A cost-effectiveness analysis of sensor-augmented insulin pump therapy and automated insulin suspension versus standard pump therapy for hypoglycemic unaware patients with type 1 diabetes.

OBJECTIVE: To assess the cost-effectiveness of sensor-augmented insulin pump therapy with "Low Glucose Suspend" (LGS) functionality versus standard pump therapy with self-monitoring of blood glucose in patients with type 1 diabetes who have impaired awareness of hypoglycemia. METHODS: A clinical trial-based economic evaluation was performed in which the net costs and effectiveness of the two treatment modalities were calculated and expressed as an incremental cost-effectiveness ratio (ICER). The clinical outcome of interest for the evaluation was the rate of severe hypoglycemia in each arm of the LGS study. Quality-of-life utility scores were calculated using the three-level EuroQol five-dimensional questionnaire. Resource use costs were estimated using public sources. RESULTS: After 6 months, the use of sensor-augmented insulin pump therapy with LGS significantly reduced the incidence of severe hypoglycemia compared with standard pump therapy (incident rate difference 1.85 [0.17-3.53]; P = 0.037). Based on a primary randomized study, the ICER per severe hypoglycemic event avoided was $18,257 for all patients and $14,944 for those aged 12 years and older. Including all major medical resource costs (e.g., hospital admissions), the ICERs were $17,602 and $14,289, respectively. Over the 6-month period, the cost per quality-adjusted life-year gained was $40,803 for patients aged 12 years and older. CONCLUSIONS: Based on the Australian experience evaluating new interventions across a broad range of therapeutic areas, sensor-augmented insulin pump therapy with LGS may be considered a cost-effective alternative to standard pump therapy with self-monitoring of blood glucose in hypoglycemia unaware patients with type 1 diabetes.

Effectiveness of antidepressants in the treatment of major depressive disorder in Latin America.

Objective. Painful physical symptoms occur frequently in patients with major depressive disorder (MDD), and although numerous studies report the effect of antidepressants on emotional aspects of depression, few focus on their effect on physical symptoms. This observational study was conducted, in a clinical practice setting, to determine antidepressant treatment decisions and their outcome on the physical and emotional symptoms of MDD. Methods. Patients with a mean score ≥2 for pain-related items on the Somatic Symptom Inventory (SSI) were classified with painful physical symptoms (PPS +) and differentiated from the remaining patients (PPS -). Severity of depression and physical pain were determined using the 17-item Hamilton Depression Rating Scale (HAMD17) and Clinical Global Impressions of Severity Scale (CGI-S), and Visual Analog Scale (VAS), respectively. Results. At baseline, 72.6% of patients were PPS+. Compared to PPS- patients, PPS +patients were, on average, significantly more depressed at baseline (mean difference [95% CI]: HAMD17 4.6 [3.6, 5.5] and CGI-S 0.3 [0.2, 0.4]; all p<0.0001), and remained more depressed and in greater pain at endpoint (HAMD17p=0.0074, CGI-S P =0.0151, and VAS P <0.0001). In addition, fewer PPS+ patients (65.8%) achieved remission (total HAMD17≤7) compared to PPS- patients (74.6%, P =0.0180). Conclusions. Painful physical symptoms are prevalent in MDD patients, highlighting the importance of addressing both the physical and emotional symptoms of depression.

Major depressive disorder in Latin America: the relationship between depression severity, painful somatic symptoms, and quality of life.

BACKGROUND: We report on two multi-center, prospective, observational studies (H6U-BC-LRAG and H6U-BL-LRAH) to determine the clinical profile of Latin American outpatients with major depressive disorder (MDD) and the relationship between depression severity, painful somatic symptoms, and quality of life. METHOD: Patients (n = 989) with MDD were classified according to the presence (SS+) or absence (SS-) of painful somatic symptoms using the Somatic Symptom Inventory (SSI). Visual Analogue Scale (VAS) quantified pain severity, HAMD17 and CGI-S determined depression severity, while the Quality of Life in Depression Scale (QLDS) quantified subjective well-being. RESULTS: At baseline, patients had an average CGI score of 4.5 (+/- 0.8) and HAMD17 score of 24.9 (+/- 7.2). Of the patients studied, 72.6% reported painful somatic symptoms (95% CI: 69.8, 75.4), with women 2.7 times more likely to be SS+ than men (p < 0.0001). Adjusted mean HAMD17 (26.79) and CGI-S (4.53) scores for SS+ patients were significantly (p < 0.0001) higher than for SS- patients (HAMD(17): 22.87; CGI-S: 4.28). SS+ patients had greater severity of pain across all VAS measures (p < 0.0001). The presence of somatic symptoms had a significantly deleterious effect on quality of life (p < 0.0001). CONCLUSION: Greater severity of painful somatic symptoms was associated with increased depression severity and reduced quality of life. We concluded that both emotional and physical manifestations of MDD must be addressed for successful treatment.