Efficacy of venlafaxine extended-release capsules in nondepressed outpatients with generalized anxiety disorder: A 6-month randomized controlled trial

CONTEXT: Generalized anxiety disorder (GAD) is a chronic disorder that is associated with debilitating psychic and somatic symptoms. Venlafaxine extended-release (XR) capsules have been shown to be effective in short-term treatment of patients with GAD without major depressive disorder (MDD), but long-term data are needed to establish whether this agent confers persistent benefits. OBJECTIVE: To compare the 6-month efficacy and safety of a flexible dosage of venlafaxine XR in outpatients with GAD without associated MDD. DESIGN: Six-month, randomized, double-blind, placebo-controlled, parallel-group trial conducted May 1996 to October 1997. SETTING: Fourteen outpatient clinics and private psychiatric practices in the United States. PARTICIPANTS: A total of 251 outpatients aged 18 years or older who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for GAD, had sufficient symptoms to require treatment, and did not have coexisting MDD. INTERVENTIONS: Participants were randomly assigned to receive either placebo (n=127) or venlafaxine XR (75, 150, or 225 mg/d, as required to control symptoms; n=124) for 28 weeks. MAIN OUTCOME MEASURES: Changes from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score, the HAM-A psychic anxiety factor score, and the Clinical Global Impressions (CGI) scale Severity of Illness and Global Improvement scores, compared by intervention group. RESULTS: During weeks 6 through 28, response rates in the venlafaxine XR group were 69% or higher compared with rates of 42% to 46% in the placebo group (P<.001). By an evaluable-patient analysis, venlafaxine XR compared with placebo significantly improved anxiety scores from week 1 or 2 through week 28 on all primary efficacy measures, including the HAM-A total (P<.001), the HAM-A psychic anxiety factor (P<.001), and the CGI scale scores (P<.001). Adjusted mean changes from baseline to week 28 using last-observation-carried-forward methods were for HAM-A, venlafaxine XR -13.4, placebo -8.7 (P<.001); for HAM-A psychic anxiety score, venlafaxine XR -7.4, placebo -4.2 (P<.001); and for CGI-Improvement, venlafaxine XR 2.2, placebo 3.0 (P<.001). The most common treatment-emergent adverse event was nausea, followed by somnolence and dry mouth. CONCLUSIONS: This study is the first placebo-controlled demonstration of the long-term efficacy of any drug class in treating outpatients with DSM-IV-diagnosed GAD. Venlafaxine XR is an effective, rapidly acting, safe, once-daily agent for both the short- and long-term treatment of anxiety and may provide an important alternative to currently available anxiolytics. JAMA. 2000.     

Multifocal nodular fatty infiltration of the liver mimicking metastatic disease on CT: imaging findings and diagnosis using MR imaging

The aim of this study was to describe the MR appearance of multifocal nodular fatty infiltration of the liver (MNFIL) using T1-weighted in-phase (IP) and opposed-phase (OP) gradient-echo as well as T2-weighted turbo-spin-echo sequences with fat suppression (FSTSE) and without (HASTE). Magnetic resonance imaging examinations at 1.5 T using T1-weighted IP and OP-GRE with fast low angle shot (FLASH) technique, and T2-weighted FSTSE, T2-weighted HASTE of 137 patients undergoing evaluation for focal liver lesions were reviewed. Five patients were identified in whom CT indicated metastatic disease; however, no liver malignancy was finally proven. Diagnosis was confirmed by biopsy (n = 3), additional wedge resection (n = 1) or follow-up MRI 6–12 months later (n = 5). Regarding the identified five patients, the number of focal liver lesions was 2 (n = 2) and more than 20 (n = 3). The MR imaging characteristics were as follows: OP-image: markedly hypointense (n = 5); IP image: isointense (n = 2) or slightly hyperintense (n = 3); T2-weighted FSTSE-image: isointense (n = 5); T2-weighted HASTE image isointense (n = 1); slightly hyperintense (n = 4). On OP images all lesions were sharply demarcated and of almost spherical configuration (n = 5). Further evaluation by histology or follow-up MR imaging did not give evidence of malignancy in any case. Histology revealed fatty infiltration of the liver parenchyma in three patients. Magnetic resonance follow-up showed complete resolution in two patients and no change in three patients. Multifocal nodular fatty infiltration can simulate metastatic disease on both CT and MR imaging. The combination of in-phase (IP) and opposed-phase (OP) gradient-echo imaging can reliably differentiate MNFIL from metastatic disease. Received: 15 September 1999 Revised: 3 February 2000; Accepted: 7 February 2000     

Cologne high-dose sequential chemotherapy in relapsed and refractory Hodgkin lymphoma: results of a large multicenter study of the German Hodgkin Lymphoma Study Group (GHSG).

BACKGROUND: We designed a dose- and time-intensified high-dose sequential chemotherapy regimen for patients with relapsed and refractory Hodgkin lymphoma (HD). PATIENTS AND METHODS: Eligibility criteria included age 18-65 years, histologically proven primary progressive (PD) or relapsed HD. Treatment consisted of two cycles DHAP (dexamethasone, high-dose cytarabine, cisplatinum); patients with chemosensitive disease received cyclophosphamide followed by peripheral blood stem cell harvest; methotrexate plus vincristine, etoposide and BEAM plus peripheral blood stem cell transplantation (PBSCT). RESULTS: A total of 102 patients (median age 34 years, range 18-64) were enrolled. The response rate was 80% (72% complete response, 8% partial response). With a median follow-up of 30 months (range 3-61 months), freedom from second failure (FF2F) and overall survival (OS) were 59% and 78% for all patients, respectively. FF2F and OS for patients with early relapse were 62% and 81%, for late relapse 65% and 81%; for PD 41% and 48%, and for multiple relapse 39% and 48%, respectively. In multivariate analysis response after DHAP (P <0.0001) and duration of first remission (PD and multiple relapse versus early and late relapse; P=0.0127) were prognostic factors for FF2F. Response after DHAP (P <0.0081), duration of first remission (P=0.0017) and anemia (P=0.019) were significant for OS. CONCLUSION: Based on the promising results of this study, a prospective randomized European intergroup study was started comparing this intensified regimen with two courses of DHAP followed by BEAM (HD-R2 protocol).     

Abstracts from the XIIth Scientific Meeting of the Argentine Society of Arterial Hypertension

Epidemiologic Survillance of Cardiovascular Disease Mollar G, Cavalieri L, Galarza C, Waisman G, Beratarrechea A, Petrlik E, Langlois E, Soriano F, Marchetti M, and Gonzalez B de Quirós F Programas Médicos de Plan de Salud del Hospital Italiano de Buenos Aires

To enhance efficacy of health care, surveillance activities are required, especially with chronic prevalent diseases. Epidemiologic surveillance allows US to quantify and qualify health problems, settle priorities, identify high risk groups, manage and monitor health care systems, detect frequency changes in events, and assess performance of prevention and disease management programs. We have developed a surveillance system that identifies and reports daily on patients having cardiovascular disease (CVD) who are uncontrolled.

Objective: To evaluate the accomplishment of blood pressure (BP) measurement in people with CVD belonging to a health care system included in an epidemiological surveillance list.

Design: Cohort study between 1/1/2004 and 9/1/2004.

Methods: Patients 60 years old or older identified by surveillance system during the first term of 2004, were followed up. Patients were identified as having CVD through electronic medical record using international classification for primary attention (ICPA).

Patients are reported by the software system when presenting any of the following criteria: no blood pressure record during the past 6 months, blood pressure above 140/90 in the last record, and if diabetic A1C above 7.5%.

The connection with the appointment system allowed us to detect previously the patient’s attendance and, 15 min before his or her medical appointment, send the patient to be examined by the executors of a chronic disease program, according to the JNC VII guidelines.

The BP measurement is a common intervention to most chronic diseases because it increases cardiovascular risk, hence it is considered a process indicator of the surveillance system.

Results: Of the 24,411 patients having CVD, 5506 (26%) were listed during the first term, mean age was 74 years and 65% were female. By the end of 2004, 4660 (85%) patients had blood pressure recorded with an average values of 136.76 mmHg for systolic and 77.51 for diastolic blood pressure. Blood pressure was assessed three times in average.

Conclusion: Surveillance system allowed identifying of and intervening in a high proportion of patients.     

Testicular Function During Exhaustive Endurance Training

In brief Exhaustive endurance training may suppress testicular function. This tentative conclusion was drawn from a study of six endurance athletes who underwent 2 weeks of prolonged running and cycling. No significant changes were noted for strength, weight, or body fat. However, persistent fatigue developed in all subjects. Their plasma testosterone decreased 17% (from 673 to 558 ng/dl, p <.05), and sperm count decreased, though not significantly. All reported a decline in sexual activity and sex drive, which may be related to the development of general fatigue and could be an early sign of overtraining stress.     

Assessing Children's Mealtime Problems With the Mealtime Behavior Questionnaire

A caregiver questionnaire that assesses mealtime problems in children aged 2 to 6 years old was developed. Community caregivers (n = 712) completed the Mealtime Behavior Questionnaire (MBQ) and measures of child behavior and family mealtime behaviors and environment. Exploratory and confirmatory factor analyses revealed and validated the MBQ's 4 subscales (food refusal/avoidance; food manipulation; mealtime aggression/distress; and choking/, gagging/vomiting). Mealtime problems occurred from “sometimes” to “always” for 1% to 61% of the sample. The MBQ demonstrated excellent to fair internal consistencies, and preliminary evidence for validity was found.     

Akzidentelle Quadrizepstenodese durch arthroskopische Kreuzbandplastik

Adjustable loop button fixations are commonly applied in anterior cruciate ligament (ACL) surgery. In the following case of a young female soccer player, the combination of soft tissue interposition and tunnel malplacement led to an accidental tenodesis of the quadriceps tendon. This resulted in a massive restriction of the joint function which was resolved by arthroscopic removal of the transplant and fixation. The patient gained full range of motion 8 weeks postoperatively.     

Perceived HIV Treatment Norms Modify the Association Between HIV-Related Stigma and Adherence to Antiretroviral Therapy Among Persons Living with HIV in Baltimore,Maryland

AIDS and Behavior - Adherence to antiretroviral therapy (ART) is associated with reduced HIV-related morbidity/mortality and ongoing transmission; however, the extent to which this association is...