Safety and efficacy of switching from low molecular weight heparin to dabigatran in patients undergoing elective total hip or knee replacement surgery.

BACKGROUND: The aim of this study was to assess the safety and efficacy of switching therapy from low molecular weight heparin (LMWH; enoxaparin) to dabigatran for prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip or knee replacement surgery (THR/TKR). METHODS: This was a prospective, multicenter, open-label, single-arm, observational, study in patients undergoing THR or TKR who were to receive enoxaparin 40 mg for thromboprophylaxis. Enoxaparin was initiated before or after surgery according to local practice, and was switched to dabigatran 220 mg once daily at a time point chosen by the investigator. The coprimary endpoints were major bleeding events, and the composite of symptomatic VTE and all-cause mortality, from last use of enoxaparin to 24 h after last intake of dabigatran. RESULTS: Altogether, 168 (81 THR, 87 TKR) patients were enrolled, of whom 161 received both enoxaparin and dabigatran, 2 received dabigatran only and 5 received enoxaparin only. The median time of the first dabigatran tablet was 24.0 h after the last LMWH dosage and the median number of days on dabigatran treatment was 36 days. No symptomatic VTE or death occurred during the study. One major bleeding event was seen at the surgical site and required treatment cessation. Three minor bleeding events were observed. CONCLUSIONS: In the normal clinical setting, switching from LMWH to dabigatran in patients who had undergone THR and TKR was safe and effective in preventing VTE. The reported adverse events and serious adverse events were consistent with the known safety profile for dabigatran. Switching from a subcutaneous to an oral anticoagulant may offer greater convenience in the outpatient setting after discharge. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01153698.

Gender-related differences in symptoms of patients with suspected breathing disorders in sleep: a clinical population study using the sleep disorders questionnaire.

BACKGROUND: Gender-related differences in the symptom profile of patients with suspected sleep disordered breathing (SDB) may be one explanation of the clinical underrecognition of SDB in women. STUDY OBJECTIVES: The aim of this study was to prospectively assess gender-related differences in presenting symptoms in a clinical sample of patients with suspected sleep disordered breathing. DESIGN: Administration of the Sleep Disorders Questionnaire prior to clinical and polysomnographic evaluation. Responses obtained from the questionnaire were used to construct 4 independent symptom scales: sleep apnea (SA), periodic limb movement syndrome (PLM), psychiatric sleep disorder (PSY), and narcolepsy (NAR). Analyses of variance were used to examine the effect of gender, AHI, and age on the symptom scales. Associations between gender and each diagnostic scale of the questionnaire were determined by multiple analyses of covariance. SETTING: Tertiary pulmonary referral center. PARTICIPANTS: 2739 men and 782 women with suspected SDB. All patients who were referred to the sleep laboratory underwent full-night polysomnography, irrespective of the likelihood of SDB. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Overall, men scored significantly higher on items related to worsening of snoring/breathing with alcohol (P < 0.001) and smoking history (P < 0.01) than women. Complaints such as witnessed apneas (P < 0.001) and worsening of snoring in supine position (P < 0.05), however, were more frequently reported by men with an apnea-hypopnea index (AHI) < 5/hr, compared with AHI-matched women. There were no significant differences in these items in patients with an AHI > 15/hr. In contrast, women complained significantly more often of insomnia, restless legs, depression, nightmares, palpitations at night, and hallucinations than men. As a result, women had significantly higher scores on the PLM, PSY, and NAR scales of the Sleep Disorders Questionnaire (P < 0.001, for all). After adjustments for age, body mass index, AHI, arousal index, oxygen saturation data, and smoking history, by means of multiple analyses of covariances, gender differences remained significant (P < 0.001, for all scales). CONCLUSIONS: We observed significant gender-related differences in presenting symptoms of patients with sleep disordered breathing at a tertiary level. These differences should be taken into consideration in clinical evaluation of women with suspected sleep disordered breathing.

[Pharmacological management of stable COPD]. / Medikamentöses Management der stabilen COPD.

Pharmacotherapy for stable COPD depends on the severity of the disease. Thus, decisions on therapeutic interventions should be based not solely on the degree of airflow obstruction but also on symptoms, exercise tolerance, frequency and severity of exacerbations, and health-related quality of life. The progressive nature of COPD necessitates a stepwise increase of medication (step-up approach) depending on the severity of the disease. Although none of the currently available medications has been shown to modify the abnormal reaction to inhaled noxious particles and gases that lead to COPD, pharmacotherapy has beneficial effects on the clinical course of the disease by controlling symptoms, increasing exercise tolerance and improving general health status.

Circulating plasma levels of vascular endothelial growth factor in patients with sleep disordered breathing.

INTRODUCTION: Cellular vascular endothelial growth factor (VEGF) expression is increased in response to regional hypoxia, however, contradictory results were reported on the effects of systemic hypoxemia on circulating VEGF levels. This study investigated plasma concentrations of VEGF in patients with a variable degree of overnight hypoxemia due to sleep disordered breathing (SDB). METHODS: VEGF levels were assessed by ELISA in non-activated (VEGFbl) and thrombin stimulated platelet rich plasma (VEGFprp) of 45 patients with SDB: Group 1 patients with obstructive sleep apnea and an apnea-hypopnea index (AHI) > 15/h; Group 2 subjects with an AHI < 5/h; Group 3 patients on CPAP treatment for sleep apnea. RESULTS: 39 patients were included in the final analysis. Patients in Group 1 had a higher %time of sleep with SaO2 <90% and a significantly lower mean and minimum overnight oxygen saturation than subjects in Group 2 and patients in Group 3 (P<0.05). Despite significant differences in overnight oxygenation, VEGFbl and VEGFprp concentrations were not significantly different between the three study groups. However, plasma levels of VEGFbl were significantly higher (P = 0.02) in SDB patients with arterial hypertension (n = 19; VEGFbl: 14.0+/-3.3 pg/ml) than in those without arterial hypertension (n = 20; VEGFbl: 10.9+/-5.2 pg/ml). There were no relationships between VEGF levels and polysomnographic oxygenation parameters. In univariate analysis we observed significant relationships for VEGFbl with BMI (C: 0.393; P<0.05) and serum fibrinogen (C: 0.399; P<0.05). CONCLUSIONS: Circulating plasma VEGF levels in patients with sleep disordered breathing may be unrelated to night time hypoxemia (257 Words).