OBJECTIVETo evaluate the efficacy and safety of empagliflozin versus placebo as add-on therapy in patients with type 2 diabetes and inadequate glycemic control with linagliptin and metformin. RESEARCH DESIGN AND METHODSPatients with HbA 1c ‡8.0% and £10.5% ( ‡64 and £91 mmol/mol) while receiving stable-dose metformin received open-label linagliptin 5 mg (n = 606) for 16 weeks. Subsequently, those with HbA 1c ‡7.0 and £10.5% ( ‡53 and £91 mmol/mol) were randomized to receive double-blind, double-dummy treatment with empagliflozin 10 mg (n = 112), empagliflozin 25 mg (n = 111), or placebo (n = 110) for 24 weeks; all patients continued treatment with metformin and linagliptin 5 mg. The primary end point was the change from baseline in HbA 1c after 24 weeks of double-blind treatment. RESULTSAt week 24, empagliflozin significantly reduced HbA 1c (mean baseline 7.96-7.97% [63-64 mmol/mol]) versus placebo; the adjusted mean differences in the change from baseline with empagliflozin 10 and 25 mg versus placebo were 20.79% (95% CI -1.02, -0.55) (28.63 mmol/mol [-11.20, -6.07 mmol/mol]) and 20.70% (95% CI -0.93, -0.46) (27.61 mmol/mol [-10.18, -5.05 mmol/mol]), respectively (both P < 0.001). Fasting plasma glucose and weight were significantly reduced in both empagliflozin groups versus placebo (P < 0.001 for all comparisons). More patients receiving placebo than empagliflozin 10 and 25 mg reported adverse events during double-blind treatment (68.2%, 55.4%, and 51.8%, respectively). CONCLUSIONSEmpagliflozin treatment for 24 weeks improved glycemic control and weight versus placebo as an add-on to linagliptin 5 mg and metformin and was well tolerated.

Background An aging population with a growing burden of chronic complex illnesses will seriously challenge the public health care system. Consequently, novel and efficacious treatment approaches are highly warranted. Based on our experiences with concentrated treatment formats for other health challenges, we developed a highly concentrated interdisciplinary group rehabilitation approach for chronic illnesses. Objective We aim to explore the acceptability of the intervention and describe potential changes in functional impairment at follow-up. Methods The cornerstones of the intervention are as follows: (1) prepare the patient for change prior to treatment, (2) focus on health promoting microchoices instead of symptoms, and (3) expect the patient to integrate the changes in everyday living with limited hands-on follow-up. The intervention will be delivered to patients with highly diverse primary symptoms, namely patients with low back pain, post–COVID-19 symptoms, anxiety and depression, and type 2 diabetes. Results Recruitment started between August 2020 and January 2021 (according to the illness category). For initial 3-month results, recruitment is expected to be completed by the end of 2021. Conclusions If successful, this study may have a substantial impact on the treatment of low back pain, post–COVID-19 symptoms, anxiety and depression, and type 2 diabetes, which together constitute a major socioeconomic cost. Further, the study may widen the evidence base for the use of the concentrated treatment format in a diverse group of medical conditions. International Registered Report Identifier (IRRID) DERR1-10.2196/32216

Background A number of treatment approaches have shown efficacy for depression and/or anxiety, yet there is a paucity of research on potentially cost-effective concentrated approaches. Based on our previous experience with concentrated treatment in disorders such as Obsessive–Compulsive Disorder and chronic fatigue, we proposed that this novel approach could be useful for other conditions, including depression and/or anxiety. As a pre-requisite for a future randomized controlled trial, the aim of this study was to investigate the acceptability, satisfaction and effectiveness of a transdiagnostic, interdisciplinary group treatment delivered during 5 consecutive days to groups of 6–10 patients with depression and/or anxiety. Methods This was a non-randomized clinical intervention pilot study in line with a published protocol. Forty-two consecutively referred patients, aged 19–47 (mean age 31.7, SD = 8.12) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age when the symptoms became a problem was 20.9 years. Mean number of prior treatment courses was 2.77 (SD = 2.19; range 0–8). Acceptability was defined as the proportion of eligible patients who accepted and completed the treatment. Satisfaction was evaluated by Client Satisfaction Questionnaire-8. Secondary objectives were to assess the treatment effectiveness by questionnaires at pre-treatment, seven days post-treatment and three months follow-up. Results The treatment was highly acceptable (91.3% accepted, all completed), and patients were highly satisfied with the treatment, including the amount. Functional impairment, as measured by Work and Social Adjustment Scale (WSAS) improved significantly (p < .0005) from “severe” (mean 25.4 SD = 6.59) to “less severe” (mean 13.37, SD = 9.43) at 3 months follow-up. Using the Generalized Anxiety Disorder Scale (GAD-7) and the Patient Health Questionnaire (PHQ-9), the effect sizes at 3 months follow-up were 1.21 for anxiety and 1.3 for depression. More than 80% reported reduced utilization of mental health care, and 67% had not used, or had used the family doctor less, for anxiety or depression. 52% had not used, or had reduced, medication for their disorder. Conclusions  The concentrated, interdisciplinary treatment approach yielded promising results. Long-term follow up is warranted. Trial registration This study is registered in Clinical Trials, identifier NCT05234281 and approval date 09/02/2022.

At least 65 million people suffer from long COVID. Treatment guidelines are unclear, especially pertaining to recommendations of increased activity. This longitudinal study evaluated safety, changes in functional level and sick leave following a concentrated rehabilitation program for patients with long COVID. Seventy-eight patients (19–67 years) participated in a 3-day micro-choice based rehabilitation program with 7-day and 3-month follow-up. Fatigue, functional levels, sick leave, dyspnea and exercise capacity were assessed. No adverse events were reported and 97.4% completed the rehabilitation. Fatigue measured with Chalder Fatigue Questionnaire decreased at 7-days [mean difference (MD = − 4.5, 95% CI − 5.5 to − 3.4) and 3-month (MD = − 5.5, 95% CI − 6.7 to − 4.3). Sick leave rates and dyspnea were reduced (p < 0.001) and exercise capacity and functional level increased (p < 0.001) at 3-month follow-up regardless of severity of fatigue at baseline. Micro-choice based concentrated rehabilitation for patients with long COVID was safe, highly acceptable and showed rapid improvements in fatigue and functional levels, sustaining over time. Even though this is a quasi-experimental study, the findings are of importance addressing the tremendous challenges of disability due to long COVID. Our results are also highly relevant for patients, as they provide the base for an optimistic outlook and evidence supported reason for hope.