scholarly journals Long-Term Use of Low-Molecular-Weight Heparins (LMWH) for Cancer-Associated Venous Thromboembolism (VTE): Patients’ Perception in Tropique, a Prospective, Multicenter, Observational Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4272-4272 ◽  
Author(s):  
Dominique Farge ◽  
Philippe Debourdeau ◽  
Norbert Claude Gorin ◽  
Anne Lamblin ◽  
Francis Cajfinger
Keyword(s):  
Side Effects ◽  
Treatment Satisfaction ◽  
Research Funding ◽  
Symptom Relief ◽  
Term Treatment ◽  
Anticoagulant Treatment ◽  
Treatment Expectations ◽  
Patients With Cancer ◽  
Long Term Treatment

Abstract Introduction Long-term treatment with LMWH is the recommended standard for patients with cancer-associated VTE [1, 2]. Data on the long-term prescription of LMWH and treatment follow-up in clinical practice, and particularly the patient’s view on the treatment, are scarce. The main objective of TROPIQUE was to document the prescription and use of LMWH in these patients. A sub-study aimed to assess patients’ perception of long-term anticoagulant treatment with LMWH based on the validated Perception AntiCoagulant Treatment Questionnaire (PACT-Q) [2]. Methods Adult cancer patients with recent symptomatic VTE from the TROPIQUE study were asked to fill-in a PACT-Q at inclusion and at 6 months or study end. PACT-Q1 administered at study start included “Treatment Expectations” (7 items) measured by separate scores expressed on a 5-point Likert scale. PACT-Q2 performed at 6 months or at the end of the study included “Convenience” and “Anticoagulant Treatment Satisfaction” (13 and 7 items, respectively) measured by global scores on a 0-to-100 scale. Results A total of 409 patients (49.9% female), aged 65±12.1 years, were consecutively included from November 2012 to August 2013. Most of cancers were solid tumors; 81% of patients received chemotherapy and 60.9% of cancers were metastatic. Mean treatment duration was 5.28 ± 2.07 months and 98.0% of patients were treated for 3 months or more. PACT-Q1 and PACT-Q2 were collected on a voluntarily basis from 269 (67.8%) and 139 (34.0%) patients, respectively. At study start patients’ treatment expectations were high, particularly regarding the confidence in the treatment to prevent blood clots (mean 3.94 ± 0.75), the expectations of symptom relief (mean 3.98 ± 1.04) and the importance of ease of use (mean 4.22 ± 0.9) while 54.3% of patients had low or no expectations of treatment-related side effects (bruise, bleeding) (mean 2.45±1.1). The treatment was considered convenient (global score 79.7 ± 17.1), with the majority of patients reporting small or no difficulties with taking the treatment (subcutaneous injections) and with regards to impact on daily life. The impact of treatment-related side effects on activities was reported as low. A proportion of 69.1% of patients were overall satisfied or very satisfied with their anticoagulant treatment whereas the experience with treatment-related side effects was worse or much worse than expected for only 12.9% of patients. The “Anticoagulant Treatment Satisfaction” global score was 62.9 ± 16.7. Abstract 4272. Table 1: Cancer patient’s perception of long-term anticoagulant treatment with LMWH [n (%)] Selected perception items* Not at all or to a small extent Moderately Very much or extremely Mean score on Likert scale ± SD PACT-Q1 Treatment expectations (n=269) Confident in preventing clots Symptom relief Side effects (n=267) Importance of ease to use - 10 (3.7) 22 (8.2) 145 (54.3) 17 (6.3) - 45 (16.7) 38 (14.1) 76 (28.5) 14 (5.2) - 214 (79.6) 209 (77.7) 46 (17.2) 238 (88.5) - 3.94 ± 0.75 3.98 ± 1.04 2.45 ± 1.1 4.22 ± 0.9 PACT-Q2 Convenience (n=138) Difficulty in taking treatment (n=137) Difficulties regarding daily life Bother in follow-up required Difficulties on regular intake Side effects impact on activities - 92 (67.2) 101 (73.2) 101 (73.2) 114 (82.6) 116 (84.1) - 37 (27) 26 (18.8) 16 (11.6) 17 (12.3) 14 (10.1) - 8 (5.8) 11 (8.0) 7 (5.1) 7 (5.1) 8 (5.8) 79.7 ± 17.1 Treatment satisfaction (n=137) Experience with side effects (n=132) Worse or much worse 17 (12.9) As expected 55 (41.7) Better or much better 60 (45.5) 62.9 ± 16.7 Overall satisfaction (n=136) Unsatisfied or very unsatisfied 10 (7.4) Neutral 32 (23.5) Satisfied or very satisfied 94 (69.1) *Only some items selected from the PACT questionnaire are shown Conclusion Patients with cancer-associated VTE had high expectations regarding anticoagulant treatment and long-term treatment with LMWH is perceived as convenient with a high degree of patient satisfaction. These results suggest that cancer patient’s capability to accept long-term injectable anticoagulant treatment is probably underestimated. These encouraging observations of patient perception of the anticoagulant therapy are essential in view of improving health professional’s adherence to established treatment recommendations on cancer-associated VTE [3]. 1- Farge D, J Thromb Haemost. 2013 Jan;11(1):56-70. 2- Prins MH, Health Qual Life Outcomes, 2009. 7: p. 9. 3- Debourdeau P, Support Care Cancer. 2008 Dec;16(12):1333-41 Disclosures Farge: Pfizer: Research Funding; LEO Pharma: Research Funding. Debourdeau:Pfizer: Research Funding; LEO Pharma: Research Funding. Cajfinger:Pfizer: Research Funding; LEO Pharma: Research Funding.

scholarly journals Long-Term Efficacy and Safety of Low-Molecular-Weight Heparins (LMWH) for Cancer-Associated Venous Thromboembolism (VTE) in Tropique, a Prospective Non-Interventional Observational Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4273-4273 ◽  
Author(s):  
Dominique Farge ◽  
Philippe Debourdeau ◽  
Norbert Claude Gorin ◽  
Anne Lamblin ◽  
Francis Cajfinger
Keyword(s):  
Major Bleeding ◽  
Research Funding ◽  
Term Treatment ◽  
Efficacy And Safety ◽  
Patients With Cancer ◽  
Recommended Treatment ◽  
Long Term Treatment ◽  
History Of ◽  
Antineoplastic Treatment

Abstract Introduction Long-term treatment with LMWH is the standard therapy for patients with cancer-associated VTE. Recommended treatment regimen include the prescription of LMWH at treatment doses according to approved administration schedule for at least 3 months in the absence of severe renal insufficiency (CrCl<30 mL/min) [1, 2]. The TROPIQUE study documented the prescription and use of long-term treatment with LMWH in cancer patients. Here we report the findings on the secondary outcomes, clinical efficacy and safety. Methods Adult patients with cancer-associated VTE receiving antineoplastic treatment or palliative care were eligible to participate. Efficacy outcomes measures were VTE recurrence including deep-vein thrombosis (DVT) and pulmonary embolism (PE), visceral thrombosis and central venous catheter (CVC)-associated thrombosis. Safety outcomes included all and major bleeding according to ISTH definition [3], thrombocytopenia and deaths. Incidences of 7% of VTE recurrence and 6% of major bleeding were expected. With a sample of 384 patients, the rate of VTE recurrence and major bleeding would be detected with a precision of ±2.6% and ±2.4%, respectively, with a 95% confidence interval. A total of 400 patients were therefore planned to be included in the study. Results A total of 409 patients with symptomatic cancer-associated VTE (Table 1) aged 65±12.1 years of whom 49.9% female were consecutively included from November 2012 to August 2013. A history of previous VTE was found in 54 (13.2%), surgery or trauma in 100 (24.4%), CVC in 303 (74.1%) and an immobilization over 1 month in 47 (11.5%) patients, respectively. At study inclusion, 30 (7.3%) patients had platelet count ≤ 100 x109/L, and 129 (31.5%) had reported anemia while 16 (3.9%) patients had a history of bleeding in the last month. At baseline, more than 80% of patients presented with at least a PE or a lower-limb DVT of s. Table 1 VTE diagnosis at baseline (patients at least with one of the following) VTE diagnosis (at least one of the following) n (%) PE 145 (35.5) DVT lower limb 193 (47.2) Proximal 107 (56.0) Distal 72 (37.7) DVT upper limb 45 (11.0) Visceral thrombosis 16 (3.9) CVC-associated thrombosis 66 (16.1) Mean treatment duration was 5.28 ± 2.07 months. As the majority of patients were treated with tinzaparin (73.6%), clinical outcomes are therefore presented for tinzaparin, other LMWH and all LMWH (Table 2). A total of 21 events of VTE recurrence occurred in 19 patients during the overall study period, with a Kaplan-Meir estimate of the probability of VTE recurrence at 6 months of 6.1%. Table 2 Outcomes in patients with cancer-associated VTE treated with long-term LMWH [n (%)]. Patients treated Tinzaparin n=301 Other LMWH n=108 All LMWH n=409 Patients documented n=292 n=100 n=392 Patients with at least 14 (4.8) 5 (5) 19 (4.8)  one VTE recurrence - - - Events (2 patients had 3 4 7  more than one event) 5 1 6 DVT 0 1 1 PE 6 1 7 Visceral thrombosis CVC-associated thrombosis Bleeding n=292 n=100 n=392 All 44 (15.1) 11 (11.0) 55 (14.0) Major 16 (5.5) 7 (7.0) 23 (5.9) Thrombocytopenia n=290 n=100 n=390  (n platelets/mm3) 53 (18.3) 15 (15.0) 68 (17.4) All n=65 n=17 n=82 < 50,000 22 5 27 Drop > 50% 15 2 17 Deaths n=301 n=107 n=408 All 102 (33.9) 44 (41.1) 146 (35.8) Cause of death* n=100 n=44 n=144 LMWH treatment** 1# 0 1## Cancer 87 39 126 Sepsis 4 1 5 Bleeding 4 1 5 Antineoplastic treatment 1 0 1 PE 0 1 1 Other 7 3 10 *Multiple causes of death may have been reported in the same patient; **fatal bleeding reported as LMWH-related; #n=99; ## n=143 Kaplan-Meier estimate of the probability of bleeding at 6 months was 15.9% while corresponding estimates were 18.1% for thrombocytopenia and 34.5% for deaths. Of the five (3.5%) patients who reported fatal bleedings one was reported as related to the LMWH treatment. No heparin-induced thrombocytopenia was reported in the study. Conclusion Clinical outcomes were consistent with previous observations in this patient population except a lower incidence of VTE recurrence compared with previous studies. Study results tend to confirm the favorable efficacy and safety profile of LMWH for the long-term treatment of patients with cancer-associated VTE, when used according to recommended treatment duration and respecting contra-indications. Schulman. J Throm Haemost. 2005 Apr;3(4):692-4.Farge J Thromb Haemost. 2013 Jan;11(1):56-70.Debourdeau P, J Thromb Haemost. 2013 Jan;11(1):71-80 Disclosures Farge: Pfizer: Research Funding; LEO Pharma: Research Funding. Debourdeau:Pfizer: Research Funding; LEO Pharma: Research Funding. Cajfinger:Pfizer: Research Funding; LEO Pharma: Research Funding.

Patients’ perception of long-term, low-molecular weight heparins for cancer-associated thrombosis (CAT): Treatment expectations, convenience, and satisfaction related to patient profile.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 88-88
Author(s):  
Francis Cajfinger ◽  
Dominique Farge-Bancel ◽  
Nicolas Falvo ◽  
Marie-Antoinette Sevestre ◽  
Anne Lamblin ◽  
...  
Keyword(s):  
Treatment Satisfaction ◽  
Symptom Relief ◽  
Ease Of Use ◽  
Anticoagulant Treatment ◽  
Treatment Expectations ◽  
High Expectations ◽  
Patient Profile ◽  
Lower Treatment ◽  
Cancer Associated Thrombosis

88 Background: In the TROPIQUE study CAT pts had high expectations for anticoagulant treatment & long-term LMWH was perceived as convenient with high degree of treatment satisfaction. In this study, using the Perception of Anti-Coagulant Treatment Questionnaires (PACT-Q), we assessed the inpact of patient profile on treatment expectations, convenience and satisfaction. Methods: PACT-Q (1&2) were proposed on a voluntarily basis to cancer pts recently diagnosed with symptomatic venous thromboembolism; the global mean scores±SD was correlated to pts characteristics. Results: 269 PACT-Q1 & 139 PACT-Q2 were analysed &135 pts done both of them. In all pts, the highest mean scores were for expectations of symptom relief (4.22±0.9), confidence in preventing clots (3.98±1.04) & importance of simplicity of use (3.94±0.75). For clot prevention men were more confident (4.06±0.81) vs women (3.85±0.88). Expectations of symptom relief was higher in women (4.07±0.98) vs men (3.89±1.09). Importance of ease of use was higher in treated pts (4.27±0.89) vs no therapy (4.00±0.99) & pts with age ≥ 49 (4.46±0.59) vs < 49 years (3.98±1.07). At the end of the study, PACT-Q2 answers showed, an Anticoagulant Treatment Satisfaction scores of 62.9±16.7. 67.2% of pts felt strongly reassured & 48.5% were satisfied with symptom decrease. 69.1% of pts were satisfied / very satisfied with their anticoagulant treatment. Treatment-related side effects were as expected (41.7%), better/much better than expected (45.5%). 80.6% of pts reported higher ease with tinzaparin and 76.2% with other LMWH. According to pts characteristics, satisfaction was higher in men (64.4±17.7) vs women (61.0±15.0), in non-metastatic (64.6±16.9) vs metastatic (61.1±16.2). ECOG (3-4) pts reported lower treatment convenience with higher satisfaction vs ECOG (0-1); 80.0% of ECOG (3-4) pts were satisfied/very satisfied with anticoagulant treatment. 70.0% of ECOG (1-0) patients stated symptom decrease & 80.0 % a feeling of reassurance. Conclusions: pt’s profile influenced positively the perception of long-term LMWH treatment but not the convenience & treatment satisfaction.

Advances in the Management of Parkinsons Disease

1976 ◽  
Vol 21 (3) ◽  
pp. 139-148 ◽  
Author(s):  
C. D. Marsden
Keyword(s):  
Side Effects ◽  
Replacement Therapy ◽  
Term Treatment ◽  
Parkinsons Disease ◽  
Complex Time ◽  
Optimum Dosage ◽  
New Approaches ◽  
Long Term Treatment ◽  
Near Future

The treatment of Parkinson's disease today is complex, time-consuming, but rewarding. The introduction of levodopa has not cured the disease, but has provided the most powerful therapy available yet. Its use is limited by side effects and careful titration to optimum dosage, often in combination with other drugs, is required. Despite best therapy, some patients never respond, and others begin to lose benefit after some years of therapy. New problems, such as the ‘on-off’ effect have appeared with long-term treatment, and require careful adjustment of dosage. As with any replacement therapy, a balance between sub-optimal benefit and side effects has to be discovered and maintained by careful and frequent review. New approaches to treatment may offer further improvement in the near future.

The Common Side Effects of Long Term Treatment with Clozapine and Their Impact: a Sri Lankan Experience

2015 ◽  
Vol 30 ◽  
pp. 1586
Author(s):  
S.W. Kotalawala ◽  
K.P.M. Dalpatadu ◽  
C.U. Suraweera ◽  
K.G.C.L. Kapugama ◽  
H.G.V.W. Wijesiri ◽  
...  
Keyword(s):  
Side Effects ◽  
Term Treatment ◽  
Sri Lankan ◽  
Long Term Treatment ◽  
The Common

Lithium and related mood stabilizers

2012 ◽  
pp. 1198-1208
Author(s):  
Robert M. Post
Keyword(s):  
Bipolar Disorder ◽  
Side Effects ◽  
Mood Stabilizer ◽  
Term Treatment ◽  
Careful Consideration ◽  
Mood Stabilizers ◽  
Illness Onset ◽  
Predictors Of Response ◽  
Long Term Treatment

Lithium is the paradigmatic mood stabilizer. It is effective in the acute and prophylactic treatment of both mania and, to a lesser magnitude, depression. These characteristics are generally paralleled by the widely accepted anticonvulsant mood stabilizers valproate, carbamazepine (Table 6.2.4.1), and potentially by the less well studied putative mood stabilizers oxcarbazepine, zonisamide, and the dihydropyridine L-type calcium channel blocker nimodipine. In contrast, lamotrigine has a profile of better antidepressant effects acutely and prophylactically than antimanic effects. Having grouped lithium, valproate, and carbamazepine together, it is important to note they have subtle differences in their therapeutic profiles and differential clinical predictors of response (Table 6.2.4.1). Response to one of these agents is not predictive of either a positive or negative response to the others. Thus, clinicians are left with only rough estimates and guesses about which drug may be preferentially effective in which patients. Only sequential clinical trials of agents either alone or in combination can verify responsivity in an individual patient. Individual response trumps FDA-approval. Given this clinical conundrum, it is advisable that patients, family members, clinicians, or others carefully rate patients on a longitudinal scale in order to most carefully assess responses and side effects. These are available from the Depression Bipolar Support Alliance (DBSA), the STEP-BD NIMH Network, or www.bipolarnetworknews.org and are highly recommended. The importance of careful longitudinal documentation of symptoms and side effects is highlighted by the increasing use of multiple drugs in combination. This is often required because patients may delay treatment-seeking until after many episodes, and very different patterns and frequencies of depressions, manias, mixed states, as well as multiple comorbidities may be present. Treating patients to the new accepted goal of remission of their mood and other anxillary symptoms usually requires use of several medications. If each component of the regimen is kept below an individual's side-effects threshold, judicious use of multiple agents can reduce rather than increase the overall side-effect burden. There is increasing evidence of reliable abnormalities of biochemistry, function, and anatomy in the brains of patients with bipolar disorder, and some of these are directly related to either duration of illness or number of episodes. Therefore, as treatment resistance to most therapeutic agents is related to number of prior episodes, and brain abnormalities may also increase as well, it behooves the patient to begin and sustain acute and long-term treatment as early as possible. Despite the above academic, personal, and public health recommendations, bipolar disorder often takes ten years or more to diagnose and, hence, treat properly. In fact, a younger age of onset is highly related to presence of a longer delay from illness onset to first treatment, and as well, to a poorer outcome assessed both retrospectively and prospectively. New data indicate that the brain growth factor BDNF (brain-derived neurotrophic factor) which is initially important to synaptogenesis and neural development, and later neuroplasticity and long-term memory in the adult is involved in all phases of bipolar disorder and its treatment. It appears to be: 1) both a genetic (the val-66-val allele of BDNF) and environmental (low BDNF from childhood adversity) risk factor; 2) episode-related (serum BDNF decreasing with each episode of depression or mania in proportion to symptom severity; 3) related to some substance abuse comorbidity (BDNF increases in the VTA with defeat stress and cocaine self-administration); and 4) related to treatment. Lithium, valproate, and carbamazepine increase BDNF and quetiapine and ziprasidone block the decreases in hippocampal BDNF that occur with stress (as do antidepressants). A greater number of prior episodes is related to increased likelihood of: 1) a rapid cycling course; 2) more severe depressive symptoms; 3) more disability; 4) more cognitive dysfunction; and 5) even the incidence of late life dementia. Taken together, the new data suggest a new view not only of bipolar disorder, but its treatment. Adequate effective treatment may not only (a) prevent affective episodes (with their accompanying risk of morbidity, dysfunction, and even death by suicide or the increased medical mortality associated with depression), but may also (b) reverse or prevent some of the biological abnormalities associated with the illness from progressing. Thus, patients should be given timely information pertinent to their stage of illness and recovery that emphasizes not only the risk of treatments, but also their potential, figuratively and literally, life-saving benefits. Long-term treatment and education and targeted psychotherapies are critical to a good outcome. We next highlight several attributes of each mood stabilizer, but recognize that the choice of each agent itself is based on inadequate information from the literature, and sequencing of treatments and their combinations is currently more an art than an evidence-based science. We look forward to these informational and clinical trial deficits being reduced in the near future and the development of single nucleotide polymorphism (SNP) and other neurobiological predictors of individual clinical response to individual drugs. In the meantime, patients and clinicians must struggle with treatment choice based on: 1) the most appropriate targetting of the predominant symptom picture with the most likely effective agent (Table 6.2.4.1 and 6.2.4.2) the best side-effects profile for that patient (Table 6.2.4.2 and 6.2.4.3) using combinations of drugs with different therapeutic targets and mechanisms of action (Table 6.2.4.3 and 6.2.4.4) careful consideration of potential advantageous pharmacodynamic interactions and disadvantageous pharmacokinetic drug-drug interactions that need to be avoided or anticipated.

Side Effects Of Long-Term Treatment With Danazol And Stanozolol In Hereditary Angioedema

2007 ◽  
Vol 119 (1) ◽  
pp. S275 ◽  
Author(s):  
K. Bork ◽  
L. Zingale ◽  
H. Farkas ◽  
A. Bygum ◽  
L. Bouillet ◽  
...  
Keyword(s):  
Side Effects ◽  
Hereditary Angioedema ◽  
Term Treatment ◽  
Long Term Treatment

scholarly journals P709 Is azathioprine safe as long-term treatment in paediatric patients with inflammatory bowel disease?

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S573-S573
Author(s):  
M A Martínez Ibeas ◽  
I Bacelo Ruano ◽  
S Rodríguez Manchón ◽  
M Velasco Rodríguez-Belvís ◽  
J F Viada Bris ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Adverse Effects ◽  
Term Treatment ◽  
Tpmt Activity ◽  
Duration Of Treatment ◽  
Median Dosage ◽  
Long Term Treatment ◽  
Inflammatory Bowel

Abstract Background The toxicity of azathioprine (AZA) includes myelosuppression, infections, pancreatitis, photosensitivity, and hepatotoxicity. The aim of this study was to describe the adverse effects profile of azathioprine as long-term treatment in paediatric inflammatory bowel disease (IBD). Methods An observational, descriptive and retrospective study was performed in the paediatric IBD Unit of a tertiary care hospital from September 2008 to December 2018. It was included patients under 18 diagnosed with IBD who were treated with AZA during their follow-up. We recorded epidemiological data, thiopurine methyltransferase (TPMT) enzyme activity, AZA side effects, and the dosage the patients were receiving when these effects took place. Bone marrow suppression (BMS) was defined as leukopenia, thrombocytopenia and/or anaemia. Acute pancreatitis (AP) induced by azathioprine was considered when two of these criteria (Atlanta 2012) were met: lipase increase (&gt; 3 times normal value), congruent signs and symptoms and/or echographic findings, without other possible aetiology and with complete recovery after AZA withdrawal. Results We included 52 patients, being 31 men (59.6%). They were diagnosed with Crohn′s disease (CD) (73%), ulcerative colitis (UC) (21%) and IBD-unclassified (6%). The median TPMT activity was 17 U/ml (14.2–19.2). Up to 63.5% developed adverse effects by AZA with a median time from the beginning of treatment of 11.4 months (2.6–26.4) and a median dosage of 2 mg/kg/day (1.7–2.3). The most frequent side effect was BMS (52%). These patients had a median TPMT activity of 16.9 U/ml (14.2–18.9), the median duration of treatment was 14 months (3.9–27.7), and the median dosage was 2 mg/kg/d (1.8–2.5). BMS was more frequent in patients with UC (p 0.04) and longer treatment (p 0.08). No differences were found according to age, sex or TPMT activity. Up to 11.5% developed AP, the median duration of treatment until its appearance was 1.5 months (0.7–43.3) and the median dosage was 2 mg/kg/d (1.5–2.5). No differences were found related to age, sex, diagnosis or dosage. Other side effects were: 3 flu-like symptoms, 3 opportunistic infections, 2 hypertransaminasemia, and 1 patient with elevated pancreatic enzymes and hyperbilirubinemia. AZA was discontinued in 14 patients (43.8%): in 6 due to AP, in 4 due to severe lymphopenia, in 2 because of Epstein-Barr virus infection, in 1 due to flu-like symptoms and in 1 with several adverse effects. Conclusion More than half of the patients treated with AZA presented side effects, mainly BMS, although most of them were mild and temporary, and the withdrawal of the drug was not necessary. It seems that TPMT activity is not useful to predict BMS, but this adverse effect could be related to a longer treatment.

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