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J G Kotsanos

Publications and source records attributed to J G Kotsanos.

13 recordsLinked to original sources
PubMed2000

Factors associated with nocturnal hypoglycaemia among patients with type 2 diabetes new to insulin therapy: experience with insulin lispro.

AIM: To identify factors associated with nocturnal hypoglycaemia in patients with type 2 diabetes who were new (< 2 months therapy) to insulin therapy. METHODS: A randomised, multicentre, 12-month parallel open-label study compared the clinical safety and efficacy of insulin lispro with regular human insulin. A cohort of North American patients completed a health-related quality of life (HRQOL) questionnaire which included questions related to the Health Beliefs Model (HBM). Measurements of hypoglycaemia rate and short-and long-term glucose control assessed clinical safety and efficacy. Three hundred and sixty-five type 2 diabetic patients were enrolled in the study, and 195 North American patients completed the HRQOL questionnaire. RESULTS: After adjustment for demographic and psychological factors, the study population demonstrated lower nocturnal hypoglycaemia risk with insulin lispro. Higher nocturnal hypoglycaemia risk was associated with reduced body mass index (b.m.i.), lower age, and basal ultralente insulin therapy. The associated hypoglycaemia risk was lower with increased alcohol consumption. Patients who completed the HRQOL survey demonstrated higher risk for nocturnal hypoglycaemia if they: (1) had more troublesome hyperglycaemia symptoms in the week before starting insulin; (2) were more confident in their ability to control their diabetes; or (3) thought that diabetes control did not offer a clear health benefit. Nocturnal hypoglycaemia risk was inversely associated with fear of hypoglycaemia. CONCLUSIONS: Type 2 diabetic patients new to insulin therapy demonstrated lower risk of nocturnal hypoglycaemia with insulin lispro. Practitioners should consider patient characteristics and psychological factors that may predispose type 2 diabetes patients to nocturnal hypoglycaemia when initiating insulin therapy.

Aged↗
PubMed1999

Direct medical charges associated with myocardial infarction in patients with and without diabetes.

OBJECTIVES: This study was designed to measure the direct medical charges for patients with and without diabetes who experience myocardial infarction. METHODS: We completed a retrospective cohort analysis (from the third-party payer perspective) to determine the total direct medical charges (eg, hospitalizations, outpatient visits, pharmacy, and emergency room visits) incurred by an inner city sample of 293 patients during the 12 months following myocardial infarction during the period from January 1993 through February 1997. RESULTS: The 87 patients with diabetes had a higher per patient total direct medical charge (inclusive of initial hospitalization) compared to the 206 patients without diabetes ($18,577 versus $26,414) and approximately $3000 more per person year of observation. Hospitalizations (initial and during the follow-up period) accounted for 88% of the total direct medical charges. The mean charge for the initial hospitalization was higher for patients with diabetes ($12,730 versus $15,394). In a subset, the mean charge per cardiovascular-related hospitalization that occurred during the follow-up period was also higher for patients with diabetes ($6344 versus $9648). CONCLUSIONS: Consistent with what we expected, patients with diabetes incurred higher total direct medical charges as a result of and following myocardial infarction. These data can be used in future cost-effectiveness evaluations for therapies developed to treat patients with diabetes who experience myocardial infarction or for therapies designed to reduce the risk of macrovascular complications associated with diabetes.

Adult↗
PubMed1999

Development and validation of the Diabetes Quality of Life Clinical Trial Questionnaire.

OBJECTIVE: The objective of this study was to develop a valid and reliable health-related quality of life (HRQOL) questionnaire for use in multinational clinical trials of patients with type I and type II diabetes. METHODS: Through patient focus groups and expert clinician panels in the United States (US) and France, relevant HRQOL domains for patients with type I and type II diabetes were identified. A draft questionnaire was developed by including validated, widely used generic and diabetes-specific domains and by developing original questions as required. A pilot study (n = 123) was conducted to evaluate the psychometric properties of the draft questionnaire with revisions being subsequently made. Data collected from two multinational clinical trials of patients with type I and type II diabetes were used to further validate and enhance the questionnaire (DQLCTQ). RESULTS: A total of 942 patients were recruited in the clinical trials from Canada, France, Germany, and the United States. The mean age was 33.8 years for patients with type I diabetes (n = 468) and 58.2 years for patients with type II diabetes (n = 474). The mean HbAlc level at baseline was 8.6. The revised version of the questionnaire (DQLCTQ-R) contains a total of 57 questions comprising 8 generic and disease-specific domains, as follows: Physical Function; Energy/Fatigue; Health Distress; Mental Health; Satisfaction; Treatment Satisfaction; Treatment Flexibility; and Frequency of Symptoms. Intraclass correlation coefficients range from 0.74 to 0.90 and Cronbach's alphas range from 0.77 to 0.90. With very few exceptions, all eight domains were able to discriminate between type I and type II diabetes, tight and poor metabolic control, male and female, and good and poor self perceived control of diabetes. Four domains (Treatment Satisfaction, Health/Distress, Mental Health, and Satisfaction) were responsive to clinical change in metabolic control. CONCLUSION: The DQLCTQ-R is a reliable, valid, and comprehensive HRQOL instrument. It is suitable in multinational clinical trials to evaluate new or alternative treatments for patients with type I and type II diabetes.

Adult↗
PubMed1998

Potential economic benefits of lower-extremity amputation prevention strategies in diabetes.

OBJECTIVE: To estimate the potential economic benefits of selected strategies from published literature--educational interventions, multidisciplinary clinics, and insurance coverage for therapeutic shoes--to reduce the incidence of lower-extremity amputation among individuals with diabetes. RESEARCH DESIGN AND METHODS: We developed a model to estimate the expected incidence and associated costs of lower-extremity amputation in a hypothetical cohort of 10,000 people with diabetes. Prevention strategies were assumed to be targeted at individuals with a history of foot ulcer, and benefits were estimated over a period of 3 years. RESULTS: The total potential economic benefits (discounted at 5%) of strategies to reduce amputation risk ranged from $2.0 to $3.0 million ($2,900 to $4,442 per person with a history of foot ulcer) over 3 years. Benefits were highest for educational interventions. Most benefits were found to accrue among individuals aged > or = 70 years. CONCLUSIONS: Strategies to reduce the risk of lower-extremity amputation may generate substantial economic benefits and should be a standard component of routine diabetes care. Benefits may best be achieved through a partnership of government, private payers, health care service providers and producers, and individuals with diabetes.

Age Factors↗
PubMed1997

Development of performance measures for seven chronic diseases. Health Outcomes Work Group of the Pharmaceutical Research and Manufacturers of America.

BACKGROUND: In 1994 the Washington, DC-based Pharmaceutical Research and Manufacturers of America (PhRMA) initiated a project to develop performance measures for seven chronic diseases-chronic obstructive pulmonary disease, chronic stable angina, depression, diabetes mellitus, hypercholesterolemia, hypertension, and rheumatoid arthritis-that are commonly treated with pharmaceuticals. The project was coordinated by PhRMA's Health Outcomes Work Group (HOWG), an ad hoc committee that addresses issues concerning health outcomes research. METHODOLOGY: For each of the seven diseases, HOWG assembled a panel of clinical experts from the pharmaceutical industry to develop the quality-of-care performance measures. HOWG wanted the measures to be ones that health plans could use to improve the quality of care, that were based on reliable data that could be standardized to account for patient population differences, and that were practical to institute (not cost prohibitive). By the end of a 1 1/2-day working session, each panel had developed at least one preliminary performance measure. Following the panels' meeting, background literature searches were conducted and supporting documentation was obtained. The panels then sent the revised performance measures to appropriate professional organizations for informal review. Another round of revisions was then completed. CHALLENGES AND NEXT STEPS: HOWG's experience in developing these measures, which contain either or both the important clinical processes and outcomes for the respective diseases, has highlighted current challenges in the performance measure arena, such as the availability, validity, and varying sources of data. The PhRMA performance measures should be subjected to further external review and pilot tests before implementation.

Arthritis, Rheumatoid↗
PubMed1997

Diabetic ketoacidosis charges relative to medical charges of adult patients with type I diabetes.

OBJECTIVE: To determine the medical charges for treating diabetic ketoacidosis (DKA) episodes relative to direct medical care charges of adult patients with type I diabetes. RESEARCH DESIGN AND METHODS: Using data from an electronic medical record system, we identified adult patients with type I diabetes who had received inpatient or outpatient care on at least two occasions between 1 January 1993 and 30 June 1994. Resources and charges for hospitalizations, emergency room visits, outpatient visits, and pharmaceuticals were recorded during this period. One additional year of information was collected to assess the resources and charges associated with multiple DKA episodes. RESULTS: A total of 200 patients were identified, of whom 72 (36.0%) experienced a total of 161 DKA episodes. The direct medical care charges associated with DKA episodes represented 28.1% of the direct medical care charges for the cohort of patients with type I diabetes. The average charge per DKA episode was $6,444. The estimated annual medical care charge for each patient was $7,855 ($13,096 per patient experiencing a DKA episode versus $4,907 per patient not experiencing an episode). Multiple DKA episodes were experienced by 24 (12.0%) of the study patients and accounted for 55.6% of the direct medical care charges for these patients. CONCLUSIONS: DKA episodes represented more than $1 of every $4 spent on direct medical care for adult patients with type I diabetes and $1 of every $2 in those patients experiencing multiple episodes. Interventions that are capable of even a modest reduction in the number of DKA episodes could produce substantial cost savings in a health care system and could be particularly cost-effective in adult patients with recurrent DKA.

Adult↗
PubMed1997

Health-related quality-of-life results from multinational clinical trials of insulin lispro. Assessing benefits of a new diabetes therapy.

OBJECTIVE: To compare health-related quality of life (HRQOL) in patients with diabetes receiving insulin lispro with patients receiving regular human insulin (Humulin R). RESEARCH DESIGN AND METHODS: We performed two randomized comparative studies over a 6-month period (3 months per treatment). Primary analyses used crossover baseline to 3-month changes in HRQOL scores. Ninety-three principal investigators in Canada, France, Germany, and the U.S. participated in these studies. One HRQOL crossover study included 468 patients with type I diabetes; the other HRQOL crossover study included 474 patients with type II diabetes. In both studies, patients were taking insulin at least 2 months before enrollment. Primary outcomes included two generic HRQOL domains, energy/fatigue and health distress, and two diabetes-specific domains, treatment satisfaction and treatment flexibility. Thirty secondary outcomes included both generic and diabetes-specific measures. Secondary outcome domains were controlled for multiplicity in the analyses. RESULTS: Primary analyses showed that treatment satisfaction scores (P < 0.001) and treatment flexibility scores (P = 0.001) were higher for insulin lispro in type I diabetic patients. No other significant treatment differences were detected using the data from these 6-month crossover studies. CONCLUSIONS: Treatment satisfaction and treatment flexibility were significantly improved in patients with type I diabetes using insulin lispro. Other HRQOL findings were comparable for insulin lispro and regular human insulin. Insulin lispro appears to have a measurable impact on lifestyle benefits in patients with type I diabetes, as demonstrated by increased treatment satisfaction and treatment flexibility.

Adult↗
PubMed1997

Resource utilization and work or school loss reported by patients with diabetes: experience in diabetes training programs.

Diabetes exerts a major economic impact on healthcare in the United States both in terms of direct and indirect costs. Diabetes management and education programs designed to assist patients in achieving more optimal glycemic control represent a potential mechanism for reducing the morbidity and costs associated with diabetes. The relationship between HbA1c and patient hospitalizations and between HbA1c and days lost from work or school related to diabetes within the past year were evaluated. A cohort of 2359 patients with diabetes (188 type I, 2171 type II) referred to a comprehensive diabetes self-management training program was included in the analyses. Overall, 350 (14.8%) patients reported hospitalization, and 212 (9.0%) reported days lost from work or school. Patients with type I diabetes reported more hospitalizations (26.1% vs 13.9% and days lost (19.2% vs 8.1%) than type II patients. For the hospitalization outcome, the multivariate analyses indicated that younger age, the number of co-morbidities, and the duration of diabetes exerted a greater influence on the reported numbers of hospitalization than glycemic control. For the days lost outcome, the multivariate analyses indicated that there was a marginally significant association between patients with poor glycemic control and reported work or school loss related to diabetes (odds ratio = 1.5; 95% confidence interval, 1.0-2.2). These data suggest that interventions that improve glycemic control may decrease indirect costs related to diabetes.

Absenteeism↗
PubMed1992

Clinical economics: a method for prospective health resource data collection.

Information about the economic benefit of new drugs is becoming increasingly important for formulary considerations, reimbursement policies and related considerations. Although economic benefits of drugs have been analysed and reported, the economic benefits of drugs have rarely been examined in the course of randomised therapeutic trials. We designed a modular survey instrument, the Resource Utilisation Survey (RUS), to collect economic outcomes in prospective trials. A pilot test of the RUS was conducted using clinical trial methods in a study of nizatidine versus placebo in preventing ulcers induced by nonsteroidal anti-inflammatory drugs. The purpose of the pilot study was to evaluate the RUS instrument and corresponding study design issues in clinical trials for either acute or chronic diseases. With the lessons learned from the pilot study, the RUS has been used successfully in other ongoing clinical trials.

Economics, Pharmaceutical↗
PubMedDate not supplied

Analysis of mortality in pergolide-treated patients with Parkinson's disease.

Parkinson's disease, because of its progressive degenerative nature, is associated with increased disability and mortality compared with mortality in the general population. We examined mortality data from three clinical trials involving 1,330 patients with Parkinson's disease treated with pergolide as an adjunct to levodopa or levodopa/carbidopa therapy. The ratio of observed deaths to expected deaths in the general population of the same age, gender, race distribution, and period of observation was 2.3 for the 3 studies combined. The ratio is lower than that in Parkinson's disease patients treated prior to the introduction of levodopa, consistent with ratios with levodopa and levodopa combination therapy. The ratio is slightly higher than in Parkinson's disease patients treated with levodopa and levodopa combination therapy, which may be attributable to differing patient characteristics in the populations studied.

Adolescent↗