A Prospective, Observational Registry Study to Evaluate Effectiveness and Safety of Hyaluronic Acid-Based Dermal Fillers in Routine Practice: Interim Analysis Results with One Year of Subject Follow-Up

AbstractObjective: Our purpose was to assess the effect of a new hyaluronic acid-based (Hymovis®) injections on joint space width narrowing in patients diagnosed with knee osteoarthritis.Methods: A prospective clinical trial was conducted in the Department of Orthopedics and Traumatology II from the Clinical County Hospital, Tîrgu Mureș, Romania. Thirty-five patients diagnosed with idiopathic knee osteoarthritis received two intraarticular injections with hyaluronic acid-based hydrogel (24 mg of hyaluronic acid/3 ml) at one-week interval. Anteroposterior radiographs were obtained before the injections, at six and twelve months after. Minimum joint space width was measured by two senior orthopaedics surgeons at each follow up. Each radiograph was measured again by the same evaluators two weeks apart.Results: Thirty-one patients were present at the final follow-up. A minor reduction in mean weight was noticed (from 82.2 kg ± 16.2 kg to 80.9 kg ± 16.0, p > 0.398) without any correlation with joint space width narrowing. There were no major changes at the first follow up (6 months) regarding joint space narrowing. A reduction in joint space width was observed however at 12 months varying from 4.4 mm (SD ± 1.64, range 1.8-7.1) at the first assessment to 4.3 mm (SD ± 1.26, range 0.0-6.8) at the final follow-up but with no statistical difference (p=0.237).Conclusion: No significant modification in joint space width at the final follow-up secondarily proved that two injections of Hymovis® may slow down narrowing in the knee joint space over a one-year period.

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Anticoagulation Practice in Patients with Cancer-Associated Thrombosis: Insights from GeCAT, a German Prospective Registry Study

Oncology Research and Treatment ◽

10.1159/000521698 ◽

2021 ◽

Author(s):

Robert Klamroth ◽

Marianne Sinn ◽

Christiane Pollich ◽

Sven Bischoff ◽

Anja Lohneis ◽

...

Keyword(s):

Anticoagulant Therapy ◽

Patient Adherence ◽

Vitamin K Antagonists ◽

Significant Proportion ◽

Anticoagulation Therapy ◽

Routine Practice ◽

Registry Study ◽

Patients With Cancer ◽

Study Results

Introduction: Cancer-associated venous thrombosis (CAT) is a common and serious complication of active malignancies, increasing in frequency during systemic treatment and radiotherapy. Due to a high risk of recurrence and bleeding, the administration of anticoagulants for initial treatment and secondary prevention of CAT is challenging. We conducted a prospective registry study of patients with acute CAT to evaluate the way treatment is given to these patients in routine practice. Methods: From May 2015 to May 2017, all consecutive patients with acute venous thromboembolism (VTE) admitted to specialty or emergency departments of the participating hospitals in Berlin, Germany, were entered in the registry. Patients with cancer underwent extensive baseline evaluation including the type and location of thrombosis and use of anticoagulant therapy. Follow-up assessments were made at discharge and by telephone interviews at 3 and 6 months. Results: A total of 382 patients with acute CAT were enrolled in the study, representing 24.5% of all patients with thrombosis. 70.4% of CAT patients had deep vein thromboses (DVT), 48.2% had pulmonary embolism (PE), and 18.6% had concurrent PE and DVT. A significant proportion of VTE (27%) were asymptomatic and were diagnosed only incidentally. At baseline, 97.9% of the patients received anticoagulant therapy, predominantly with low-molecular-weight heparin (LMWH) (n=334, 87.4%). Direct oral anticoagulants (DOACs) were given to 5.8% of patients, and vitamin K antagonists (VKAs) were rarely used (<2% of patients). Changes in the prescription of antithrombotic agents were seen at discharge from hospital and during follow-up. Overall, the use of LMWH declined during follow-up, while the proportion of patients treated with DOACs increased to 32.4% at 6 months. At baseline, the most frequently used LMWH were enoxaparin and nadroparin, but many patients were switched to once daily tinzaparin prior to discharge. Initially and after discharge the majority of patients were treated by oncologists. Overall, 263 (68.8%) and 222 (58,1%) patients were still alive and could be contacted at 3 and 6 months of follow-up, respectively. Of these, 84.0% and 71.6% were still on anticoagulant therapy (58.6% and 36.5% on LMWH). Conclusion: In accordance with the guidelines, the majority of CAT patients received anticoagulation therapy for the recommended minimum duration of 3-6 months. LMWH remained the preferred option throughout the study, demonstrating good patient adherence. In deviation from guideline recommendations and available study results during the study period, more than a quarter of CAT patients were treated with DOACs. Only recently, DOACs have been established as another option for anticoagulation in CAT patients.

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The long-term effect of intra-articular hyaluronic acid on pain and functional status in knee osteoarthritis (one year follow-up)

The Pain Clinic ◽

10.1163/15685690260494898 ◽

2002 ◽

Vol 14 (4) ◽

pp. 331-337

Author(s):

Selda Bagis ◽

Gunsah Sahin ◽

Volkan Oztuna ◽

Abtullah Milcan ◽

Canan Erdogan ◽

...

Keyword(s):

Hyaluronic Acid ◽

Knee Osteoarthritis ◽

Functional Status ◽

Term Effect ◽

Long Term Effect ◽

One Year

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Interim Analysis of a Multicenter Trial of High Dose (HD) Imatinib in Newly Diagnosed Early Chronic Phase (CP) Patients (pt) with Chronic Myeloid Leukemia (CML).

Blood ◽

10.1182/blood.v106.11.1085.1085 ◽

2005 ◽

Vol 106 (11) ◽

pp. 1085-1085 ◽

Cited By ~ 1

Author(s):

Jorge Cortes ◽

Francis Giles ◽

August J. Salvado ◽

Karen McDougall ◽

Jerald Radich ◽

...

Keyword(s):

Interim Analysis ◽

Mutational Analysis ◽

Dose Intensity ◽

High Dose ◽

Molecular Response ◽

Newly Diagnosed ◽

Entire Treatment Period ◽

Log Reduction ◽

One Year

Abstract While imatinib (400 mg daily) results in 12 mo complete cytogenetic responses (CCyR) in 76% of pt, complete molecular responses (CMR) at this time are in the range of 4–6%. A single center study recently showed higher 12 mo CMR when newly diagnosed CP pt were given 800 mg daily. We report here an interim analysis of similar patients treated in a Phase II single arm multicenter setting with 800 mg imatinib daily. Eligible pt. were ≥18y, had normal organ function and were newly diagnosed. Prior hydroxyurea or imatinib was allowed for ≤ 1 mo. Treatment dose was adjusted for ≥Gr3 toxicity. Peripheral blood (PB) PCR and FISH were measured every 3 mo in a central laboratory (Quest, Northridge, CA) and marrow cytogenetics and PCR was done at 1 yr in the same laboratory. The primary endpoint was molecular response at one year. Secondary endpoints included hematologic response, marrow cytogenetic response at 1 yr, progression/loss of response and safety. Accrual of 115 pt in 29 institutions was completed in April 2005 and the current report is based on 20 pt reaching 12 mo follow up by May 2005. Median follow up is 5 mo (0.2–16 mo). Median age is 51 (19–81). Sokal classification was predominantly low (73.1%) or intermediate (17.3%). To date, 11/115 patients have gone off study (4 withdrew, 4 AEs, 2 progression, 1 protocol violation). The 2 early progressing patients were withdrawn following 10 and 11 mo of treatment respectively. PB PCR showed an initial decline in both patients with a subsequent rise after 3 and 6 months respectively. Mutational analysis in these patients showed wild type (wt) bcr/abl in one and an E255V mutation identified at 6 mo in the second. Median Dose Intensity for the entire population is 98% (29–100%). By 6 mo, 24/52 pt (46%) already had a BCR-ABL/ABL ratio <0.045% (>3 log reduction from baseline). Sixteen of twenty pt (80%) have CCyR at one year with 11/20 (55%) showing non detectable levels of transcripts. The 5 pt with CCyR still showing detectable BCR-ABL/ABL ratios have a mean reduction of 3.21 (2.54–4.47) log from baseline. Two pt with MCyR have 3–15% Ph+ cells in marrow with PB FISH that is either negative or marginally positive (1.2%). PCR in these patients at 12 mo shows a 3.28 and 2.24 log reduction below the median baseline respectively. Two additional pt at 12 mo continue to have 40 and 95% PH+ metaphases in their marrow and 7% FISH positive cells in PB of both. PCR at 12 mo for these pt shows a < 2 log reduction of BCR-ABL/ABL ratio from baseline for both. Additional mutational analysis is being performed. We conclude that 800 mg daily of imatinib results in a high rate of CMR for newly diagnosed pt by 12 mo of treatment. The treatment was relatively well tolerated and could be delivered in a multicenter setting with sustained dose intensity over the entire treatment period.

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A multicenter randomized trial for the effectiveness of structured discharge and follow-up protocol on readmission rate in COPD patients receiving LTOT/NIV: one-year interim analysis.

10.1183/13993003.congress-2018.oa5410 ◽

2018 ◽

Cited By ~ 1

Author(s):

Begüm Ergan ◽

Tugba Goktalay ◽

Pinar Ergun ◽

Dicle Yi̇lmaz ◽

Birsen Ocakli ◽

...

Keyword(s):

Randomized Trial ◽

Interim Analysis ◽

Readmission Rate ◽

Multicenter Randomized Trial ◽

Copd Patients ◽

One Year

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Quantitative Evaluation of Meniscal Healing Process of Degenerative Meniscus Lesions Treated with Hyaluronic Acid: A Clinical and MRI Study

Journal of Clinical Medicine ◽

10.3390/jcm9072280 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2280

Author(s):

Alessandra Berton ◽

Umile Giuseppe Longo ◽

Vincenzo Candela ◽

Federico Greco ◽

Francesca Maria Martina ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Hyaluronic Acid ◽

Global Assessment ◽

Resonance Imaging ◽

White Zone ◽

Sf 36 ◽

Meniscus Lesions ◽

Significant Difference ◽

One Year

Purpose: We aimed to evaluate clinical efficacy and healing effects of conservative management of degenerative meniscus lesions (DMLs) with a hyaluronic acid (HA) hydrogel. Methods: Patients were subjected to two HA injections two weeks apart. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient’s Global Assessment (PtGA) and Clinical Observer Global Assessment (CoGA) of the disease were assessed at baseline, 30, and 60 days after treatment. Short Form (36) Health Survey (SF-36) was assessed at baseline and 60 days after treatment. One year after treatment, patients were called to know whether any of them had undergone arthroscopic partial meniscectomy (APM). All patients underwent magnetic resonance imaging using a 1.5-T Magnetic Resonance Imaging (MRI) scanner (Siemens Aera), which included a T2 mapping pulse sequence with multiple echoes at baseline and 60 days after treatment. Results: 40 patients were enrolled. WOMAC score, physical function subscale, PtGA and CoGA, and SF-36 showed a statistically significant difference between baseline and follow-up. One year after treatment, only one patient had undergone APM. A decrease in the T2 measurement was detected in the posterior horn medial meniscus in 39% of cases in both the red and red–white zone, and in 60% of cases in the white zone; in the posterior horn lateral meniscus in 55% of cases in both the red and white zones, and in 65% of cases in the red–white zone. Only for the latter, there was a statistically significant difference between baseline and posttreatment T2 measurements. Conclusion: This study supports the use of HA in the conservative management of DML as it is clinically effective and enhances meniscus healing as demonstrated by T2 measurements. Moreover, it reduces the need for APM at 1-year follow-up.

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1029 Anthracycline and trastuzumab-induced subclinical cardiac damage and its prevention in the SAFE trial. Myocardial strain imaging and 3D echo interim analysis data

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez319.624 ◽

2020 ◽

Vol 21 (Supplement_1) ◽

Author(s):

G Barletta ◽

L Livi ◽

F Martella ◽

I Desideri ◽

F Venditti ◽

...

Keyword(s):

Repeated Measures ◽

Interim Analysis ◽

Myocardial Strain ◽

Strain Imaging ◽

Left Ventricular ◽

Controlled Study ◽

3D Echo ◽

One Year ◽

Myocardial Strain Imaging

Abstract Background Benefit of anthracyclines and trastuzumab therapies on disease-free survival in breast cancer is well known. Cardiotoxicity is a feared potential complication of both drugs. It usually progresses from cardiomyocyte injury to silent left ventricular dysfunction (LVD) which often becomes symptomatic and irreversible. Therefore, its prevention and early detection are of paramount importance in these cancer patients. Purpose SAFE trial (CT registry ID: NCT2236806) is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effects of Bisoprolol (B) (5 mg, twice daily), Ramipril (R) (5 mg, twice daily) or the combination of the two (R + B), compared to placebo (P), on subclinical heart heart damage. Interim data of left ventricular function monitored with 3D Echo and Myocardial Strain Imaging are presented. Methods Out of 225 patients asked to participate, 191 were enrolled (mean age 48.9 ± 9.0 years). Follow-up monitoring (at 3, 6, 12 months[m]) comprised 3D ejection fraction (3D-LVEF) and Global Longitudinal Strain (GLS). One patient had sub-acute anthracyclines cardiotoxicity. Data at one year of 123 patients were available (34 P, 28 R, 31 B, 30 R + B). Results At time 0, no significant differences in age, body mass index, hemodynamic parameters were observed among arms. Data of 3D-LVEF and GLS at time 0 and during follow-up are reported in the figure (p level versus time 0 – GLS repeated measures). There was a significant reduction in 3D LVEF and increase in GLS in P arm (3D LVEF: 3m: -3.3%, 6m: - 5.2%, 12m: -3.7%; GLS: 3m: +5,7%, 6m: +7.8%, 12m: + 7,1%). A similar, though less significant, worsening of 3D LVEF (-2.4%,-1.9%,-2.2% at 3, 6, 12m, respectively) and GLS (+2.7%, +3.2% at 3 and 6m, respectively) was found in R arm. In B and B +R arms there was a worsening at 6m (3D LVEF -2.5%, GLS +2.7%), whereas at 12m only GLS increased (+3.2%) in B, not in B + R. Arm differences were significant (repeated measures two ways) both for 3D LVEF (two-way repeated measures ANOVA, p level = 0.038, observed power 0.855) and GLS (p level = 0.002, observed power 0.973). Conclusions This interim analysis of the SAFE trial shows that demonstration of subclinical cardiotoxicity is feasible with 3D echo and myocardial strain imaging. Significant subclinical damage potentially leading to LVD is present at one year. Both B alone on in combination with R may be a successful cardioprotective strategy in patients treated with anthracyclines and trastuzumab. Abstract 1029 Figure. Time course of GLS and 3D LVEF

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