Improved Self-Esteem in Artists After Participating in the "Building Confidence and Self-Esteem Toolbox Workshop".

Performing and creative artists have unique occupational and lifestyle stresses and challenges that can negatively affect self-esteem. Low self-esteem not only has serious implications for their psychological and physical health, it can also affect their performance, and creativity. There is a need to establish effective interventions to deal with this issue. To the best of our knowledge, there are no reported studies specific to workshops or interventions on enhancing self-esteem for artists. The Al and Malka Green Artists' Health Centre at the Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada, is a unique multidisciplinary, and integrative clinic serving the special needs of the artist population. We developed a workshop entitled "Building Confidence and Self Esteem Toolbox Workshop" to address this need. We then designed a single-blind, randomized, prospective, pilot study to evaluate the effectiveness of the workshop on enhancing self-esteem in artists, and to evaluate the long-term effectiveness of using the recommended tools in maintaining a healthy self-esteem, as well as maintaining physical and emotional health. Both quantitative and qualitative data were collected. A validated "Self-Esteem Checkup" questionnaire was administered pre- and immediately post workshop, as well as at 2, 6, and 12 months post workshop. Open-ended questions were posed to study participants via email at 2 and 12 months following the workshop, and at 6 months in in-person interviews. Thirty-five professional artists consented to participate in the study, with 26 completing all study visits. Mean scores for all time points, and the individual questionnaire statement mean scores for the five timepoints increased significantly post-workshop and remained statistically significantly improved by the 3rd follow-up 12 months later (p < 0.001). The mean self-esteem rating score increased significantly post-workshop and remained statistically significantly improved by the 3rd follow-up 12 months later (p < 0.01). Qualitative data showed positive feedback on the utilization of the tools learned in the workshop that helped maintain this improvement over a 1-year period. This workshop may be an effective means of addressing the issue of self-esteem in artists. Further controlled studies of larger sample size and longer duration are needed to confirm these findings.

Tolerability outcomes of a multicenter, observational, open-label, drug-surveillance study in patients with type 2 diabetes mellitus treated with pioglitazone for 2 years.

OBJECTIVE: Pioglitazone (PIO), a thiazolidinedione (TZD), is reported to be highly effective in the treatment of type 2 diabetes mellitus, but is associated with edema, heart failure, and weight gain. This study documented long-term tolerability outcomes of patients taking pioglitazone and assessed how troublesome these adverse events were for the patients. METHODS: This was a prospective, multicenter, observational, open-label, drug-surveillance study that followed patients for 2 years. Patients were already taking or received prescriptions for PIO (PIO group) or a non-TZD (comparator group). Data on glycosylated hemoglobin, fasting plasma glucose, and physician-assessed hypoglycemia were gathered every 4 to 6 months. Patients answered a questionnaire about edema, shortness of breath, and weight gain and were asked to self-assess how troublesome these events were. Peripheral edema and weight gain were selected for post hoc analysis. The Edema Severity scale (ranging from no edema to very deep edema causing gross distortion to amputation) was used to evaluate peripheral edema. Physicians determined the relationship between treatment and serious adverse events. RESULTS: Investigators at 176 sites across Canada enrolled 1871 patients (53 patients in the comparator group were later excluded for receiving PIO). Data from 1527 PIO patients and 291 comparator patients were analyzed (mean age: 59.5 years PIO, 61.6 years comparator; males: 58.0% PIO, 59.8% comparator; white: 77.9% PIO, 81.4% comparator; mean weight: 87.2 kg PIO, 86.1 kg comparator). Median dose of PIO was 30 mg/d. Edema and weight gain were the only adverse events for which statistical models were fitted. Results at 2 years were as follows: peripheral edema-p25.1% (383/1527) of patients in the PIO group, 16.5% (48/291) in the comparator group (adjusted odds ratio [OR]: 1.92 [95% CI, 1.32-2.79]); pulmonary edema-1.3% (20/1527) PIO, 0.7% (2/291) comparator; heart failure-2.4% (37/1527) PIO, 1.4% (4/291) comparator; weight gain-49.6% (757/1527) PIO, 36.8% (107/291) comparator; mean weight gain-2.19 kg PIO (n = 1344), 0.34 kg comparator (n = 251) (adjusted OR: 1.70 [95% CI, 1.29-2.22]). Patient self-assessment at 2 years revealed: edema-rated very or extremely troublesome by 11.2% (29/258) PIO, 13.8% (5/36) comparator; shortness of breath on exertion-15.1% (174/1153) PIO, 16.2% (32/198) comparator (rated very or extremely troublesome by 8.6% [15/174] PIO, 21.9% [7/32] comparator); shortness of breath lying down and at night occurred less frequently (1.8%-4.5% in both groups) than shortness of breath on exertion; and weight gain-rated very or extremely troublesome by 4.8% (22/455) PIO, 2.9% (2/70) comparator. Deaths occurred in approximately 2% of patients in each group (37/1527 PIO, 6/344 comparator); none of the deaths in the PIO group were judged by the investigators to be related to the study drug. CONCLUSIONS: After 2 years of treatment, the incidences of heart failure (2.4%) and pulmonary edema (1.3%) in the patients who received PIO in this observational study were low and consistent with published literature. In this study, patients in the PIO group experienced more peripheral edema (adjusted OR, 1.92) and greater weight gain (adjusted OR, 1.70) than did patients in the non-TZD (comparator) group. The subjective assessment of the troublesome nature of these adverse events on these patients taking PIO was low.

Metabolic effects of pioglitazone in combination with insulin in patients with type 2 diabetes mellitus whose disease is not adequately controlled with insulin therapy: results of a six-month, randomized, double-blind, prospective, multicenter, parallel-group study.

BACKGROUND: Type 2 diabetes mellitus (DM) is a progressive disease. Initial therapy begins with dietary and lifestyle modifications. However, as the disease progresses, glycemic control becomes more difficult to attain, often requiring > or =1 oral antihyperglycemic medication (OAM), and finally the addition of insulin to the OAMs and insulin monotherapy. OBJECTIVE: This study was designed to determine the effect of pioglitazone 30 mg plus insulin (PIO + INS) versus placebo plus insulin (PLB + INS) on glycemic control, the serum lipid profile, and selected cardiovascular risk factors in patients with type 2 DM whose disease was inadequately controlled with insulin therapy alone despite efforts to intensify such treatment. METHODS: This was a 6-month, randomized, double-blind, prospective, multicenter, placebo-controlled, parallel-group study. Patients with type 2 DM and a glycosylated hemoglobin (HbA(1c)) value > or =7.5% who were using insulin (with or without OAMs) entered a 3-month insulin intensification phase to achieve blood glucose targets with insulin monotherapy. After insulin intensification, those patients with HbA(1c) values > or =7.0% were randomized to PIO + INS or PLB + INS. The primary end point was the change in HbA(1c) from baseline. Cardiovascular risk markers (highly sensitive C-reactive protein [hs CRP] and plasminogen activator inhibitor-1 [PAI-1]) were measured at baseline and end point. RESULTS: Of the 289 patients randomized to treatment (mean [SD] age, 58.9 [7.1] years; 164 women, 125 men), 142 received PIO + INS and 147 received PLB + INS. A total of 263 patients completed the study. After 6 months, PIO + INS reduced mean HbA(1c) (-0.69%; P < 0.002) and mean fasting plasma glucose ([FPG] -1.45 mmol/L; P < 0.002) from baseline. PLB + INS produced no significant changes in HbA(1c) or FPG. The between-treatment differences for HbA(1c) (-0.55%; P < 0.002) and FPG (-1.80 mmol/L; P < 0.002) occurred despite a reduction of insulin dose in the PIO + INS group from baseline (-0.16 U/d . kg; P < 0.002). Significant between-group differences were observed for high-density lipoprotein cholesterol (0.13 mM; P < 0.002), triglycerides (ratio of geometric mean [PIO/PLB], 0.871; P < 0.01), atherogenic index of plasma (-0.11; P < 0.002), PAI-1 (-5.10 U/mL; P < 0.001), and hs CRP (-1.47 mg/L; P < 0.05). The rate of clinical and biochemical hypoglycemia (blood glucose <2.8 mmol/L) did not differ statistically between treatment groups, but reported incidences of subjective hypoglycemia occurred more often with PIO + INS than with PLB + INS (90 vs 75; P < 0.05). Edema was more common with PIO + INS than with PLB + INS (20 vs 5 instances, respectively), as was gain (mean [SEM]) in body weight (4.05 [4.03] vs 0.20 [2.92] kg, respectively). CONCLUSION: Adding pioglitazone to insulin in these study patients with type 2 DM whose disease was inadequately controlled with insulin monotherapy further improved their glycemic control.

Economic benefits of pioglitazone for treating patients with Type 2 diabetes.

Diabetes remains a significant economic burden to national healthcare systems. The traditional oral agents used to treat Type 2 diabetes do not address the underlying insulin resistance responsible for the development of diabetes. Newer medications, such as the thiazolidinediones, have been shown to reverse some of the metabolic processes believed to be responsible for the development of insulin resistance and ultimately, Type 2 diabetes. A comprehensive economic evaluation of pioglitazone using a modelling approach indicates that pioglitazone is a cost-effective therapy for patients with Type 2 diabetes when used in combination with either a sulfonylurea or metformin. This drug profile analyzes the clinical data on the use of piogltiazone for the treatment of Type 2 diabetes and the various economic evaluations of pioglitazone in the literature.

A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus.

OBJECTIVE: The goal of this study was to compare the effects of 2 doses of pioglitazone hydrochloride (a thiazolidinedione insulin sensitizer) with placebo on glycated hemoglobin (HbA(1c)), insulin sensitivity, and lipid profiles in patients with type 2 diabetes mellitus who had suboptimal glycemic control and mild dyslipidemia. METHODS: Patients with type 2 diabetes mellitus (HbA(1c) >/=6.5% and /=7% to <8%) or high (>/=8% to

New solutions for type 2 diabetes mellitus: the role of pioglitazone.

Type 2 diabetes mellitus remains a significant burden to the Canadian healthcare system. Over 2 million Canadians have diabetes, with 85 to 90% having type 2 diabetes. Insulin resistance is a major pathophysiological mechanism in the development of type 2 diabetes. Insulin resistance can be defined as an impaired biological response to the metabolic and/or mitogenic effects of either exogenous or endogenous insulin. As a consequence of insulin resistance, type 2 diabetes is characterised by decreased glucose transport and utilisation at the level of muscle and adipose tissue and increased glucose production by the liver. The traditional oral agents used to treat type 2 diabetes clearly do not address the underlying insulin resistance responsible for the development of diabetes. Thiazolidinediones (TZDs) represent a relatively new class of oral hypoglycaemic medications that have been shown to reverse some of the metabolic processes believed responsible for the development of insulin resistance and, ultimately, type 2 diabetes. Research has demonstrated that TZDs activate peroxisome proliferator activator receptors, in particular, the gamma-receptor isoform. Pioglitazone is a TZD that reduces plasma glucose levels by increasing peripheral glucose utilisation and decreasing hepatic glucose production. Clinical studies with pioglitazone have demonstrated the following: absolute reductions in glycosylated haemoglobin of 0.8 to 2.6%; reductions in fasting plasma glucose of 1.7 to 4.4 mmol/L; an increase in high density lipoprotein cholesterol of 8.7 to 12.6%; and a decrease in triglycerides of 18.2 to 26.0%, with no significant effects on low density lipoprotein or total cholesterol.