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1.
G Ital Nefrol ; 30(2)2013.
Article in Italian | MEDLINE | ID: mdl-23832463

ABSTRACT

BACKGROUND: Anaemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies, higher haemoglobin (Hb) levels (around 11-13 g/dL) are associated with improved survival and quality of life compared to Hb levels around 9-10 g/dL. Randomized studies found that targeting higher Hb levels with ESA causes an increased risk of death, mainly due to adverse cardiovascular outcomes. It is possible that this is mediated by ESA dose rather than haemoglobin concentration, although this hypothesis has never been formally tested. METHODS: We present the protocol of the Clinical Evaluation of the Dose of Erythropoietins (C.E. DOSE) trial, which will assess the benefits and harms of a high versus a low ESA dose therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD). This is a randomized, prospective open label blinded end-point (PROBE) design trial due to enroll 900 haemodialysis patients. Patients will be randomized 1:1 to 4000 UI/week i. v. versus 18000 UI/week i. v. of epoetin alfa, beta or any other epoetin in equivalent doses. The primary outcome of the trial is a composite of cardiovascular events. In addition, quality of life and costs of these two strategies will be assessed. The study has been approved and funded by the Italian Agency of Drugs (Agenzia Italiana del Farmaco (AIFA)) within the 2006 funding plan for independent research on drugs (registered at www.clinicaltrials.gov (NCT00827021)).


Subject(s)
Anemia/drug therapy , Hematinics/administration & dosage , Renal Dialysis , Anemia/economics , Anemia/etiology , Diabetic Nephropathies/complications , Disease Management , Dose-Response Relationship, Drug , Double-Blind Method , Female , Hematinics/adverse effects , Hematinics/economics , Hematinics/pharmacology , Hematinics/therapeutic use , Hemoglobins/analysis , Humans , Kidney Failure, Chronic/blood , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Meta-Analysis as Topic , Middle Aged , Observational Studies as Topic , Outcome Assessment, Health Care , Quality of Life , Renal Dialysis/adverse effects , Renal Dialysis/economics , Research Design , Risk
2.
G Ital Cardiol ; 14(7): 505-7, 1984 Jul.
Article in Italian | MEDLINE | ID: mdl-6489661

ABSTRACT

We have studied the sexual dysfunction in 115 couples under 60 years a member of whom had overcome a myocardial infarction (M.I.) not less than 6 months and no more than 2 years. We used two distinct questionnaires filled in anonymously one by the patients, the other by their partners. 70 (60,8%) patients have sexual dysfunction in post infarction as: partner's lack of co-operation 34 (48,6%), premature ejaculation 12 (17,1%), erectile failure 7 (10%), frigidity 6 (8,6%), sexual dissatisfaction 4 (5,7%), retarded ejaculation 2 (2,9%), various disorders 5 (7,1%), 58 (50,4%) partners have sexual dysfunction as: frigidity 22 (37,9%), sexual dissatisfaction 19 (32,8%), partners lack of co-operation 7 (12,1%), erectile failure 3 (5,2%), retarded ejaculation 2 (3,5%), various disorders 5 (8,6%). An important factor in sexual dysfunction is the partner's fear concerning the coitus which could provoke another heart attack due to stress and consequently the consort's death. We emphasize the importance acquired by the physician's tasks in favouring a complete psychophysical recovery in patients with previous M.I. whenever there are no rehabilitation institutes.


Subject(s)
Myocardial Infarction/psychology , Sexual Behavior , Adult , Fear , Female , Humans , Male , Middle Aged , Myocardial Infarction/complications , Sexual Dysfunction, Physiological/etiology
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