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1.
Can J Urol ; 30(1): 11414-11418, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36779947

RESUMO

INTRODUCTION: To evaluate the effectiveness of a standardized multimodal pain pathway for gender affirming orchiectomy (GAO) in adequately addressing postoperative pain while reducing the prescribing of unnecessary opioids. MATERIALS AND METHODS: A standardized discharge pain pathway for GAO +/- scrotectomy or testicular implants was implemented between May 2020 and March 2022. A retrospective analysis was performed on all consecutive patients who underwent GAO with a single surgeon. Patients answered five questions on postoperative pain management at their 3 week follow up. RESULTS: A total of 69 patients were included in the study. Mean age was 34.3 years (SD ± 10.5; IQR 26-39) with a mean body mass index (BMI) of 27.1 (SD ± 7.5; IQR 22.3-31). No patients were taking narcotics preoperatively. Mean 4.7 tablets (SD ± 4.5; range 0-30) oxycodone tablets taken by GAO patients without concurrent procedures, with 33 patients (47.8%) taking fewer than 4 tablets. Thirteen patients (18.8%) required no narcotics. Four patients (5.8%) requested an additional narcotic prescription, none of whom underwent a concurrent procedure. There was no significant association between BMI and the number of oxycodone tablets taken. All patients used at least one recommended alternative therapy (acetaminophen, ibuprofen and ice packs) with 41 patients (59.4%) using all three. CONCLUSION: Most patients achieved adequate postoperative pain control as requests for additional narcotic prescriptions were low. Almost half of patients used < 4 tablets, and all patients employed at least one alternative non-narcotic analgesic. Based on these findings, we plan to decrease the quantity of opioids on discharge.


Assuntos
Analgésicos Opioides , Oxicodona , Masculino , Humanos , Adulto , Analgésicos Opioides/uso terapêutico , Oxicodona/uso terapêutico , Estudos Retrospectivos , Orquiectomia/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/prevenção & controle
2.
Urology ; 156: 211-215, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33971189

RESUMO

OBJECTIVE: To examine voluntary reports in the Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, categorize complications and assign device-related causality with transurethral resection of the prostate (TURP), prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT). METHODS: A review was performed using the terms "Urolift," "Rezum," and "transurethral resection of the prostate" between 01/01/2015 and 12/31/2019. Duplicate and incomplete reports were excluded. The Gupta system was used to report complications and device related causality.1 Pearson's Chi-square analysis was performed to compare minor (Level 1) versus major (Levels 2-4) complications. RESULTS: A total of 548 events were examined. After removal of duplicates (n = 60), irrelevant reports (n=65), and incomplete information (n = 14), we included 409 events (74.6%). Of the 409 events, 214 were for TURP, 112 for TWVT, and 83 for PUL. In aggregate, 39.4% of events were minor/Level 1 (n=161/409). The proportion of subjects with Level 2-4 complications versus Level 1 complications was significantly higher for PUL than TURP or TWVT [X2 (2, N = 408) = 41.4023, P < .00001]. Device causality was attributable to device malfunction in 60.4% of cases (n=247/409). CONCLUSION: Device malfunction was noted in all groups and 39.4% of these were minor (Level 1). However, the majority of PUL reports noted a Level 3 or 4 complication (50.6%, 42/83), primarily bleeding related. Previous studies have not revealed significant risk of bleeding and suggests a discrepancy between study data and real-world experience that may alter patient counseling practices.


Assuntos
Bases de Dados Factuais , Falha de Equipamento/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia , Vigilância de Produtos Comercializados , Prostatectomia/efeitos adversos , Prostatectomia/instrumentação , Hiperplasia Prostática/cirurgia , United States Food and Drug Administration , Obstrução do Colo da Bexiga Urinária/cirurgia , Humanos , Masculino , Hiperplasia Prostática/complicações , Índice de Gravidade de Doença , Estados Unidos , Obstrução do Colo da Bexiga Urinária/etiologia
3.
Acute Med Surg ; 8(1): e636, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33747534

RESUMO

AIM: Gunshot wounds (GSW) to the penis represent a rare type of traumatic injury in the civilian United States population. Although small, single-center studies have reported results of care for these types of injured patients, no national analyses have examined this group. METHODS: A cohort of patients with GSW to the penis was identified using the 2017 American College of Surgeons Trauma Quality Programs database, a comprehensive national database of 753 accredited trauma centers. RESULTS: Gunshot wounds to the penis occurred in 722 patients, which represents 1.7% of all GSW patients (n = 41,017). Gunshot wounds from altercations with law enforcement or accidental discharge of a firearm were rare; the vast majority (n = 655, 90.7%) occurred as a result of assault, intentional self-harm, attempted suicide, or attempted homicide. Patients with a major concomitant non-genitourinary injury comprised 119 (16.5%) patients of the cohort. Most patients (n = 499, 69.1%) underwent a genitourinary procedure during their trauma admission. Penile salvage was successful in most cases, with only 13 (1.8%) patients requiring completion penectomy. Most patients (87.8%) required admission with a median length of stay of 49.8 h. Most patients were treated at the initial trauma center without requiring transfer to another center, and complications during admission were rare. CONCLUSIONS: This analysis, the first national examination of care of patients with GSW to the penis, reveals overall favorable outcomes. Admission and surgical intervention were required in most patients, but penectomy was rare and length of stay was generally short. These results will guide resource utilization and quality improvement efforts in this patient cohort.

4.
Urology ; 146: 140-144, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32946909

RESUMO

OBJECTIVES: We hypothesize that men with diabetes mellitus whose inflatable penile prosthesis (IPP) implantation is delayed for unacceptably high hemoglobin A1c (HbA1c) will have durable improvements in their glycemic control after achieving acceptable HbA1c levels for surgery. METHODS: Per institutional protocol, an A1c <9% must be documented prior to IPP placement. After IRB approval, a single surgeon IPP database was retrospectively queried for data specific to diabetes mellitus management. Men without HbA1c values at ≥1-year follow-up were excluded. Univariate and multivariate statistical analyses were performed to assess associations with sustained HbA1c control. RESULTS: From January 2011 to March 2019, 138 diabetics undergoing IPP were identified. Thirty-seven were excluding for insufficient follow-up. Nineteen of the 101 analyzed men (18.8%) were delayed a median 4 months (range 2-17) for elevated HbA1c values (median 10.1, range 9.1-12.3). Following improvements, median preoperative HbA1c remained higher (8.2% vs 7.0%) in delayed men (P < .001). Among delayed recipients, 11 (58%) improved without medication changes while insulin was newly initiated (5) or dosage was increased (5) in 42%. At 32 months follow-up, a HbA1c <9% was similarly maintained in delayed and nondelayed men (74% vs 87%, P = .17). Delayed men more commonly required insulin therapy at follow-up (89.5% vs 54.9%, P = .008), but had a similar median change in BMI (+0.1 vs +0.1, P = .65). Device infection occurred in 1 nondelayed patient (0.7%). CONCLUSION: Men who improve HbA1c for IPP surgery are likely to demonstrate persistent improvement. IPP implantation appears to be safe in diabetic men with HbA1c <9%.


Assuntos
Diabetes Mellitus Tipo 2/sangue , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Disfunção Erétil/cirurgia , Hemoglobinas Glicadas/análise , Implante Peniano/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/complicações , Procedimentos Cirúrgicos Eletivos/normas , Disfunção Erétil/sangue , Disfunção Erétil/etiologia , Seguimentos , Controle Glicêmico/normas , Humanos , Masculino , Pessoa de Meia-Idade , Implante Peniano/normas , Prótese de Pênis/efeitos adversos , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Resultado do Tratamento
5.
Urology ; 146: 96-100, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32828869

RESUMO

OBJECTIVE: To evaluate the findings of magnetic resonance imaging (MRI) of the ipsilateral hip(s) as part of the workup of men with chronic orchialgia (CO). METHODS: Following IRB approval, a retrospective chart review was performed from a single surgeon database of all men with a diagnosis of CO from June 2018 to October 2019 who underwent subsequent hip MRI evaluation. RESULTS: Ten men were identified. Median age was 51 years and median duration of pain was 10 months. MRI was obtained after testis pathology was ruled out. Pain was noted in the groin (100%) and hip (50%). Hip MRI identified overt labral tears in 8 men (10/12 hips evaluated, 83%) and labral fraying in the remaining 2 (16.7%). Standard plain film radiography was performed in 6 men prior to MRI, all of which were negative. Following MRI, 5 men underwent hip injection with steroid and local analgesic with lasting resolution (2 men) or significant improvement in pain (2 men; 80%, follow-up 3-15 months). Two men had complete resolution of pain with 8 weeks of physical therapy. CONCLUSION: Hip MRI has a high rate of diagnosis of labral tear in appropriately selected men referred to the urologist for CO. Identification of orthopedic pathology may avoid unnecessary antibiotics, opiates, or urological surgery. Referrals to orthopedics and/or physical therapy for intervention may lead to resolution of pain.


Assuntos
Artralgia/diagnóstico , Dor Crônica/diagnóstico , Erros de Diagnóstico/prevenção & controle , Epididimite/diagnóstico , Articulação do Quadril/patologia , Adulto , Idoso , Dor Crônica/etiologia , Epididimite/complicações , Articulação do Quadril/diagnóstico por imagem , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Melhoria de Qualidade , Encaminhamento e Consulta , Estudos Retrospectivos , Escroto/diagnóstico por imagem
6.
Sex Med Rev ; 7(1): 167-177, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30509896

RESUMO

INTRODUCTION: The artificial urinary sphincter (AUS) has long been regarded as the gold standard for surgical correction of male stress urinary incontinence (SUI). Despite impressive rates of initial success for restoration of continence, durability may wane to the point of considering revision surgery. AIM: To provide a review of existing data as well as personal experience regarding patient selection, surgical technique, and postoperative troubleshooting for the AUS. METHODS: A systematic review of the peer-reviewed literature was performed to identify relevant and contemporary articles regarding perioperative and long-term management of the AUS. Additional input is presented based on clinical experience of the senior author. MAIN OUTCOME MEASURE: The main outcome measures are durability, patient satisfaction, mechanical failure, and urethral erosion. RESULTS: In addition to a thorough history and examination, preoperative screening should include office cystoscopy to rule out bladder neck contracture in patients with a history of radical prostatectomy. Perineal cuff placement appears superior to alternative approaches. Prior radiation and use of the 3.5-cm cuff are risk factors for future erosion. Newer findings suggest that subsequent recurrence of SUI may be due to restrictive encapsulation, rather than true atrophy, with implications for revision surgery. CONCLUSION: The AUS remains an excellent option for surgical correction of moderate to severe male SUI. Detailed preoperative evaluation and patient selection are critical. The challenge of downstream recurrent SUI after AUS can be effectively managed for most patients with a structured approach. Chouhan JD, Terlecki RP. A User's Guide for Surgery Involving the Artificial Urinary Sphincter. Sex Med Rev 2019;7:167-177.


Assuntos
Prostatectomia/efeitos adversos , Implantação de Prótese/métodos , Uretra/fisiopatologia , Incontinência Urinária por Estresse/cirurgia , Esfíncter Urinário Artificial , Humanos , Masculino , Satisfação do Paciente , Qualidade de Vida , Recuperação de Função Fisiológica , Resultado do Tratamento , Uretra/anatomia & histologia , Incontinência Urinária por Estresse/fisiopatologia , Incontinência Urinária por Estresse/psicologia
7.
Int. braz. j. urol ; 44(4): 697-703, July-Aug. 2018. tab
Artigo em Inglês | LILACS | ID: biblio-954078

RESUMO

ABSTRACT Introduction: We compared characteristics of patients undergoing prostate biopsy in a high-risk inner city population before and after the 2012 USPSTF recommendation against PSA based prostate cancer screening to determine its effect on prostate biopsy practices. Materials and Methods: This was a retrospective study including patients who received biopsies after an abnormal PSA measurement from October 2008-December 2015. Patients with previously diagnosed prostate cancer were excluded. Chi-square tests of independence, two sample t-tests, Mann-Whitney U tests, and Fisher's exact tests were performed. Results: There were 202 and 208 patients in the pre-USPSTF and post-USPSTF recommendation cohorts, respectively. The post-USPSTF cohort had higher median PSA (7.8 versus 7.1ng/mL, p=0.05), greater proportion of patients who were black (96.6% versus 90.5%, p=0.01), and greater percentage of biopsy cores positive for disease (58% versus 29.5%, p<0.001). Multivariable analysis supported that the increase in PSA was independent of the increase in the proportion of patients who were black. The proportion of patients who were classified as D'Amico intermediate and high-risk disease increased in the post-USPSTF cohort and approached statistical significance (70.1% versus 58.8%, p=0.12). Conclusions: Our study suggests that the USPSTF recommendations may have led to an increase in pre-biopsy PSA as well as greater volume of disease. Also, a greater proportion of patients were being classified with intermediate or high risk disease. While the clinical significance of these findings is unknown, what the data suggests is somewhat troubling. Future research should further examine these changes in a larger cohort as well as resultant long-term outcomes.


Assuntos
Humanos , Masculino , Idoso , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Antígeno Prostático Específico/sangue , Guias de Prática Clínica como Assunto/normas , Medição de Risco/métodos , Biópsia Guiada por Imagem/normas , Neoplasias da Próstata/etnologia , Neoplasias da Próstata/sangue , Padrões de Referência , Hospitais Urbanos , Análise Multivariada , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Estatísticas não Paramétricas , Detecção Precoce de Câncer/normas , Gradação de Tumores , Pessoa de Meia-Idade
8.
Int Braz J Urol ; 44(4): 697-703, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29617073

RESUMO

INTRODUCTION: We compared characteristics of patients undergoing prostate biopsy in a high-risk inner city population before and after the 2012 USPSTF recommendation against PSA based prostate cancer screening to determine its effect on prostate biopsy practices. MATERIALS AND METHODS: This was a retrospective study including patients who received biopsies after an abnormal PSA measurement from October 2008-December 2015. Patients with previously diagnosed prostate cancer were excluded. Chi-square tests of independence, two sample t-tests, Mann-Whitney U tests, and Fisher's exact tests were performed. RESULTS: There were 202 and 208 patients in the pre-USPSTF and post-USPSTF recommendation cohorts, respectively. The post-USPSTF cohort had higher median PSA (7.8 versus 7.1ng/mL, p=0.05), greater proportion of patients who were black (96.6% versus 90.5%, p=0.01), and greater percentage of biopsy cores positive for disease (58% versus 29.5%, p<0.001). Multivariable analysis supported that the increase in PSA was independent of the increase in the proportion of patients who were black. The proportion of patients who were classified as D'Amico intermediate and high-risk disease increased in the post-USPSTF cohort and approached statistical significance (70.1% versus 58.8%, p=0.12). CONCLUSIONS: Our study suggests that the USPSTF recommendations may have led to na increase in pre-biopsy PSA as well as greater volume of disease. Also, a greater proportion of patients were being classified with intermediate or high risk disease. While the clinical significance of these findings is unknown, what the data suggests is somewhat troubling. Future research should further examine these changes in a larger cohort as well as resultant long-term outcomes.


Assuntos
Biópsia Guiada por Imagem/normas , Guias de Prática Clínica como Assunto/normas , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Medição de Risco/métodos , Idoso , Detecção Precoce de Câncer/normas , Hospitais Urbanos , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Gradação de Tumores , Neoplasias da Próstata/sangue , Neoplasias da Próstata/etnologia , Padrões de Referência , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Estatísticas não Paramétricas
10.
Urol Case Rep ; 13: 19-21, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28435787

RESUMO

High grade mucinous urothelial carcinoma is a rare pathological variant. There is still controversy as to its nomenclature and classification. We report the case of a 64 year old female with history of pelvic pain who was incidentally discovered to have a left upper pole renal mass. Left nephroureterectomy was performed and histopathological examination revealed high grade mucinous urothelial carcinoma. Accurate diagnosis of this distinct pathological entity will allow for better understanding of phenotypic behavior and inform best treatment strategies.

11.
Urology ; 105: 171-174, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28412334

RESUMO

We present 2 patients found to have ovotesticular disorder of sexual development (otDSD) in late adolescence. Two 15-year-old phenotypically male patients presented to a large pediatric hospital with different complaints: 1 with concern for testicular rupture after a straddle injury; 1 with gynecomastia. Further workup, including imaging and laboratory tests, was performed before surgical exploration. The first patient had unilateral ovotestis, contralateral testis, and SRY-negative 46,XX karyotype. The second patient with gynecomastia had unilateral ovotestis with hemi-uterus and fallopian tube, contralateral ovarian tissue, and 46,XX/47,XXY Klinefelter mosaic karyotype. Although rare, phenotypically normal male patients may present later with ovotesticular disorder of sexual development.


Assuntos
Transtornos Ovotesticulares do Desenvolvimento Sexual/diagnóstico , Adolescente , Feminino , Humanos , Masculino
12.
Can J Urol ; 23(3): 8324-8, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27347631

RESUMO

Retroperitoneal hemorrhage and an associated hematoma are uncommon but potentially serious complications following ureteroscopy with laser lithotripsy. However, no reports of serious bleeding complications have been published regarding ureteroscopy without laser lithotripsy in the management of stone disease. We report of such a case here and then review the current literature in order to discuss the incidence, risk factors, and management of such events.


Assuntos
Hemorragia/etiologia , Espaço Retroperitoneal , Ureteroscopia/efeitos adversos , Idoso de 80 Anos ou mais , Humanos , Litotripsia a Laser , Masculino , Cálculos Ureterais/cirurgia
13.
J Sex Med ; 9(8): 2182-6, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-22759917

RESUMO

INTRODUCTION: Penile implant surgery continues to be an important option for men with erectile dysfunction. Advancements in technology of implants have contributed to improved survival from mechanical breakdown. Prosthesis infection remains a serious adverse event. For the last 8 years, the Titan implant (Coloplast Corporation, Minneapolis, MN, USA) has been available with an infection-retardant polyvinylpyrrolidone coating. AIM: To compare the infection rates between coated three-piece inflatable penile prostheses (IPPs) with the previous non-coated model. MAIN OUTCOME MEASURES: Infection-related revisions reported in the physician-generated, manufacturer-tabulated patient information forms (PIFs). METHODS: PIFs reported into the voluntary, post-market registry of Coloplast Corporation from July 14, 2000 to September 30, 2011 were retrospectively reviewed. Infection-related revisions entered into the product evaluation database for coated and non-coated IPPs were compared. Data were analyzed using Pearson's chi-squared test. RESULTS: The database included 36,391 PIFs related to primary IPP implantation. At 11 years of follow-up, 4.6% (7,031) of non-coated IPPs were removed or replaced due to infections, whereas 1.4% (29,360) of hydrophilic-coated implants reported replacements due to device infections. The hydrophilic coating of the IPP components makes the device slippery and prevents bacterial attachment. The hydrophilic coating allows rapid absorption of antibiotics in an aqueous solution and allows these water-soluble antibiotics to elute off the device into the implant spaces. Unfortunately, information pertaining to what agents were used in the studies patients was not tabulated. The rate of revision due to device infection was reduced 69.56% in patients with hydrophilic-coated IPPs (P<0.001). CONCLUSION: To the best of our knowledge, this is the longest post-marketing registry report related to IPP infections. At 8 years of follow-up, the hydrophilic-coated IPPs demonstrated a significant reduction in revision rates due to infection when compared with the 11-year follow-up of non-coated implants. Since there was no information or uniformity of antibiotics used in the soaking solution, it is uncertain which antibiotic selection provided the best results. In vitro testing against known infectious agents may further benefit IPP patients by reducing the prosthesis infection rate.


Assuntos
Prótese de Pênis/efeitos adversos , Prótese de Pênis/estatística & dados numéricos , Infecções Relacionadas à Prótese/epidemiologia , Adulto , Antibacterianos/uso terapêutico , Disfunção Erétil/tratamento farmacológico , Disfunção Erétil/cirurgia , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Vigilância de Produtos Comercializados , Infecções Relacionadas à Prótese/tratamento farmacológico , Infecções Relacionadas à Prótese/etiologia , Infecções Relacionadas à Prótese/prevenção & controle , Estudos Retrospectivos , Estados Unidos/epidemiologia
14.
J Oncol Pharm Pract ; 17(3): 155-9, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-20447949

RESUMO

BACKGROUND: The administration of docetaxel requires the use of dexamethasone for the prevention of hypersensitivity reactions (HSRs) and fluid retention reactions (FRRs). The manufacturer recommends dexamethasone for 3 days starting the day before docetaxel. This regimen has the potential for nonadherence so the utility of a single dexamethasone dose would be welcomed. OBJECTIVE: To ascertain the incidence of HSRs and FRRs after receiving a single dose of intravenous dexamethasone before docetaxel administration. DESIGN: Retrospective chart review. SETTING: Data set from an oncology clinic affiliated with a large, tertiary, academic, teaching hospital. PATIENTS: Ninety patients (median age 59 years, range 40-92 years) with cancer (primarily breast cancer, nonsmall cell lung cancer and head/neck cancer) who received docetaxel. MEASUREMENTS AND RESULTS: Patients with heart failure, renal failure, chronic edema, current steroid use and/or prostate cancer were excluded from the study. Seven patients (7.8%) experienced a HSR requiring a treatment intervention (fluid bolus, oxygen, steroid, and/or diphenhydramine). Eleven patients (12.2%) had documented fluid retention. The mean docetaxel dose at the onset of fluid retention was 247.2 ± 134.5 mg/m(2). LIMITATIONS: This single center evaluation with a small sample size had the potential for incomplete collection of the adverse events from the medical records due its retrospective nature. CONCLUSION: Hypersensitivity reactions and FRRs occurred in 7.8% and 12.2% of patients, respectively. This is lower than the rates reported by the manufacturer with the oral premedication regimen.


Assuntos
Antineoplásicos/administração & dosagem , Dexametasona/administração & dosagem , Hipersensibilidade a Drogas/prevenção & controle , Edema/prevenção & controle , Glucocorticoides/administração & dosagem , Pré-Medicação , Taxoides/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/efeitos adversos , Docetaxel , Esquema de Medicação , Hipersensibilidade a Drogas/etiologia , Edema/induzido quimicamente , Feminino , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxoides/efeitos adversos , Texas
15.
Pharmacotherapy ; 30(7): 666-83, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20575632

RESUMO

Idiopathic thrombocytopenic purpura (ITP) is a platelet disorder that affects approximately 1 in 10,000 people. In adults, the rate of spontaneous remission is only 5%, and generally, it is a chronic disease persisting for more than 6 months. Chronic refractory ITP may be defined as the failure of any modality to keep the platelet count above 20 x 10(3)/mm(3) for an appreciable time without unacceptable toxicity. Many pharmacologic treatments have been used to manage chronic refractory ITP by attempting to increase platelet counts by decreasing the rate of destruction of these cells. They include, but are not limited to, azathioprine, danazol, dapsone, combination chemotherapy, cyclosporine, and rituximab. However, these therapies offer modest response rates and can cause adverse events that necessitate drug discontinuation. The recent United States Food and Drug Administration approval of the thrombopoietin mimetics, romiplostim and eltrombopag, has provided clinicians with a novel approach for treating chronic refractory ITP. By stimulating platelet production, these drugs offer patients with this disease an alternative to the other agents. The preapproval phase III study with subcutaneous romiplostim showed significantly higher overall response rates versus placebo in both splenectomized and nonsplenectomized patients (83% for romiplostim vs 7% for placebo, p<0.0001). Twenty-five percent of patients receiving romiplostim achieved a platelet count greater than 50 x 10(3)/mm(3) after 1 week, and 50% achieved this platelet count within 2-3 weeks. The preapproval phase III study with oral eltrombopag demonstrated that 70% of patients receiving 50 mg/day and 81% of patients receiving 75 mg/day achieved a platelet count of at least 50 x 10(3)/mm(3) by day 43 (p<0.001 vs placebo for both 50 and 75 mg). Forty-four percent and 62% of patients achieved a platelet count of at least 50 x 10(3)/mm(3) by day 8 with eltrombopag 50 and 75 mg/day, respectively. When deciding which of these agents to prescribe, considerations include oral versus injectable dosage form, adverse-event profiles, and patient adherence with both taking the drug and keeping clinic appointments for monitoring of platelet counts. Several studies are under way to evaluate these drugs in chronic refractory ITP as well as other disease states. Long-term data will also be needed to assess the safety and efficacy of these agents.


Assuntos
Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Receptores Fc/uso terapêutico , Trombopoetina/uso terapêutico , Adulto , Anticorpos Monoclonais , Anticorpos Monoclonais Murinos , Benzoatos , Doença Crônica/tratamento farmacológico , Ensaios Clínicos Fase III como Assunto , Humanos , Hidrazinas , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/imunologia , Pirazóis , Receptores Fc/administração & dosagem , Receptores Fc/imunologia , Proteínas Recombinantes de Fusão/imunologia , Proteínas Recombinantes de Fusão/farmacologia , Proteínas Recombinantes de Fusão/uso terapêutico , Rituximab , Trombopoese/efeitos dos fármacos , Trombopoese/imunologia , Trombopoetina/imunologia
16.
J Oncol Pharm Pract ; 13(1): 5-15, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17621562

RESUMO

OBJECTIVE: To provide a review of the clinical data supporting the use of sunitinib (Sutent), a multitargeted, small molecule, tyrosine kinase inhibitor, with focus on its approved indication for the treatment of advanced renal cell carcinoma in patients with metastatic disease requiring drug therapy. DATA SOURCE: : A MEDLINE search of the medical literature was conducted using the terms 'sunitinib' and 'SU11248'. References from the articles were reviewed and relevant sources were included. DATA SUMMARY: The introduction of dual tyrosine kinase receptor inhibitors is a novel approach to treating advanced metastatic renal cell carcinoma (mRCC) by preventing angiogenesis and tumor growth. Based on its ability to inhibit several targets involved in angiogenesis and endothelial cell proliferation, sunitinib offers patients with mRCC an alternative for treatment. A recent Phase III study evaluating sunitinib as first-line therapy showed a significant difference when compared to interferonalfa (IFN-alpha) for a progression-free survival of 11 months in the sunitinib arm and 5 months in the IFN-alpha arm (hazard ratio 0.42; 95% CI 0.32-0.54; P50.001). Two Phase II trials determined sunitinib was effective as second-line therapy in mRCC patients who failed previous cytokine treatment. Partial response rates were 40% (95% CI 28%-53%) and 34% (95% CI 25%-44%). Multiple ongoing trials are currently underway to evaluate sunitinib for first-line therapy in mRCC.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Indóis/uso terapêutico , Neoplasias Renais/tratamento farmacológico , Pirróis/uso terapêutico , Antineoplásicos/efeitos adversos , Antineoplásicos/farmacocinética , Antineoplásicos/farmacologia , Carcinoma de Células Renais/patologia , Proliferação de Células/efeitos dos fármacos , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Humanos , Indóis/efeitos adversos , Indóis/farmacocinética , Indóis/farmacologia , Neoplasias Renais/patologia , Metástase Neoplásica , Neovascularização Patológica , Pirróis/efeitos adversos , Pirróis/farmacocinética , Pirróis/farmacologia , Sunitinibe
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