BackgroundThe independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre‐DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐DM on survival outcomes in the GISSI‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial.Methods and ResultsWe assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI‐HF trial, who were stratified by presence of DM (n=2852), pre‐DM (n=2013), and non‐DM (n=2070) at baseline. Compared with non‐DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐DM patients and those with pre‐DM. Cox regression analysis showed that DM, but not pre‐DM, was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01–1.29, respectively).ConclusionsPresence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336.
BackgroundEffective treatments have been introduced for inflammatory arthritides (IAs) in the last decades. However, adherence remains suboptimal.ObjectivesThe aim of the study was to assess treatment adherence among patients with IAs treated with bDMARDs in a community hospital with the Italian 5-item Compliance Questionnaire for Rheumatology (I-CQR5) [1] and the hospital administrative claims database.MethodsWe conducted a monocentric, cross-sectional, observational study in IA patients (disease duration >1 year, undergoing treatment with self-administered bDMARDs, capable to complete the questionnaire unaided) recruited in a community hospital from February to October 2018. Treatment adherence was defined according to I-CQR5 and to the Medication Possession Ratio (MPR) obtained from the claims database. To investigate variables associated with adherence, demographic, social, and clinical characteristics were considered. I-CQR5 has 5 questions, with Likert-answering scale ranging from 1 to 4, an algorithm allows to classify the patient as poorly or highly adherent (i.e. likely to take >=80% of their medications correctly) [1]. MPR was obtained by dividing the number of dosage units withdrawn by patients by the prescribed number of dosage units. Agreement between the I-CQR5 and MPR definition of high adherence definitions was tested with McNemars test, while the association with patients characteristics with chi-square or Fishers exact test.ResultsA total 174 patients completed the I-CQR5 (median age 60 years, range 51-67; 37% males), affected by ankylosing spondylitis (16%), rheumatoid arthritis (RA) (62%), psoriatic arthritis (22%) with a median duration of 15 years (range 10-20). Etanercept (49%), adalimumab (20%), abatacept (8%) and tocilizumab (7.5%) were the most prescribed first-line biologics. Association with a conventional synthetic DMARDs was prescribed to 3.4% of subjects. High adherence rate, assessed with I-CQR5, was 83% overall, and 85% in RA patients. Significant differences were observed between highly and poorly adherent patients according to I-CQR5: lower educational status (lower primary or secondary school, and the use of cDMARDs were associated with poor adherence (both with p<0.001); while the use of bDMARDs was negatively associated with high adherence (p<0.05). High adherence rate measured with MPR was 72%. The agreement between high adherence, measured with I-CQR5 and MPR, was low p=0.005).ConclusionThe study showed that IA patients treated with bDMARDs with a higher educational level are more adherent to physician prescription, as assessed by I-CQR5. I-CQR5 might overestimate adherence compared to MPR. In our study, the high adherence rate measured with I-CQR5 was higher compared with a report from a large outpatient clinic in the same area, which was limited to RA patients (85% vs 40,1%) [1] Our study may suggest that adherence benefits more from a close and stable relationship with the health care practitioner, such as in our centre, which is smaller than large outpatients clinics in ...
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