Anti-Spermatogenic Efficacy of Nonhormonal Male Contraceptive Agent, H2-Gamendazole, in Mice, Rats, Rabbits, and Nonhuman Primates (Rhesus), and a Multiple Low Dose Oral Regimen That Gives 100% Infertility with Complete Reversibility.

Abstract In this phase 1/2 study, we explored the feasibility and activity of an oral regimen of lenalidomide with low-dose dexamethasone and low-dose oral cyclophosphamide (RdC) in patients with primary systemic light chain amyloidosis. RdC was given for up to 12 cycles in prespecified cohorts at escalated doses: 13 patients were treated in phase 1 and 24 in phase 2; 65% were previously untreated, and most had renal and/or cardiac involvement and elevated cardiac biomarkers. Lenalidomide 15 mg/d and cyclophosphamide 100 mg/d were further evaluated in phase 2. On intention to treat, 20 (55%) patients achieved a hematologic response, including 3 (8%) complete remissions. Hematologic responses were seen at all dose levels and in 4 of 5 patients who had received bortezomib previously. An organ response was recorded in 22% of patients on intention-to-treat and in 40% of patients who survived at least 6 months. The median time to progression was 10 months and the 2-year survival was 41%. Fatigue, nonneutropenic infections, and rash were the most common toxicities. The results of the present study show that RdC is an oral regimen with activity in primary systemic light chain amyloidosis and may be an additional treatment option, especially for patients with preserved organ function or for patients who cannot receive or who relapse after bortezomib. This study is registered at www.clinicaltrials.gov as NCT00981708.

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Use of a low-dose oral contraceptive containing norethindrone acetate and ethinyl estradiol in the treatment of moderate acne vulgaris

Clinical Journal of Women s Health ◽

10.1053/cjwh.2001.25638 ◽

2001 ◽

Vol 1 (3) ◽

pp. 123-131 ◽

Cited By ~ 16

Author(s):

J. Michael Maloney ◽

Deborah I. Arbit ◽

Mary Flack ◽

Constance McLaughlin-Miley ◽

Cynthia Sevilla ◽

...

Keyword(s):

Oral Contraceptive ◽

Low Dose ◽

Ethinyl Estradiol ◽

Acne Vulgaris ◽

Dose Oral ◽

Dose Oral Contraceptive ◽

Norethindrone Acetate

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Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

Hämostaseologie ◽

10.1055/s-0037-1619507 ◽

2001 ◽

Vol 21 (02) ◽

pp. 77-81 ◽

Cited By ~ 2

Author(s):

G. Finazzi

Keyword(s):

Clinical Trials ◽

Large Scale ◽

Low Dose ◽

Randomized Clinical Trials ◽

Oral Anticoagulants ◽

Collaborative Study ◽

Clinical Problem ◽

Vascular Events ◽

Dose Oral ◽

Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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Relationship Between Total Prothrombin, Native Prothrombin and the International Normalized Ratio (INR)

Thrombosis and Haemostasis ◽

10.1055/s-0038-1656342 ◽

1992 ◽

Vol 68 (02) ◽

pp. 160-164 ◽

Cited By ~ 3

Author(s):

P J Braun ◽

K M Szewczyk

Keyword(s):

Anticoagulant Therapy ◽

Oral Anticoagulant ◽

Inverse Relationship ◽

Low Dose ◽

Oral Anticoagulant Therapy ◽

International Normalized Ratio ◽

Antigen Assay ◽

Dose Oral ◽

Anticoagulated Patients ◽

Sensitive Method

SummaryPlasma levels of total prothrombin and fully-carboxylated (native) prothrombin were compared with results of prothrombin time (PT) assays for patients undergoing oral anticoagulant therapy. Mean concentrations of total and native prothrombin in non-anticoagulated patients were 119 ± 13 µg/ml and 118 ± 22 µg/ml, respectively. In anticoagulated patients, INR values ranged as high as 9, and levels of total prothrombin and native prothrombin decreased with increasing INR to minimum values of 40 µg/ml and 5 µg/ml, respectively. Des-carboxy-prothrombin increased with INR, to a maximum of 60 µg/ml. The strongest correlation was observed between native prothrombin and the reciprocal of the INR (1/INR) (r = 0.89, slope = 122 µg/ml, n = 200). These results indicated that native prothrombin varied over a wider range and was more closely related to INR values than either total or des-carboxy-prothrombin. Levels of native prothrombin were decreased 2-fold from normal levels at INR = 2, indicating that the native prothrombin antigen assay may be a sensitive method for monitoring low-dose oral anticoagulant therapy. The inverse relationship between concentration of native prothrombin and INR may help in identification of appropriate therapeutic ranges for oral anticoagulant therapy.

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