During the entry examination, leg ulcers were present in 2.5% of 2,075 patients 10 years of age and older with sickle cell disease who entered into the Cooperative Study of Sickle Cell Disease (CSSCD) between 1979 and 1986. Prevalence rates were highest among patients with sickle cell anemia and sickle cell anemia with thalassemia genotypes. Among sickle cell anemia patients free of ulcers at entry, the overall incidence was 5.73 per 100 person years in those having associated alpha-thalassemia and 9.97 for those without. Among sickle cell anemia patients with two alpha genes, the estimated incidence of leg ulcers is 2.38 per 100 person years and 6.12 per 100 person years among sickle cell anemia patients with three alpha genes (P less than .05). In both groups, the incidence was highest among those patients over 20 years of age and considerably higher among males than females (P less than .001). Leg ulcers were nonexistent in patients with sickle beta plus thalassemia and sickle hemoglobin C disease. Low steady-state hemoglobin is associated with a higher incidence of ulcer formation (P less than .0001) in sickle cell anemia patients. The protective effect of hemoglobin F is apparent at all levels of total hemoglobin among sickle cell anemia patients and those with associated alpha-thalassemia.
This study evaluated the efficacy and safety of desvenlafaxine succinate extended-release in major depressive disorder (MDD). Method: Adult outpatients with DSM-IV-defined MDD were randomly assigned to desvenlafaxine 100 mg/day (N = 114), 200 mg/day (N = 116), or 400 mg/day (N = 113) or placebo (N = 118) for 8 weeks. Efficacy variables included change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D 17 , the primary efficacy measure), Clinical Global Impressions-Improvement scale (CGI-I), Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions-Severity of Illness scale (CGI-S), rates of response (≥ 50% decrease from baseline HAM-D 17 score) and remission (HAM-D 17 score ≤ 7), and Visual Analog Scale-Pain Intensity overall score. The study was conducted from November 2003 to November 2004. Results: At the final on-therapy evaluation, the mean HAM-D 17 scores for desvenlafaxine 100 mg/day (12.75) and 400 mg/day (12.50) were significantly lower than for placebo (15.31; p = .0038 and p = .0023, respectively); for desvenlafaxine 200 mg/day, the mean score was 13.31 (p = .0764). CGI-I and Montgomery-Asberg Depression Rating Scale results were significant for all groups; CGI-S results were significant with 100 mg/day and 400 mg/day. Response rates were significantly greater for desvenlafaxine 100 mg/day (51%) and 400 mg/day (48%) versus placebo (35%; p = .017 and p = .046, respectively); the response rate for desvenlafaxine 200 mg/day was 45% (p = .142). Remission rates were significantly greater for desvenlafaxine 400 mg/day (32%) versus placebo (19%; p = .035); remission rates were 30% for desvenlafaxine 100 mg/day (p = .093) and 28% for desvenlafaxine 200 mg/day (p = .126). Visual Analog Scale-Pain Intensity results were significant for desvenlafaxine 100 mg/day versus placebo (p = .002), but not for the higher doses. The most commonly reported adverse events were nausea, insomnia, somnolence, dry mouth, dizziness, sweating, nervousness, anorexia, constipation, asthenia, and abnormal ejaculation/orgasm. Conclusions: Desvenlafaxine is effective and well tolerated in the short-term treatment of MDD.
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