scholarly journals 12-month post-trial follow-up of participants in the Australian arm of the second low-dose colchicine trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S M Nidorf ◽  
C Budgeon ◽  
J W Eikelboom ◽  
K Murray ◽  
L Nidorf ◽  
...  

Abstract Background In the Australian arm of the LoDoCo2 trial, colchicine 0.5mg daily compared with placebo markedly reduced the risk of cardiovascular (CV) events in patients with chronic coronary disease (2.0 vs 3.9 events per 100 person years, HR 0.51; 95% CI 0.39–0.67). The purpose of this analysis was to explore CV and non-CV outcomes in the Australian cohort out to one year after cessation of trial medication. Methods Information was collected on all potential CV events and non-CV deaths as well as a range of other co-morbidities. All CV events were blindly adjudicated. The analysis examined the primary outcome (a composite of CV death, myocardial infarction, ischemic stroke, and unscheduled revascularization) and non-CV deaths by initial randomized treatment from the beginning of the trial up until one year after cessation of trial medication. A landmark analysis was then used to examine these outcomes from the date of last contact during the trial until one year after cessation of trial medication. Results The clinical status was confirmed in 1819/1824 (99.7%) participants who were alive at the end of the trial, and in 100% of those participants still taking trial medication at the end of the trial. During post-trial follow up, 515 patients (28.2%) were taking non-study colchicine, including 278 (30.5%) originally randomized to colchicine and 237 (25.9%) randomized to placebo. Over the entire follow-up period that included the 12-month period after the trial medication was ceased, the effect of prior exposure to colchicine on the primary CV outcome was still evident (2.2 vs 3.8 events per 100 person years, HR 0.58; 95% CI 0.45–0.74), however no post-trial CV benefit were apparent in the landmark analysis (3.3 vs 3.4 events per 100 person years, HR 0.97; 95% CI 0.56–0.1.69). Over the entire course of follow-up the incidence of new cancer (7.9% vs 7.2% RR 0.91; 95% CI 0.66–1.25) and non-CV death (0.9 vs 0.6 events per 100 person years, HR 1.44; 95% CI 0.92–2.27) was no different in the treatment groups. Conclusion Although the CV benefits of colchicine treatment that emerged during the trial were still evident in the year after stopping study treatment, no additional CV benefit accrued after it was ceased. These data suggest that colchicine should be continued long-term to maximize its CV benefits. FUNDunding Acknowledgement Type of funding sources: None.

1976 ◽  
Vol 129 (3) ◽  
pp. 252-260 ◽  
Author(s):  
Myrna M. Weissman ◽  
Stanislav V. Kasl

SummaryThis paper reports on the clinical status, help-seeking and subsequent treatment experiences of 150 women one year after they had completed out-patient maintenance treatment by amitriptyline and/or psychotherapy for a depressive episode.While the majority of patients were asymptomatic at follow-up, a substantial minority had a return of acute symptoms and 2 per cent made minor suicide attempts during the year. Admission to hospital was rare. However, only 30 per cent of the patients did not seek any treatment during the year and the majority received some psychotropic medication.The findings support the long-term need for prompt access to treatment by patients who have recovered from an acute depression.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 1588-1588
Author(s):  
Mohamed Bradai ◽  
Serge Pissard ◽  
Mohand Tayeb Abad ◽  
Agnes Dechartres ◽  
Jean-Antoine Ribeil ◽  
...  

Abstract Context: Benefits of HU treatment in thalassemic patients are controversial. Most studies agree that HU decreases transfusion requirements in patients with TI, whereas results in patients with TM are inconsistent. Objectives: To assess the proportion of good responders to HU and the factors associated with good response. Methods: We initiated HU treatment in 54 thalassemic patients (9 TI and 45 TM). Median ages at first transfusion were 57 months (32–252) in TI and 13 months (4–60) in TM patients. Median ages at inclusion were 12.4 years (4.4–54.9) in TI and 9.9 years (2.0–21.0) in TM patients. Median numbers of erythrocyte concentrates (EC) transfused the year before HU were 3 (1–9) in TI and 12 (8–16) in TM patients (10–65). Good response was defined as more than 70% decrease of transfusional needs one year after beginning HU, partial response as a decrease between 40 and 70%, and non response as a decrease of less than 40%. Patients were transfused when their hemoglobin (Hb) level was < 6g/dL; not transfused when Hb was > 7 g/dL; decision to transfuse was based on clinical status for Hb level between 6 and 7 g/dL. Mean HU dose was 17 ± 2 mg/kg/d (13–21). Mean follow-up was 29.3 ± 14 months. Results: Eight (90%) TI and 20 (44.5%) TM patients had a good response to HU. No TI and 9 (20%) TM patients had a partial response to HU. One (10%) TI and 16 (35,5%) TM patients had no response to HU. Clinical and hematological tolerance were good except for one 55 yr old TI patient who developed in the 3rd year of treatment an acute myeloblastic leukemia. Retrospectively, a malignant transformation of a pre-existent myeloproliferative disorder can not be excluded and the responsibility of HU is questionable. A better response to HU was associated with a later beginning of transfusion (p=0.02), a higher pre-HU Hb (p= 0.0004), codon 6(-A) mutation (p= 0.002), and with TI diagnosis (p=0.03). On the contrary, Gγ-158 C/C genotype (Xmn1−/−) (p= 0.0001) was associated with a worse response. After adjustment, decrease of transfusional needs was associated with the number of CE transfused the year before HU treatment (p= 0.001), Xmn1 polymorphism (p= 0.003) and the age at the beginning of HU (p=0.03) but not with the type of thalassemia. In conclusion, HU may represent an alternative to transfusions for both TI and TM patients in countries with limited blood supplies when beginning early.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A Salyamova ◽  
A Khromova ◽  
O Kvasova ◽  
N Burko ◽  
V Oleinikov

Abstract Objective To study the incidence of side effects from muscle tissue during therapy with atorvastatin at various doses in patients with acute ST-segment elevation myocardial infarction (STEMI) during 48 weeks of follow-up. Methods The study included 115 STEMI patients aged 30 to 65 years (mean age 51.7±9.5 years). Patients were randomized to atorvastatin treatment groups. Group 1 included 59 people who took atorvastatin 80 mg / day; group 2 - 56 patients who received moderate doses of atorvastatin. The compared persons were matched by age, sex, and anthropometric data. Initially on the 7–9th days, after 24 and 48 weeks of follow-up, the CPK-MB serum level was analyzed. Muscle damage was assessed after 5–6, 24, 48 weeks of follow-up according to the development of the following symptoms: pain, fatigue, muscle weakness, decreased physical activity - on a 10-point scale. Results The CPK-MB level in the 1st group initialy was 701.5 [95% CI 391; 1012] U / L, after 24 weeks - 162.8 [95% CI 130.2; 195.4] U / L (p&lt;0.001), after 48 weeks - 205.6 [95% CI 134.8; 276.4] U / L (p&lt;0.001). In group 2, the dynamics of CPK-MB: on days 7–9 - 522.7 [95% CI 115.8; 755.1 U / L, after 24 weeks - 141.4 [95% CI 122.6; 160.3] U / L (p=0.0004), after 48 weeks - 150.5 [95% CI 123.9; 177.1] U / L (p=0.0003). A detailed analysis in four patients of the 1st group revealed an increase in CPK-MB &gt;4 upper limit of normal (ULN) after 48 weeks of follow-up (6.8%). Moreover, symptoms of muscle damage against the background of pathological CPK-MB values were observed only in two people (3.4%). In patients of the 2nd group after 24–48 weeks of therapy with atorvastatin, there was no increase in CPK-MB &gt;4 ULN. In addition, there were no cases of drug withdrawal in any of the groups due to an increase in CPK-MB&gt;10 ULN. Clinical symptoms of muscle damage after 5–6th, 24th and/or 48th weeks of follow-up were diagnosed in the 1st group in 41 patients (69.5%), in the 2nd group - in 31 people (55%) (p=0.11). Conclusion In STEMI patients on the background of 48-week therapy with atorvastatin, no serious adverse effects on the muscle tissue were revealed, which testifies in favor of the safety of high-dose statin therapy. The incidence of myalgia did not depend on the dose of the drug. FUNDunding Acknowledgement Type of funding sources: None.


2021 ◽  
Author(s):  
Anton Köhler ◽  
Anna-Lina Sarkis ◽  
Daniel Alexander Heinrich ◽  
Lisa Müller ◽  
Laura Handgriff ◽  
...  

Context: Primary aldosteronism (PA) causes left ventricular hypertrophy (LVH) via hemodynamic factors and directly by aldosterone effects. Specific treatment by mineralocorticoid receptor antagonists (MRA) or adrenalectomy (ADX) has been reported to improve LVH. However, cardiovascular benefit could depend on plasma renin concentration (PRC) in patients on MRA. Patients and Objective: We analyzed data from 184 patients from the Munich center of the German Conn’s Registry, who underwent echocardiography at time of diagnosis and one year after treatment. To assess the effect of PRC on cardiac recovery we stratified patients on MRA according to suppression (n=46) or non-suppression of PRC (n=59) at follow-up and compared them to PA patients after ADX (n=79). Results: At baseline, patients treated by ADX or MRA had comparable left ventricular mass index (LVMI, 61.7 vs 58.9 g/m2.7, p= 0.591). Likewise, patients on MRA had similar LVMI at baseline, when stratified into treatment groups with suppressed and unsuppressed PRC during follow-up (60.0 vs 58.1 g/m2.7, p= 0.576). In all three groups we observed a significant reduction in LVMI following treatment (p<0.001). However, patients with suppressed PRC had no decrease in pro-BNP levels and the reduction of LVMI was less intense than in patients with unsuppressed PRC (4.1 vs 8.2 g/m2.7, p= 0.033) or after ADX (9.3 g/m2.7, p= 0.019). Similarly, in multivariate analysis, higher PRC was correlated with the regression of LVH. Conclusion: PA patients with suppressed PRC on MRA show impaired regression of LVH. Therefore, dosing of MRA according to PRC, could improve their cardiovascular benefit.


2008 ◽  
Vol 97 (1) ◽  
pp. 50-55 ◽  
Author(s):  
J. Virkkunen ◽  
M. Venermo ◽  
J. Saarinen ◽  
L. Keski-Nisula ◽  
P. Apuli ◽  
...  

Background and Aims: Investigating the impact of percutaneous transluminal angioplasty (PTA) on clinical status and health related quality of life in patients with claudication and critical limb ischaemia (CLI). Material and Methods: 61 patients and 64 limbs underwent a primary PTA (30 claudication and 34 CLI cases). Clinical status was graded according to Ahn and Rutherford and ankle/brachial index (ABI). Quality of life was assessed using the Nottingham Health Profile (NHP) preoperatively, one month and one year after the procedure. Triplex scan evaluation of the treated arterial segment was carried out postoperatively and one year after the procedure. Results: Claudication: 24/27 patients underwent one-year follow up, after which 20/24 had no claudication. In triplex evaluation 17 (63.0%) treated segments were open with 0–50% restenosis, 9 (33.3%) with 51–99% restenosis and one (3.7%) was occluded. CLI: 13/34 (38.2%) patients underwent one-year follow-up after which eight patients (61.5%) were asymptomatic and five (38.1%) had claudication. In triplex evaluation there was 0–50% restenosis in 6 (46.2%) segments treated with PTA and 51–99% restenosis in 7 (53.8%) segments. 21 (61.8%) patients did not conclude the one year follow up: 7 had died, 5 had undergone bypass surgery and 6 an amputation and 3 did not attend the follow-up up for unknown reasons. Quality of life: For CLI patients, improvement was observed in the domain of pain, which continued throughout the follow-up period. Among the claudicants, the domain of physical mobility was improved at one month's follow-up, but this effect disappeared during the following year and could not be seen at one the one- year follow-up. Conclusions: Technical success and one-year results in claudication are good, and the rate of complications is low. However, although PTA resulted in an immediate improvement in the quality of life, this effect was not seen in the long term. In critical limb ischemia there was a group of patients in whom PTA led to a significant benefit in terms of limb salvage and quality of life.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Kulchetscki ◽  
A.P Ferraz ◽  
F.C Gouvea ◽  
F.K.B Alexandre ◽  
M.P Mayrink ◽  
...  

Abstract Background Chagas disease (ChD) is a major cause of non-ischemic cardiomyopathy (NICM) in Latin America and is becoming more frequent in other parts of the world, especially due to immigration movements. Ventricular Tachycardia (VT) is more common in this type of NICM than others, and finding an effective treatment strategy still is a challenge. Catheter ablation is an option, but there is poor data regarding its efficacy and safety. Purpose Evaluate the outcomes after VT catheter ablation in ChD patients. Methods Data were collected by VT studies reports and patient record analysis, including comorbidities and clinical status at baseline and on follow-up. We analyzed all-cause mortality, one-year VT recurrence rate and procedure related major complications. Results Between January 2013 and December 2018, 157 catheter ablation procedures in 121 ChD patients were performed in our institution. The mean follow-up time was 22.6±22.1 (mean ± SD) months. Overall post procedure mortality was 33.1%, and mean survival time was 51.2 months (95% CI: 44.8–58. NYHA functional class (p=0.022), ejection fraction (p=0.020) and immediate ablation result (p 0.002) were predictors of all-cause mortality in the follow-up. Clinical VT inducibility after ablation was a predictor of VT recurrence at one year (p=0.04). An epicardial approach was performed in 125 (79%) procedures, and accidental right ventricle (RV) puncture occurred in 23 (18.4%), in which open-chest surgery for bleeding hemostasis was necessary in 4 procedures (3.2%). Conclusion Mortality and recurrence rates in ChD patients after VT ablation were high, and correlated with heart failure severity. Epicardial approach is often necessary in this subset of patients. There was a correlation between immediate ablation results and recurrence. Kaplan-Meier of cumulative survival Funding Acknowledgement Type of funding source: None


1978 ◽  
Vol 132 (5) ◽  
pp. 500-505 ◽  
Author(s):  
Ian Berg ◽  
Dorothy Fielding

SummaryThirty-two school-phobic youngsters of mean age 13 years were randomly allocated to two treatment groups after stratifying for sex. Length of in-patient management in a psychiatric hospital unit for young adolescents was evaluated. One group was admitted for three months and the other for six. Care was taken to ensure that cases had been fairly distributed between the groups by comparing them on a variety of clinical features. Follow-up assessments were carried out in a reliable fashion at six months, one year and two years after discharge. Outcome, overall, was similar to that found in a previous follow-up study for the same unit, in that symptoms of emotional disturbance and social impairment tended to persist in a considerable proportion of cases over the period of review. Length of stay in hospital did not affect outcome as far as the boys were concerned; the findings in relation to the girls was less certain and it seems likely that longer in-patient treatment improves outcome in school-phobic girls.


2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Ian Rodway ◽  
Julie Gander

Background. This retrospective, two cohort series study was designed to compare a room temperature, glycerol-preserved composite pinned bone allograft (G-CPBA) with the same graft type provided in a frozen state (F-CPBA) for use as a cervical interbody spacer in anterior cervical discectomy and fusion (ACDF). Methods. A comprehensive chart review was performed for 67 sequential patients that received either a F-CPBA or a G-CPBA and had at least one-year follow-up. Twenty-eight patients had received G-CPBA grafts and 37 patients had received F-CPBA grafts. Two additional 2-level patients had received one of each type of grafts. Results. At 3 months, 45.3% (29 of 64) of glycerol-preserved and 41.4% (29 of 70) of frozen allografts, respectively, were considered to be fused radiographically. At 12 months, 100% of both treatment groups (41 glycerol-preserved and 45 frozen) were considered fused. Fusion rates for G-CPBA were statistically similar to F-CPBA at both 3 and 12 months (P=0.6535 and >0.999, resp.). There were no allograft related complications in either treatment group. Conclusions. 100% fusion rates were attained by both treatment groups at 12 months and were similar at short-term follow-up for all comparable levels. Level of Evidence. Level of evidence is III.


1997 ◽  
Vol 170 (4) ◽  
pp. 338-344 ◽  
Author(s):  
Ariel Stravynski ◽  
Giles Gaudette ◽  
Alain Lesage ◽  
Nira Arbel ◽  
Pascale Petit ◽  
...  

BackgroundModels of sex therapy for sexual dysfunction in single men are available, but their value is not well established. This controlled study compared three approaches to the treatment of sexually dysfunctional single men.MethodSixty-nine single men diagnosed as sexually dysfunctional were randomly assigned to treatments focusing on either their sexual dysfunction, their interpersonal problems, a combination of both or a waiting list; 51 completed treatment and 50 the one-year follow-up. Treatment was administered in small groups in 15 weekly sessions and four six-weekly sessions during the first six months of a year-long follow-up.ResultsNo clinically meaningful change was observed during the waiting period. In contrast, a significant and equivalent improvement was observed in all treatment groups by the end of treatment. However, differences between them were in evidence at 6 and 12 months' follow-up.ConclusionsBoth treatments paying attention to the patients' interpersonal difficulties resulted in significantly better outcomes overall than the approach that concentrated on problems in sexual functioning alone.


2018 ◽  
Vol 20 (2) ◽  
pp. 119
Author(s):  
Shahnaz Begum ◽  
Fatima Begum ◽  
Shamima Yeasmin ◽  
Tania Sultana ◽  
Afroza Begum ◽  
...  

<p><strong><em>Background:</em></strong> Primary hyperparathyroidism (PHPT) is the third most endocrine disorder after diabetes and thyroid disease. The objective of this study was to observe the outcome of those patients who had positive parathyroid scan with Technetium-99m (<sup>99m</sup>Tc) sestamibi scan  referred to National Institute of Nuclear Medicine &amp; Allied Sciences (NINMAS) to perform parathyroid scan.<strong></strong></p><p><strong><em>Patients and Methods</em></strong><em>:</em> This longitudinal observational type of study was carried out at NINMAS, from January 2016 to December 2016. A total number of 43 hyperparathyroid patients who had positive parathyroid scan were included in this study during one year follow up period. There clinical status, biochemical profile &amp; treatment history were evaluated Chi-quire and paired t-test were used to analyze the variables.</p><p><strong><em>Results:</em></strong><strong> </strong>Among 43 study patients, number of male patients was 26 (60.5%) and female patients were 17 (39.5%). The mean ± SD age was 42.44 ± 12.11 years and majority was in age group 41-50 years<strong>. </strong>It was observed that 40 (93.0%) patients were symptomatic and only 3 (7.0%) were asymptomatic. Regarding symptoms, majority (81.4%) patients had bone pain followed by renal stone (58.1%). More than half (55.8%) patient had abdominal pain or cramps. Twenty nine (67.4.0%) patients undergone operation and 14 (32.6%) patients did not receive operative treatment at the one year follow up period.  Among 43 patients 29 (67.4%) were operated and all operated patients relieved their symptoms whereas patients 14 (32.6%) had not undergone operation and their symptoms persisted. There was strong statistical significant association (P&lt;0.05) between operation and relief of symptoms. The biochemical profile of study patients showed that preoperative mean serum calcium level was 10.92±2.85 mg/dl which reduced after operation (7.53±2.75 mg/dl). The mean value of serum parathyroid hormone (PTH) level also reduced from 748±744.77 pg/ml to 171.61±168.23 pg/ml.</p><p><strong><em>Conclusion:</em></strong> Among all patients, 67.4% received operative treatment and were relieved from symptoms at one year follow up. Significant number of hyperparathyroid patients (32.6%) failed to receive operative treatment due to poor economic condition. More awareness is needed among physicians and patients about immediate operative treatment to alleviate their sufferings as well as to avoid crippling complications.</p><p>Bangladesh J. Nuclear Med. 20(2): 119-123, July 2017</p>


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