ABSTRACT
PURPOSE OF INVESTIGATION: To compare the effects of desogestrel (DSG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 21 days followed by either seven days of EE ten mcg (21/7-active) or no treatment (DSG/EE+no Tx) on hemostatic markers. MATERIALS AND METHODS: This was a randomized, multicenter, open-label study that enrolled healthy premenopausal women. Non-inferiority of 21/7-active to DSG/EE+no Tx was determined if the upper limit of the two-sided 95% CI of the mean treatment difference in prothrombin fragment 1+2 (F1+2) over 24 weeks between groups was < 130 pmol/L. RESULTS: 246 subjects (n = 125, 21/7-active; n = 121, DSG/EE+no Tx) comprised the primary analysis. Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively). LS mean treatment difference was -11.8 pmol/L (95% CI: -54.8, 31.2). CONCLUSION: The effect of adding EE ten mcg to the seven-day hormone-free interval of DSG/EE on F1+2 levels was non-inferior to traditional DSG/EE.
Subject(s)
Blood Coagulation/drug effects , Contraceptives, Oral, Combined/pharmacology , Contraceptives, Oral, Sequential/pharmacology , Desogestrel/pharmacology , Ethinyl Estradiol/pharmacology , Fibrin Fibrinogen Degradation Products/drug effects , Peptide Fragments/drug effects , Protein C/drug effects , Protein S/drug effects , Prothrombin/drug effects , Adult , Antithrombins/blood , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Sequential/administration & dosage , Desogestrel/administration & dosage , Ethinyl Estradiol/administration & dosage , Female , Fibrin Fibrinogen Degradation Products/metabolism , Humans , Partial Thromboplastin Time , Peptide Fragments/blood , Protein C/metabolism , Protein S/metabolism , Young AdultABSTRACT
Although recent animal and clinical studies suggest that Doppler-derived indexes may be useful for the characterization of ventricular diastolic behavior, the hemodynamic basis for the preload dependency of these indexes has not previously been fully elucidated. Accordingly, effects of reduction of left atrial load on the pressure-flow velocity relation were characterized in 10 anesthetized, closed-chest dogs during transient inferior vena caval occlusion by means of simultaneously recorded left atrial and left ventricular micromanometric pressure measurement and transesophageal Doppler echocardiograms. Within four or five beats after inferior vena caval balloon occlusion, left atrial loading was reduced as evidenced by a decrease in the slope of the left atrial v wave from 21 +/- 4 to 13 +/- 4 mm Hg/sec (p less than 0.001) and by a decrease in the first crossover point of left atrial and left ventricular pressures from 5.6 +/- 1.1 to 2.9 +/- 1.5 mm Hg (p less than 0.001). This decrease in left atrial loading resulted in reductions during early diastole of minimum left ventricular pressure (from 1.0 +/- 0.8 to -0.4 +/- 1.2 mm Hg, p less than 0.001), the maximum early forward (i.e., left atrial pressure greater than left ventricular pressure) transmitral pressure gradient (from 2.8 +/- 0.8 to 2.4 +/- 0.5 mm Hg, p less than 0.01); the slope of the rapid filling pressure wave (from 44 +/- 11 to 38 +/- 10 mm Hg/sec, p less than 0.025); and the area of the reversed (i.e., left ventricular pressure greater than left atrial pressure) transmitral pressure gradient (from 79 +/- 42 to 53 +/- 33 mm Hg.msec, p less than 0.05). During late diastole, both the heights and slopes of the left atrial and left ventricular a waves fell, resulting in a decrease in the maximum late transmitral pressure gradient (from 1.2 +/- 0.7 to 0.9 +/- 0.5 mm Hg, p less than 0.05). Vena caval occlusion also altered Doppler transmitral velocity profiles during both the early and late phases of diastole. Peak velocity of the E wave decreased (from 50 +/- 11 to 41 +/- 7 cm/sec, p less than 0.01) as did acceleration (from 880 +/- 222 to 757 +/- 258 cm/sec2, p less than 0.025) and deceleration (from 597 +/- 260 to 429 +/- 197 cm/sec2, p less than 0.025). Peak velocity of the A wave also fell (from 29 +/- 9 to 22 +/- 5 cm/sec, p less than 0.005). Abrupt inferior vena caval occlusion did not significantly change heart rate or mean aortic pressure.(ABSTRACT TRUNCATED AT 400 WORDS)
Subject(s)
Blood Flow Velocity , Blood Pressure , Mitral Valve/physiology , Animals , Constriction, Pathologic/physiopathology , Diastole , Dogs , Echocardiography , Echocardiography, Doppler , Vena Cava, Inferior/physiology , Ventricular FunctionABSTRACT
Endoscopic vesicourethral suspension is an acceptable procedure for the treatment of true stress urinary incontinence, and is associated with a high success rate and little morbidity. Endoscopic vesical neck suspension was performed in 60 patients, with cure of the incontinence in 49 (82 per cent). A higher success rate was achieved in patients without a prior hysterectomy and/or surgical procedure to correct incontinence. Abnormalities on urodynamic testing may be somewhat suggestive of outcome. However, these studies cannot be used to predict success or failure.
