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5. Consumption of clotting factors in severe haemophilia patients undergoing prophylaxis and on-demand treatment in Italy

Author

Giampaolo A, Abbonizio F, Puopolo M, Arcieri R, Mannucci PM, Hassan HJ, Accorsi A, Ettorre PC, Schiavoni M, Palareti G, Rodorigo G, Valdré L, Amaddii G, Billio A, Notarangelo L, Iannacaro P, Muleo P, Biasioli C, Rossi V, Alatri A, Testa S, Vincenzi D, Scapoli G, Morfini M, Molinari AC, Lapecorella M, Mariani G, Baudo F, Caimi MT, Federici AB, Gringeri A, Santagostino E, Marietta M, Coppola A, Perricone C, Schiavulli M, Miraglia E, Rocino A, Zanon E, Gagliano F, Mancuso G, Siragusa S, Rivolta F, Tagliaferri A, Gamba G, Iorio A, Oliovecchio E, Dragani A, Arbasi MC, Albertini P, Mancino A, Lombardo VT, Latella C, D'Incà M, Landolfi Raffaele, Biondo Francesca, Mazzucconi MG, Santoro Cristina, Mameli AL, Piseddu G, Schinco PC, Messina M, Rossetti G, Barillari G, Feola G, Franchini M, Gandini G, Castaman G, Rodeghiero F, Italian Association of Haemophilia Centres, DI MINNO, GIOVANNI, Giampaolo, A, Abbonizio, F, Puopolo, M, Arcieri, R, Mannucci, Pm, Hassan, Hj, Accorsi, A, Ettorre, Pc, Schiavoni, M, Palareti, G, Rodorigo, G, Valdré, L, Amaddii, G, Billio, A, Notarangelo, L, Iannacaro, P, Muleo, P, Biasioli, C, Rossi, V, Alatri, A, Testa, S, Vincenzi, D, Scapoli, G, Morfini, M, Molinari, Ac, Lapecorella, M, Mariani, G, Baudo, F, Caimi, Mt, Federici, Ab, Gringeri, A, Santagostino, E, Marietta, M, Coppola, A, DI MINNO, Giovanni, Perricone, C, Schiavulli, M, Miraglia, E, Rocino, A, Zanon, E, Gagliano, F, Mancuso, G, Siragusa, S, Rivolta, F, Tagliaferri, A, Gamba, G, Iorio, A, Oliovecchio, E, Dragani, A, Arbasi, Mc, Albertini, P, Mancino, A, Lombardo, Vt, Latella, C, D'Incà, M, Landolfi, Raffaele, Biondo, Francesca, Mazzucconi, Mg, Santoro, Cristina, Mameli, Al, Piseddu, G, Schinco, Pc, Messina, M, Rossetti, G, Barillari, G, Feola, G, Franchini, M, Gandini, G, Castaman, G, Rodeghiero, F, and Italian Association of Haemophilia, Centres

Subjects
Clotting factor, Male, Pediatrics, medicine.medical_specialty, Factor VIII, business.industry, Haemophilia A, Hematology, Disease, medicine.disease, Haemophilia, Hemophilia A, Hemophilia B, Factor IX, On demand treatment, Coagulation, Italy, Surveys and Questionnaires, medicine, Humans, Female, National registry, business, Coagulation Disorder
Abstract

Dear Sir, Treatment of haemophilia is costly, and it must be carefully monitored by physicians and health authorities, so as to improve the planning of the supply of factor concentrates obtained from the fractionation of human plasma or by recombinant technology. Therapy with coagulation factors can be used either prophylactically to prevent bleeding, which entails multiple weekly infusions, or on-demand, through infusion of the amount of factors determined by the severity of the disease and patient’s weight, to stop ongoing bleeding. According to a recent study, factor VIII (FVIII) consumption among persons with haemophilia A (HA) has increased in countries with high-income economies (Stonebraker et al., 2010). In Italy, haemophiliacs and other persons with congenital coagulation disorders are monitored by the National Registry of Congenital Coagulopathies (NRCC) established at the Istituto Superi=

Published
2011

6. Thalidomide-dexamethasone as up-front therapy for patients with newly diagnosed multiple myeloma: thrombophilic alterations, thrombotic complications, and thromboprophylaxis with low-dose warfarin

Author

CINI, MICHELA, ZAMAGNI, ELENA, TACCHETTI, PAOLA, TOSI, PATRIZIA, CAVO, MICHELE, Valdré L, Palareti G, Patriarca F, Legnani C, Catalano L, Masini L, Gozzetti A, Cini M, Zamagni E, Valdré L, Palareti G, Patriarca F, Tacchetti P, Legnani C, Catalano L, Masini L, Tosi P, Gozzetti A, and Cavo M

Subjects
Adult, Male, Factor VIII, Anticoagulants, Factor V, Thrombosis, Venous Thromboembolism, Hematology, Middle Aged, Thrombophilia thromboprophylaxis, Thalidomide-dexamethasone, Dexamethasone, Thalidomide, Multiple myeloma, Risk Factors, Case-Control Studies, Humans, Thrombophilia, Female, Prothrombin, Warfarin, Venous thromboembolism, Activated Protein C Resistance, Aged, Multiple Myeloma
Abstract

Venous thromboembolism (VTE) is a major complication of myeloma therapy recently observed with the increasing use of up-front thalidomide and dexamethasone (thal-dex). The pathogenesis of thal-induced VTE is not well recognized, and the role of prothrombotic factors, especially of thrombophilic abnormalities, is not yet determined.Two hundred and sixty-six patients with newly diagnosed multiple myeloma (MM) were primarily treated with thal-dex in preparation for subsequent high-dose therapy and autologous stem-cell transplantation. Out of these 266 patients, 190 were evaluated for thrombophilic alterations at baseline, and 125 of them were also re-assessed after thal-dex therapy.The presence of genetic thrombophilic polymorphisms among patients with MM was superimposable to that of normal controls and was associated with a twofold increase in the relative risk of VTE. aAPCR and elevated factor VIII levels were frequent, albeit transient, alterations and were not associated with a significant increase in the risk of VTE. Two hundred and forty-six patients received a thromboprophylaxis with fixed low-dose warfarin (1.25 mg/day) during thal-dex therapy. Of these patients (or 10.6%), 26 had symptomatic VTE events. Their patients-years rate of VTE (35.5%) was significantly lower in comparison with the 86.2% rate recorded among the first 19 patients who initially entered the study and did not receive any kind of thromboprophylaxis (P = 0.043).On the basis of these data, a baseline thrombophilic work up is not recommended in patients with receiving up-front thal-dex. For these patients, fixed low-dose warfarin may be a valuable prophylaxis against VTE.

Published
2010

7. Italian Registry of Haemophilia and Allied Disorders. Objectives, methodology and data analysis

Author

IORIO A, OLIOVECCHIO E, MORFINI M, MANNUCCI PM, CONTINO L, ACCORSI A, CIAVARELLA N, SCHIAVONI M, SCARAGGI FA, RODORIGO G, VALDRÉ L, TARGHETTA R, TAGARIELLO G, RADOSSI P, MUSSO R, CULTRERA D, MULEO G, IANNACARO P, BIASIOLI C, TESTA S, ALATRI A, VINCENZI D, SCAPOLI G, MOLINARI AC, BOERI E, CAPRINO D, MARIANI G, LAPECORELLA M, CARLONI MT, CANTORI I, SANTAGOSTINO E, GRINGERI A, FEDERICI AB, MARIETTA M, PEDRAZZOLI P, DI MINNO G, PERRICONE C, SCHIAVULLI M, ROCINO A, BERRETTINI M, ZANON E, MANCUSO G, TAGLIAFERRI A, RIVOLTA F, FERRANTE F, DRAGANI A, ROSSI A, ALBERTINI P, MACCHI S, D'INCA M, DE ROSSI G, LUCIANI M, LANDOLFI R, MAZZUCCONI MG, SANTORO C, PISEDDU G, CARLA SCHINCO P, ROSSETTI G, BARILLARI G, FEOLA G, GANDINI G, FRANCHINI M, CASTAMAN G., COPPOLA, Antonino, SIRAGUSA, Sergio, MALATO, Alessandra, SACCULLO, Giorgia, MANCINO, Antonio, IORIO A, OLIOVECCHIO E, MORFINI M, MANNUCCI PM, CONTINO L, ACCORSI A, CIAVARELLA N, SCHIAVONI M, SCARAGGI FA, RODORIGO G, VALDRÉ L, TARGHETTA R, TAGARIELLO G, RADOSSI P, MUSSO R, CULTRERA D, MULEO G, IANNACARO P, BIASIOLI C, TESTA S, ALATRI A, VINCENZI D, SCAPOLI G, MOLINARI AC, BOERI E, CAPRINO D, MARIANI G, LAPECORELLA M, CARLONI MT, CANTORI I, SANTAGOSTINO E, GRINGERI A, FEDERICI AB, MARIETTA M, PEDRAZZOLI P, DI MINNO G, COPPOLA A, PERRICONE C, SCHIAVULLI M, ROCINO A, BERRETTINI M, ZANON E, MANCUSO G, SIRAGUSA S, MALATO A, SACCULLO G, TAGLIAFERRI A, RIVOLTA F, FERRANTE F, DRAGANI A, ROSSI A, MANCINO A, ALBERTINI P, MACCHI S, D'INCA M, DE ROSSI G, LUCIANI M, LANDOLFI R, MAZZUCCONI MG, SANTORO C, PISEDDU G, CARLA SCHINCO P, ROSSETTI G, BARILLARI G, FEOLA G, GANDINI G, FRANCHINI M, and CASTAMAN G

Subjects
methodology, haemophilia, Settore MED/15 - Malattie Del Sangue
Published
2008

8. Italian Registry of Haemophilia and Allied Disorders. Objectives, methodology and data analysis

Author

Iorio, A, Oliovecchio, E, Morfini, M, Mannucci, Pm, Contino, L, Accorsi, A, Ciavarella, N, Schiavoni, M, Scaraggi, Fa, Rodorigo, G, Valdré, L, Targhetta, R, Tagariello, G, Radossi, P, Musso, R, Cultrera, D, Muleo, G, Iannacaro, P, Biasioli, C, Testa, S, Alatri, A, Vincenzi, D, Scapoli, G, Molinari, Ac, Boeri, E, Caprino, D, Mariani, G, Lapecorella, M, Carloni, Mt, Cantori, I, Santagostino, E, Gringeri, A, Federici, Ab, Marietta, M, Pedrazzoli, P, Di Minno, G, Coppola, A, Perricone, C, Schiavulli, M, Rocino, A, Berrettini, M, Zanon, E, Mancuso, G, Siragusa, S, Malato, A, Saccullo, G, Tagliaferri, A, Rivolta, F, Ferrante, F, Dragani, A, Rossi, A, Mancino, A, Albertini, P, Macchi, S, Hassan, J, D'Inca, M, De Rossi, G, Luciani, M, Landolfi, R, Mazzucconi, Maria Gabriella, Santoro, Cristina, Piseddu, G, Carla Schinco, P, Rossetti, G, Barillari, G, Feola, G, Gandini, G, Franchini, M, Castaman, G., Iorio, A, Oliovecchio, E, Morfini, M, Mannucci, Pm, Contino, L, Accorsi, A, Ciavarella, N, Schiavoni, M, Scaraggi, Fa, Rodorigo, G, Valdré, L, Targhetta, R, Tagariello, G, Radossi, P, Musso, R, Cultrera, D, Muleo, G, Iannacaro, P, Biasioli, C, Testa, S, Alatri, A, Vincenzi, D, Scapoli, G, Molinari, Ac, Boeri, E, Caprino, D, Mariani, G, Lapecorella, M, Carloni, Mt, Cantori, I, Santagostino, E, Gringeri, A, Federici, Ab, Marietta, M, Pedrazzoli, P, DI MINNO, Giovanni, Coppola, A, Perricone, C, Schiavulli, M, Rocino, A, Berrettini, M, Zanon, E, Mancuso, G, Siragusa, S, Malato, A, Saccullo, G, Tagliaferri, A, Rivolta, F, Ferrante, F, Dragani, A, Rossi, A, Mancino, A, Albertini, P, Macchi, S, Hassan, J, D'Inca, M, De Rossi, G, Luciani, M, Landolfi, R, Mazzucconi, Mg, Santoro, C, Piseddu, G, Carla Schinco, P, Rossetti, G, Barillari, G, Feola, G, Gandini, G, Franchini, M, and Castaman, G.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Adolescent, Haemophilia A, MEDLINE, Haemophilia, Severity of Illness Index, haemophilia, registry, von willebrand's disease, von willebrand’s disease, Blood Coagulation Disorders, Inherited, Von willebrand, Severity of illness, Health care, Computer software, medicine, Humans, Haemophilia B, Registries, Age of Onset, Child, Genetics (clinical), Societies, Medical, Aged, business.industry, Infant, Hematology, General Medicine, Middle Aged, medicine.disease, Databases as Topic, Italy, Child, Preschool, Data Interpretation, Statistical, Female, Medical emergency, business
Abstract

National haemophilia registries are powerful instruments to support health care and research. A national registry was established in Italy by the Ministry of Health until 1999. Since 2003 the Italian Association of Haemophilia Centres (AICE) started a new programme aiming at building up the Italian Registry of Haemophilia and Allied Disorders. The AICE identified an expert panel to steer the registry. A computer software to assist patient management was developed and all the AICE-affiliated haemophilia treatment centres (HTC) were prompted to adopt it. Twice a year a predefined set of anonymized data is centralized and merged into a national database. Duplicated entries are managed through a confidentiality sparing mechanism. The database covers sociodemographic, clinical, laboratory and treatment data. A subset of data are shared with the Ministry of Health (Istituto Superiore di Sanita,ISS).Overall, data were collected six times by 43 of 49 HTC; 41 centres updated their patients' records up to December 2006. The database contains 6632 unique records, 442 of them referring to dead patients. Database growth and missing data clearance showed a constantly positive trend over time. The database has collected records of the following alive patients - haemophilia A: 1364 severe, 398 moderate and 935 mild; haemophilia B: 231 severe, 138 moderate and 204 mild; von Willebrand's disease: 1208 type 1, 346 type 2 and 96 type 3. Inhibitor patients were 296 (of which 194 high responders and 65 low responders).The Italian registry run by AICE adds to the list of the available national haemophilia registries and is intended to establish treatment guidelines and foster research projects in Italy.

Published
2008

9. Malignancies in patients with haemophilia

Author

Agliaferri, A, Di Perna, C, Santoro, C, Schinco, P, Santoro, R, Rossetti, G, Coppola, A, Morfini, M, Castaman, G, Scaraggi, Fa, Pasca, S, Macchi, S, Valdré, L, Zanon, E, Serino, M, Napolitano, M, Cantori, I, Giuffrida, A, Delios, G, Radossi, P, and Franchini, M.

Published
2011

14. Evolution of untreated calf deep-vein thrombosis in high risk symptomatic outpatients: The blind, prospective CALTHRO study

Author

Lelia Valdrè, Michelangelo Sartori, Carlotta Brusi, Giuliana Guazzaloca, Gualtiero Palareti, Cristina Legnani, Eleonora Conti, Gianfranco Lessiani, Giuseppina Rodorigo, Benilde Cosmi, Palareti G, Cosmi B, Lessiani G, Rodorigo G, Guazzaloca G, Brusi C, Valdré L, Conti E, Sartori M, and Legnani C.

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Deep vein, Risk Assessment, Fibrin Fibrinogen Degradation Products, Young Adult, Double-Blind Method, Predictive Value of Tests, Risk Factors, medicine, Humans, Prospective Studies, COMPRESSION ULTRASONOGRAPHY, Ultrasonography, Doppler, Color, Prospective cohort study, Aged, Aged, 80 and over, Immunoassay, Venous Thrombosis, Leg, Chi-Square Distribution, VENOUS THROMBEMBOLISM, Vascular disease, business.industry, Venous Thromboembolism, Hematology, Middle Aged, Prognosis, medicine.disease, Thrombosis, Surgery, Venous thrombosis, medicine.anatomical_structure, Predictive value of tests, Ambulatory, Disease Progression, Female, business, Chi-squared distribution, Biomarkers
Abstract

SummaryThe natural history of calf deep-vein thrombosis (DVT) is still uncertain and it is debated whether it warrants to be diagnosed and treated. We aimed to investigate the complication rate of untreated isolated calf DVT (ICDVT). Symptomatic outpatients were prospectively managed with serial compression ultrasonography (SCUS). Those without proximal DVT and with likely pre-test clinical probability (PCP) or altered D-dimer received immediate subsequent complete examination of calf deep veins (CCUS) by a different operator. The result of CCUS was kept blind both to the managing doctor and the patient and disclosed after three months. Primary outcome was the rate of venous thromboembolism at three months. We examined 431 subjects (196 males; median age 68.0 years) in whom five outcomes were recorded (1.2%; 95% confidence intervals [CI]: 0.4–2.7). If CCUS results had been available, outcomes would have been recorded in 3/424 patients (0.7%; 95% CI: 0.2–2.1) with two events in subjects negative at both serial and complete CUS. ICDVT was diagnosed in 65 subjects (15.3%; 95% CI: 12–19); of whom 59 remained uneventful (one was lost to follow-up). A significant higher rate of outcomes was recorded in subjects with than without ICDVT (5/64; 7.8%; 95% CI: 3–17 vs. 3/351; 0.8%; 95% CI: 0–2; p=0.003). However, after excluding two events picked at serial CUS in subjects with ICDVT, the difference became barely significant (3/64; 4.7%; 95% CI: 1–13; p=0.049). Thrombotic evolution of untreated ICDVT in high-risk subjects may be relevant. Larger studies are needed to address this issue.

Published
2010

15. The Wells rule and D-dimer for the diagnosis of isolated distal deep vein thrombosis

Author

Benilde Cosmi, Gualtiero Palareti, Elisabetta Favaretto, Giuliana Guazzaloca, Michela Cini, Michelangelo Sartori, Lelia Valdrè, Giuseppina Rodorigo, Cristina Legnani, Sartori M, Cosmi B, Legnani C, Favaretto E, Valdré L, Guazzaloca, G, Rodorigo G, Cini M, and Palareti G.

Subjects
Male, medicine.medical_specialty, Deep vein, Diagnostic accuracy, Sensitivity and Specificity, Fibrin Fibrinogen Degradation Products, Compression ultrasonography, Predictive Value of Tests, D-dimer, Diagnosis, Prevalence, medicine, Humans, cardiovascular diseases, Aged, Ultrasonography, Venous Thrombosis, business.industry, Reproducibility of Results, Thrombosis, Hematology, Middle Aged, medicine.disease, Surgery, Venous thrombosis, Cross-Sectional Studies, medicine.anatomical_structure, ROC Curve, Predictive value of tests, Female, Radiology, business, Calf thrombosi, Algorithms, Wells score
Abstract

Background: Pretest clinical probability with the Wells rule and D-dimer have been widely investigated for the diagnosis of symptomatic proximal deep vein thrombosis (DVT) of the lower limbs, but they have not been formally tested for symptomatic isolated distal DVT diagnosis. Objective: To evaluate the diagnostic accuracy of the Wells rule and D-dimer for isolated distal DVT. Design, Setting, and Patients: This was a single-center, cross-sectional study including 873 consecutive outpatients with suspected DVT, in whom pretest clinical probability determination, D-dimer determination (STA Liatest; cut-off of 95% for isolated distal DVT. not available

Published
2012

16. Benefits of prophylaxis versus on-demand treatment in adolescents and adults with severe haemophilia A: the POTTER study.

Author

Tagliaferri A, Feola G, Molinari AC, Santoro C, Rivolta GF, Cultrera DB, Gagliano F, Zanon E, Mancuso ME, Valdré L, Mameli L, Amoresano S, Mathew P, and Coppola A

Subjects
Adolescent, Adult, Age Factors, Child, Cost-Benefit Analysis, Drug Administration Schedule, Drug Costs, Factor VIII adverse effects, Factor VIII economics, Hemarthrosis blood, Hemarthrosis diagnosis, Hemarthrosis economics, Hemophilia A blood, Hemophilia A diagnosis, Hemophilia A economics, Hemostatics adverse effects, Hemostatics economics, Humans, Italy, Male, Middle Aged, Prospective Studies, Quality of Life, Severity of Illness Index, Time Factors, Treatment Outcome, Young Adult, Factor VIII administration & dosage, Hemarthrosis prevention & control, Hemophilia A drug therapy, Hemostatics administration & dosage
Abstract

Rigorous evidence is lacking on long-term outcomes of factor VIII (FVIII) prophylaxis initiated in adolescent or adult patients with severe haemophilia A. The prospective, open-label Prophylaxis versus On-demand Therapy Through Economic Report (POTTER) study (ClinicalTrials.gov NCT01159587) compared long-term late secondary prophylaxis (recombinant FVIII-FS 20-30 IU/kg thrice weekly) with on-demand treatment in patients aged 12 to 55 years with severe haemophilia A. The annual number of joint bleeding episodes (primary endpoint), total bleeding episodes, orthopaedic and radiologic (Pettersson) scores, health-related quality of life (HRQoL), pharmacoeconomic impact, and safety were evaluated over a > 5-year period (2004-2010). Fifty-eight patients were enrolled at 11 centres in Italy; 53 (27 prophylaxis, 26 on demand) were evaluated and stratified into 2 age subgroups (12-25 and 26-55 years). Patients receiving prophylaxis experienced a significantly lower number of joint bleeding episodes vs the on-demand group (annualised bleeding rate, 1.97 vs 16.80 and 2.46 vs 16.71 in younger and older patients, respectively; p=0.0043). Results were similar for total bleeding episodes. Prophylaxis was associated with significantly fewer target joints (p< 0.001), better orthopaedic (p=0.0019) and Pettersson (p=0.0177) scores, better HRQoL, and fewer days of everyday activities lost (p< 0.0001) but required significantly higher FVIII product consumption. The POTTER study is the first prospective, controlled trial documenting long-term benefits of late secondary prophylaxis in adolescents and adults with severe haemophilia A. The benefits of reduced bleeding frequency, improved joint status, and HRQoL may offset the higher FVIII consumption and costs.

Published
2015
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17. Evolution of untreated calf deep-vein thrombosis in high risk symptomatic outpatients: the blind, prospective CALTHRO study.

Author

Palareti G, Cosmi B, Lessiani G, Rodorigo G, Guazzaloca G, Brusi C, Valdré L, Conti E, Sartori M, and Legnani C

Subjects
Adult, Aged, Aged, 80 and over, Biomarkers blood, Chi-Square Distribution, Disease Progression, Double-Blind Method, Female, Fibrin Fibrinogen Degradation Products metabolism, Humans, Immunoassay, Male, Middle Aged, Predictive Value of Tests, Prognosis, Prospective Studies, Risk Assessment, Risk Factors, Time Factors, Ultrasonography, Doppler, Color, Venous Thromboembolism blood, Venous Thromboembolism diagnostic imaging, Venous Thrombosis blood, Venous Thrombosis diagnostic imaging, Young Adult, Leg blood supply, Venous Thromboembolism etiology, Venous Thrombosis complications
Abstract

The natural history of calf deep-vein thrombosis (DVT) is still uncertain and it is debated whether it warrants to be diagnosed and treated. We aimed to investigate the complication rate of untreated isolated calf DVT (ICDVT). Symptomatic outpatients were prospectively managed with serial compression ultrasonography (SCUS). Those without proximal DVT and with likely pre-test clinical probability (PCP) or altered D-dimer received immediate subsequent complete examination of calf deep veins (CCUS) by a different operator. The result of CCUS was kept blind both to the managing doctor and the patient and disclosed after three months. Primary outcome was the rate of venous thromboembolism at three months. We examined 431 subjects (196 males; median age 68.0 years) in whom five outcomes were recorded (1.2%; 95% confidence intervals [CI]: 0.4-2.7). If CCUS results had been available, outcomes would have been recorded in 3/424 patients (0.7%; 95% CI: 0.2-2.1) with two events in subjects negative at both serial and complete CUS. ICDVT was diagnosed in 65 subjects (15.3%; 95% CI: 12-19); of whom 59 remained uneventful (one was lost to follow-up). A significant higher rate of outcomes was recorded in subjects with than without ICDVT (5/64; 7.8%; 95% CI: 3-17 vs. 3/351; 0.8%; 95% CI: 0-2; p=0.003). However, after excluding two events picked at serial CUS in subjects with ICDVT, the difference became barely significant (3/64; 4.7%; 95% CI: 1-13; p=0.049). Thrombotic evolution of untreated ICDVT in high-risk subjects may be relevant. Larger studies are needed to address this issue.

Published
2010
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18. No early signs of atherosclerotic alterations in carriers of inherited thrombophilia.

Author

Palareti G, Valdré L, Favaretto E, Bovina V, Cini M, and Legnani C

Subjects
Aged, Atherosclerosis genetics, Atherosclerosis pathology, Carotid Arteries diagnostic imaging, Carotid Arteries pathology, Female, Humans, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Risk Factors, Statistics, Nonparametric, Thrombophilia genetics, Thrombophilia pathology, Ultrasonography, Atherosclerosis etiology, Heterozygote, Thrombophilia complications
Abstract

Background: Congenital thrombophilia is a risk factor for venous thromboembolism (VTE). Whether it is associated with increased risk of arterial disease is today a matter of debate. We aimed to look for early signs of atherosclerotic alterations in carriers of inherited thrombophilic alterations (ITA)., Methods: Between January 2006 and September 2008 ultrasonography assessment of the carotid arteries with measurement of intima-media thickness (IMT), and determination of the ankle/brachial pressure index (ABI), was performed in: a) 161 carriers of ITA (deficiency of antithrombin, protein C or S, factor V Leiden or prothrombin G20210A mutations), 84 of whom with previous VTE, and b) 180 subjects without ITA, matched for age, sex and previous VTE. All subjects were <66 year old., Results: Carotid plaques were found in 8 subjects [3 (1.9%) with ITA]. Increased IMT values (>1mm) were detected in 6 subjects with and 1 without thrombophilia (p=0.055). The prevalence of IMT values>90(th) percentile was not different in subjects with/without thrombophilia (15.2% vs 11.6%, p=0.416). At multivariate analysis only age was significantly associated with increased odds ratios for IMT values>90(th) percentile. No subjects had abnormal (<0.9) ABI values., Conclusions: The present study, the first to investigate the presence of atherosclerotic markers in relatively young subjects with inherited thrombophilia, did not find a particular prevalence of signs of early atherosclerotic markers in these subjects.

Published
2010
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19. Thalidomide-dexamethasone as up-front therapy for patients with newly diagnosed multiple myeloma: thrombophilic alterations, thrombotic complications, and thromboprophylaxis with low-dose warfarin.

Author

Cini M, Zamagni E, Valdré L, Palareti G, Patriarca F, Tacchetti P, Legnani C, Catalano L, Masini L, Tosi P, Gozzetti A, and Cavo M

Subjects
Activated Protein C Resistance genetics, Adult, Aged, Anticoagulants administration & dosage, Case-Control Studies, Dexamethasone adverse effects, Factor V genetics, Factor VIII metabolism, Female, Humans, Male, Middle Aged, Multiple Myeloma blood, Prothrombin genetics, Risk Factors, Thalidomide adverse effects, Thrombophilia blood, Thrombophilia genetics, Venous Thromboembolism chemically induced, Venous Thromboembolism prevention & control, Warfarin administration & dosage, Dexamethasone administration & dosage, Multiple Myeloma drug therapy, Thalidomide administration & dosage, Thrombophilia chemically induced, Thrombosis chemically induced, Thrombosis prevention & control
Abstract

Background: Venous thromboembolism (VTE) is a major complication of myeloma therapy recently observed with the increasing use of up-front thalidomide and dexamethasone (thal-dex). The pathogenesis of thal-induced VTE is not well recognized, and the role of prothrombotic factors, especially of thrombophilic abnormalities, is not yet determined., Material and Methods: Two hundred and sixty-six patients with newly diagnosed multiple myeloma (MM) were primarily treated with thal-dex in preparation for subsequent high-dose therapy and autologous stem-cell transplantation. Out of these 266 patients, 190 were evaluated for thrombophilic alterations at baseline, and 125 of them were also re-assessed after thal-dex therapy., Results: The presence of genetic thrombophilic polymorphisms among patients with MM was superimposable to that of normal controls and was associated with a twofold increase in the relative risk of VTE. aAPCR and elevated factor VIII levels were frequent, albeit transient, alterations and were not associated with a significant increase in the risk of VTE. Two hundred and forty-six patients received a thromboprophylaxis with fixed low-dose warfarin (1.25 mg/day) during thal-dex therapy. Of these patients (or 10.6%), 26 had symptomatic VTE events. Their patients-years rate of VTE (35.5%) was significantly lower in comparison with the 86.2% rate recorded among the first 19 patients who initially entered the study and did not receive any kind of thromboprophylaxis (P = 0.043)., Conclusions: On the basis of these data, a baseline thrombophilic work up is not recommended in patients with receiving up-front thal-dex. For these patients, fixed low-dose warfarin may be a valuable prophylaxis against VTE.

Published
2010
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