Functional impairment of systemic scleroderma patients with digital ulcerations: results from the DUO Registry

OBJECTIVES: Digital ulcers (DUs) are frequent manifestations of systemic scleroderma (SSc). This study assessed functional limitations due to DUs among patients enrolled in the Digital Ulcer Outcome (DUO) Registry, an international, multicentre, observational registry of SSc patients with DU disease. METHODS: Patients completed at enrolment a DU-specific functional assessment questionnaire with a 1-month recall period, measuring impairment in work and daily activities, and hours of help needed from others. Physician-reported clinical parameters were used to describe the population. For patients who completed at least part of the questionnaire, descriptive analyses were performed for overall results, and stratified by number of DUs at enrolment. RESULTS: This study included 2327 patients who completed at least part of the questionnaire. For patients with 0, 1–2, and ≥3 DUs at enrolment, mean overall work impairment during the prior month among employed/self-employed patients was 28%, 42%, and 48%, respectively. Across all included patients, ability to perform daily activities was impaired on average by 35%, 54%, and 63%, respectively. Patients required a mean of 2.0, 8.7, and 8.8 hours of paid help and 17.0, 35.9, and 63.7 hours of unpaid help, respectively, due to DUs in the prior month. Patients with DUs had more complications and medication use than patients with no DUs. CONCLUSIONS: With increasing number of DUs, SSc patients reported more impairment in work and daily activities and required more support from others

Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry

OBJECTIVES: The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). METHODS: The DUO Registry is a European, prospective, multicentre, observational, registry of SSc patients with ongoing digital ulcer disease, irrespective of treatment regimen. Data collected included demographics, SSc duration, SSc subset, internal organ manifestations, autoantibodies, previous and ongoing interventions and complications related to digital ulcers. RESULTS: Up to 19 November 2010 a total of 2439 patients had enrolled into the registry. Most were classified as either limited cutaneous SSc (lcSSc; 52.2%) or diffuse cutaneous SSc (dcSSc; 36.9%). Digital ulcers developed earlier in patients with dcSSc compared with lcSSc. Almost all patients (95.7%) tested positive for antinuclear antibodies, 45.2% for anti-scleroderma-70 and 43.6% for anticentromere antibodies (ACA). The first digital ulcer in the anti-scleroderma-70-positive patient cohort occurred approximately 5 years earlier than the ACA-positive patient group. CONCLUSIONS: This study provides data from a large cohort of SSc patients with a history of digital ulcers. The early occurrence and high frequency of digital ulcer complications are especially seen in patients with dcSSc and/or anti-scleroderma-70 antibodies

Retrospective Analysis of Therapeutic Drug Monitoring Data for Treatment of Bipolar Disorder with Lamotrigine

Introduction: Lamotrigine is licensed for treatment of epilepsy and prevention or at least delay of depressive episodes in bipolar disorder. The accepted therapeutic reference range (TRR) of lamotrigine for anticonvulsant treatment is 3000-14000ng/ml. This TRR is often used for the therapy of bipolar disorders as well. This work presents serious doubts about this approach. Methods: KONBEST, a large TDM database containing patients' characteristics including diagnoses, doses, comedication and serum concentrations, was analyzed. Out of a total of 3459 lamotrigine samples, 360 patients suffered from bipolar disorder. 82 of them benefitted from therapy with lamotrigine as judged by the clinical global impression of improvement (CGI-I) scale. Patients with a score of minimally (3), much (2) or very much improved (1) were considered as responders. Results: The recommended lamotrigine maintenance dose for bipolar disorder is 200mg/day; the doses prescribed in our samples ranged from 25 to 450mg/day. Only 32 concentrations (39.0%) fitted into the TRR recommended for therapy of epilepsy; 50 (61.0%) did not reach it, none exceeded it. The lowest concentration was 177ng/ml, the highest 11871ng/ml. A mean lamotrigine serum concentration of 33412563ng/ml ((X) over bar +/- SD) was detected in the patients who benefitted. Discussion: The authors conclude that in bipolar disorder lower lamotrigine serum concentrations lead to therapeutic benefit

Alleskönner Vitamin D?

Many indications are discussed for vitamin D substitution, such as osteoporosis, autoimmune diseases, cancer and psychiatric diseases. Also discussed is the fact that the majority of the German population suffer from a vitamin D deficiency. Review of the study results for these individual diseases and a critical analysis of the currently established therapeutic reference range, which defines a vitamin D deficiency. A literature search was carried out in the statements of the German Society for Nutrition, in scientific publications and journals. The study results on prevention and therapy of various diseases with vitamin D show inconsistent results. Well-established indications are the prevention of rickets in babies and the supportive therapy for osteoporosis. The currently established reference range for the definition of a vitamin D deficiency came from studies where vitamin D deficiency was correlated to an increase in parathyroid hormone. Different laboratories use different methods for measurement of vitamin D levels. More studies are needed to clarify the role of vitamin D in the prevention and treatment of various diseases. Another problem is that different laboratories do not use the same measurement methods to determine vitamin D and the use of different methods leads to widely varying results which cannot be compared. Therefore, a standardization of the methods would be desirable