The long-term safety and tolerability of ispaghula husk

Abstract

The safety and tolerability of ispaghula husk, which can now be used as an adjunct to diet for the treatment of mild-to-moderate hypercholes terolaemia, was assessed in 93 healthy subjects over a 52-week period. The study looked at the nutritional, biochemical, and haematological effects of ispaghula. Over the study period there were small but statistically significant changes in some measurements of minerals and vitamin lev els, and in some haematological and biochemical parameters. However, none of these were of clini cal significance, with the possible exception of changes in vitamin B₁₂ levels. A daily dose of 10.5 g ispaghula was well tolerated and the major ity of adverse events recorded were minor, of short duration and either unrelated or possibly related to the study treatment. The results suggest that ispaghula husk can be used with confidence for the long-term treatment of mild-to-moderate hypercholesterolaemia.