Objectives: This study evaluated the association between weight loss and change in depression among patients with type 2 diabetes mellitus (T2DM). Methods: Weight change from 2008 to 2009 among respondents (with and w...Objectives: This study evaluated the association between weight loss and change in depression among patients with type 2 diabetes mellitus (T2DM). Methods: Weight change from 2008 to 2009 among respondents (with and without T2DM) in the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) was calculated. Change in depression was calculated as change from 2008 to 2009 in Patient Health Questionnaire-9 (PHQ-9) scores. Respondents with weight loss (>1%, >3%, >5%) were compared with respondents with weight gain (≥1%). Multivariate regression adjusted for baseline characteristics. Results: Among those with T2DM, more respondents with weight loss (n = 779) improved their depression scores, compared with respondents with weight gain (n = 731): 32.9%, 36.9%, 39.8% for >1%, >3%, and >5% weight loss, respectively, vs. 28.7% for weight gain (p<0.05). More respondents with weight loss improved the severity level of depression compared with respondents with weight gain (p < 0.05). After adjustment, T2DM respondents with weight loss had significantly greater improvement in depression scores (p < 0.05) and had 2 - 3 times higher odds of improving depression severity than T2DM respondents with weight gain (OR: 2.22 for >1%, 2.96 for >3%, and 3.31 for >5% weight loss, p < 0.01). Similar improvement in depression scores and severity of depression related to weight loss was observed among all SHIELD respondents (with and without T2DM). Conclusions: Our findings demonstrate an association between weight loss and improvement in depression over a 1-year period in adults with T2DM, and suggest the need for further investigation with respect to causality.展开更多
Bioequivalence is a critical tool that links the results of clinical studies to the pharmaceutical products that have undergone various manufacture changes. Although in vivo BE studies are still regarded as the "...Bioequivalence is a critical tool that links the results of clinical studies to the pharmaceutical products that have undergone various manufacture changes. Although in vivo BE studies are still regarded as the "gold standard" for evaluating the therapeutic equivalence of pharmaceutically equivalent drug products, in vitro testing as a sufficiently reliable surrogate for an in vivo BE study (biowaiver) has been increasingly accepted by regulatory agencies for some drug products. The guidances and regulations on biowaivers for oral solid dosage forms have facilitated the application of the biowaiving approach in formulation development for a new drug product, line extensions, a generic drug product development and post-approval changes both for innovator and generic drug products. Although biowaivers have demonstrated to reduce the drug development time and cost, the regional regulatory differences in the current requirements for biowaivers may complicate the decision to take the biowaiver approach. Time to file a biowaiver request to obtain a formal approval from the agency may be too long to risk project timelines, especially in the late stages of development. Since Japan does not accept the BCS based biowaiver, a decision to use the approach in the US and EU may present future issues for registration in Japan. The agreed BE strategy with one agency may not always work with another authority, which may result in a BE study for a region and a biowaiver request from another. When biowaivers are being considered as part of registration strategy, the different regulatory requirements for biowaivers, the time and expense of conducting in vivo BE studies versus the application for biowaiver and the overall impact on product development costs and timeline must be carefully considered and balanced.展开更多
Objective： Patients with poorly controlled diabetes have more medical complications and are more difficult to manage. The objective of the present study was to evaluate the clinical outcomes of successful implementat...Objective： Patients with poorly controlled diabetes have more medical complications and are more difficult to manage. The objective of the present study was to evaluate the clinical outcomes of successful implementation of an employer initiated community pharmacist-based disease management program for diabetic patients with poorly controlled diabetes. Methods： Employees with poorly controlled diabetes （glycosylated hemoglobin （A1 C） level 〉 7.5%） were identified fi＇om a large diabetes disease management program, in a rural setting in Texas, US. A longitudinal retrospective study was conducted, analyzing clinical indicators in the diabetes patients following the community pharmacist-based disease management program. The program involved a comprehensive drug therapy assessment and individualized disease management education. Primary outcome measured in the present study was A1C levels, assessed at the baseline visit and at the end of the intervention. Results： A total of 64 patients with poorly controlled diabetes were identified. Significant improvement in mean clinical outcome scores was achieved for A1C levels （p = 0.0011）. At the end of the 1 year longitudinal intervention, targeted body mass index and A1C goals were attained by 35.9% （p 〈 0.001） and 15.6% patients, respectively. The 10 patients reaching goal levels post intervention were in the group that had baseline A1C of 7.5 to 9%. However, patients with 〉 9% A1C levels at baseline had a significant reduction （mean 2.1, p 〈 0.001） post intervention. Conclusion： The community pharmacist-based diabetes disease management program improved A1C levels of patients with poorly controlled diabetes.展开更多
This study documents the number of ambulatory visits associated with gastroesophageal reflux disease (GERD) in the United States. Sample data from nearly 80,000 patients captured by the National Ambulatory Medical Car...This study documents the number of ambulatory visits associated with gastroesophageal reflux disease (GERD) in the United States. Sample data from nearly 80,000 patients captured by the National Ambulatory Medical Care Survey (NAMCS; 1998-2001) were analyzed. Basic demographics of patients with GERD and factors associated with each visit were assessed. Approximately 38.53 million of 2.653 billion adult outpatient visits made in the United States during the study period were GERD-related. GERD-related visits increased by 46.5%from 1998 to 2001. Most GERD-related visits were by women (54.7%) with an average age of 56.0 years, compared with patients without GERD, who were even more likely to be women (62.2%) and younger (52.6 years). Patients with GERD were more likely to have multiple reasons (50.5%) and multiple diagnoses (79.3%) per medical visit versus non-GERD patients (37.6%and 48.4%, respectively). Utilization of data from the NAMCS reveals that GERD-related visits increased annually during the study period. Patients with GERD are more likely to see a physician if they have concomitant medical conditions, making GERD a condition that is very likely untreated in a high percentage of individuals.展开更多
背景：血管紧张素转换酶（angiotensin-converting enzyme，ACE）抑制剂可降低心肌梗死（myocardial infarction，MI）的危险，但是还不清楚血管紧张素受体拮抗剂是否具有同样的效果。
目的：评价血管紧张素受体拮抗剂坎地沙坦对心力...背景：血管紧张素转换酶（angiotensin-converting enzyme，ACE）抑制剂可降低心肌梗死（myocardial infarction，MI）的危险，但是还不清楚血管紧张素受体拮抗剂是否具有同样的效果。
目的：评价血管紧张素受体拮抗剂坎地沙坦对心力衰竭患者MI和其他冠脉事件的影响。
设计、地点和参试者：“坎地沙坦治疗心力衰竭：降低病死率和发病率评价”（Candesartan in Heart Failure：Assessment of Reduction in Mortality and Morbidity，CHARM）计划是一项随机、安慰剂对照研究。研究入选有纽约心脏病协会分级Ⅱ至Ⅳ级症状的患者（平均年龄，66[SD，11]岁）。在心力衰竭最佳治疗的基础上，随机接受坎地沙坦（目标剂量，32mg每天一次）或匹配的安慰剂。患者入选期为1999年3月至2001年3月。分组的7599例患者中，4004例（53％）有MI病史，1808例（24％）患有心绞痛。基线时，服用ACE抑制剂3125例（41％）；服用β-阻滞剂4203（55％）例；降脂药物3153例（42％）；阿斯匹林4246例（56％）；利尿药6286例（83％）。
主要观测指标：该分析的主要终点为坎地沙坦或安慰剂组心力衰竭患者心血管死亡和非致死性MI复合发生率。
结果：在37．7个月的中位随访期间，坎地沙坦组（775例患者[20．4％]）心血管死亡和非致死性MI主要终点的发生率明显低于安慰剂组（868[22．9％]）（风险比[hazard ratio，HR]，0．87；95％可信区间[confidence interval，CI]，0．79-0．96；P=0．004；所需治疗例数[numbe rneeded to treat，NNT]，40）。与安慰剂组（522[13．8％]）比较，坎地沙坦组（459[12．1％]）单纯非致死性MI也明显降低（HR，0．86；95％CI，0．75-0．97；P=0．02；NNT，59）。在CHARM试验预先设定的不同亚组和分析间，心血管死亡和非致死性MI危险的降低相似。坎地沙坦对不稳定心绞痛或冠脉血运重建导致的住院没有影响。结论：坎地沙坦能明显降低心力衰竭患者发生心血管死亡或非致死性MI复合终点的危险。展开更多
文摘Objectives: This study evaluated the association between weight loss and change in depression among patients with type 2 diabetes mellitus (T2DM). Methods: Weight change from 2008 to 2009 among respondents (with and without T2DM) in the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD) was calculated. Change in depression was calculated as change from 2008 to 2009 in Patient Health Questionnaire-9 (PHQ-9) scores. Respondents with weight loss (>1%, >3%, >5%) were compared with respondents with weight gain (≥1%). Multivariate regression adjusted for baseline characteristics. Results: Among those with T2DM, more respondents with weight loss (n = 779) improved their depression scores, compared with respondents with weight gain (n = 731): 32.9%, 36.9%, 39.8% for >1%, >3%, and >5% weight loss, respectively, vs. 28.7% for weight gain (p<0.05). More respondents with weight loss improved the severity level of depression compared with respondents with weight gain (p < 0.05). After adjustment, T2DM respondents with weight loss had significantly greater improvement in depression scores (p < 0.05) and had 2 - 3 times higher odds of improving depression severity than T2DM respondents with weight gain (OR: 2.22 for >1%, 2.96 for >3%, and 3.31 for >5% weight loss, p < 0.01). Similar improvement in depression scores and severity of depression related to weight loss was observed among all SHIELD respondents (with and without T2DM). Conclusions: Our findings demonstrate an association between weight loss and improvement in depression over a 1-year period in adults with T2DM, and suggest the need for further investigation with respect to causality.
文摘Bioequivalence is a critical tool that links the results of clinical studies to the pharmaceutical products that have undergone various manufacture changes. Although in vivo BE studies are still regarded as the "gold standard" for evaluating the therapeutic equivalence of pharmaceutically equivalent drug products, in vitro testing as a sufficiently reliable surrogate for an in vivo BE study (biowaiver) has been increasingly accepted by regulatory agencies for some drug products. The guidances and regulations on biowaivers for oral solid dosage forms have facilitated the application of the biowaiving approach in formulation development for a new drug product, line extensions, a generic drug product development and post-approval changes both for innovator and generic drug products. Although biowaivers have demonstrated to reduce the drug development time and cost, the regional regulatory differences in the current requirements for biowaivers may complicate the decision to take the biowaiver approach. Time to file a biowaiver request to obtain a formal approval from the agency may be too long to risk project timelines, especially in the late stages of development. Since Japan does not accept the BCS based biowaiver, a decision to use the approach in the US and EU may present future issues for registration in Japan. The agreed BE strategy with one agency may not always work with another authority, which may result in a BE study for a region and a biowaiver request from another. When biowaivers are being considered as part of registration strategy, the different regulatory requirements for biowaivers, the time and expense of conducting in vivo BE studies versus the application for biowaiver and the overall impact on product development costs and timeline must be carefully considered and balanced.
文摘Objective： Patients with poorly controlled diabetes have more medical complications and are more difficult to manage. The objective of the present study was to evaluate the clinical outcomes of successful implementation of an employer initiated community pharmacist-based disease management program for diabetic patients with poorly controlled diabetes. Methods： Employees with poorly controlled diabetes （glycosylated hemoglobin （A1 C） level 〉 7.5%） were identified fi＇om a large diabetes disease management program, in a rural setting in Texas, US. A longitudinal retrospective study was conducted, analyzing clinical indicators in the diabetes patients following the community pharmacist-based disease management program. The program involved a comprehensive drug therapy assessment and individualized disease management education. Primary outcome measured in the present study was A1C levels, assessed at the baseline visit and at the end of the intervention. Results： A total of 64 patients with poorly controlled diabetes were identified. Significant improvement in mean clinical outcome scores was achieved for A1C levels （p = 0.0011）. At the end of the 1 year longitudinal intervention, targeted body mass index and A1C goals were attained by 35.9% （p 〈 0.001） and 15.6% patients, respectively. The 10 patients reaching goal levels post intervention were in the group that had baseline A1C of 7.5 to 9%. However, patients with 〉 9% A1C levels at baseline had a significant reduction （mean 2.1, p 〈 0.001） post intervention. Conclusion： The community pharmacist-based diabetes disease management program improved A1C levels of patients with poorly controlled diabetes.
文摘This study documents the number of ambulatory visits associated with gastroesophageal reflux disease (GERD) in the United States. Sample data from nearly 80,000 patients captured by the National Ambulatory Medical Care Survey (NAMCS; 1998-2001) were analyzed. Basic demographics of patients with GERD and factors associated with each visit were assessed. Approximately 38.53 million of 2.653 billion adult outpatient visits made in the United States during the study period were GERD-related. GERD-related visits increased by 46.5%from 1998 to 2001. Most GERD-related visits were by women (54.7%) with an average age of 56.0 years, compared with patients without GERD, who were even more likely to be women (62.2%) and younger (52.6 years). Patients with GERD were more likely to have multiple reasons (50.5%) and multiple diagnoses (79.3%) per medical visit versus non-GERD patients (37.6%and 48.4%, respectively). Utilization of data from the NAMCS reveals that GERD-related visits increased annually during the study period. Patients with GERD are more likely to see a physician if they have concomitant medical conditions, making GERD a condition that is very likely untreated in a high percentage of individuals.
文摘背景：血管紧张素转换酶（angiotensin-converting enzyme，ACE）抑制剂可降低心肌梗死（myocardial infarction，MI）的危险，但是还不清楚血管紧张素受体拮抗剂是否具有同样的效果。
目的：评价血管紧张素受体拮抗剂坎地沙坦对心力衰竭患者MI和其他冠脉事件的影响。
设计、地点和参试者：“坎地沙坦治疗心力衰竭：降低病死率和发病率评价”（Candesartan in Heart Failure：Assessment of Reduction in Mortality and Morbidity，CHARM）计划是一项随机、安慰剂对照研究。研究入选有纽约心脏病协会分级Ⅱ至Ⅳ级症状的患者（平均年龄，66[SD，11]岁）。在心力衰竭最佳治疗的基础上，随机接受坎地沙坦（目标剂量，32mg每天一次）或匹配的安慰剂。患者入选期为1999年3月至2001年3月。分组的7599例患者中，4004例（53％）有MI病史，1808例（24％）患有心绞痛。基线时，服用ACE抑制剂3125例（41％）；服用β-阻滞剂4203（55％）例；降脂药物3153例（42％）；阿斯匹林4246例（56％）；利尿药6286例（83％）。
主要观测指标：该分析的主要终点为坎地沙坦或安慰剂组心力衰竭患者心血管死亡和非致死性MI复合发生率。
结果：在37．7个月的中位随访期间，坎地沙坦组（775例患者[20．4％]）心血管死亡和非致死性MI主要终点的发生率明显低于安慰剂组（868[22．9％]）（风险比[hazard ratio，HR]，0．87；95％可信区间[confidence interval，CI]，0．79-0．96；P=0．004；所需治疗例数[numbe rneeded to treat，NNT]，40）。与安慰剂组（522[13．8％]）比较，坎地沙坦组（459[12．1％]）单纯非致死性MI也明显降低（HR，0．86；95％CI，0．75-0．97；P=0．02；NNT，59）。在CHARM试验预先设定的不同亚组和分析间，心血管死亡和非致死性MI危险的降低相似。坎地沙坦对不稳定心绞痛或冠脉血运重建导致的住院没有影响。结论：坎地沙坦能明显降低心力衰竭患者发生心血管死亡或非致死性MI复合终点的危险。
