Good Safety and Tolerance Profiles of Long Term Treatment of Advanced Multiple Myeloma (MM) with Bortezomib.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4811-4811
Author(s):  
Jean El-Cheikh ◽  
Anne-Marie Stoppa ◽  
Reda Bouabdallah ◽  
Diane Coso ◽  
Jean-Marc Schiano de Collela ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Term Treatment ◽  
Term Therapy ◽  
Cycle Duration ◽  
Disease Response ◽  
Number Of Patients ◽  
Long Term Treatment ◽  
Grade 3

Abstract Bortezomib is a first-in-class proteasome inhibitor approved for the treatment of MM patients who have received at least one prior therapy. Classically, patients receive bortezomib 1.3 or 1.0 mg/m2 by IV bolus on days 1, 4, 8, and 11 of a 21-day cycle, associated or not to dexamethasone, for a total number of 8 cycles. Such administration schema is associated with a remarkable anti-tumor activity and response. However, a significant number of patients who are initially responders to bortezomib, will progress after drug discontinuation, raising the question of long term or maintenance treatment with bortezomib. The objective of this analysis was to evaluate the tolerance and safety profiles of long term treatment with bortezomib in a cohort of 16 patients with relapsed and/or refractory MM treated in a single institution. Eligible patients for this analysis are those who had relapsed MM, and who continued to receive bortezomib (1.3 or 1.0 mg/m2) as a long term therapy beyond the classical 8 cycles. All medical charts were uniformly reviewed in detail for assessment of toxicity, safety and response. The median age was 53 (range, 27–74) years. The majority of patients had already received at least one prior autologous or allogeneic stem cell transplantation (n=12; 75%). Also, 12 patients (75%) had received prior treatment with thalidomide at a median dose of 200 mg/day, for a median duration of 7 months. Before treatment with bortezomib, 7 patients (44%) already had some form of peripheral neuropathy (PN). With a median follow-up of 16 months from bortezomib initiation, patients from this series received a median of 10 (range, 9–16) cycles of bortezomib administered over a median period of 11 (range, 7–35) months. Overall, 6 patients had evidence of bortezomib-associated PN (38%; 4 grade 1, 1 grade 2 and 1 grade 3; sensory symptoms in all cases). Other bortezomib-related toxicities included thromobopenia (n=8; 50%; 1 grade 1, 5 grade 2, and 2 grade 3–4). General fatigue was also common and was encountered in 5 (31%) patients. Overall, bortezomib-associated toxicities led to dose reduction or increase of treatment cycle duration in 9 patients (56%), but none of the patients had to definitively discontinue treatment because of unacceptable toxicity. At last follow-up, 6 patients are still receiving bortezomib, 4 patients died from disease progression, no patient died from treatment-related causes, and the remaining 12 patients are still alive. Long term treatment with bortezomib was associated with an objective disease response rate in 87% (95%CI, 60–98%) of patients (n=14; 3 CR, 8 VGPR, 3 PR). The Kaplan-Meier estimate for overall survival is shown in the figure below. Though relatively small, results from this series suggest that long term treatment with bortezomib is feasible. Toxicity, tolerance and safety profiles of long term treatment are comparable to those observed with the standard schedule and manageable after dose reduction. Therefore, prospective studies aiming to optimize bortezomib administration schedule and duration (beyond the classical 8 cycles) are warranted, since such long term treatment can yield major objective disease response. Figure Figure

scholarly journals Refractory Acute Interstitial Nephritis in the Setting of Nivolumab Therapy

2021 ◽  
Vol 2021 ◽  
pp. 1-4 ◽  
Author(s):  
Antonio Faieta ◽  
Tavis Dancik
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Interstitial Nephritis ◽  
Acute Interstitial Nephritis ◽  
Term Treatment ◽  
Steroid Dependent ◽  
Long Term Treatment ◽  
Grade 3

A 65-year-old male patient with metastatic CCRCC developed steroid-dependent, grade 3 AIN secondary to nivolumab weeks after its initiation that resulted in 3 hospitalizations with acute renal failure. The patient was started on MM and his AIN was successfully controlled after a 2-year period of follow-up. Refractory renal AIN resulting from PD-1 inhibitor use is rare, and its successful treatment with mofetil mycophenolate with a 2-year follow-up in a patient with metastatic CCRCC has not been reported. This case is important because not only was his renal irAEs controlled but also long-term treatment with MM did not result in progression of metastatic disease.

scholarly journals Evaluation of efficacy and safety of long-term use of amtolmetin guacil in rheumatic diseases: results of a 9-month observational AURORA study (Amtolmetin guacil: allRussian Register for Osteoarthritis, Rheumatoid arthritis and Ankylosing spondylitis)

2019 ◽  
Vol 57 (1) ◽  
pp. 66-74
Author(s):  
A. E. Karateev ◽  
E. L. Nasonov ◽  
S. I. Glukhova ◽  
A. A. Barakat ◽  
R. L. Gibadullina ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ankylosing Spondylitis ◽  
Rheumatic Diseases ◽  
Rating Scale ◽  
Term Therapy ◽  
Control Group ◽  
Number Of Patients ◽  
Long Term Treatment

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of rheumatic diseases (RD). In some cases, their long-term use is advisable: NSAIDs slow the progression of spondylarthritis, are an important element in the control of chronic pain in osteoarthritis (OA) and rheumatoid arthritis (RA). However, the risk of serious adverse events (AE) should be considered. A good choice for long-term therapy may be amtolmetin guacil (AMG), which rarely induce gastrointestinal AE.The aimof the study was to assess the effect and safety of long-term use of AMG in RD.Material and methods.An open observational study was conducted in which AMG (Nayzilat) was assigned to 442 patients with OA (mean age 60.6±10.2 years, women 88.7%), 126 patients with RA (55.0±14.0 years, women 84.2%) and 73 with ankylosing spondylitis (AS, 47.0±12.0 years, women 30.0%). The dose of AMG depended on the clinical situation and was determined by the attending physician: from 1800 to 600 mg/day. The main criterion of the effect was the changes of pain by numeric rating scale (NRS), additional measures of efficacy were pain on the WOMAC and HAQ for OA, DAS28 for RA, BASDAI, BASFI and ASDAS-CRP for AS. The result of treatment was evaluated during three consecutive visits every 3 months (9 months of follow-up).Results and discussion.At the end of follow-up 65.2% of patients with OA, 75.3% of patients with RA and 82.2% of patients with AS continued treatment with AMG. The reasons for discontinuation of treatment were significant reduction or absence of pain (70.3%), the patient's decision (26.6%) or AE (3.1%). At the end of follow-up, there was a significant decrease in pain intensity compared to the baseline: in OA, the median pain decreased from 5.6 [4.1; 6.9] to 3.4 [1.7; 5.1], in RA from 5.8 [4.0; 7.5] to 3.4 [2.0; 4.8], in AS from 5.8 [4.2; 7.5] to 3.1 [1.5; 5.0] according to NRS, the difference was significant in all groups (p<0.001). In OA, the median WOMAC pain decreased from 127 [24; 159] to 13.7 [14; 40] (p<0.001), the average HAQ value – from 0.54±0.44 to 0.34±0.26 (p<0.001). In RA, the average value of DAS28 decreased from 4.81±1.18 to 4.30±1.24 (p<0.05). The number of painful and swollen joints, ESR and C-reactive protein also significantly decreased. In AS, the median BASDAI index decreased from 4.5 [1.0; 8.0] to 3.0 [0; 8.0] (p<0.001). The number of patients with high activity according to ASDAS-CRP (>3.5) decreased from 76.9 to 25.8% (p<0.001). The BASFI index did not changed. 77.9% of patients with OA, 77.0% with RA and 74.5% with AS were satisfied with the results of AMG treatment. AMG tolerance was good. Mild dyspepsia was observed in 15–25% of patients. AE, which caused the discontinuation of therapy, were observed only in 6 (0.93%) patients. There was no development or deterioration of hypertension, as well as other cardiovascular complications.Conclusion.AMG is an effective NSAID with good tolerability, which is advisable to use for long-term treatment of RD. Limitations are the open nature of the study and the absence of a control group.

scholarly journals Experience with Low-Dose Sodium Valproate in Idiopathic Generalized Epilepsy Patients: A Long-Term Follow-Up Study on Selective Cohort from North India

2021 ◽  
Vol 12 (01) ◽  
pp. 046-050
Author(s):  
Deepak Goel ◽  
Manish Mittal
Keyword(s):  
Low Dose ◽  
Term Treatment ◽  
North India ◽  
High Dose ◽  
Idiopathic Generalized Epilepsy ◽  
Number Of Patients ◽  
Long Term Treatment ◽  
Generalized Epilepsy

Abstract Background Idiopathic generalized epilepsy (IGE) is found in 20 to 30% of all patients presenting with seizures. Most of the patients require lifelong drug treatment. Efficacy and tolerability are important issues while selecting the most appropriate drug for a person with IGE. Objective The aim of this study was to look for usefulness of small dose valproate (<1,000 mg/day) in long-term treatment of IGE patients. Methods Diagnosis of IGE made with standard criteria among all patients presenting with seizures. Patients put on full doses of valproate (>1,000 mg/day) in first year, then reduction started in next year in patients with full seizure remission, and finally maintained on lowest possible dose of valproate. Lowest dose was defined as the minimum dose without seizures (between 200 and 900 mg/day). Patients, who were refractory on monotherapy, were put on add-on drug and followed for remission and reduction in doses of valproate at minimum possible dose. Results IGE was diagnosed in 21% of all patients presenting with seizures. Among 420 patients of IGE 368 (87.5%) were started on high-dose valproate monotherapy, 155 (42.1%) were responsive to single drug while 213 (57.9%) had been given add-on drug either lamotrigine or clonazepam or both. After minimum 3-year follow-up, 298 (81%) could be managed on low-dose valproate (<1,000 mg) without any relapse during 12 to 80 months follow-up. Conclusion Significant number of patients with IGE can be managed on low-dose valproate with good seizure control and less side effects.

Six-And-A-Half Years of Experience with Three Two-Liter Daily Exchanges in CAPD

1988 ◽  
Vol 8 (3) ◽  
pp. 207-210 ◽  
Author(s):  
Jorge E. Henao ◽  
Gonzalo Mejia ◽  
Mario Arbelaez ◽  
Jorge L. Arango ◽  
Alvaro Garcia ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Survival Rates ◽  
Laboratory Data ◽  
Term Treatment ◽  
Actuarial Survival ◽  
Hospitalization Rates ◽  
Number Of Patients ◽  
Long Term Treatment

Our continuous ambulatory peritoneal dialysis (CAPD) program consists of three 2- L daily exchanges (usually two of 1.5% and one of 4.25% dextrose concentration). Between March 1981 and November 1987, 87 patients were started on this program. Mean age was 35 years, 55% were males, and mean follow-up was 20.1 ± 2 months for a total experience of 1748 patient months. At the end of the study, 27 (31%) were still on CAPD, 43 (49.5%) had received renal transplants, 8 (9.2%) had returned to hemodialysis, 6 (6.9%) had been transferred to other units, 2 (2.3%) died, and 1 (1.1%) voluntarily quit. Actuarial survival rates were 90%, 81 %, and 57% for patients, method, and catheters, respectively, at 66 months. Peritonitis appeared at a rate of one episode per 14 patient months for a total of 121 episodes occurring in 51 patients. Rates of other complications were not higher than those reported by others. Hospitalization rates were low. Hypertension improved, patient weight did not change, and laboratory data tended towards normal levels or normalized. In selected patients, three 2- L exchanges per day appear to be enough for an adequate CAPD, even for long-term treatment. At the same time, it allows a 25% reduction in cost and risk of peritonitis. Larger number of patients and longer follow-up periods will be required to exactly define its real usefulness and safety.

scholarly journals Efficacy and safety of long-term therapy with nucleos(t)ide analogues in chronic hepatitis B

2019 ◽  
Vol 91 (2) ◽  
pp. 40-47
Author(s):  
E K Ibragimov ◽  
D T Abdurakhmanov ◽  
T P Rozina ◽  
E N Nikulkina ◽  
E L Tanaschuk ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Term Treatment ◽  
Term Therapy ◽  
Efficacy And Safety ◽  
Number Of Patients ◽  
Long Term Treatment

Nucleos(t)ide analogues are first-line therapies for the treatment of chronic hepatitis B. However, the efficacy and safety of long-term treatment and the necessary duration of therapy remains the subject of discussion. Aim. To assess the efficacy and safety of long-term treatment with nucleos(t)ide analogues in patients with chronic hepatitis B. Materials and methods. We conducted an observational study in 101 chronic hepatitis B (HBeAg-negative and HBeAg-positive) patients treated (3 years) with entecavir, tenofovir or telbivudine. Results and discussion. Treatment with entecavir and tenofovir was associated with high rate of virologic and biochemical response (95%) and HBeAg seroconversion (93% and 67%, respectively). Cumulative rate of virologic resistance was 0; 3.1% and 43.5% for tenofovir, entecavir and telbivudine, respectively. Long-term nucleos(t)ide analogues treatment resulted in a regress of liver fibrosis (from 8.92 to 7.18 kPa, р0.0001) and reduction in the number of patients with advanced fibrosis (from 48.1% to 13.8%, р0.0001). Entecavir and tenofovir were safe and well tolerated, while treatment with telbivudine was associated with development of myopathy in 13% of cases. Conclusion. Entecavir and tenofovir might be recommended for the treatment of chronic hepatitis B because of having potent antiviral effect, high genetic barriers against resistance and good safety.

Long-Term Treatment Outcomes for Heroin Dependence: The 11-Year Follow-Up of the ATOS Study

2013 ◽  
Author(s):  
Christina Marel ◽  
Maree Teesson ◽  
Shane Darke ◽  
Katherine Mills ◽  
Joanne Ross ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Term Treatment ◽  
Heroin Dependence ◽  
Long Term Treatment

The Role of Arthroscopy in the Treatment of Gouty Arthritis of the Knee Case presentation

2018 ◽  
Vol 69 (8) ◽  
pp. 2236-2239
Author(s):  
Marius Moga ◽  
Mark Edward Pogarasteanu ◽  
Dumitru Ferechide ◽  
Antoine Edu ◽  
Chen Feng Ifrim
Keyword(s):  
Gouty Arthritis ◽  
Surgical Techniques ◽  
Term Treatment ◽  
Clinical Aspects ◽  
Associated Lesions ◽  
Number Of Patients ◽  
Long Term Treatment ◽  
Functional Scores ◽  
Urate Crystals

Gout is a metabolic disease involving the impregnation of joints and other tissues with urate crystals. The onset is often brutal, and it manifests itself with pain and inflammation in the affected joint. The treatment usually involves rest, ice, NSAIDs and anti-gout medication. The long-term treatment involves medication and dietary changes. In the joint, urate crystals are deposited in the synovial, in the cartilage and in the menisci. In the arthroscopic practice, the gouty knee is a rare occurrence. We present a relevant case, that of a 57 years old patient without a prior gout diagnosis where we found urate crystal deposits covering the synovium, cartilage and meniscus, and we discuss the current and recent year Pub Med indexed literature in order to evaluate the possibilities for arthroscopic treatment of this pathology. We looked at the number of patients involved, their characteristics, and the surgical techniques used. We also looked at the temporal relation of the arthroscopic intervention to the recent gout attacks, and at the described lesions that were found. Also, we evaluated the papers for joint liquid analysis, gout drug treatment, and description of clinical aspects involved and associated lesions. Finally, we looked at the follow-up, at the functional scores used to monitor the patient�s evolution, at the associated medication and at the long-term outcomes, if described. We have found opinions to vary. In the end, we draw conclusions pertaining to the practical short-term and long-term use of knee arthroscopy in the treatment of gout.

scholarly journals The changes of corneal biomechanical properties with long-term treatment of prostaglandin analogue measured by Corvis ST

2020 ◽  
Author(s):  
Na Wu ◽  
Yuhong Chen ◽  
Yaping Yang ◽  
Xinghuai Sun
Keyword(s):  
Open Angle Glaucoma ◽  
Corneal Thickness ◽  
Biomechanical Properties ◽  
Term Treatment ◽  
Prostaglandin Analogue ◽  
Corvis St ◽  
Long Term Treatment ◽  
Corneal Biomechanical Properties

Abstract Background: To investigate the corneal biomechanical changes in primary open angle glaucoma (POAG) patients treated with long-term prostaglandin analogue (PGA). Methods: 111 newly diagnosed POAG patients, including 43 high tension glaucoma (HTG) and 68 normal tension glaucoma (NTG), were measured by Corvis ST to obtain intraocular pressure (IOP), central corneal thickness (CCT) and corneal biomechanical parameters at baseline and at each follow-up visit after initiation of PGA treatment. The follow-up measurements were analyzed by the generalized estimate equation model with an exchangeable correlation structure. Restricted cubic spline was employed to estimate the dose-response relation between follow-up time and corneal biomechanics．Results: The mean follow-up time was 10.3 ± 7.02 months. Deformation amplitude (β=-0.0015, P=0.016), the first applanation velocity (AV1, β=-0.0004, P=0.00058) decreased and the first applanation time (AT1, β=0.0089, P<0.000001) increased statistically significantly with PGA therapy over time after adjusting for age, gender, axial length, corneal curvature, IOP and CCT. In addition, AT1 was lower (7.2950 ± 0.2707 in NTG and 7.5889 ± 0.2873 in HTG, P=0.00011) and AV1 was greater (0.1478 ± 0.0187 in NTG and 0.1314 ± 0.0191 in HTG, P=0.00002) in NTG than in HTG after adjusting for confounding factors.Conclusions: Chronic use of PGA probably influences the corneal biomechanical properties directly, which is to make cornea less deformable. Besides, corneas in NTG tended to be more deformable compared to those in HTG with long-term treatment of PGA.

scholarly journals Long term dual antiplatelet therapy after myocardial infarction: retrospective analysis in an outpatient population

2021 ◽  
Author(s):  
Gennaro Ratti ◽  
Antonio Maglione ◽  
Emilia Biglietto ◽  
Cinzia Monda ◽  
Ciro Elettrico ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Term Treatment ◽  
Multivessel Disease ◽  
Coronary Syndrome ◽  
Anticoagulant Drugs ◽  
Long Term Treatment ◽  
Risk Condition ◽  
History Of

Long term treatment with ticagrelor 60 mg and low-dose aspirin are indicated after acute coronary syndrome (ACS). We retrospectively reviewed aggregate data of 187 patients (155 M and 38 F) (mean age 63.8±9 years) in follow up after ACS with at least one high risk condition (Multivessel disease, diabetes, GFR<60 mL/min, history of prior myocardial infarction, age >65 years) treated with ticagrelor 60 mg twice daily (after 90 mg twice daily for 12 months). The results were compared with findings (characteristics of the patients at baseline, outcomes, bleeding) of PEGASUS-TIMI 54 trial and Eu Label. The highrisk groups were represented as follows: multivessel disease 105 pts (82%), diabetes 63 pts (33%), GFR< 60 mL/min 27 pts (14%), history of prior MI 33 pts (17%), >65 year aged 85 pts (45%). Treatment was withdrawn in 7 patients: 3 cases showed atrial fibrillation and were placed on oral anticoagulant drugs, one developed intracranial bleeding, in three patients a temporary withdrawal was due to surgery (1 colon polyposis and 2 cases of bladder papilloma). Chest pain without myocardial infarction occurred in 16 patients (revascularization was required in 9 patients). Dyspnea was present in 15 patients, but was not a cause for discontinuation of therapy. Long term treatment with ticagrelor 60 mg twice daily plus aspirin 100 mg/day showed a favourable benefit/risk profile after ACS.  In this study all patients had been given ticagrelor 90 mg twice daily for 12 months and the 60 mg twice daily dosage was started immediately thereafter, unlike PEGASUS-TIMI 54 trial in which it was prescribed within a period ranging from 1 day to 1 year after discontinuation of the 90 mg dose. This makes our results more consistent with current clinical practice. However, a careful outpatient follow-up and constant counseling are mandatory to check out compliance to therapy and adverse side effects.

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