Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study

OBJECTIVE: Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications. RESEARCH DESIGN AND METHODS: In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28-40 kg/m2, and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured. RESULTS: After 1 year of treatment, the orlistat group lost 6.2 +/- 0.45% (mean +/- SEM) of initial body weight vs. 4.3 +/- 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost > or = 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA1c (P < 0.001) and fasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P < 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low. Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients. CONCLUSIONS: Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.     

Echocardiographic follow-up in patients with mild to moderate mitral stenosis: is a yearly examination justified?

The result of this study showed that echocardiographic and Doppler parameters in patients with mild to moderate mitral stenosis did not undergo any major changes over a relatively long observation period, reflecting the substantial stability of the valve disease process. Thus, unless such patients experience clinical deterioration, a yearly echocardiographic examination appears to be unjustified.     

Decline and stabilization of managerial motivation over a 20-year period.

Investigated the decline in managerial motivation that began in the early 1960's to determine when and if it stabilized. Data for 1972–1973 (N?=?86) and 1980 (N?=?124) were added to findings for 1960–1961 (N?=?287) and 1967–1968 (N?=?129) showing that managerial motivation as measured by the Miner Sentence Completion Scale (MSCS) continued to decline into the early 1970's and then apparently leveled off. These findings for University of Oregon undergraduate business students were substantiated using similar samples from Georgia State University obtained in 1975 and 1979, as well as comparable groups from other universities. Previously existing differences between male and female business students, which showed that females obtained considerably lower scores on the MSCS, have now disappeared. The overall results continue to indicate major managerial talent shortages for some years to come. Managerial motivation may have experienced a resurgence in the business schools in recent years. The data indicate that decreases have been most conspicuous on attitudes toward authority, competitiveness, assertiveness, and the desire to perform routine communications and decision-making functions. (24 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The tinnitus intensive therapy habituation program: A 2-year follow-up pilot study on subjective tinnitus.

Objectives: To explore the effects of a new tinnitus treatment program (tinnitus intensive therapy [TIT]) based on auditory perception principles and neural habituation. Methods: A follow-up study with measurement of treatment effects every third month over a 2-year period in which the cases were their own controls. Participants: There were 25 participants with a mean age 50.1 years (SD = 16.1); 10 women (52.7 years; SD = 16.8) and 15 men (48.3 years; SD = 15.9). The participants were recruited from clinical population admitted to a polyclinic tinnitus treatment program in western Germany. Results: There was a significant reduction of tinnitus in the follow-up period. Mean baseline tinnitus scores (Tinnitus Fragebogen; Goebel & Hiller, 1998) at the start of the treatment were 50.9 (SD = 14.5) and the final scores were 14.2 (SD = 5.9). In total, the clinical improvement over the follow-up period was 72.1%. Conclusion: The TIT program showed a significant clinical treatment effect and should be tested further in a multicenter treatment project. The findings support the Jastreboff habituation model of tinnitus, but social cognitive factors should also be taken into account. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Sexual function in patients with disseminated sclerosis. A 5-year follow-up study

Sexual dysfunction is known to occur in multiple sclerosis (MS). The purpose of the study is to describe the change in sexual function and symptoms in a five year follow-up study. Forty-nine patients (27 females, 22 males) with definite MS were interviewed and examined. The number of patients with sexual dysfunction increased significantly (p = 0.004) and involved females and males equally. Males usually had one or two symptoms, while females frequently had two or more symptoms. It is concluded that the risk of sexual dysfunction increases over time. Further studies concerning treatment possibilities are needed.     

Combined modality therapy in previously untreated patients with advanced Hodgkin's disease: A 24-year follow-up study

PURPOSE: To describe the long-term results of treatment with chemotherapy plus adjuvant low-dose, involved-field radiation therapy (CMT) in patients with advanced Hodgkin's disease. Data on disease-free and failure-free survival, second malignancies, and the results of salvage therapy are presented. PATIENTS AND METHODS: From 1969 to 1989, CMT was administered to 186 patients with previously untreated stage IIB, III, and IV Hodgkin's disease. Chemotherapy included MVVPP (47%), MOPP (25%), MOPP/ABVD (26%) and ABVD (2%). After 6 months of chemotherapy, patients received radiation to all involved sites with the exception of the bone marrow. RESULTS: The failure-free survival for all patients was 63% at 5 years, 56% at 10 years, and 40% at 23.5 years, respectively. Significantly worse results were observed in patients older than 40 years and those with stage IV disease. The overall survival of 45 patients after recurrence was 39% at 10 years, but was only 21% if the initial complete remission lasted less than 1 year. Thus far, 21 of 165 patients (12.7%) who achieved complete remission have developed a second malignancy, and 16 have died. CONCLUSIONS: In comparison with comparable chemotherapy programs, chemotherapy plus radiation therapy may improve disease-free survival; however, the results of treatment in patients older than age 40 or with stage IV disease are still poor. Although patients with initial remissions lasting longer than 1 year can have durable second remissions, the long-term disease-free survival is poor and in the current series the majority of failures were due to recurrent Hodgkin's disease.     

Prediction of response to treatment in a randomized clinical trial of couple therapy: A 2-year follow-up.

Many studies have examined pretreatment predictors of immediate posttreatment outcome, but few studies have examined prediction of long-term treatment response to couple therapies. Four groups of predictors (demographic, intrapersonal, communication, and other interpersonal) and 2 moderators (pretreatment severity and type of therapy) were explored as predictors of clinically significant change measured 2 years after treatment termination. Results demonstrated that power processes and expressed emotional arousal were the strongest predictors of 2-year response to treatment. Moderation analyses showed that these variables predicted differential treatment response to traditional versus integrative behavioral couple therapy and that more variables predicted 2-year response for couples who were less distressed when beginning treatment. Findings are discussed with regard to existing work on prediction of treatment response, and directions for further study are offered. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Sustained good glycaemic control in NIDDM patients by implementation of structured care in general practice: 2-year follow-up study

In primary care it is difficult to treat the growing number of non-insulin-dependent diabetic (NIDDM) patients according to (inter)national guidelines. A prospective, controlled cohort study was designed to assess the intermediate term (2 years) effect of structured NIDDM care in general practice with and without 'diabetes service' support on glycaemic control, cardiovascular risk factors, general well-being and treatment satisfaction. The 'diabetes service', supervised by a diabetologist, included a patient registration system, consultation facilities of a dietitian and diabetes nurse educator, and protocolized blood glucose lowering therapy advice which included home blood glucose monitoring and insulin therapy. In the study group (SG; 22 general practices), 350 known NIDDM patients over 40 years of age (206 women; mean age 65.3 +/- SD 11.9; diabetes duration 5.9 +/- 5.4 years) were followed for 2 years. The control group (CG; 6 general practices) consisted of 68 patients (28 women; age 64.6 +/- 10.3; diabetes duration 6.3 +/- 6.4 years). Mean HbA1c (reference 4.3-6.1%) fell from 7.4 to 7.0% in SG and rose from 7.4 to 7.6% in CG during follow-up (p = 0.004). The percentage of patients with poor control (HbA1c > 8.5%) shifted from 21.4 to 11.7% in SG, but from 23.5 to 27.9% in CG (p = 0.008). Good control (HbA1c < 7.0%) was achieved in 54.3% (SG; at entry 43.4%) and 44.1% (CG; at entry 54.4%) (p = 0.013). Insulin therapy was started in 29.7% (SG) and 8.8% (CG) of the patients (p = 0.000) with low risk of severe hypoglycaemia (0.019/patient year). Mean levels of total and HDL-cholesterol (SG), triglycerides (SG) and diastolic blood pressure (SG + CG) and the percentage of smokers (SG) declined significantly, but the prevalence of these risk factors remained high. General well-being (SG) did not change during intensified therapy. Treatment satisfaction (SG) tended to improve. Implementation of structured care, including education and therapeutic advice, results in sustained good glycaemic control in the majority of NIDDM patients in primary care, with low risk of hypoglycaemia. Lowering cardiovascular risk requires more than reporting results and referral to guidelines.     

Hyperglycemia and compositional lipoprotein abnormalities as predictors of cardiovascular mortality in type 2 diabetes: a 15-year follow-up from the time of diagnosis

OBJECTIVE: We studied the 15-year cardiovascular mortality and morbidity of newly diagnosed patients with type 2 diabetes and of nondiabetic control subjects and the predictors of cardiovascular mortality in diabetic patients. RESEARCH DESIGN AND METHODS: We performed a 15-year prospective study of 133 middle-aged patients with newly diagnosed type 2 diabetes and 144 control subjects. Cardiovascular risk factors were assessed in both groups at baseline and after 5 and 10 years. RESULTS: Total mortality was markedly higher in patients with type 2 diabetes (total: 44.3 vs. 12.9% for men, age-adjusted odds ratio [OR] 5.0, P < 0.001; 44.4 vs. 11.0% for women, OR 5.2, P < 0.001), which was due to increased cardiovascular mortality (ORs for men and women: 6.2 and 11.2, respectively, P < 0.001 for both). The incidences of fatal and nonfatal myocardial infarction and stroke were likewise higher in diabetic patients. In univariate analyses and various multiple logistic regression analyses, hyperglycemia was a constant predictor of cardiovascular mortality assessed at the time of diagnosis or at 5- or 10-year examinations. Moreover, lipoprotein abnormalities characteristic of type 2 diabetes (low HDL cholesterol, high LDL triglycerides or apolipoprotein B levels, and low LDL cholesterol/apolipoprotein B ratio as a marker for LDL size) were predictive of cardiovascular death in these analyses. CONCLUSIONS: This long-term study of a well-characterized group of newly diagnosed patients strengthens the view that the prognosis in middle-aged subjects is markedly impaired and that both hyperglycemia and compositional lipoprotein abnormalities are predictors of cardiovascular mortality in patients with type 2 diabetes.     

Endoscopic pancreaticobiliary procedures in patients with a Billroth II resection: a 10-year follow-up study

PURPOSE: To report uveitis associated with human immunodeficiency virus (HIV) infection and to suggest guidelines for treatment. METHODS: Six HIV-seropositive patients (10 eyes) with anterior or posterior uveitis or both were evaluated. After ineffective prolonged treatment with systemic and topical corticosteroids, specific systemic antiretroviral therapy with zidovudine was initiated in all patients. Aqueous humor was cultured in three eyes of three patients, and vitreous humor was cultured in one eye of one patient. RESULTS: In all 10 eyes of six patients, there was resolution of inflammation in 10 to 42 days after commencement of treatment with zidovudine (600 to 800 mg/day), despite no or minimal response to corticosteroids. Cultures of aqueous humor from three eyes of three patients and culture of vitreous humor from one eye of one patient were positive for HIV; no other organism was isolated. Systemic evaluation disclosed no other identifiable cause for the uveitis in any patient. CONCLUSIONS: Infection with HIV appears to be a cause of uveitis. A trial of zidovudine may be warranted in HIV-seropositive patients with uveitis that is poorly responsive to corticosteroid treatment when no other cause is identified. The efficacy of other retroviral agents was not determined.     

Steroid therapy during the early stage of progressive IgA nephropathy. A 10-year follow-up study

This study was undertaken to clarify the effect of corticosteroids on the long-term clinical course of the early stage of progressive IgA nephropathy. The early stage of progressive IgA nephropathy was defined as having moderate proteinuria between 1 and 2 g/day, creatinine clearance values of 70 ml/min or more, and a histological severity score of 7 or more. The number of patients who fulfilled these three conditions during 12 years from 1972 and then were continuously followed up for 10 years or more in our renal unit was 46. Twenty of them received steroid treatment for an average period of 18 months, and the remaining 26 patients had no steroid treatment. The initial data of proteinuria, creatinine clearance values, frequency of hypertensive cases, and histological scores of 7 or more were not different between the two groups: 1.4 +/- 0.4 vs. 1.3 +/- 0.3 g/day, 85 +/- 14 vs. 88 +/- 13 ml/min, 25 vs. 38%, and 10.7 +/- 2.5 vs. 11.0 +/- 3.0, respectively. During the follow-up period of 10 years, the renal survival rate was significantly different between the two groups (100 vs. 84% 5 years after starting therapy and 80 vs. 34% 10 years later; p < 0.001). The final creatinine clearance values were significantly different between the two groups (54 +/- 35 vs. 20 +/- 29 ml/min; p < 0.005). On the other hand, the patient groups with mild histological changes or decreased renal function due to moderate proteinuria showed no significant differences in the final outcome. These results indicate that corticosteroids are beneficial in stabilizing the renal function for a long time during the early stage of progressive IgA nephropathy, although this study was not a randomized one.     

Salary as a predictor of salary: A 20-year study.

This study investigated the value of using salary after a few yr. in an organization as a predictor of, and therefore as an intermediate criterion for, salary at a later date. Salary data were collected for each yr. of the 20-yr. careers of 52 aircraft engineers. The salaries were combined to yield yearly distributions, 1 for beginning salary and 1 for each yr. of experience. The resulting distributions were intercorrelated and the following results obtained: (a) 92% of the intercorrelations were significant at the .01 level, (b) correlations between equidistant yr. became larger as tenure increased, and (c) the variance of salaries increased with increasing tenure. It is concluded that salary early in a man's career can be used as an intermediate criterion. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Cephalometric evaluation of the changes in patients wearing complete dentures: a 20-year study

The purpose of this continuing longitudinal investigation was to study the changes on the craniofacial complex in complete denture wearers; herein are reported the 20-year findings. At the onset of the study complete dentures were made for 64 persons. Two dentures techniques were employed: a complex method of construction and a simplified method. At the start of the project the patients' ages ranged from 30 to 60 years (average age 53 years) and all had been edentulous for at least 1 year (range 1 to 30 years). Lateral cephalometric radiographs were made immediately after initial placement of the dentures and during subsequent years (1, 2, 3, 4, 5, 7, 10, 15, and 20). The same cephalostat was used throughout and all films were exposed with the teeth in centric occlusion. Thirty-four subjects presented for the 20-year follow-up. Of this number, the radiographs of 24 subjects (14 women and 10 men; average age 65.5 years [range 50-83 years]) (12 complex denture wearers; 12 simplified technique denture wearers) were used in this report (10 had denture alterations over the 20-year period that excluded them). The 20-year observations corroborate earlier findings. There is a loss of the vertical dimension of occlusion as viewed from the right profile, and the mandible rotates in a counterclockwise fashion resulting in an increase in relative prognathism. The maxillary alveolus was stable, the mandibular alveolus resorbed, and the dentures rotated counterclockwise and shifted slightly forward. The observed changes were not significantly affected by the sex of the patient or by the denture technique employed.     

Neuropsychological functioning among the nonpsychotic relatives of schizophrenic patients: A 4-year follow-up study.

In a prior study of 54 relatives of patients with schizophrenia and 72 control participants, 3 neuropsychological functions met the criteria for risk indicators of the schizophrenia genotype: executive functioning, memory, and auditory attention. In an assessment of the stability of these findings, the sample was reexamined 4 years after the initial assessment. Three test scores were found to differ between groups (Immediate Verbal Memory, Delayed Verbal Memory, and Dichotic Listening Digits Detected) or to show a significant Group?×?Gender interaction (immediate and delayed verbal and visual memories). None of the test scores showed Group?×?Time interactions, suggesting that the discriminating power of the tests was stable over time. Evidence for deficits in working memory and rule learning on the object alternation test was also found. These results support the idea that neuropsychological dysfunction among relatives of patients with schizophrenia is a stable trait caused by the familial predisposition to schizophrenia. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Lifelong severe verrucosis associated with human papillomavirus type 2: report of a case with a 38-year follow-up

Sulfite ion (HSO3-) is one of the products when elemental sulfur is oxidized by the hydrogen sulfide:ferric ion oxidoreductase of Thiobacillus ferrooxidans AP19-3. Under the conditions in which HSO3- is accumulated in the cells, the iron oxidase of this bacterium was strongly inhibited by HSO3-. Since cytochrome c oxidase is one of the most important components of the iron oxidase enzyme system in T. ferrooxidans, effects of HSO3- on cytochrome c oxidase activity were studied with the plasma membranes of HSO3(-)-resistant and -sensitive strains of T. ferrooxidans, OK1-50 and AP19-3. The enzyme activity of AP19-3 compared with OK1-50 was strongly inhibited by HSO3-. To investigate the inhibition mechanism of HSO3- in T. ferrooxidans, cytochrome c oxidases were purified from both strains to an electrophoretically homogeneous state. Cytochrome c oxidase activity of a purified OK1-50 enzyme was not inhibited by 5 mM HSO3-. In contrast, the same concentration of HSO3- inhibited the enzyme activity of AP19-3 50%, indicating that the cytochrome c oxidase of OK1-50 was more resistant to HSO3- than that of AP19-3. Cytochrome c oxidases purified from both strains were composed of three subunits. However, the molecular weight of the largest subunit differed between OK1-50 and AP19-3. Apparent molecular weights of the three subunits of cytochrome c oxidases were 53,000, 24,000, and 19,000 for strain AP19-3 and 55,000, 24,000, and 19,000 for strain OK1-50, respectively.     

Decrease in glomerular filtration rate in Japanese patients with type 2 diabetes is linked to atherosclerosis

OBJECTIVE: We assessed the effects of atherosclerosis on the glomerular filtration rate (GFR) in patients with type 2 diabetes and who had micro- or normoalbuminuria. RESEARCH DESIGN AND METHODS: A total of 61 Japanese patients with type 2 diabetes were recruited from inpatients of Osaka City University Hospital. They ranged in age from 40 to 69 years (28 men and 33 women). Each subject collected a 24-h urine sample for quantitative analysis of albumin. Absence of albuminuria was defined as a urinary albumin excretion level of <30 mg/24 h (n = 36) and microalbuminuria as a level of 30-300 mg/24 h. The GFR was estimated using 99mTc diethylenetriamine pentaacetic renogram method. As indexes of atherosclerosis, we measured the intimal-medial thickness (IMT) and distensibility of the carotid artery using high-resolution B-mode ultrasonagraphy and an echo-tracking system. We measured the resistance index (RI) of the renal interlobar arteries by pulsed Doppler sonography. RESULTS: The clinical characteristics of type 2 diabetic patients with and without microalbuminuria did not differ except for duration of diabetes, which was longer in the patients with microalbuminuria. GFR also did not differ between the patients with and without microalbuminuria. GFR was significantly correlated with the patient's age (r = -0.256, P < 0.05), carotid IMT (r = -0.326, P < 0.05), carotid stiffness beta (r = -0.449, P < 0.001), and renal arterial RI (r = -0.365, P < 0.05). In multiple regression analysis, independent factors associated with GFR were carotid IMT (R2 = 0.108, P = 0.0102), carotid stiffness beta (R2 = 0.208, P = 0.0003), and renal artery RI (R2 = 0.130, P = 0.0043). CONCLUSIONS: The decline in GFR in type 2 diabetic patients in the early stages of nephropathy may be due in part to atherosclerosis.