New Products for Patients With Diabetes

W. Steven Pray, PhD, DPh; Joshua J. Pray, PharmD candidate

Disclosures

US Pharmacist. 2004;29(1) 

In This Article

Insulin

Products for the patient with diabetes proliferate at an astounding rate. Nearly every month, pharmacy journals contain advertisements for new and innovative products. Recent changes include removal of older insulin formulations, the introduction of new insulin analogs, innovations in blood glucose measurement, and a proliferation of new administration technologies (e.g., insulin dosers, insulin pens). To obtain the most recent information, it is vital to visit manufacturers' Web sites; even primary medical literature is usually outdated in regard to the newest generation of diabetic products. This article will briefly review some of these changes.

Animal insulins are gradually being phased out by the manufacturers, Eli Lilly and Novo Nordisk. Novo Nordisk discontinued all of its purified pork products in favor of human insulins and insulin analogs. The only purified pork insulins still produced by Lilly are Iletin II Regular and Iletin II NPH. Eventually, all purified pork insulins may be phased out.

Pharmacists watched with interest when the first insulin analog, Humalog (insulin lispro), was introduced in 1996, followed several years later by Novolog (insulin aspart). These products were advantageous in that they did not have to be injected one hour before a meal like nonprescription insulins. In 2001, Aventis launched Lantus (insulin glargine) as a product to help avoid nocturnal hypoglycemia. Humalog Mix 75/25 was the first analog mix, designed to have rapid onset but intermediate duration. Articles in the trade press informed pharmacists that the insulin analog market will further fragment with the imminent introduction of insulin glulisine, which will be known as Apidra (from Aventis). Apidra is a recombinant DNA technology insulin analog differing from human insulin by the replacement of two amino acids in the B-chain of insulin.[1] This alteration yields an analog with a more rapid onset and a shorter duration than regular human insulin when given subcutaneously (SQ). The SQ half-life of human insulin is 86 minutes; Apidra's SQ half-life is only 42 minutes.[1] The company also warns patients that the rapid onset of Apidra mandates that it be given within 15 minutes before a meal, within 20 minutes of starting a meal, or immediately after a meal.

The short duration of Apidra requires that it be used in conjunction with a longer-acting insulin or with insulin pump therapy. Aventis also manufactures Lantus, the only single-entity insulin analog that has longer activity; it would be a natural complement to Apidra.[2]

Apidra may be used in an insulin pump, although it should not be diluted or mixed with any other insulin.[1,3] Patients may wish to mix Apidra with other insulins in a syringe. The only insulin that can be mixed with Apidra is NPH human insulin. The mixture should be injected immediately after the mixture is made.

The concentration of Apidra is 100 U/mL. Apidra is equipotent to human insulin, in that 1 unit of Apidra lowers blood glucose the same amount as 1 unit of human insulin.[1] Patients should never change their insulin regimen without approval from the physician/endocrinologist monitoring their diabetes.[1] This prohibition applies to switching insulin strength (100 U vs. 500 U), type (NPH to Lente), species (purified pork to human), or brand (Lilly to NovoNordisk/ ReliOn, or vice versa).

The 10-mL vials of Apidra should be stored in a refrigerator until opened. Opened vials may be refrigerated or unrefrigerated.[1] If the vial is kept out of the refrigerator, the ambient temperature should not exceed 77°F. The vial should be discarded 28 days after it was opened, regardless of whether it was refrigerated.

Evidently, Aventis will delay the launch of Apidra until the FDA approves its delivery device, the OptiClick pen (perhaps in late 2004). Details on the pen are sketchy; most Web sites that mention the OptiClick are not in English.

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