The effect of short-term (21-day) orlistat treatment on the physiologic balance of six selected macrominerals and microminerals in obese adolescents.
OBJECTIVE
Orlistat is a gastrointestinal lipase inhibitor used to reduce dietary fat absorption and could be used to treat overweight and obesity in adolescents. The primary objective was to assess whether orlistat has an effect on the physiologic balance of three macrominerals (calcium, phosphorus and magnesium) and three microminerals (iron, zinc and copper).


METHODS
This was a 21-day, double-blind, randomized, parallel-group, placebo-controlled mineral balance study conducted in adolescent obese volunteers (BMI >or=85th percentile, adjusted for age and gender). Subjects were maintained on a hypocaloric diet with a normal daily mineral content in both treatment groups and received oral treatment with orlistat 120 mg (n = 16) or placebo (n = 16) three times daily for 21 days. Following a 14-day equilibration period, balances for calcium, phosphorus, magnesium, iron, copper and zinc were measured for days 15-21. Serum and urine electrolytes were also measured at baseline and at the end of treatment.


RESULTS
On average, orlistat inhibited dietary fat absorption by approximately 27%. This degree of dietary fat inhibition caused no significant changes in mineral balance between orlistat and placebo groups. In addition, serum and urine electrolytes (sodium and potassium) as well as urinary creatinine excretion were not affected by orlistat treatment. Orlistat was well tolerated; adverse events occurred mainly in the gastrointestinal tract and were of mild or moderate intensities.


CONCLUSIONS
Administration of orlistat had no significant effect on the balance of six selected minerals in adolescent obese patients.
Zhi
Jianguo
J
Hoffmann-La Roche Inc, Nutley, New Jersey, USA. jianguo.zhi@roche.com
Moore
Rema
R
Kanitra
Linda
L
D000293:Adolescent; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D002648:Child; D004041:Dietary Fats / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D004573:Electrolytes / Q000097:blood / Q000652:urine; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D005243:Feces / Q000737:chemistry; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D007783:Lactones / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008903:Minerals / Q000097:blood / Q000378:metabolism* / Q000652:urine; D009765:Obesity / Q000188:drug therapy / Q000378:metabolism*; D000077403:Orlistat
D019440:Anti-Obesity Agents; D004041:Dietary Fats; D004573:Electrolytes; D004791:Enzyme Inhibitors; D007783:Lactones; D008903:Minerals; D000077403:Orlistat