Danazol Treatment in Lower Risk MDS Patient with Severe Thrombocytopenia: A Monocentric Experience

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5615-5615
Author(s):  
Alfredo Molteni ◽  
Marta Riva ◽  
Emanuele Ravano ◽  
Rosa Greco ◽  
Enrica Morra

Abstract Background: Severe thrombocytopenia is an uncommon event in lower risk MDS patients, but it may significantly influence the prognosis. In fact, when it occurs, major bleeding may be a life-threatening complication. No licensed pharmacologic approach is nowadays available yet for these patients. Eltrombopag seems to be a very interesting product, but its efficacy and safeness are still to be better demonstrated. Romiplostim could be suitable too, but, at present, its safety is uncertain in MDS patients. Also danazol, an attenuated androgen, seems to have some ability to increase the platelet count in this context. Patients and methods: We retrospectively reviewed 17 thrombocytopenic patients affected by MDS, treated with danazol and observed for at least 6 months. Three patients of these had a therapy-related MDS. At the starting time of danazol therapy, the IPSS was “low” or “intermediate-1” in 16 cases; “intermediate-2” in 1 case. The IPSS-R was “very low”, “low” or “intermediate” in 16 cases; “very high” in 1 case. In 14 patients the platelet count was lower than 25x109/L, in the other 3 lower than 40x109/L, but with spontaneous bleeding. The initial dose was 600 mg/day for all the patients. The IWG criteria of response (Cheson 2006) were adopted. The outcomes were observed after 3 and 6 months from the beginning of therapy. Only descriptive statistical analysis was used. Results: At the beginning of therapy, the average platelet count of the 17 patients was 22.6 x109/L (S.D. 8.8, range 6-38). After 3 months, the therapy with danazol was ongoing in 16 patients (in 1 case the drug was discontinued due to renal failure). Platelet improvement, according to IWG criteria, was observed in 8 cases (47%). The average platelet count was 45.3x109/L (S.D. 32.9, range 4-133). The only one “high risk” patient did not show response. After 6 months danazol was still ongoing in 11 patients (in 5 cases the drug was stopped for inefficacy). The response according to IWG criteria was evident in 9 patients (52% of the initial 17 patients). The average platelet count was 66x109/L (S.D. 63.9, range 11-218). Adverse events recorded were as follows: increase in transaminases in 3 cases (in 2 of these the dose was reduced to 400 mg/day); severe but reversible renal failure in 1 case (the drug was stopped); moderate increasing of serum creatinine in 1 case (the drug was reduced to 400 mg/day); reversible cutaneous rush (the drug was reduced to 400mg/day); amenorrhea in 1 case (the only fertile woman in the series); weight loss and loss of appetite in 1 case, weight gain in 1 case. Conclusions This series confirms the efficacy of danazol to improve platelet count in approximately half of patients with severe thrombocytopenia due to “low-risk” MDS. In all patients with increased platelet count, the response was clinically significant. The response may not be immediate. Actually, there was an improvement of platelet count even after three months of therapy. The toxicity profile of this drug is low. The mechanism of action of danazol in MDS patients remains unclear. Waiting for more information on the efficacy and safety of eltrombopag from the clinical trials in progress, danazol may be a good therapeutic option for these patients. Disclosures Off Label Use: Danazol in MDS patients with severe trhombocytopenia.

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4375-4375 ◽  
Author(s):  
Marta Riva ◽  
Lara Crucitti ◽  
Emanuele Ravano ◽  
Michele Nichelatti ◽  
Gianluigi Reda ◽  
...  

Abstract Background: Severe thrombocytopenia is an uncommon event in patients (pts) with lower-risk MDS, but it may significantly affect the prognosis. No specific pharmacological approaches other than hypometilating agents (not licensed in Europe in lower-risk MDS), able to improve platelet count in this setting, are currently available. Trials testing efficacy and safety of Eltrombopag are ongoing (Oliva 2017). Few data were reported about danazol, an attenuated androgen, that seems to have also some effectiveness in this still unmet need (Wattel 1994; Chan 2002). Aims: To assess the efficacy and safety of danazol in improving the platelet count in low risk MDS pts with severe thrombocytopenia. Methods: We retrospectively reviewed 35 thrombocytopenic MDS pts treated with danazol. The initial and maximal dose was 600 mg/day for all pts, modulated according to response and toxicity. The response was evaluated according to IWG response criteria (Cheson 2006). The outcome was strictly observed every 3 months (mo) up to the 12th mo, and the platelets average number in each observation moment was described. The time to response, the response rate and the enduring of response were also recorded. Results: Of the 35 pts, according to 2016 WHO classification, 4 pts were MDS-ULD; 19 were MDS-MLD (3 of them with medullar hypocellularity), 7 were MDS-EB1 and 5 were affected by MDS/MPN. At baseline the platelet count was lower than 20x10^3/mL in 11 pts, the median was 23x10^3/mL . At starting time of danazol therapy the IPSS-R cytogenetic class of risk was very low in 2 cases, low in 28 cases, intermediate in 3 cases and very high in 1 case. Cytogenetic was not available in one patient. In the 30 MDS pts, the IPSS-R was "very low" in 1 patient, "low" in 16, "intermediate" in 7, "high" in 4 and "very high" in 1. In 1 case it was not evaluable due to the lack of cytogenetics. Two pts were not included in the analysis because they were treated for less than 3 mo (in 1 case danazol was withdraw to permit the beginning of another therapy and in 1 case due to death for other neoplastic disease). The response rate was 63,6% (21 responders on 33 evaluable). Median time to response was 3.5 mo (range 0.3 - 12.4 mo); the average response time was 5.09 mo. In the first year of treatment, the platelet count (evaluated at baseline, 3, 6, 9 and 12 mo) changed in a significant way (F test after repeated measures ANOVA: p < 0.001 as shown in Figure 1). Pairwise comparisons of platelet count according to Bonferroni showed a significant difference for baseline vs. 3 mo (p = 0.0013), baseline vs 6 mo (p = 0.0255), baseline vs 9 mo (p = 0.0047) and baseline vs 12 mo (p = 0.0014); however, no significant differences (p ≥ 0.05) in counts were seen for all the further pairwise comparisons at 3, 6, 9 and 12 mo. The median and average duration of the response for the entire population were respectively 12,5 and 32,5 mo. Only 6 of the 21 responders (28%) lost the response (the median and average duration of response were respectively 5.8 and 12.9 mo). Within the 21 responders, the median progression free survival was not reached after 24 mo. The probability to maintain the response after 50 mo was assessed at 58.2% (C.I. 24.1% to 81.4% - Figure 2). The overall survival showed a significant difference (logrank test: p = 0.0064) between responders and non-responders (Figure 3). Adverse events recorded were as follows: moderate (grade 1 and 2) increase in transaminases in 4 cases (with reduction of danazol to 400 mg/day); 1 case of severe but reversible liver toxicity (grade 3) (with subsequently drug suspension); severe (grade 3) but reversible renal failure in 1 case (the drug was stopped); moderate (grade 1 and 2) increasing of serum creatinine in 6 case (with reduction of danazol to 400 mg/day in 2 of these); reversible cutaneous rash in 3 cases; amenorrhea in 1 case (the only fertile woman in the series); weight loss and loss of appetite in 1 case, weight gain in 1 case. Conclusion: Even if the mechanism of action of danazol in pts with MDS is unclear, this series confirms its efficacy to improve platelet count in the most of MDS pts with severe thrombocytopenia. The response was often clinically significant. It may not be immediate but seems to be reachable after 3-6 mo of treatment. A responsive patient has a good probability to maintain a long-lasting response. The toxicity profile of this drug is acceptable. Waiting for more effective options, danazol may be a good therapeutic option for these pts. Disclosures Riva: Jannsen and Cilag: Consultancy; Novartis: Consultancy; Celgene: Consultancy. Reda:Celgene: Consultancy; Janssen and Cilag: Consultancy; Gilead: Consultancy; ABBVIE: Consultancy. Molteni:AMGEN: Consultancy; Novartis: Consultancy; Italfarmaco: Consultancy; Celgene: Consultancy; Janssen and Cilag: Consultancy.


Author(s):  
Alexander Jahncke ◽  
Victoria Kay ◽  
Benjamin Fiore

ABSTRACT Trimethoprim–sulfamethoxazole, otherwise known as Bactrim or Septra, is a commonly prescribed antibiotic for soft tissue infections. Drug-induced thrombocytopenia is a rare but serious adverse reaction to sulfonamide antibiotics like Bactrim/Septra. A 34-year-old active duty marine male with no significant past medical history presented with a chief complaint of a rash on his lower extremities. The patient stated that 2 weeks earlier, he was prescribed Bactrim for cellulitis at the site of a new tattoo. The intern noted a petechial rash that was pathognomonic for thrombocytopenia. Laboratory testing confirmed the patient’s thrombocytopenia with platelets of 2,000/μL on initial complete blood count, without pancytopenia or other coagulopathies. The blood smear indicated a profound lack of platelets but otherwise normal cell counts and morphology. In the emergency department, the patient was typed and crossed, platelets were ordered, and hematology–oncology was consulted. Once admitted to the internal medicine ward, he was administered glucocorticoids as well as platelet transfusions. He was monitored for 3 days and discharged with a diagnosis of resolved drug-induced thrombocytopenia. This case illustrates the importance of conducting a thorough review of systems and physical examination in stable and otherwise healthy patients. In this case, the seemingly benign rash was one of the only clinical signs of severe thrombocytopenia, with a high risk of spontaneous bleeding in clinically significant organ systems. It is important to recognize immune thrombocytopenic purpura as a potential complication of Bactrim/Septra, as this antibiotic is widely used by military providers in operational settings.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 531-531 ◽  
Author(s):  
Damon E. Houghton ◽  
Jeffrey P. Laux ◽  
Nigel S. Key ◽  
Neil A Zakai ◽  
Thomas C. Shea ◽  
...  

Abstract Background: Venous thromboembolism (VTE), bleeding, and thrombocytopenia are common occurrences during treatment of hematological malignancies. When VTE is complicated by severe thrombocytopenia, the safety and efficacy of anticoagulation is unclear. Methods: Single center retrospective chart review of subjects between 4/2004-12/2015 with active hematological malignancy and either 1) acute or chronic VTE on anticoagulation before platelet count dropped below 50k/µL or 2) acute VTE occurring while platelets were <50k/µL. Primary outcomes: time to recurrent VTE or clinically significant bleeding within 100 days from onset of severe thrombocytopenia. Exclusion criteria: age <18 years, hospice care, heparin-induced thrombocytopenia, thrombotic thrombocytopenic purpura, or contraindication to anticoagulation (excluding thrombocytopenia). Charts were reviewed to determine anticoagulation management strategy during episodes of severe thrombocytopenia and to confirm primary outcomes.Kaplan-Meier curves were created from time to event data for recurrent VTE and clinically significant bleeding by anticoagulation strategy and was censored for death, lost to follow up, and the opposite outcome. Incidence rates (IR) and incidence rate ratios (IRR) were calculated using person time with platelets<50k/µLfor recurrent VTE, clinically significant bleeding, and combined incidence of bleeding or recurrent VTE (composite outcome). Results: Over 11.5 years, 78 patients met inclusion criteria. Mean age was 53 years (range 19-81) and median duration of severe thrombocytopenia was 14 days (IQR 6-35). The initial treatment strategies when platelets dropped below 50k/µL were (i) therapeutic dose of anticoagulation with supportive platelet transfusions to maintain a count > 40-50,000/µL (n=43, 55%), (ii) no anticoagulation (n=33, 42%), and (iii) reduced or prophylactic dose anticoagulation (n=2, 3%). Clinically significant bleeding occurred in 13 patients with a median number of days to bleed of 8 (interquartile range 5-22) with the majority (n = 11, 85%) occurring on or before day 30 (Figure). Two patients experienced a life threatening bleed. Recurrent VTE occurred in 6 patients with a median number of days to recurrence of 62 (IQR 40-91) with the majority occurring after day 40 (n = 5, 83%: Figure). The median platelet count most proximate to event: bleeding, 38k/µL (range 5k-212k); recurrent VTE, 225k/µL (range 21k-407k). No recurrent VTE or bleeding resulted in death. Clinically significant bleeding within 100 days after the onset of severe thrombocytopenia occurred in 12/45 (27%) patients receiving anticoagulation vs. 1/33 (3%) patients when anticoagulation was held (IRR 17.7, 95% CI 2.62-756.98). Recurrent VTE occurred in 1/45 (2%) patients in the anticoagulation group versus 5/33 (15%) patients when anticoagulation was held (IRR 0.3, 95% CI 0.01-2.64). The composite outcome occurred in 13/45 (29%) patients in the anticoagulation group versus 6/33 (18%) patients when anticoagulation was held (IRR 3.2, 95% CI 1.13-10.26). Conclusions: The significantly higher rate of major bleeding and composite outcome in patients getting therapeutic dose anticoagulation with supportive platelet transfusions during episodes of severe thrombocytopenia raises concerns over this treatment as the primary management strategy for VTE in patients with hematological malignancies and severe thrombocytopenia. Initially, bleeding risk is high on anticoagulation yet the risk of recurrent VTE is low. However, with time and platelet recovery these risks reverse. The fluctuating risk of bleeding and recurrent VTE over time in patients with hematological malignancies and severe thrombocytopenia illustrates that anticoagulation strategies should vary in aggressiveness depending on degree and duration of thrombocytopenia.Safety and efficacy trials incorporating dynamic risk-adapted anticoagulation strategies are urgently needed to determine the best treatment strategy for VTE occurring in patients with hematologic malignancies and severe thrombocytopenia. Acknowledgments: Supported by NIH CTSA at the University of North Carolina (UL1TR001111) and UNC Hematology T32 (5T32HL007149-39). Figure. Figure. Figure. Figure. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Silvius Frimmel ◽  
Michael Hinz ◽  
Joerg Henschel ◽  
Steffen Mitzner ◽  
Sebastian Koball

Abstract Background and Aims Hemolytic uraemic syndrome (HUS) is a known rare complication of Streptococcus pneumonia infections (SP-HUS) and is characterized by microangiopathic hemolytic anemia, thrombocytopenia and renal failure. In adults it is associated with a higher mortality than HUS due to other etiologies. Method Case Report Results A 33-years old female patient with a history of alcohol abuse was referred to hospital with hypotension and symptoms of infection, including high fever and diarrhea, which had occurred since three days. On admission the patient presented with septic shock and was transferred to the intensive care unit. There she showed signs of hemolytic uraemic syndrome, including severe thrombocytopenia (11 Gpt/l), schistocytosis, elevated lactate-dehydrogenase (LDH; max. 2300 U/l), low haptoglobine (&lt;0,3g/l) and acute anuric renal failure with need of continuous renal replacement therapy. Severe confusion and necrotic lesions of the extremities completed the clinical picture. Plasma exchange (PE) was initiated under suspected thrombocytopenic thrombotic purpura (TTP). Under PE the clinical situation did not ameliorate and signs of severe HUS persisted. A total of four PE were realized, TTP was excluded by Factor VIII-ADAMTS13-activity above the diagnostic limit. In the peripheral blood cultures Streptococcus pneumonia was detected, and antimicrobial was deescalated from piperacillin/tazobactam to penicillin G. Under the clinical picture of a persistent severe pneumococcal associated HUS, without clinical benefit of PE, we decided to start therapy with eculizumab, a monoclonal anti-C5-antibody, approved for the therapy of aHUS and with anecdotical evidence of efficacy in SP-HUS. We started with 1200 mg of ECZ, followed by doses of 900 mg weekly with a total of four doses. Under therapy thrombocyte count normalized, renal function ameliorated and dialysis could be discontinued, the levels of haptoglobin and LDH normalized. The patient could be referred to a rehabilitation clinic, where renal function normalized and no further signs of hemolysis were seen three months after discontinuation of therapy under monitoring. The forefoot remained necrotic with need of surgery in future, the ischemic lesions of the hands completely disappeared. Conclusion Eculizumab could provide a therapeutic option of pneumococcal associated HUS. Therapy could be safely discontinued after 1 month under strict monitoring of signs of HUS. Further studies are required to document the benefit of complement blockade therapy in severe forms of SP-HUS.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Ishigami ◽  
S Ikeda ◽  
K Doi ◽  
Y Hamatani ◽  
Y Ide ◽  
...  

Abstract Background Thrombocytopenia is sometimes found in routine blood tests and is associated with an increased risk of mortality in general population. We have previously reported that atrial fibrillation (AF) patients with thrombocytopenia have a higher mortality than those without thrombocytopenia. However, association of the degree of thrombocytopenia with cause of death in AF patients is unknown. Purpose We aimed to investigate the association of baseline platelet count with cause of death including cardiac death, intracranial death, malignancy, infection, extracranial bleeding death, renal failure death, respiratory failure death and undetermined death. Methods The Fushimi AF Registry was designed to enroll all of the AF patients in Fushimi-ku, Kyoto. Fushimi-ku is densely populated with a total population of 283,000 and is assumed to represent a typical urban community in Japan. We started to enroll patients from March 2011, and follow-up data with baseline platelet counts less than 150,000/μL were available in 853 patients by the end of September 2020. We divided them into 3 groups according to baseline platelet level: Mild thrombocytopenia (100,000–149,999/μL, n=703), Moderate thrombocytopenia (50,000–99,999/μL, n=120), and Severe thrombocytopenia (&lt;50,000/μL, n=30). Results In the entire cohort, the mean age was 76 years, 34% were women, the mean body weight and body mass index was 59.3 kg and 22.9 kg/m2, and the median platelet count were 121,000/μL (interquartile range 109,000 to 141,000/μL). Compared to Mild thrombocytopenia, patients with Moderate or Severe thrombocytopenia were more likely to have chronic kidney disease (42.2% vs 54.2% vs 73.3%, p=0.0003), have higher HAS-BLED score (1.90 vs 2.14 vs 2.00, p=0.047) and lower hemoglobin (12.8g/dL vs 11.7g/dL vs 11.2g/dL, p&lt;0.0001) and were less often prescribed anti platelet drugs. Age, sex, body weight, systolic blood pressure, previous stroke, previous major bleeding, hypertension, diabetes mellitus, CHADS2 score and CHA2DS2-VASc score were comparable between three groups. During the median follow-up period, the incidence rate (per 100 person-years) of all-cause death was 6.82 vs 15.27 vs 9.64. (p&lt;0.001) On univariate analysis, the incidence of all-cause death was higher in Moderate group than Mild group. (HR: 2.15; 95% CI 1.61–2.87, p&lt;0.0001), but there was no significant difference between Mild and Severe groups. (HR: 1.44; 95% CI 0.78–2.64, p=0.243). The incidence of cardiac death was comparable between three groups. (Mild vs Moderate: HR 0.65; 95% CI 0.15–2.75, p=0.56, Mild vs Severe: HR 1.11; 95% CI 0.15–8.23, p=0.92) Regarding other causes of death such as intracranial bleeding, extracranial bleeding, malignancy, infection, renal failure, respiratory failure and undetermined cause, there was no significant difference. Conclusion Mortality was higher according to the degree of thrombocytopenia in AF patients, but the cause of death was not different among three groups. FUNDunding Acknowledgement Type of funding sources: None.


2018 ◽  
Vol 2018 ◽  
pp. 1-6
Author(s):  
Natsuki Shima ◽  
Keiichi Sumida ◽  
Masahiro Kawada ◽  
Akinari Sekine ◽  
Masayuki Yamanouchi ◽  
...  

A 42-year-old woman with systemic lupus erythematosus (SLE) was admitted to our hospital for evaluation of severe thrombocytopenia. She was treated with steroids, intravenous cyclophosphamide, intravenous immunoglobulin, and plasma exchange, but her thrombocytopenia did not improve. Renal biopsy showed class IV-S(C) + V lupus nephritis, according to the classification of the International Society of Nephrology/Renal Pathology Society. The PA-IgG and serum thrombopoietin (TPO) levels were elevated. Her thrombocytopenia responded to off-label administration of eltrombopag, which was discontinued after 42 months. At 18 months after stopping eltrombopag, the platelet count was 19.3 × 104/μL. Eltrombopag may be a therapeutic option for SLE patients with severe thrombocytopenia refractory to conventional therapy.


Author(s):  
Alessandro Squizzato ◽  
Silvia Galliazzo ◽  
Elena Rancan ◽  
Marina Di Pilla ◽  
Giorgia Micucci ◽  
...  

AbstractOptimal management of venous thromboembolism (VTE) in cancer patients with thrombocytopenia is uncertain. We described current management and clinical outcomes of these patients. We retrospectively included a cohort of cancer patients with acute VTE and concomitant mild (platelet count 100,000–150,000/mm3), moderate (50,000–99,000/mm3), or severe thrombocytopenia (< 50,000/mm3). Univariate and multivariate logistic regression analyses explored the association between different therapeutic strategies and thrombocytopenia. The incidence of VTE and bleeding complications was collected at a 3-month follow-up. A total of 194 patients of whom 122 (62.89%) had mild, 51 (26.29%) moderate, and 22 (11.34%) severe thrombocytopenia were involved. At VTE diagnosis, a full therapeutic dose of LMWH was administered in 79.3, 62.8 and 4.6% of patients, respectively. Moderate (OR 0.30; 95% CI 0.12–0.75), severe thrombocytopenia (OR 0.01; 95% CI 0.00–0.08), and the presence of cerebral metastasis (OR 0.06; 95% CI 0.01–0.30) were independently associated with the prescription of subtherapeutic LMWH doses. Symptomatic VTE (OR 4.46; 95% CI 1.85–10.80) and pulmonary embolism (OR 2.76; 95% CI 1.09–6.94) were associated with the prescription of full therapeutic LMWH doses. Three-month incidence of VTE was 3.9% (95% CI 1.3–10.1), 8.5% (95% CI 2.8–21.3), 0% (95% CI 0.0–20.0) in patients with mild, moderate, and severe thrombocytopenia, respectively. The corresponding values for major bleeding and mortality were 1.9% (95% CI 0.3–7.4), 6.4% (95% CI 1.7–18.6), 0% (95% CI 0.0–20.0) and 9.6% (95% CI 5.0–17.4), 48.2% (95% CI 16.1–42.9), 20% (95% CI 6.6–44.3). In the absence of sound evidence, anticoagulation strategy of VTE in cancer patients with thrombocytopenia was tailored on an individual basis, taking into account not only the platelet count but also VTE presentation and the presence of cerebral metastasis.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Michinori Mayama ◽  
Mamoru Morikawa ◽  
Takashi Yamada ◽  
Takeshi Umazume ◽  
Kiwamu Noshiro ◽  
...  

Abstract Background Currently, there is a disagreement between guidelines regarding platelet count cut-off values as a sign of maternal organ damage in pre-eclampsia; the American College of Obstetricians and Gynecologists guidelines state a cut-off value of < 100 × 109/L; however, the International Society for the Study of Hypertension in Pregnancy guidelines specify a cut-off of < 150 × 109/L. We evaluated the effect of mild thrombocytopenia: platelet count < 150 × 109/L and ≥ 100 × 109/L on clinical features of pre-eclampsia to examine whether mild thrombocytopenia reflects maternal organ damage in pre-eclampsia. Methods A total of 264 women were enrolled in this study. Participants were divided into three groups based on platelet count levels at delivery: normal, ≥ 150 × 109/L; mild thrombocytopenia, < 150 × 109/L and ≥ 100 × 109/L; and severe thrombocytopenia, < 100 × 109/L. Risk of severe hypertension, utero-placental dysfunction, maternal organ damage, preterm delivery, and neonatal intensive care unit admission were analyzed based on platelet count levels. Estimated relative risk was calculated with a Poisson regression analysis with a robust error. Results Platelet counts indicated normal levels in 189 patients, mild thrombocytopenia in 51 patients, and severe thrombocytopenia in 24 patients. The estimated relative risks of severe thrombocytopenia were 4.46 [95 % confidence interval, 2.59–7.68] for maternal organ damage except for thrombocytopenia, 1.61 [1.06–2.45] for preterm delivery < 34 gestational weeks, and 1.35 [1.06–1.73] for neonatal intensive care unit admission. On the other hand, the estimated relative risks of mild thrombocytopenia were 0.97 [0.41–2.26] for maternal organ damage except for thrombocytopenia, 0.91 [0.62–1.35] for preterm delivery < 34 gestational weeks, and 0.97 [0.76–1.24] for neonatal intensive care unit admission. Conclusions Mild thrombocytopenia was not associated with severe features of pre-eclampsia and would not be suitable as a sign of maternal organ damage.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S438-S439
Author(s):  
Tanner M Johnson ◽  
Amanda Howard ◽  
Kerry Schwarz ◽  
Lorna Allen ◽  
Misha Huang ◽  
...  

Abstract Background Recurrent Clostridioides difficile infection (rCDI) within 180 days of the index episode is associated with a 33% increase in mortality and, to-date, few treatment options exist to prevent recurrent infection. Bezlotoxumab (BEZ) is a novel therapeutic option for the prevention of rCDI, yet limited data exist regarding its effectiveness in patients at high-risk for recurrence outside of controlled trials. This study aimed to compare BEZ to a historical standard of care (SoC) cohort for the prevention of rCDI in patients at high risk for recurrence. Methods A multi-center retrospective cohort study of patients within an academic health-system with one or more risk factors for rCDI. Patients received SoC with oral vancomycin (VAN) or fidaxomicin (FDX) from January 2015 to December 2017 or BEZ, in addition to oral SoC, from September 2017 to September 2019. The primary outcome was rCDI within 90 days of completion of oral VAN or FDX. Secondary outcomes included all-cause readmission, all-cause mortality, and safety events at 90 days. Results One-hundred twenty patients received BEZ in addition to SoC (n=47) or SoC alone (n=73). Mean (SD) age was 55 (16) years, mean (SD) number of lifetime CDI was 3 (2) episodes, and 30.8% of patients had severe CDI. Six (12.8%) patients in the BEZ cohort and thirty-one (42.5%) in the SoC cohort experienced rCDI at 90 days [OR (95% CI) = 0.20 (0.07-0.53), p=&lt; 0.01]. Incidence of all-cause mortality (2.1% vs 5.5%, p=0.67) and all-cause readmission (42.6% vs 56.2%, p=0.20) within 90 days were not statistically different between groups. Patient body weight, timing of BEZ administration, CDI severity, nor prior receipt of fecal microbiota transplantation significantly affected BEZ effectiveness. BEZ was well tolerated with one infusion-related reaction. There were no heart failure exacerbations among BEZ recipients and two exacerbations identified from control group. Conclusion In patients with at least one risk factor for rCDI, BEZ in addition to SoC was associated with lower rates of recurrent infection than SoC alone and may be a reasonable adjunct therapy in high risk patient populations. Disclosures matthew miller, PharmD, Allergan (Speaker’s Bureau)Tetraphase (Speaker’s Bureau)


2015 ◽  
Vol 8 (2) ◽  
pp. 256-263 ◽  
Author(s):  
Jiaxin Niu ◽  
Teresa Goldin ◽  
Maurie Markman ◽  
Madappa N. Kundranda

Background: Immune thrombocytopenic purpura (ITP) is a rare acquired bleeding disorder with an estimated incidence of 1 in 10,000 people in the general population. The association of ITP with breast cancer is an even rarer entity with very limited reports in the English literature. Case Presentation: We report a case of a 51-year-old female with no significant past medical history who presented with sudden onset of malaise, syncope, gingival bleed and epistaxis. She was found to have severe thrombocytopenia (platelet count 6,000/μl) and anemia (hemoglobin 7.2 g/dl). Her workup led to the diagnosis of metastatic ductal breast cancer with extensive bone metastasis. Bone marrow biopsy demonstrated myelophthisis which was initially thought to be consistent with her presentation of thrombocytopenia and anemia. Therefore, the patient was started on hormonal therapy for the treatment of her metastatic breast cancer. After 3 months of therapy, she did not improve and developed severe mucosal bleeding. Her clinical presentation was suspicious for ITP and immune-mediated anemia, and hence she was started on steroids and intravenous immunoglobulin. The patient had a dramatic response to therapy with normalization of her platelet count and hemoglobin within 2 weeks. Conclusion: To our knowledge, this is the first reported case of metastatic breast cancer presenting with symptomatic ITP and anemia, and both symptoms are postulated to be immune-mediated.


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