PubMed · 10173270
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G Cowley, K Springen. 1997-09-29. After fen-phen.. https://pubmed.ncbi.nlm.nih.gov/10173270/
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A rapid high-performance liquid chromatographic method for the quantitation of citalopram in human plasma is presented. The sample preparation involved liquid-liquid extraction of citalopram with hexane-isoamyl alcohol (98:2 v/v) and back-extraction of the drug to 0.02 M hydrochloric acid. Liquid chromatography was performed on a cyano column (45 x 4.6 mm, 5 microm particles), the mobile phase consisted of an acetonitrile-phosphate buffer, pH 6.0 (50:50, v/v). The run time was 2.6 min. The fluorimetric detector was set at an excitation wavelength of 236 nm and an emission wavelength of 306 nm. Verapamil was used as the internal standard. The limit of quantitation was 0.96 ng/ml using 1 ml of plasma. Within- and between-day precision expressed by relative standard deviation was less than 7% and inaccuracy did not exceed 6%. The assay was applied to the analysis of samples from a pharmacokinetic study.
Eight European centers recruited 605 obese patients (BMI 30-45 kg/m2) for a six month period of weight loss with sibutramine (10 mg/d) combined with an individualized 600 kcal/d deficit. 467 (77%) patients with > 5% weight loss were then randomized to sibutramine (10 mg/day) and placebo groups over a further 18 months. Initially weight loss progressed to a total of -11.3 +/- 5.5 kg. After randomization the placebo group regained weight to -4.7 +/- 7.2 kg from baseline at 2 years; the sibutramine group only showed slight weight regain to -10.2 kg +/- 9.3 kg (mean group difference 5.5 kg, 95% C.I. 2.9, 8.1, p < 0.001). VLDL fell and HDL increased more than expected by weight loss. Twenty (3%) patients were withdrawn because of increases in blood pressure. This individualized management program achieves metabolically significant and sustained weight loss in 77% of obese patients.