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Title: Sertraline Effective, Well-Tolerated in Geriatric Patients With and Without Comorbidity: Presented at ECNP

"Sertraline Effective, Well-Tolerated in Geriatric Patients With and Without Comorbidity: Presented at ECNP"

By Bruce Sylvester Special to DG News BARCELONA, SPAIN -- October 9, 2002 -- Sertraline therapy for major depression is effective and well tolerated by geriatric patients with and without medical comorbidity. The finding was reported here October 8 at the 15th Congress of the European College of Neuropsychopharmacology. The research team designed the study and the data analysis to determine the efficacy of sertraline in patients over 60 years and to compare efficacy among patient subgroups who did and did not have comorbidities, said lead researcher Dr. Javaid Sheikh, professor of psychiatry at Stanford University School of Medicine, Stanford, California. The investigators enrolled 752 subjects with major depression according to DSM-IV and a score of more than 18 on the 17-item Hamilton Depression scale (HAM-D). Three-hundred and sixty of the 728 subjects in the intent-to-treat (ITT) group received sertraline (54 percent female; mean age of 70 years, baseline mean HAMD-17 of 21.4) and 368 patients were using placebo (58 percent female; mean age of 69.6 years, baseline mean HAMD-17 of 21.4). Dr. Sheikh and his team defined medical comorbidity as "the presence of one or more of the following three categories of illnesses: vascular comorbidity (cardiovascular, cerebrovascular, or peripheral vascular disease), diabetes, or arthritis." Patients with and without comorbidity were compared using standard scales, including HAMD-17, CGI, SF-36, and Q-LES-Q. The researchers also studied the data for any differences in therapeutic responses among comorbid sub-groups -- those with and without vascular disease, with and without diabetes, and with and without arthritis. At baseline, medical comorbidity was more common in women than men (41 percent versus 59 percent, p<0.05) and associated significantly with hormone replacement therapy (1 percent versus 22 percent, p<0.05). At baseline the data also indicated that medical comorbidity correlated to significantly lower quality of life scores (58.3 versus 61.3, p<0.05), and significantly more impaired scores on the selected SF-36 factors. Patients treated with sertraline had significantly greater improvements on the primary outcome measures of HAMD-17 compared to placebo. At endpoint, 206 sertraline intent-to-treat (ITT) comorbid subjects reached a group mean of 7.6-point reduction on HAMD-17. And 216 ITT-endpoint comorbid placebo subjects had a group mean reduction of six points. At endpoint, 53 non-comorbid ITT subjects using sertraline reached a group HAMD-17 mean reduction of 8.8 points. And 67 ITT placebo subjects reached a mean reduction of 6.3 points. Sertraline completers with comorbidity (181) reached a mean reduction of 8.1 HAMD-17. Comorbid placebo completers (185) reached a mean reduction of 6.1 points . Sertraline completers without comorbidity (43) reached a mean HAMD-17 reduction of 10 points. Placebo completers without comorbidity reached a mean reduction of 7.2 points. For overall CGI-scores, evaluation of sertraline and placebo data by comorbidity interactions showed no statistically significant differences. The analyses indicated no significant differences in therapeutic outcome among sub-groups of those with and without vascular disease, with and without diabetes and with and without arthritis. The investigators noted modest improvement in quality of life scores at the end of eight weeks for both treatment groups. Medical comorbidity did not appear as a factor in the improvement measures. Sertraline was well tolerated in medically comorbid patients with no increase in discontinuations due to adverse effects compared to those with no medical comorbidity. The study received funding from Pfizer Inc.

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