leuprolide and Anemia

This open-label study evaluated the efficacy and safety of a new leuprolide acetate 45 mg 6-month depot formulation in 151 men with prostate cancer who received 2 intramuscular injections administered 24 weeks apart.. The primary efficacy measurement was the proportion of patients achieving suppression of serum testosterone to ≤ 50 ng dl(-1) from week 4 through week 48. Adverse events (AEs) and hormonal and safety laboratory values were monitored.. The primary efficacy end point was achieved in 93.4% of subjects (95% confidence interval (89.2%, 97.6%)). There were nine escapes from testosterone suppression during the study, none of which were accompanied by a rise in PSA. By week 4, mean testosterone concentration was suppressed below castrate levels to 15.9 ng dl(-1); suppression was maintained for the entire 24-week duration of each depot injection. No mean increase in testosterone was observed after the second injection. Mean PSA levels were maintained below 3 ng ml(-1) from week 14 through the 48-week treatment period. The most frequent AE was flushing (58.3%). Injection site reactions were reported in 24.5% of patients.. Leuprolide acetate 45 mg 6-month depot demonstrated rapid and sustained testosterone suppression through 12 months and was well tolerated. This 6-month leuprolide acetate depot will decrease the number of annual injections in the treatment of prostate cancer.

Topics: Aged; Aged, 80 and over; Androgen Antagonists; Anemia; Antineoplastic Agents, Hormonal; Biomarkers, Tumor; Blood Glucose; Chemistry, Pharmaceutical; Hemoglobins; Humans; Leuprolide; Luteinizing Hormone; Male; Middle Aged; Prostate-Specific Antigen; Prostatic Neoplasms; Testosterone; Treatment Outcome

The aim of this guideline is to provide clinicians with an update to the 2015 Clinical Practice Guideline on the Management of Uterine Fibroids. As new information and evidence has become available since 2015, the Gynaecology Clinical Practice Committee of the Society for Obstetricians and Gynaecologists of Canada has determined that an addendum to that document was necessary to inform members about treatment modalities for uterine fibroids.. Implementation of this guideline update should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas, having considered the disease process and available treatment options and reviewed the risks and anticipated benefits.. Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2015 to April 2018, using appropriate controlled vocabulary (uterine fibroids, myoma, leiomyoma, myomectomy, myolysis, heavy menstrual bleeding, and menorrhagia) and key words (myoma, leiomyoma, fibroid, myomectomy, uterine artery embolization, hysterectomy, heavy menstrual bleeding, menorrhagia). The reference lists of articles identified were also searched for other relevant publications. Results were restricted to systematic reviews, randomized controlled trials or controlled clinical trials, and observational studies. There were no date limits, but results were limited to English or French language materials. Searches were updated on a regular basis and incorporated in the guideline to April 2018. Most of the unpublished data have not been evaluated scientifically. The product monograph was also reviewed up to December 31st, 2018.. The majority of fibroids are asymptomatic and require no intervention or further investigations. For symptomatic fibroids such as those causing menstrual abnormalities (e.g., heavy, irregular, and prolonged uterine bleeding), iron deficiency anemia, or bulk symptoms (e.g., pelvic pressure/pain, obstructive symptoms), hysterectomy is a definitive solution. However, it is not the preferred solution for women who wish to preserve fertility and/or their uterus. The selected treatment should be directed towards an improvement in symptomatology and quality of life. The cost of the therapy to the health care system and to women with fibroids must be interpreted in the context of the cost of untreated disease conditions and the cost of ongoing or repeat investigative or treatment modalities.. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care.

Topics: Anemia; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Female; Gonadotropin-Releasing Hormone; Hematinics; Humans; Iron Compounds; Leiomyoma; Leuprolide; Liver Function Tests; Menorrhagia; Norpregnadienes; Uterine Neoplasms

Haemoglobin levels often decline into the anaemic range with androgen deprivation therapy (ADT). We conducted a chart review of patients receiving ADT for metastatic prostate cancer to assess anaemia-related symptoms.. 135 stage IV prostate cancer cases were reviewed for treatment type; haemoglobin values before and after treatment; and symptoms of anaemia. Mean haemoglobin levels before and after for all treatment forms, for leuprolide alone, and for combination leuprolide/bicalutamide were calculated and evaluated for significant differences. The numbers of patients developing symptoms were recorded and the effects of specific therapies evaluated.. For all ADT treated patients, mean haemoglobin declined by -1.11 g/dL (p<.0001). Leuprolide-alone treated patients had a mean decline of -1.66 g/dL (p<0.0001). Leuprolide and bicalutamide combination treatment caused a mean decline of -0.78 g/dL (p=0.0426). 16 of 43 patients had anemia symptoms. Contingency analysis with Fisher's exact test shows patients receiving leuprolide therapy alone versus other forms of ADT were significantly less likely to have symptoms (chi(2)=0.0190).. The present study confirms that ADT results in a significant drop in haemoglobin levels into the anaemic range. A number of patients become symptomatic from this change. Practitioners should monitor haemoglobin levels, and treat symptomatic patients.

Topics: Aged; Androgen Antagonists; Anemia; Anilides; Antineoplastic Agents, Hormonal; Combined Modality Therapy; Goserelin; Hemoglobins; Humans; Leuprolide; Linear Models; Male; Neoplasm Metastasis; Nitriles; Prostatic Neoplasms; Retrospective Studies; Tosyl Compounds

Androgen deprivation therapy (ADT) is a commonly used treatment for metastatic prostate cancer. A 78-year-old patient with metastatic prostate cancer had transfusion-dependent anemia develop while on ADT. The patient also had hereditary hemorrhagic telangiectasia (HHT), with chronic gastrointestinal blood loss. Blood transfusions were required every 3 weeks for 4 months to keep hemoglobin levels above 8 g/dL, despite discontinuation of ADT. The anemia, which had been well managed with iron therapy before ADT, was worsened by the loss of bone marrow-stimulating testosterone effects. The case highlights testosterone's important role in erythrocyte production. Practitioners should monitor hemoglobin levels in patients undergoing ADT.

Topics: Adenocarcinoma; Aged; Androgen Antagonists; Anemia; Antineoplastic Agents, Hormonal; Blood Transfusion; Gastrointestinal Hemorrhage; Hemoglobins; Humans; Leuprolide; Male; Prostatic Neoplasms; Telangiectasia, Hereditary Hemorrhagic

Erythropoiesis is stimulated by androgens either through a direct action on bone marrow cells or through increased erythropoietin production. Androgen deprivation is a known cause for anaemia. The aim of this study was to evaluate the effect of neoadjuvant hormone therapy prior to radical surgery on haemoglobin (Hb) and haematocrit (Ht) levels in localised prostate cancer.. 47 patients with clinical localised prostate cancer were given LH-RH analogs plus flutamide for complete androgenic blockade (CAB) for at least 3 months prior to radical prostatectomy. A blood profile was obtained prior to start CAB and 3 months after therapy, and peri-operative transfusional requirements were evaluated. To assess any significant changes. Student's t test was used in the statistical analysis of paired data.. In our study all patients (100%) showed decreased Hb and Ht levels after 3 months on CAB. Mean decline for Hb was 1.9 g/dL (range 1.6-2.2) p:0.0001, and for Ht 5.8% (range 4.8-6.8) p:0.0001. Hb was lower than 12 g/dL in 10.6% patients after hormone therapy and anaemia results were normocytic-normochromic. 60% patients needed peri-operative blood transfusion, 2 units of packed cells on average.. Neoadjuvant CAB prior to radical prostatectomy results in a significant decline of Hb and Ht levels after 3 months treatment. Such decline may contribute to increase peri-operative transfusional requirements in a group of patients undergoing aggressive surgery which in itself involves a significant blood loss.

Topics: Androgen Antagonists; Anemia; Antineoplastic Agents, Hormonal; Chemotherapy, Adjuvant; Flutamide; Hematocrit; Hemoglobins; Humans; Leuprolide; Male; Prostatic Neoplasms; Triptorelin Pamoate

(1) The reference treatment for uterine leiomyoma with major symptoms is surgery. (2) Leuprorelin and triptorelin, two Gn-RH analogues, are the first drugs to be licensed in France for preoperative treatment of uterine leiomyoma associated with anaemia, when a reduction in the size of the leiomyoma is necessary to facilitate or modify the surgical technique. (3) A double-blind placebo-controlled trial of leuprorelin in nearly 300 anaemic women showed no advantage in terms of the need for non autologous transfusion. (4) Three double-blind placebo-controlled trials have shown that leuprorelin reduces the volume of uterine leiomyomas, but whether or not this facilitates or modifies the surgical technique is not known. An unblinded trial versus lynestrenol in non anaemic women showed a superior effect of leuprorelin on the size of the leiomyoma, but again there were no data on a possible effect on the choice of surgical technique. (5) In the absence of comparative double-blind trials, the observed effects of triptorelin on the choice of surgical technique are uninterpretable. (6) The adverse effects of leuprorelin are mainly linked to its hormone effect, i.e. flushing, headache, vaginitis and vaginal dryness. There are no recent reviews of the adverse effects of triptorelin in this setting. (7) In practice, for anaemic women with leiomyomas requiring surgery, there is no proof that leuprorelin and triptorelin have any tangible clinical advantages.

Topics: Anemia; Antineoplastic Agents, Hormonal; Female; France; Humans; Leiomyoma; Leuprolide; Preoperative Care; Randomized Controlled Trials as Topic; Treatment Outcome; Triptorelin Pamoate

Acute vaginal bleeding secondary to uterine myomas can be a devastating event. We report the use of a combined therapeutic approach in a patient who presented with protracted bleeding of a myomatous uterus that was equivalent in size to a 38 week gestation. This patient's course was further complicated by her refusal of blood or blood products.

Topics: Acute Disease; Adult; Anemia; Combined Modality Therapy; Contraceptives, Oral, Synthetic; Drug Therapy, Combination; Estrogens, Conjugated (USP); Female; Hematocrit; Humans; Injections, Subcutaneous; Leiomyoma; Leuprolide; Preoperative Care; Tampons, Surgical; Time Factors; Treatment Refusal; Uterine Hemorrhage; Uterine Neoplasms