scholarly journals Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma

2018 ◽  
Vol 13 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Luca Bonadiman ◽  
Paola Turco
Keyword(s):  
Beclomethasone Dipropionate ◽  
Time Dependent ◽  
Adherence To Treatment ◽  
Fluticasone Furoate ◽  
Once Daily ◽  
Hospitalization Rates ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Bronchial asthma is an inflammatory disease of the airways. Beclomethasone dipropionate/Formoterol (BDP/F) and Fluticasone furoate/Vilanterol (FF/V) are two of the most effective LABA/ICS combinations for managing persistent bronchial asthma. Aim of the study was to compare the outcomes achieved in mild-tomoderate asthma patients assuming BDP/F 100/6 μg b.i.d. (Group A) or FF/V 92/22 μg once-daily (Group B) for 12-months. No head-to-head long-term comparison is available at present. Methods: Data were automatically and anonymously obtained from the institutional database: FEV1% predicted values; the exacerbation and hospitalization rates; days of hospitalization; GP and/or specialist visits; days of inactivity; courses of systemic steroids and/or antibiotics were recorded at baseline and after 3, 6 and 12 months of both treatments. The overall adherence to treatments was also calculated. The propensity score method was used for matching and comparing the two cohorts of patients; Anova and Wilcoxon tests were used for checking the trends and time-to-time comparisons over the period; statistical significance was accepted for p < 0.05. Results: The PS-matching process returned a cohort of 40 group A patients matched with 40 patients of group B, fully comparable for demographics, clinical characteristics, and comorbidities. The improvement in lung function was significant in both groups (p < 0.001), even if it was significantly higher and time-dependent in group B. The mean (±SE) exacerbation rate/patient changed from 0.63 (±0.13) at baseline to 0.53 (±0.12) after three; to 0.58 (±0.13) after six, and to 0.60 (±0.18) after twelve months in group A (p = ns), while from of 1.05 (±0.16) at baseline, to 0.28 (±0.07) after three; to 0.33 (±0.08) after six, and to 0.18 (±0.08) after twelve months in group B (p < 0.001), respectively. The mean hospitalization rate/patient changed from 0.25 ± 0.07 at baseline to 0.15 (±0.06) after three; to 0.08 (±0.04) after six, and to 0.13 (±0.05) after twelve months in group A (p = ns), while from 0.30 (±0.07) at baseline to 0.08 (±0.04) after three; to 0.10 (±0.05) after six, and to 0.03 (±0.03) after twelve months in group B (p < 0.001), respectively. Also mean duration of hospitalization and days of inactivity were in favour of FF/V treatment over time (in both cases p < 0.001). GP’s visits were reduced by both treatments (p < 0.007 in group A and p < 0.001 in group B, respectively, while Specialist’s visits only dropped during FF/V (p < 0.001). Steroid and antibiotic courses were significantly reduced by both treatments, even if more systematically in group B (p < 0.001 vs p < 0.007, and p < 0.001 vs p < 0.044, respectively). Moreover, changes in all outcomes considered proved time-dependent during the FF/V treatment only, particularly over the second semester. Finally, the overtime adherence to treatment was higher by 22 days during FF/V . Conclusions: Both the ICS/LABA combinations proved effective, even if characterized by different patterns of effectiveness either in terms of lung function and of long-term clinical outcomes. Only the once-daily inhalation of combined FF/V 92/22 μg once-daily optimized systematically the exacerbation and hospitalization rates in mild-tomoderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 once-daily μg proved progressive and time-dependent over the twelve-month period of the study, and associated to a higher adherence to treatment.

scholarly journals Fluticasone furoate/vilanterol 92/22 µg once a day: a 12-month study on outcomes in mild to moderate asthma

2018 ◽  
Vol 12 ◽  
pp. 175346661878989 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Luca Bonadiman ◽  
Paola Turco
Keyword(s):  
Forced Expiratory Volume ◽  
Time Dependent ◽  
Adherence To Treatment ◽  
Fluticasone Furoate ◽  
Exacerbation Rate ◽  
Once Daily ◽  
Moderate Asthma ◽  
Hospitalization Rates ◽  
The Mean ◽  
Over Time

Background: Fluticasone furoate/vilanterol (FF/V) is an effective long-acting β2 agonist/inhaled corticosteroid combination for managing persistent bronchial asthma. The aim of the study was to assess the outcomes achievable in patients with mild to moderate asthma receiving FF/V 92/22 µg once daily for 12 months. Methods: Data were automatically and anonymously obtained from the institutional database: forced expiratory volume in 1 s predicted values; the exacerbation and hospitalization rates; days of hospitalization; general practitioner (GP) or specialist visits; days of inactivity; courses of systemic steroids or antibiotics were recorded at baseline and after 3, 6 and 12 months of treatment. The overall adherence to treatment was also calculated. Analysis of variance was used for checking the trends of variables. The improvement in lung function was significant ( p < 0.001) and time dependent. The mean (±standard error) exacerbation rate per patient changed from 1.05 (±0.16) at baseline to 0.28 (±0.07) after 3 months, 0.33 (±0.08) after 6 months and 0.18 (±0.08) after 12 months ( p < 0.001). The mean hospitalization rate per patient changed from 0.30 (±0.07) at baseline to 0.08 (±0.04) after 3 months, 0.10 (±0.05) after 6 months and 0.03 (±0.03) after 12 months ( p < 0.001). Also mean duration of hospitalization and days of inactivity were reduced over time ( p < 0.001). GP visits were also reduced, together with specialist visits (both p < 0.001). Steroid and antibiotic courses dropped significantly ( p < 0.001 and p < 0.001, respectively). Moreover, changes in all outcomes considered proved time dependent, particularly over the second semester. Finally, over time, adherence to treatment was high. Conclusions: The once-daily inhalation of combined FF/V 92/22 µg optimized systematically the exacerbation and hospitalization rates in mild to moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 µg once daily proved to be time dependent over the period of the study.

scholarly journals Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/ Formoterol 100/6 μg b.i.d.: a 12-week cost analysis in mild-to-moderate asthma

2016 ◽  
Vol 11 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Chiara Distante ◽  
Luca Bonadiman ◽  
Paola Turco ◽  
Sergio Iannazzo
Keyword(s):  
National Health Service ◽  
Lung Function ◽  
Health Service ◽  
Cost Analysis ◽  
National Health ◽  
Beclomethasone Dipropionate ◽  
Fluticasone Furoate ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Asthma is a disease with high cost for the National Health Service. Two of the most recent LABA/ICS combinations for persistent bronchial asthma are Beclomethasone dipropionate/Formoterol (B/F) delivered via the Nexthaler device and Fluticasone furoate/Vilanterol (F/V) delivered via the Ellipta device. No comparison has been carried out yet in terms of cost analysis in asthma, to our knowledge. Aim of the present monocentric, observational, retrospective study was to calculate and compare the costs of mild-to-moderate asthma patients assuming B/F 100/6 μg b.i.d. to those of patients assuming F/V 92/22 μg once-a-day over a 12-week treatment period from the Italian National Health Service perspective. Methods: Data were obtained automatically and anonymously from the institutional database of the Lung Unit of the Specialist Medical Centre (CEMS), Verona, Italy, UNI EN ISO 9001-2008 validated. FEV1 values, number of relapses, healthcare resources as hospitalizations due to asthma relapses, days of hospitalization, general practitioner (GP), specialist visits, and days of inactivity, were recorded over the study period together with the use of extra medications (systemic steroids and antibiotics). In order to compare the outcomes achieved in both groups, the propensity score matching method was used in STATA, and statistical significance was accepted for p < 0.05. Results: Clinical data of 77 patients treated with B/F b.i.d (Group A) and of 40 patients treated with F/V 92/22 μg once-a-day (Group B) were selected. The PS-matching process, designed as matching on the baseline covariates, gender, age, FEV1 and comorbidities, returned a cohort of 40 group A patients of the entire cohort matched with 40 patients of group B, fully comparable for demographics and clinical characteristics. In the PS-matched cohort, the mean (±SE) number of relapses per patient during the follow-up was 0.53 (±0.12) in group A and 0.28 (±0.07) in group B. In group A, n = 25 (62.50 %), n = 9 (22.50 %), and n = 6 (15 %) patients had 0, 1, 2 relapses, respectively. In group B, n=29 (72.50 %), and n = 11 (27.50 %) had 0 and 1 relapse, respectively. Over the study period, the average number of hospitalizations per patient was 0.15 (±0.06), with 0.28 (±0.12) days of hospitalization in group A, and 0.08 (±0.04) with 0.08 (±0.04) days of hospitalization in group B, respectively. The difference between the two groups in terms of FEV1(L) improvement vs baseline was 0.11 in favour of group B (p = 0.007). When results were compared, the improvement in lung function obtained in group B proved significantly higher both in terms of absolute FEV1 and of FEV1 % predicted. The mean (±SE) cost of hospitalizations per patient was € 345.30 (±133.23) in group A and € 172.65 (±98.18) in group B, respectively, with a mean not significant difference of - € 172.65 in favour of group B (p = 0.9). In particular, the mean (±SE) cost for visits per patient was € 26.82 (±3.73) in group A and € 11.36 (±2.30) in group B (p = 0.002), and the mean cost for rescue medications per patient was € 35.24 (±6.93) in group A, and € 18.73 (±3.38) in group B, respectively (p = 0.05). Conclusions: Even if both ICS/LABA combinations were checked over a limited period of time, they seem characterized by a different profile in terms of effect on lung function and economic impact on mild-tomoderate asthma. The once-daily inhalation of combined Fluticasone furoate/Vilanterol 92/22 μg showed the potential for enhanced clinical outcomes and reduced costs when compared to Beclomethasone dipropionate/Formoterol 100/6 μg b.i.d.

scholarly journals Correction to: Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma

2018 ◽  
Vol 13 ◽  
Author(s):  
Roberto W. Dal Negro ◽  
Luca Bonadiman ◽  
Paola Turco
Keyword(s):  
Beclomethasone Dipropionate ◽  
Respiratory Medicine ◽  
Original Research ◽  
Original Research Article ◽  
Fluticasone Furoate ◽  
Moderate Asthma ◽  
Research Article ◽  
Group A ◽  
The Mean ◽  
Group B

Correction to: Multidisciplinary Respiratory Medicine (2018) 13:18 DOI: 10.1186/s40248-018-0131-x After publication of the Original research article [1] it was brought to our attention that the sentence at pag 6 (between Fig. 3 and Fig. 4)) must be corrected as follows: “The mean duration of inactivity was 2.88 (0.63) at baseline; 1.53 (0.27) after 3; 1.40 (0.27) after 6, and 1.45 days (0.58) after twelve months (Anova: p = 0.11) in group A, while the corresponding duration in group B was 3.35 (0.63) at baseline; 0.60 (0.19) after 3; 1.10 (0.21) after 6, and 0.83 days (0.39) after 12 months (Anova; p <0.001), respectively.” In addition at pag. 7 Fig. 5 entitled “Changes in mean duration of inactivity/p. over 12 months” must be substituted with the new Fig. 5 because there is a mistake regarding anova p = 0.11 and consequently in the whole image. This Correction shows the revised Fig. 5. The original article has been updated.

Comparative Study of effectiveness of mobilization with movement (MWM) and End range mobilization (ERM) techniques in frozen shoulder

2018 ◽  
Vol 4 (4) ◽  
pp. 519-522
Author(s):  
Jeyakumar S ◽  
Jagatheesan Alagesan ◽  
T.S. Muthukumar
Keyword(s):  
Range Of Motion ◽  
Frozen Shoulder ◽  
Type I ◽  
Mean Values ◽  
Functional Activities ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Frozen shoulder is disorder of the connective tissue that limits the normal Range of motion of the shoulder in diabetes, frozen shoulder is thought to be caused by changes to the collagen in the shoulder joint as a result of long term Hypoglycemia. Mobilization is a therapeutic movement of the joint. The goal is to restore normal joint motion and rhythm. The use of mobilization with movement for peripheral joints was developed by mulligan. This technique combines a sustained application of manual technique “gliding” force to the joint with concurrent physiologic motion of joint, either actively or passively. This study aims to find out the effects of mobilization with movement and end range mobilization in frozen shoulder in Type I diabetics. Materials and Methods: 30 subjects both male and female, suffering with shoulder pain and clinically diagnosed with frozen shoulder was recruited for the study and divided into two groups with 15 patients each based on convenient sampling method. Group A patients received mobilization with movement and Group B patients received end range mobilization for three weeks. The outcome measurements were SPADI, Functional hand to back scale, abduction range of motion using goniometer and VAS. Results: The mean values of all parameters showed significant differences in group A as compared to group B in terms of decreased pain, increased abduction range and other outcome measures. Conclusion: Based on the results it has been concluded that treating the type 1 diabetic patient with frozen shoulder, mobilization with movement exercise shows better results than end range mobilization in reducing pain and increase functional activities and mobility in frozen shoulder.

scholarly journals Tamoxifen for treatment of abnormal uterine bleeding in etonorgstrel implant users: a randomized clinical trial

2019 ◽  
Vol 8 (11) ◽  
pp. 4462
Author(s):  
Ahmed N. Fetih ◽  
Ahmed M. Abbas ◽  
Fatma A. Kamel ◽  
Ihab H. El Nashar
Keyword(s):  
Oral Contraceptive ◽  
Treatment Time ◽  
Abnormal Uterine Bleeding ◽  
Once Daily ◽  
Oral Contraceptive Pills ◽  
Contraceptive Pills ◽  
Tamoxifen Group ◽  
Group A ◽  
The Mean ◽  
Group B

Background: The current study aims to compare the use of tamoxifen and oral contraceptive pills in women using implanon and complain with irregular uterine bleeding.Methods: Women attended family planning clinic using implanon presented by bleeding were invited to participate in the study. They were randomized into two groups: Group A: 100 women received Tamoxifen 10 mg twice daily for 10 days taken at the onset of an episode of bleeding or spotting episode. Group B: 100 women received Combined oral contraceptive pills (microcept) once daily for 21 days take at the onset of an episode of bleeding or spotting episode.Results: No difference regarding the baseline criteria of both groups. No difference between both groups regarding the duration of irregular bleeding in the implanon users (p=0.090). Additionally, the number of bleeding days and spotting in the last month was similar in both groups (p=0.554). The percentage of women who stopped bleeding during the period of treatment is 84% in the tamoxifen group and 92% in the COCs group, but the COCs needs longer treatment time, where the mean of days required to stop bleeding is 5.03±1.8 days in the tamoxifen group and 6.5±2.5 in the COCs group. Headache and nausea were the most prominent adverse effects found in the COCs group (p=0.000).Conclusions: Oral administration of tamoxifen 10 mg twice daily for 10 days is effective on stopping bleeding attacks in implanon users.

Tethered cord syndrome in adults

2011 ◽  
Vol 15 (3) ◽  
pp. 258-270 ◽  
Author(s):  
Jörg Klekamp
Keyword(s):  
Spinal Cord ◽  
Tethered Cord ◽  
Tethered Cord Syndrome ◽  
Neurological Deficits ◽  
Short Term ◽  
Group A ◽  
The Mean ◽  
Group B

Object The treatment of tethered cord syndromes in adults is discussed regarding the natural history and surgical indications. The author analyzes data obtained in patients who were diagnosed with a tethered cord in adulthood and either underwent surgical or conservative therapy between 1991 and 2009. Methods Since 1991, data obtained in 2515 patients with spinal cord pathologies were entered into the spinal cord database, and prospective follow-up was performed through outpatient visits and questionnaires. Of the 2515 patients, 85 adults with a tethered cord syndrome formed the basis of this study. The tethering effect was caused either by a split cord malformation, a thick filum terminale, a conus medullaris lipoma with extradural extension, or various combinations of these mechanisms. The mean age of the patients was 46 ± 13 years (range 23–74 years) and the mean follow-up duration was 61 ± 62 months. Two groups were distinguished based on the absence (Group A, 43 patients) or presence (Group B, 42 patients) of an associated lipoma or dysraphic cyst (that is, dermoid, epidermoid, or neurenteric cyst). Surgery was recommended for patients with symptoms only. Short-term results were determined within 3 months of surgery, whereas long-term outcomes (clinical recurrences) were evaluated using Kaplan-Meier statistics. Results For all patients, pain was the most common major complaint. Severe neurological deficits were rare. In Group A, 20 of 43 patients underwent surgery, whereas in Group B 23 of 42 patients underwent surgery. Among individuals who did not undergo surgery, 17 patients refused surgery and 25 patients underwent recommended conservative treatment. Short-term postoperative results indicated a significant improvement of pain and a stabilization of neurological symptoms. Long-term results showed a good prognosis in patients in whom first-time (that is, nonrevision) surgery achieved successful untethering, with a 10-year rate of neurological stabilization in 89% of Group A and a 10-year rate of neurological stabilization in 81% of Group B patients. The benefit of secondary operations in Group B was limited, with eventual clinical deterioration occurring in all patients within 10 years. For patients treated conservatively, follow-up information could be obtained in 33 of 42 patients. Twenty-eight patients remained in stable clinical condition. Only 5 of the conservatively treated patients experienced clinical deterioration over time; in 4 of these individuals with deterioration, surgery had been recommended but was refused by the patient. The clinical recurrence rate in all conservatively treated patients was 21% after 10 years. With a recommendation for surgery this figure rose to 47% within 5 years. Conclusions Surgery in adult patients with a tethered cord syndrome should be reserved for those with symptoms. In surgically treated patients, pain relief can often be achieved, and long-term neurological stabilization tends to persist more often than it does in conservatively treated patients. A conservative approach is warranted, however, in adult patients without neurological deficits. Revision surgery in patients with complex dysraphic lesions should be performed in exceptional cases only.

Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy

2020 ◽  
Vol 75 (11) ◽  
pp. 3327-3333
Author(s):  
Leonardo Calza ◽  
Vincenzo Colangeli ◽  
Marco Borderi ◽  
Diletta Testi ◽  
Bianca Granozzi ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Dual Therapy ◽  
Comparable Efficacy ◽  
Good Tolerability ◽  
Once Daily ◽  
Hiv Rna ◽  
Group A ◽  
Group B ◽  
The Cost

Abstract Background Antiretroviral dual regimens including lamivudine and one boosted PI or dolutegravir are warranted in order to optimize combination ART (cART), prevent long-term toxicity and reduce the cost of treatments. Objectives We hypothesized that a maintenance dual regimen of lamivudine plus raltegravir would be effective and as well tolerated as the dual maintenance combination of lamivudine plus dolutegravir. Methods We performed an observational, retrospective study of HIV-infected patients on suppressive ART who switched to a dual regimen containing lamivudine 300 mg once daily plus raltegravir 1200 mg once daily or dolutegravir 50 mg once daily. Results In total, 109 patients (79 men; mean age 46.4 years; mean CD4+ T lymphocyte count 605 cells/mm3) were enrolled. Overall, 50 subjects switched to lamivudine plus raltegravir (Group A) and 59 to lamivudine plus dolutegravir (Group B). After 12 months, 45 patients (90%) in Group A and 52 (88.1%) in Group B had HIV RNA &lt;20 copies/mL. No patients had severe adverse effects in either group, and the percentages of patients with mild adverse effects were comparable, except for a higher incidence of headache and sleeping disturbances in Group B than in Group A (30.5% versus 14%, P &lt; 0.001). A comparable and non-significant weight increase was reported in both groups (+1.91 kg in Group A and +2.28 kg in Group B). Conclusions In our study, dual therapies containing lamivudine plus raltegravir or dolutegravir in virologically suppressed patients showed high and comparable efficacy, as well as good tolerability.

scholarly journals Natural history of the enlarged ascending thoracic aorta: an observational long term study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Schroeder ◽  
B Bihin ◽  
M Buche ◽  
P.H Eucher ◽  
J Felix ◽  
...  
Keyword(s):  
Thoracic Aorta ◽  
Cumulative Incidence ◽  
Z Score ◽  
Mean Diameter ◽  
Group A ◽  
The Mean ◽  
Group B ◽  
Group D

Abstract   To assess the long-term outcome of patients with an enlarged ascending thoracic aorta (ATA), a retrospective study was performed. Methods Inclusion criteria: ATA diameter of 38 mm or more by ETT (813 consecutive cases). Inclusion period: 1.1.2003–31.12.2016. Results At baseline, the mean diameter of the ATA was 42±3 mm, the mean Z-score was 2.7±0.8. In the subgroup of patients with 2 ETT examinations (and no surgical cure of the ATA), the mean diameter was 41.9±4.8 mm, the mean Z-score 2.4±1.1 after a mean follow-up of 6 years. During the follow-up, 52 patients had an intervention on the ATA, 26 patients were operated within the first 3 months after the diagnostic echocardiogram. 26 patients were operated during FU. In the 791 remaining patients (without early intervention), the event rate (death, intervention on the ATA) were assessed by the competing risk model. In the group of patients with a baseline ATA diameter of less than 41 mm (Group A: n=254), the cumulative incidence of death at 5 and 10 y was 34% and 61%; in the group of patients with an ATA diameter of 41–42 mm (Group B: n=238) the incidence was 34% and 61% respectively, in the group of patients with an ATA diameter of 43–44 mm (Group C: n=147), the incidence was 32% and 58%, in the group of patients with a diameter of 45 and more (Group D: n=150), the incidence was 31.1% and 61% (NS). The cumulative incidence of surgical interventions on the ATA at 5 and 10 years was 0.4% and 1% in group A, 1.3 and 1.8% in group B, 0.7 and 1.4% in group C and 9.8 and 12.9% in group D (p&lt;0.05). Similar results were observed in patients according to the Z-scores. In the group of patients (221) with a Z-score &gt;3, the incidence of intervention at 5 and 10 y was respectively 7.6% and 10.7% (p=0.01). Conclusions – The mean diameter of the enlarged ATA remained nearly unchanged over a period of 6 years. – No impact of the enlarged ATA on survival was observed. – Only patients with an ATA diameter of 45 mm and more (or a Z-score of 3 and more) needed an intervention on the ATA at a rate of ± 10% at 10 y after the initial echocardiographic diagnosis. Funding Acknowledgement Type of funding source: None

Low-molecular-weight heparin in the acute and long-term treatment of deep vein thrombosis

2003 ◽  
Vol 89 (04) ◽  
pp. 674-680 ◽  
Author(s):  
Milena Gebska ◽  
Zbigniew Kadziola ◽  
Neelam Saba ◽  
Pilar Carrasco ◽  
Vijay Kakkar ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Term Treatment ◽  
Low Molecular Weight ◽  
Once Daily ◽  
Vein Thrombosis ◽  
Long Term Treatment ◽  
Group A ◽  
Group B ◽  
Deep Vein

SummaryLow molecular weight heparins (LMWHs) are frequently used during acute treatment of deep vein thrombosis, but their utility for long-term treatment needs to be defined.In this multi-centre trial, 378 patients with acute deep vein thrombosis were randomised to intravenous unfractionated heparin (group A), once daily subcutaneous LMWH (bemiparin) for one week (group B) or once daily bemiparin in a therapeutic dose for one week followed by a maintenance dose for 12 weeks (group C).Fifty-two per cent of patients in group A, 72% of group B and 72% of group C showed venographic reduction in thrombus size assessed objectively on day 14; 20% greater improvement in group B and C indicates not only non-inferiority of bemiparin (p = 0.00003) but also superiority (p = 0.004) compared to UFH. Day 84 venographic or Doppler sonographic recanalisation of the affected veins was demonstrated in 75.3%, 79.8% and 81.5% in groups A, B and C respectively. Mortality, recurrent thromboembolic events and bleeding were similar in the three groups.Both bemiparin regimens were more effective than UFH in reducing thrombus size during the acute phase of treatment. The efficacy in terms of recurrence of venous thromboembolism and safety of Bemiparin is similar to UFH. Bemiparin is also an effective alternative to warfarin for long-term treatment.

Long-Term Follow up of the Beneficial Effects and of Issues in Subtotal Splenectomy for Hereditary Spherocytosis

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 276-276
Author(s):  
Thomas Pincez ◽  
Corinne Guitton ◽  
Frederic Gauthier ◽  
Guenolee Lambert ◽  
Veronique Picard ◽  
...  
Keyword(s):  
Hereditary Spherocytosis ◽  
Hemoglobin Level ◽  
Mean Delay ◽  
Group A ◽  
The Mean ◽  
Total Splenectomy ◽  
Group B ◽  
Subtotal Splenectomy

Abstract Total splenectomy is recommended in symptomatic cases of hereditary spherocytosis (HS) to reduce the severity of anemia but exposes patients to long-term infectious or thrombotic complications. Alternative strategies such as subtotal splenectomy (STS) have been developed, principally for children under the age of 6 with severe HS, who are not eligible to total splenectomy because of the high infectious risk and for older patients with mild HS complaining of chronic discomfort. Since our original report, several groups have shown that STS reduced the hemolytic rate, increased the red cell lifespan while maintaining an efficient splenic phagocytic function but the extent of follow-up has been limited. In order to define the long-term benefits of STS, we report here an update of our series that includes 90 patients who underwent STS at the Bicêtre hospital between 1985 and 2013, with a median-follow-up of 9.3 years (range 1-23 years). Two groups were defined on the basis of the disease phenotype: Group A included 42 patients for whom STS was performed because of severe/intermediate HS (transfusion requirement or hemoglobin (Hb) level <95 g/dL and Group B included 48 patients with a milder HS but presenting marked icterus, gallstones requiring cholecystectomy or chronic fatigue. At the time of STS, the mean hemoglobin level was 82 g/L in Group A vs. 110 g/L in Group B. Mean age at surgery was 7.6 ± 5.4 years (0.5-25 years), significantly lower in Group A than in Group B (4.3 vs. 10 years, p<0.0001). In all cases, STS was performed by laparotomy. Preoperative mean spleen volume was 513 ± 241% of normal. Surgery reduced by 88% the initial splenic volume. A functional assessment of the splenic remnant was performed by Howell jolly body counts and by splenic scintigraphy. Splenic function was retained in 87 of 90 patients except for 3 individuals (2 post-operative necrosis of the remnant, 1 non-functional remnant). No severe infection or thrombotic event was documented during the entire period of follow-up. A sustainable hematological response was observed in 81 patients (90%) at the end of the evaluation period. The mean increase in the hemoglobin level was 27 g/L, with a hemoglobin level after STS being still higher in group B than in group A (130 ± 3.3g/L vs. 110 ± 3.3 g/L (p<0.0001). For the whole population, the mean number of transfusions per year and per patient was 0.097 after versus 1.7 before STS (for Group A only: 0.21 after vs. 3.65 before STS, p<0.0001). Of note, STS decreased the hemolytic rate but did not abrogate it: the reticulocyte count decreased from 399 ±195 G/L to 290 ±170 G/L (p<0.001), but the bilirubin level remained unchanged. Seventeen patients (33%) developed cholelithiasis during the follow-up period. Gallstones were slightly more frequent in Group A than in Group B (47% vs. 15%, p=0.03). After an initial improvement, 8 patients (19% of patients from Group A) experienced a relapse with transfusion-dependant anemia and/or decrease of the hemoglobin level below 95g/L. Relapses occurred with a mean delay of 4.6 ± 1.2 years after STS. Assessing the remnant volume by ultrasonography and/or scintigraphy, we noticed that it increased quickly during the first year after STS but at a slower rate during the subsequent 5 years. The growth was faster in patients from Group A but there was no clear correlation at the end of the follow-up period between the hemoglobin level and the volume of the remnant. During the follow-up period twenty patients (22%) underwent total splenectomy with a mean delay of 8 ± 5.6 years after STS (range 0-20.1 years). Eight patients underwent total splenectomy for recurrence of anemia, the others for recurrent discomfort/pain of the remnant (n=7), icterus (n=3), wandering spleen (n=1) and early post-STS hemorrhage (n=1). Requirement for total splenectomy was significantly higher in Group A than Group B (40 of the patients vs. 6% at the last endpoint, p<0.0001). In summary, our results show that in the long-term, STS resulted in a decrease in the hemolytic rate in HS. In children under the age of six years with severe HS, STS decreased the transfusion rate and increased the hemoglobin to a level compatible with normal growth while retaining splenic function. However, half of these patients will require total splenectomy, but at an age where it will be much safer. In milder HS, STS removed discomfort related to the high hemolytic rate whithout exposing the patients to the risks of a total splenectomy. Disclosures No relevant conflicts of interest to declare.

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