Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB.

Hot flashes are a complication of androgen deprivation therapy for prostate cancer. A phase III study showed that use of low-dose gabapentin was well tolerated and moderately decreased the frequency of hot flashes due to androgen deprivation therapy when taken for 4 weeks. The current study, an open-label continuation of the randomized study, examined the efficacy and toxicity of gabapentin when taken for (an additional) 8 weeks. Patients were allowed to start, or continue, gabapentin and to titrate the dose to maximum efficacy, up to 900 mg/d. They were asked to complete a hot flash diary daily and keep weekly logs of toxicity, satisfaction with hot flash control, and quality of life. The moderate reduction in hot flash frequency and severity in the randomized phase of the study appeared to be maintained during this continuation phase. Men originally receiving the placebo or lowest dose of gabapentin (300 mg/d) had improved hot flash control relative to that at the end of the randomized phase. Minimal adverse effects were reported. These findings suggest that low-dose gabapentin is moderately efficacious for at least 12 weeks of hot flash treatment in men undergoing androgen deprivation therapy for prostate cancer and seems to be well tolerated. (NCT00028572)

Depression, healthcare utilization, and death in heart failure: a community study.

BACKGROUND: The increasing prevalence of heart failure (HF) and high associated costs have spurred investigation of factors leading to adverse outcomes in patients with HF. Studies to date report inconsistent evidence on the link between depression and outcomes with only limited data on emergency department and outpatient visits. METHODS AND RESULTS: Olmsted, Dodge, and Fillmore county, Minnesota residents with HF were prospectively recruited between October 2007 and December 2010 and completed a 1-time 9-item Patient Health Questionnaire for depression categorized as: none to minimal (Patient Health Questionnaire score, 0-4), mild (5-9), or moderate to severe (≥10). Andersen-Gill models were used to determine whether depression predicted hospitalizations and emergency department visits, whereas negative binomial regression models explored the association of depression with outpatient visits. Cox proportional hazards regression characterized the relationship between depression and all-cause mortality. Among 402 patients with HF (mean age, 73±13 years; 58% men), 15% had moderate to severe depression, 26% mild, and 59% none to minimal depression. During a mean follow-up of 1.6 years, 781 hospitalizations, 1000 emergency department visits, 15 515 outpatient visits, and 74 deaths occurred. After adjustment, moderate to severe depression was associated with nearly a 2-fold increased risk of hospitalization (hazard ratio, 1.79; 95% confidence interval, 1.30-2.47) and emergency department visits (hazard ratio, 1.83; 95% confidence interval, 1.34-2.50), a modest increase in outpatient visits (rate ratio, 1.20; 95% confidence interval, 1.00-1.45), and a 4-fold increase in all-cause mortality (hazard ratio, 4.06; 95% confidence interval, 2.35-7.01). CONCLUSIONS: In this prospective cohort study, depression independently predicted an increase in the use of healthcare resources and mortality. Greater recognition and management of depression in HF may optimize clinical outcomes and resource utilization.

Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.

PURPOSE: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. PATIENTS AND METHODS: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. RESULTS: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. CONCLUSION: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.