Problems in testing hypolipidemic agents in phase II.
In this field, a division of phase II into three parts instead of two seems advisable. Phase IIa should be performed in small groups (10-15) of hyperlipoproteinemic patients. Investigations should be performed on: the effect of the agent on the different lipoprotein lipids; the influence of different lipoprotein concentrations on pharmacokinetics and pharmacodynamics; the influence of age and sex; the interactions with other common long-term drugs; discrete side effects only detectable with highly sensitive methods. Phase IIb extends to 100-150 patients in a multicenter study in a cross-over design including placebo and a standard drug. The aim is not only to test efficiency in different types of primary hyperlipoproteinemia but to complete the first information about drug interactions and side effects as well as to look for influences on hormonal and metabolic parameters. Phase IIc has to extend the phase IIb information to 500-1000 patients. The test for efficiency control should be easy, specific, reproducable and inexpensive. Dose recommendations should be scheduled for hyperlipoproteinemic patients with other disorders, especially those of liver and kidney function.
D002784:Cholesterol / Q000097:blood; D004341:Drug Evaluation / Q000191:economics; D005260:Female; D006728:Hormones / Q000502:physiology; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007700:Kinetics; D008055:Lipids / Q000097:blood; D008297:Male
D006728:Hormones; D000960:Hypolipidemic Agents; D008055:Lipids; D002784:Cholesterol