leuprolide and Flushing

The aim of the study was to compare the onset, incidence and frequency/intensity of hot flushes during androgen-deprivation therapy with a gonadotropin-releasing hormone antagonist (GnRH) blocker versus an agonist using data from a randomized Phase 3 clinical trial. In total, 610 prostate cancer patients received monthly degarelix (s.c., 240/80 mg, n=207, or 240/160 mg, n=202) or leuprolide (i.m., 7.5 mg, n=201) for 12 months. Data on hot flushes was collected as self-reported adverse events and in a subgroup of 254 patients with electronic diaries. The onset of hot flushes was faster on degarelix versus leuprolide, and was accompanied by higher median hot flush scores during the first 3 months. However, there were no significant differences in overall incidence rates and median hot flush scores over the entire 12 months. After the third month, incidence rates dropped below 6%, whereas prevalence rates remained constant in all the three treatment arms. In multivariate analysis, body weight and heart rate at baseline were independent predictors of hot flushes (P<0.05). Except for a more rapid onset with the GnRH antagonist, there were no major differences in the overall pattern of hot flushes between treatment options. Weight control may help to minimize the incidence of hot flushes.

Topics: Aged; Aged, 80 and over; Antineoplastic Agents, Hormonal; Body Weight; Flushing; Follow-Up Studies; Gonadotropin-Releasing Hormone; Heart Rate; Humans; Leuprolide; Male; Middle Aged; Oligopeptides; Prostatic Neoplasms; Risk Factors; Self Report; Treatment Outcome

To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis.. Phase 3, multicenter, randomized, evaluator-blinded, comparator-controlled trial.. Clinical trial sites in Canada and United States.. Two hundred seventy-four women with surgically diagnosed endometriosis.. Intramuscular injections of DMPA-SC (104 mg) or leuprolide acetate (11.25 mg), given every 3 months for 6 months, with 12 months of posttreatment follow-up.. Reduction in five endometriosis symptoms or signs (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, pelvic induration); change in bone mineral density (BMD), hypoestrogenic symptoms, bleeding, and weight.. The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment (month 6) and in reducing all five symptoms after 12 months' follow-up (month 18). Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6, with scores returning to baseline at 12 months' follow-up. No statistically significant differences in median weight changes were observed between groups. Compared with leuprolide, DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding.. Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.

Topics: Adult; Bone Density; Delayed-Action Preparations; Endometriosis; Estrogens; Female; Flushing; Humans; Injections, Subcutaneous; Leuprolide; Medroxyprogesterone Acetate; Pain; Palliative Care; Quality of Life; Single-Blind Method; Treatment Outcome; Uterine Hemorrhage

One hundred two premenopausal women with uterine myomas were treated with LA depot. All women experienced adverse effects during GnRH-a treatment. The majority experienced symptoms attributed to a rapid and sustained decrease in circulating estrogen concentrations beginning 2 to 7 weeks after initiation of treatment. A smaller percentage of women experienced transient adverse effects due to the initial surge and subsequent rapid decline of gonadal steroids. The mechanism of other adverse effects (e.g., arthralgias) remains unclear. Only 6% of women terminated LA treatment before 12 weeks because of the severity of adverse effects.

Topics: Adult; Delayed-Action Preparations; Estradiol; Estrogens; Female; Flushing; Headache; Humans; Leuprolide; Middle Aged; Osmolar Concentration; Retrospective Studies