Idraparinux versus standard therapy in the treatment of deep venous thrombosis in cancer patients: A subgroup analysis of the Van Gogh DVT trial

2010 ◽  
Vol 104 (07) ◽  
pp. 86-91 ◽  
Author(s):  
Alexander Cohen ◽  
Bruce Davidson ◽  
Herve Decousus ◽  
Alexander Gallus ◽  
Michael Gent ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Cancer Patients ◽  
Standard Therapy ◽  
Standard Treatment ◽  
Therapy Group ◽  
Vitamin K Antagonists ◽  
Hazard Ratio ◽  
Standard Therapy Group ◽  
Van Gogh

SummaryStandard treatment with heparin followed by vitamin K antagonists is frequently complicated by bleeding and recurrent venous thromboembolism (VTE) in cancer patients with VTE. To compare the efficacy, safety and overall survival of long-term idraparinux treatment to standard therapy in cancer patients we conducted a post-hoc analysis in the subgroup of non-active and active cancer patients included in the Van Gogh DVT clinical trial. The cancer patients with deep venous thrombosis (DVT) and without pulmonary embolism (PE) were randomised to standard treatment or a once-weekly subcutaneous injection of idraparinux (2.5 mg), a synthetic pentasaccharide. 421 cancer patients were included. A total of 220 patients received idraparinux and 201 were allocated to standard therapy for three months (8%) or six months (92%). A recurrent VTE was observed during the first six months in 2.5% (n=5) of the idraparinux recipients compared to 6.4% (n=12) in the standard therapy group (hazard ratio 0.39, 95% confidence interval [CI]; 0.14–1.11). The rate of bleeding was comparable (odds ratio 0.89, 95% CI; 0.50–1.59). The outcomes were similar at three months after randomisation in all patients. Of the idraparinux recipients, 22.7% (n=50) died during the study period compared to 48 patients (23.9%) in the standard treatment group (hazard ratio 0.99, 95% CI; 0.66–1.48). In conclusion, no significant safety or survival differences were observed between cancer patients with DVT treated with idraparinux for six months compared to standard therapy. Fewer recurrent VTEs were observed in the idraparinux group; however, this was not statistically significant and also because of study limitations this should be interpreted with caution.

scholarly journals The Effects of Synbiotic “Bifidobacterium lactisB94 plus Inulin” Addition on Standard Triple Therapy ofHelicobacter pyloriEradication in Children

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Gonca Handan Ustundag ◽  
Halime Altuntas ◽  
Yasemin Dilek Soysal ◽  
Furuzan Kokturk
Keyword(s):  
Triple Therapy ◽  
Standard Therapy ◽  
Therapy Group ◽  
Symptom Relief ◽  
Standard Therapy Group ◽  
Bifidobacterium Lactis ◽  
Standard Triple Therapy ◽  
H Pylori ◽  
Intent To Treat ◽  
Infection Eradication

Aim. The aim of this study is to evaluate the effects of the synbioticBifidobacterium lactisB94 plus inulin addition to the standard triple therapy onHelicobacter pylori (H. pylori)infection eradication rates.Methods. Children aged 6–16 years who had biopsy provenH. pyloriinfection were randomly classified into two groups. The first group received the standard triple therapy consisting of amoxicillin + clarithromycin + omeprazole. The second group was treated with the standard triple therapy andBifidobacterium lactisB94 (5 × 109 CFU/dose) plus inulin (900 mg) for 14 days, concurrently. Eradication was determined by14C-urea breath test 4–6 weeks after therapy discontinuation.Results. From a total of 69H. pyloriinfected children (F/M = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20/34 participants in the standard therapy group and 27/35 participants in the synbiotic group. The eradication rates were not significantly different between the standard therapy and the synbiotic groups [intent-to-treat, 58.8% and 77.1%, resp.,p= 0.16; per-protocol, 64.5% and 81.8%, resp.,p= 0.19]. There was no difference between the groups in terms of symptom relief (p= 0.193). The reported side effects were ignorable.Conclusion. Considering the eradication rates, synbiotic addition to therapy showed no superiority over the standard triple therapy conducted alone. This trial is registered withNCT03165253.

Efficacy of Atorvastatin Plus Pegylated Interferon and Ribavirin Versus Pegylated Interferon and Ribavirin Alone in Chronic Hepatitis C Patients with Genotype-3a

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Waqas Gulzar ◽  
Zafar Niaz ◽  
Sami Ullah Mumtaz ◽  
Somia Iqtadar ◽  
Tayyeba Komal ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Standard Therapy ◽  
Therapy Group ◽  
Pegylated Interferon ◽  
Rapid Virological Response ◽  
Standard Therapy Group ◽  
The Mean ◽  
Genotype 3A

Chronic hepatitis C infection has created a huge burden of disease causing serious healtheffects. The combination therapy used to treat hepatitis C virus (HCV) infection includes Pegylatedinterferon and Ribavirin. As cholesterol biosynthesis plays a pivotal role in HCV replication, the use ofvarious statins has been associated with higher sustained viral response Objective: To compare theefficacy of atorvastatin plus pegylated interferon and ribavirin versus pegylated interferon and ribavirinalone in patients of chronic hepatitis C with genotype-3a Methods: This Randomized controlled trial wasconducted at outpatient department, Mayo Hospital Lahore for six months i.e. May to November 2017.After ethical approval, 60 patients of ages 25 to 55 years of either gender with chronic hepatitis C withgenotype 3a were included in the study. Informed consent was taken from all patients. Then patients wererandomly allocated into two groups “A” and “B” using random number table. Patients in Group A receivedstandard of care treatment for chronic hepatitis C i.e. pegylated interferon and ribavirin while the patientsin Group B also received tab atorvastatin along with the standard treatment. Patients were follow up for 4week. Blood samples were collected and HCV RNA detection. All this information were entered inproforma Results: In standard therapy group, the mean age of patients was 39.50±8.39years. Inatorvastatin plus standard therapy group, the mean age of patients was 34.30±6.78years. In standardtherapy group, there were 25 (83.3%) males and 5 (16.7%) females. In atorvastatin plus standard therapygroup, there were 16 (53.3%) males and 14 (46.7%) females. After 4 weeks, Rapid Virological Response(RVR) was achieved in 4 (13.3%) patients in standard therapy group while in 14 (46.7%) in atorvastatin plusstandard therapy group. The difference was significant (p<0.05) Conclusions: Atorvastatin incombination with Pegylated interferon and ribavirin have better efficacy as compared to Pegylatedinterferon & ribavirin alone in chronic hepatitis C-3a.

Addition of the Oral NK1 Antagonist Aprepitant to Standard Antiemetics Provides Protection Against Nausea and Vomiting During Multiple Cycles of Cisplatin-Based Chemotherapy

2003 ◽  
Vol 21 (22) ◽  
pp. 4105-4111 ◽  
Author(s):  
R. de Wit ◽  
J. Herrstedt ◽  
B. Rapoport ◽  
A.D. Carides ◽  
G. Carides ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Therapy Group ◽  
Rescue Therapy ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Cumulative Probability ◽  
Pharmacokinetic Data ◽  
Standard Therapy Group ◽  
Nk1 Antagonist ◽  
Multiple Cycles

Purpose: This analysis evaluated whether the antiemetic efficacy of the NK1 receptor antagonist aprepitant (EMEND™, Merck, Whitehouse Station, NJ) plus standard antiemetics could be sustained for up to six cycles of cisplatin-based chemotherapy. Patients and Methods: Patients receiving cisplatin ≥ 70 mg/m2 were blindly assigned to receive one of the following three regimens: (1) aprepitant 375 mg 1 hour before cisplatin on day 1 and aprepitant 250 mg on days 2 to 5 (n = 35); (2) aprepitant 125 mg before cisplatin and aprepitant 80 mg on days 2 to 5 (n = 81); or (3) placebo before cisplatin on days 2 to 5 (n = 86). All groups received ondansetron 32 mg and dexamethasone 20 mg before cisplatin, and dexamethasone 8 mg on days 2 to 5. The primary end point was complete response (no emesis and no rescue therapy) over 5 days following cisplatin in up to six cycles. A cumulative probability analysis using a model for transitional probabilities was used to analyze the data. The aprepitant 375/250-mg regimen was discontinued early in light of new pharmacokinetic data. Results: In the first cycle, 64% of patients in the aprepitant group and 49% in the standard therapy group had a complete response. Thereafter, complete response rates for the aprepitant group were still 59% by cycle 6, but decreased to 34% by cycle 6 for the standard therapy group. Reasons for discontinuation were similar across treatment groups. Conclusion: Compared with patients who received standard therapy, those who received only the aprepitant regimen had better and more sustained protection against chemotherapy-induced nausea and vomiting over multiple cycles.

Peripherally Inserted Central Catheter (PICC) Related Deep Venous Thrombosis: A Retrospective Cohort Study on Incidence and Risk Factors in a Single Center

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 30-31
Author(s):  
June Iriondo ◽  
Oihane Iñarra ◽  
Beatriz Sarriegui ◽  
Nekane Sanz ◽  
Maialen Lasa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Cancer Patients ◽  
Potential Risk ◽  
Thrombotic Event ◽  
Secondary Outcome ◽  
Effective Prevention ◽  
Potential Risk Factors ◽  
Central Catheters

INTRODUCTION: The use of Peripherally Inserted Central Catheters (PICCs) has increased significantly in the last years due to their advantages compared to the other types of central catheters: easier and protocolized insertion by specialized nurse-led teams; cost-effectiveness; ease of management, ... However, an increase in the incidence of Catheter Related Thrombosis (CRT) has been observed with this type of device, especially in cancer patients and in the critical care setting. The main objective of this study is to determine the incidence of PICC related deep venous thrombosis in oncologic and onco-hematologic patients at the Donostia University Hospital, in Spain. The secondary outcome is the identification of possible risk factors associated with this event. METHODS: Using the database created and handled by the nurse-led Intravenous Therapy Team (ITT) in our center, in which all inserted PICCs are prospectively and consecutively included since 2011, a retrospective analysis was conducted on oncology and hemato-oncology-derived adult patients (over 18 years old) with a PICC inserted between May 15th 2018 and December 15th 2019. In the total population, several characteristics of the patient, of the PICC and of the thrombotic event were descriptively analyzed, and a bivariant analysis of four potential risk factors was carried out using Pearson's Chi-squared test. Patient and CRT treatment-associated risk factors were more exhaustively analyzed in the subgroup of patients with CRT. The missing data were obtained from the electronic clinical history records. RESULTS: The final study sample consisted of 1024 PICCs (n=1024), 19,10% (n=313) derived from the Hematology department and 43,62% (n=715) from the Oncology department (tables 1 and 2). The global incidence of CRT was 4,9% (n=50): 5.8% in hematologic patients and 4.5% in patients derived from Oncology. In the bivariant analysis no significant association was found between the selected potential risk factors (department of origin, PICC lumen number, PICC material and the catheter-to-vessel ratio) and CRT (table 3). In terms of the treatment administered to patients presenting CRT, in 80% of the cases (n=40) a Low Molecular Weight Heparin (LMWH) at therapeutic dose was initiated; in 10% (n=5) LMWH at a lower dose, and in 2 patients treatment could not be initiated because of thrombopenia. Finally, the PICC was withdrawn in only 8 patients after the diagnosis of the thrombotic event. CONCLUSIONS: The majority of the studies on PICC associated venous thrombosis in cancer patients are small, observational, retrospective, and without comparison groups. Here we present a work with an important sample size, a homogeneous population and with a prospective data collection. The CRT incidence has been similar to that described in the literature and significant association has not been found between the included potential risk factors and CRT. In conclusion, this study reflects the need of more trials on this subject, in particular to identify CRT risk factors in order to design effective prevention strategies. Disclosures No relevant conflicts of interest to declare.

The Risk of Deep Venous Thrombosis and Sepsis in Cancer Patients Due to PICC Lines.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4082-4082
Author(s):  
Lee Lin ◽  
Stanley Walker
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Cancer Patients ◽  
Upper Extremity ◽  
Retrospective Chart Review ◽  
Small Population ◽  
Average Patient ◽  
Cancer Types ◽  
Picc Line

Abstract Context Upper extremity deep venous thrombosis (DVT) represents 8–10% of total DVT of the limb. Long term central venous catheters represent a major cause of upper extremity DVT, especially in cancer patients. This study looks specifically at the risk posed by peripherally inserted central catheters (PICC). Purpose of the Study: To assess the risk of DVT and sepsis due to PICC lines in cancer patients as compared to non-cancer patients. Furthermore, to assess the risk of PICC line related DVT and sepsis among different cancer types. Design, Setting, and Patients: Retrospective chart review of all 190 patients (representing n=244 procedures) who had undergone a PICC line procedure in Union Memorial Hospital (Baltimore, MD) from August 2003 to December 2003. Based on their medical records, it was determined whether or not the patient had experienced PICC line related sepsis or thrombosis. Cancer as a potential risk factor was included in the information collected. 33 of 190 patients were cancer patients. Average patient age 56.7 years. Results: Preliminary results show that from August 1, 2003 to December 5, 2003, among the non-cancer patients 6 (3.8%) patients with DVT and 6 (3.8%) patients with sepsis were identified. Among the cancer patients, 3 (9.1%) patients with DVT and 3 (9.1%) patients with sepsis were identified. Though cancer patients made up only 17.4% of the patient population, they represented 33.3% of the cases of DVT and sepsis. Conclusion: Cancer patients are at a greater risk of thromboses and sepsis due to PICC lines as compared to non-cancer patients. Cancer patients, therefore, represent a unique population of PICC line patients who may require a different protocol of prophylaxis and complication prevention. While different types of cancers may pose different levels of risk (Sorensen et al), this could not be determined with confidence with the preliminary findings due to the small population evaluated so far. Non-cancer patients Cancer patients DVT 6 3.8% Sepsis 6 3.8% DVT 3 9.1% Sepsis 3 9.1%

Risk for deep venous thrombosis in pediatric cancer patients undergoing surgery

2021 ◽  
Author(s):  
Hannah R Spiegl ◽  
Jeremie H. Estepp ◽  
Chen Li ◽  
Sebastian Gil ◽  
Ankush Gosain ◽  
...  
Keyword(s):  
Venous Thrombosis ◽  
Deep Venous Thrombosis ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Pediatric Cancer Patients
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