Iqbal S U, Cunningham F, Lee A, Wang S, Hamed A, Miller D R, Ren X, Kazis L
Health Policy & Management Department, Boston University School of Public Health, Boston, MA 02118, USA.
J Clin Pharm Ther. 2007 Dec;32(6):625-32. doi: 10.1111/j.1365-2710.2007.00876.x.
To compare divalproex sodium and valproic acid for therapeutic patterns, persistence rates and predictors of hospitalization among bipolar patients on monotherapy in the Veterans Affairs (VA) healthcare system.
Using VA administrative data bases, we conducted a retrospective inception cohort study of VA patients'>or= 18 years of age who had at least one outpatient diagnoses of bipolar disorder and two continuous prescription records for the study drugs in the VA PBM pharmacy database during the study period of 1st April 2001 to 30th September 2003. Persistence for the comparative drugs was reported as continuous variable and compared using t-tests. Logistic regression models were used to examine the risk of hospitalization whereas Cox proportional hazard regression models were used to evaluate the time to hospitalization and time to interruption of therapy for the two drug groups.
We identified 4624 bipolar patients on monotherapy with valproic acid (n = 4036) and divalproex sodium (n = 588) during the study period. The descriptive statistics included sociodemographics, disability and comorbidity status and were similar for the two groups. For the crude persistence rates there were no statistically significant differences between divalproex sodium (120 days) and valproic acid (110 days). The logistic regression model for risk of hospitalization showed no statistically significant difference between the two comparators [odds ratio = 1.06, 95% confidence interval (CI) = 0.787-1.444]. The Cox model for time to interruption of therapy showed an insignificant hazard ratio (HR) for divalproex sodium vs. valproic acid (HR = 0.928, 95% CI = 0.844-1.020) and for time to hospitalization also no statistically significant difference in the HR for the two drugs (HR = 0.984, 95% CI = 0.784-1.295).
The study showed a comparable profile of generic valproic acid with divalproex sodium for persistence and predictors of hospitalization for bipolar patients on monotherapy in the VA. Results have important healthcare implications for treatment and costs.
在退伍军人事务部（VA）医疗系统中，比较丙戊酸钠和丙戊酸在双相情感障碍患者单药治疗中的治疗模式、持续率及住院预测因素。
利用VA行政数据库，我们对2001年4月1日至2003年9月30日研究期间年龄≥18岁、在VA药品福利管理（PBM）药房数据库中至少有一次门诊双相情感障碍诊断且有两种研究药物连续处方记录的VA患者进行了一项回顾性起始队列研究。将比较药物的持续情况作为连续变量报告，并使用t检验进行比较。采用逻辑回归模型检验住院风险，而Cox比例风险回归模型用于评估两组药物的住院时间和治疗中断时间。
研究期间，我们确定了4624例接受丙戊酸（n = 4036）和丙戊酸钠（n = 588）单药治疗的双相情感障碍患者。描述性统计包括社会人口统计学、残疾和合并症状况，两组相似。丙戊酸钠（120天）和丙戊酸（110天）的粗持续率在统计学上无显著差异。住院风险的逻辑回归模型显示，两种比较药物之间在统计学上无显著差异[比值比 = 1.06，95%置信区间（CI） = 0.787 - 1.444]。治疗中断时间的Cox模型显示，丙戊酸钠与丙戊酸相比风险比（HR）无显著差异（HR = 0.928，95% CI = 0.844 - 1.020），两种药物的住院时间HR在统计学上也无显著差异（HR = 0.984，95% CI = 0.784 - 1.295）。
该研究表明，在VA中接受单药治疗的双相情感障碍患者中，普通丙戊酸与丙戊酸钠在持续情况和住院预测因素方面具有可比的特征。研究结果对治疗和成本具有重要的医疗意义。
