyethyl starch (HES 130/0.4), causes fewer effects on coagulation in major orthopedic surgery than HES 200/0.5. Anesth Analg 2001;92:855-62