Cyclical spironolactone 50mg bid as a starting dose in idiopathic hirsutism reduces adverse effects

InPharma ◽  
1989 ◽  
Vol 686 (1) ◽  
pp. 2-3
Keyword(s):  
Adverse Effects ◽  
Idiopathic Hirsutism ◽  
Starting Dose

Patterns Of Non-Hematological Adverse Effects In Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP) Treated With Ponatinib – Experience At a Single Institution

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 4019-4019 ◽  
Author(s):  
Preetesh Jain ◽  
Hagop M. Kantarjian ◽  
Carlos Guillermo Romo ◽  
Alfonso Quintas-Cardama ◽  
Elias Jabbour ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Effects ◽  
Dose Reduction ◽  
Research Funding ◽  
Skin Toxicity ◽  
Qtc Prolongation ◽  
Single Institution ◽  
Dry Skin ◽  
Starting Dose ◽  
Grade 3

Abstract Introduction Ponatinib is a multi-targeted tyrosine kinase inhibitor (TKI) efficacious in pts with refractory CML. Ponatinib inhibits other tyrosine kinases (e.g. RET, FGFR, FLT3) that may lead to off target adverse effects (AE). We report a single-institution experience of frequencies of non-hematological AE among pts on therapy with ponatinib. Methods A total of 90 pts with CML-CP[49 relapsed refractory (RR), 41 frontline] treated at our institution on clinical trials with ponatinib were analyzed. AE were recorded on each pt visit and charts were reviewed for AE and risk factors. Results For RR pts (n=49)the starting dose of ponatinib was 45 mg in 42 (86%) pts. 39 (80%) had dose interruptions, due in 17 (44%) to grade 3 thrombocytopenia and in 22 (56%) to non-hematological AE (elevated pancreatic enzymes 7 pts of whom 5 had pancreatitis; body aches and headache 7; hypertension 7; skin toxicity 5; fatigue 5). 35 pts (71%) had dose reduction to 30 or 15 mg. Hypertension (H.T.) stage 2 (≥160/100 mm Hg) occurred in 15 (31%) pts; only 2 of new onset. Blood pressure was controlled in all with antihypertensives. Other cardiovascular AE included QTc prolongation in 1 pt, atrial fibrillation in 1 pt, acute myocardial infarction in 3, venous thrombosis in 3, arterial thrombosis in 4, transient ischemic attack (TIA) in 1 and Raynaud’s in 1. No pt discontinued ponatinib due to cardiovascular AE’s. Symptomatic pancreatitis developed in 8 pts (16%). Grade 3/4 elevations in serum lipase and amylase occurred in 12 (24%) pts and 2 (4%) pts respectively. Median days to onset of pancreatitis was 24 (range 7-456). 27 pts (55%) developed cutaneous toxicity including xerosis/dry skin in 10 (37%) and grade 3 erythroderma and exfoliation of the skin in 5. Four pts died, none related to ponatinib. 13 pts went off the study: 5 went to SCT, 3 progressed, 1 pt died in CCyR of multiple co-morbidities, 1 pt had progressive melanoma, 1 pt was transferred to another hospital, and 2 for ponatinib-related AE (headache in 1 and headache, fatigue, depression, and abdominal pain in 1). For pts in frontline setting (n=41) the starting dose was 45 mg in all. 29 pts (71%) had dose interruptions due to one or more of the following: grade 3/4 pancreatic enzyme elevation in 16, myelosuppression in 4, and various non-hematological AE in 15 (skin toxicity in 4, fatigue in 2, headache in 1, chest pain in 2, elevated liver enzymes in 2, suspected seizure vs. TIA in 1, grade 3 diarrhea in 1, memory disturbances in 1, and grade 3 hypertension in 1, erectile dysfunction in 1). 24 pts (59%) had dose reduction, from 45 mg to 30 mg in 20 pts and then to 15 mg in 4 pts. H.T. stage 2 occurred in 3 (7%) pts usually among patients with pre-existing H.T. Other cardiovascular AE included grade 2 QTc prolongation in 1 pt, possible TIA vs. possible seizure in 1, and Raynaud’s in 2. Pancreatitis was seen in 12 pts (29%) with grade 1-2 and 6 pts (15%) with grade 3/4. Grade 3/4 lipase/amylase elevations occurred in 16 (39%) and 3 (7%) pts. Median days to the onset of pancreatitis were 6 (4-22). 34 pts (83%) developed skin toxicity with rash (any grade) in 25 pts (61%), xerosis/dry skin in 18 pts (44%) and grade 3 erythroderma and skin exfoliation in 2 (pts may have had ≥1 type of skin AE). 2 pts discontinued therapy, due to severe xerosis in 1 and recurrent gra 4 neutropenia in another. 1 pt developed grade 2 pericarditis possibly related to ponatinib. For all the 90 pts, risk factors for cardiovascular and pancreatic toxicities included 20 (22%) smokers, 2 heavy alcohol consumers, 27 (30%) obese (BMI ≥30 Kg/m2), 30 (33%) with hypertriglyceridemia, 17 (19%) had hypercholesterolemia and 10 pts were receiving lipid lowering therapies. Conclusions Ponatinib is generally well tolerated and AEs can usually be properly managed. AE are more common in RR pts with greater frequency of hypertension, cardiovascular complications, headache, dry mouth and dose interruptions. Most pts are able to continue therapy after dose adjustments. Disclosures: Kantarjian: ARIAD: Research Funding. Cortes:Ariad, Pfizer, Teva: Consultancy; Ariad, BMS, Novartis, Pfizer, Teva: Research Funding.

scholarly journals Assessing Steroid Toxicity in the Elderly with Multiple Myeloma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5557-5557
Author(s):  
Vidhya Nair ◽  
Hadi Mohammed ◽  
Sharmeen Mahmood ◽  
Pushpinderdeep Singh Kahlon ◽  
Philip Kuriakose
Keyword(s):  
Central Nervous System ◽  
Multiple Myeloma ◽  
Nervous System ◽  
Adverse Effects ◽  
Elderly Patients ◽  
Dose Reduction ◽  
The Elderly ◽  
High Dose ◽  
Full Dose ◽  
Starting Dose

Background The mainstay of treatment for Multiple Myeloma (MM) includes various combinations of chemotherapy, which generally includes high dose steroids. The median age at diagnosis for MM is above 60 years. Patients above the age of 70 may not be considered for an auto peripheral blood transplant, resulting in being treated with chemotherapy alone. This often leads to a relatively long period of steroid exposure. Increasing age is a risk factor for decreased tolerance to steroids, and increased drug toxicity. As such, the steroid dose (usually Dexamethasone) is often considered for reduction in patients above a certain age. However, there are no clear guidelines regarding a standard dose to use in the elderly, nor is there uniformity among clinicians in the way doses are chosen. Purpose To assess a) the starting dose of Dexamethasone (dex) in the elderly, b) frequency of dose reduction of dexamethasone, c) adverse effects of dex treatment in the elderly with MM, and d) average time after dose reduction. Methods We performed a 10 year retrospective chart review on patients, age 70 or greater treated at Henry Ford Health System with a diagnosis of MM from 2000-2015. Patients were grouped by age 70-75 years, 76-80 years, and greater than 80 years based on when treatment was initiated. We investigated the starting treatment dose of dex, ranging from 1-20 mg weekly and 21-40 mg weekly. Secondly, we assessed for the occurrence of dose reduction; and, if present, the length of time to reducing the dose. Lastly, the types of adverse effects to dex leading to dose reduction were grouped by system, such as, central nervous system, musculoskeletal, endocrine, gastrointestinal and psychiatric. Data collected was categorical, thus, no statistical tests were performed as this was a descriptive study. Results A total of 150 patients were reviewed and 91 patients met the inclusion criteria. Of these patients, 8 (8.8%) were started at doses between 1-20 mg and majority (62.5%) were ages 70-75, thus, there was no relation between lower starting dose and age. Of the 91 patients, 24 (26.4%) had a dose reduction and 11 (12.1%) had both chemotherapy and dex discontinued prior to therapy completion. Majority (87.5%) of patients that had a dose reduction were initially started at 40 mg. The reasons for dose reduction included adverse effects grouped by musculoskeletal (29.17%), psychiatric (16.67%), endocrine (12.3%), central nervous system (4.17%), and gastrointestinal (4.17%). Of note, 8 patients (33.3%) had dose reductions as result of their clinical trial requirement. The average length of dex therapy before dose reduction was 17.2 months. Conclusion The majority of elderly patients (age 70 or above) with MM tolerated full doses of dex without adverse effects. Secondly, there was no relation between lower starting dose for dex and advanced age. However, since there were limited patients (n=8) who started at a low dose, other than those on clinical trials, we were not able to do a comparison of starting doses. But we were able to show that the majority of patients tolerated full dose, despite their age. The most frequent cause of steroid toxicity was musculoskeletal, such as leg swelling. On average, elderly patients were able to tolerate full dose of dex for over 1 year prior to requiring a dose reduction. Summary Our data demonstrates no correlation between advanced age in MM and lack of tolerability of high dose steroids. In conclusion, current findings do not justify reduced doses solely based on age alone. Future studies could include investigating statistical analysis on steroid exposure and survivorship. Disclosures Kuriakose: Alexion: Consultancy, Honoraria, Speakers Bureau; Bayer: Consultancy.

scholarly journals Cannabis Therapy in the Management of Fibromyalgia: A Systematic Review

2021 ◽  
Author(s):  
Yuri Borges Bitu de Freitas ◽  
Caio de Almeida Lellis ◽  
Jhenefr Ribeiro Brito ◽  
Rodrigo Souza Ramos ◽  
Maria Luiza Gonzaga de Oliveira
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Therapeutic Option ◽  
Life Quality ◽  
Pain Reduction ◽  
Catholic University ◽  
Randomized Studies ◽  
Starting Dose ◽  
Painful Syndrome

Introduction: Fibromyalgia is a painful syndrome of little known etiology, characterized by generalized pain with difficult management. Thus, cannabis therapy, a therapeutic option for other painful conditions, becomes an alternative. Objective: To review the literature on cannabis therapy in the treatment of fibromyalgia. Design and Setting: A systematic review conducted at the Pontifical Catholic University of Goiás. Methods: Systematic review. Randomized studies and clinical trials published between 01/2011 and 01/2021 were selected. Incomplete studies and those that did not fit the objectives were excluded. Results: When analyzing the combination of inhaled CBD and THC, it was concluded that, regardless of the dosage, neither showed significantly greater response than placebo. Studies pointed out that THC-rich cannabis oil, at starting dose of one drop a day, reduced pain, fatigue, and depression scores; moreover, the therapy proved tolerated and without serious adverse effects. Third-level evidence indicated better effects of nabilone on sleep than amitriptyline, without significant differences for pain, mood, and life quality. Conclusion: Different approaches to cannabis therapy for patients with fibromyalgia lead to diverse effects, with some not proving effective and others promoting pain reduction, sleep and life qualities improvements and satisfactory effects on depression and fatigue scores. Hence, scientifically relevant studies should be done on this subject.

Corticosteroids for the management of immune-related adverse events in patients receiving checkpoint inhibitors

2017 ◽  
Vol 25 (3) ◽  
pp. 544-550 ◽  
Author(s):  
Kiersten J Williams ◽  
Dennis W Grauer ◽  
David W Henry ◽  
Michelle L Rockey
Keyword(s):  
Adverse Effect ◽  
Adverse Effects ◽  
Checkpoint Inhibitor ◽  
Checkpoint Inhibitors ◽  
Cell Activity ◽  
Total Duration ◽  
Inhibitor Therapy ◽  
Related Adverse Effect ◽  
Starting Dose ◽  
Checkpoint Inhibitor Therapy

Introduction Due to enhanced T-cell activity, immune checkpoint inhibitors cause immune-related adverse effects. Corticosteroids are the mainstay of immune-related adverse effect management but the optimal strategy has not been determined, putting patients at risk for steroid-related adverse effects and potentially decreased efficacy of immunotherapy. This study aims to characterize the use of corticosteroids for the management of immune-related adverse effect. Methods and materials A retrospective, single-center evaluation of patients receiving checkpoint inhibitors was conducted. The primary objective was to evaluate corticosteroid use for immune-related adverse effects, including starting dose, taper strategy, total duration, and resumption of immunotherapy. Secondary objective was to describe the incidence and significance of hyperglycemia. Results One hundred and three patients met inclusion criteria and experienced 123 immune-related adverse effects. Prednisone was used most commonly (67%) at an average starting dose of 0.88 mg/kg (range 0.07–17.0). On average, steroid tapers began 9.2 days after initiation (range 0–89) and were continued for a total of 84.2 days (range 3–693). In 21.1% of cases, checkpoint inhibitor therapy was not delayed and 68.6% resumed checkpoint inhibitors, while the patient was taking steroids (30.4 mg prednisone on average, range 5–80). On average, checkpoint inhibitor therapy was resumed 18.6 days after detection of immune-related adverse effect (range 0–150). Clinically relevant hyperglycemia occurred in 8.9%. Conclusion Utilization of steroids for immune-related adverse effect at our institution is highly variable. The majority of patients received prolonged courses of steroids and resumed checkpoint inhibitor therapy with concomitant steroids above recommended doses. Additional monitoring for hyperglycemia and other steroid associated adverse effects should be considered.

scholarly journals The Decline of PUVA Therapy in Vietnam: Effective Treatment of Narrow Band UVB in Vietnamese Vitiligo Patients

2019 ◽  
Vol 7 (2) ◽  
pp. 256-258
Author(s):  
Hien Do Thi Thu ◽  
Nhung Do Thi Hong ◽  
Thuong Nguyen Van ◽  
Phuong Pham Thi Minh ◽  
Tam Hoang Van ◽  
...  
Keyword(s):  
Herpes Simplex ◽  
Adverse Effects ◽  
Effective Treatment ◽  
Narrow Band ◽  
Response To Therapy ◽  
Ultraviolet B ◽  
Prolonged Treatment ◽  
Efficacy And Safety ◽  
Puva Therapy ◽  
Starting Dose

AIM: To examine the efficacy and safety of Narrowband ultraviolet B (NB-UVB) in Vietnamese vitiligo patients. METHODS: We recruited thirty-one patients (14 males, 17 females), aged from 7 to 67 years, with both segmental vitiligo (SV) and non-segmental vitiligo (NSV), treated three times weekly with NB-UVB. The starting dose for adults from 15 years old and children less than 15 years old was 200 mJ/cm2 and 150 mJ/cm2, respectively, with 50 mJ/cm2 and 20 mJ/cm2 dose increments at each subsequent visit, respectively, until mild erythema lasting less than 24 hrs reported by patient, given for a period of 6 months. Response to therapy was assessed based on VASI score changes. RESULTS: Based upon our results, 38.7% (12/31) of patients achieved a very good response of more than 50% VASI changes, 41.9% (13/31) obtained a good response (VASI changed from 25 to 50%). Total good and very good response to therapy significantly increased with prolonged treatment, increasing from 19.4% to 64.5% and 80.6% after 2, 4 and 6 months, respectively. Localised NSV patients obtained good and very good response significantly more frequently than generalised NSV (55.6% versus 18.2%). Adverse effects were minimal, of which one case developed herpes simplex, and 4 cases reported mild photo burn reaction which completely disappeared after adjusting the dose. CONCLUSION: NB-UVB therapy is an effective and safe tool in the management of Vietnamese vitiligo patients.

scholarly journals Genetic Polymorphisms Associated With the Pharmacokinetics, Pharmacodynamics and Adverse Effects of Olanzapine, Aripiprazole and Risperidone

2021 ◽  
Vol 12 ◽  
Author(s):  
Paula Soria-Chacartegui ◽  
Gonzalo Villapalos-García ◽  
Pablo Zubiaur ◽  
Francisco Abad-Santos ◽  
Dora Koller
Keyword(s):  
Adverse Effects ◽  
Metabolic Effects ◽  
Individual Response ◽  
Cytochrome P450 Enzymes ◽  
Glucose And Lipid Metabolism ◽  
Starting Dose ◽  
Ultrarapid Metabolizers ◽  
Dopamine And Serotonin Receptors ◽  
Cyp3a4 Inhibitors ◽  
Extrapyramidal Effects

Olanzapine, aripiprazole and risperidone are atypical antipsychotics or neuroleptics widely used for schizophrenia treatment. They induce various adverse drug reactions depending on their mechanisms of action: metabolic effects, such as weight gain and alterations of glucose and lipid metabolism; hyperprolactinemia and extrapyramidal effects, such as tremor, akathisia, dystonia, anxiety and distress. In this review, we listed polymorphisms associated with individual response variability to olanzapine, aripiprazole and risperidone. Olanzapine is mainly metabolized by cytochrome P450 enzymes, CYP1A2 and CYP2D6, whereas aripiprazole and risperidone metabolism is mainly mediated by CYP2D6 and CYP3A4. Polymorphisms in these genes and other enzymes and transporters, such as enzymes from the uridine 5'-diphospho-glucuronosyltransferase (UGT) family and ATP-binding cassette sub-family B member 1 (ABCB1), are associated to differences in pharmacokinetics. The three antipsychotics act on dopamine and serotonin receptors, among others, and several studies found associations between polymorphisms in these genes and variations in the incidence of adverse effects and in the response to the drug. Since olanzapine is metabolized by CYP1A2, a lower starting dose should be considered in patients treated with fluvoxamine or other CYP1A2 inhibitors. Regarding aripiprazole, a reduced dose should be administered in CYP2D6 poor metabolizers (PMs). Additionally, a reduction to a quarter of the normal dose is recommended if the patient is treated with concomitant CYP3A4 inhibitors. Risperidone dosage should be reduced for CYP2D6 PMs and titrated for CYPD6 ultrarapid metabolizers (UMs). Moreover, risperidone dose should be evaluated when a CYP2D6, CYP3A4 or ABCB1 inhibitor is administered concomitantly.

scholarly journals Efficacy of Low-Dose Epinephrine Continuous Infusion in Neonatal Intensive Care Unit Patients

2021 ◽  
Vol 26 (1) ◽  
pp. 51-55
Author(s):  
Gloria Lee ◽  
Jeffrey R. Kaiser ◽  
Brady S. Moffett ◽  
Emily Rodman ◽  
Cynthia Toy ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Adverse Effects ◽  
Neonatal Intensive Care Unit ◽  
Continuous Infusion ◽  
Neonatal Intensive Care ◽  
Low Dose ◽  
Epinephrine Infusion ◽  
Starting Dose ◽  
Few Data

OBJECTIVES Although epinephrine is used in the neonatal intensive care unit, few data exist on efficacy of doses <0.05 mcg/kg/min. This study evaluates the efficacy and safety of low-dose epinephrine continuous infusion at doses <0.05 mcg/kg/min in infants. METHODS Single-center, retrospective review of hypotensive infants from 2011–2018. Charts were reviewed for initial and maximum epinephrine doses, additional vasoactive agents, short-term efficacy, and adverse effects. The primary outcome was percentage of patients initiated on low-dose epinephrine whose dose did not require titration to ≥0.05 mcg/kg/min. RESULTS A total of 115 patients met study criteria with 131 distinct occurrences of low-dose epinephrine initiation. Most patients were unresponsive to other vasopressors at the time of epinephrine initiation. The median (IQR) starting dose of low-dose epinephrine was 0.01 (0.01–0.04) mcg/kg/min and median (IQR) maximum dose was 0.04 (0.02–0.08) mcg/kg/min. Fifty-five percent were responders. Patients in this cohort demonstrated significant improvement of blood pressure and urine output (p < 0.001) without adverse effects. CONCLUSIONS Low-dose epinephrine infusion may be considered as an alternative treatment to standard starting doses in hypotensive neonatal intensive care unit patients.

The Influence of Specimen Thickness in Quantitative Electron Energy Loss Spectroscopy

1980 ◽  
Vol 38 ◽  
pp. 112-113
Author(s):  
Nestor J. Zaluzec
Keyword(s):  
Quantitative Analysis ◽  
Adverse Effects ◽  
Energy Loss ◽  
Electron Energy ◽  
Electron Energy Loss Spectroscopy ◽  
Materials Science ◽  
Light Element ◽  
Specimen Thickness ◽  
Element Analysis ◽  
Electron Energy Loss

The application of electron energy loss spectroscopy (EELS) to light element analysis is rapidly becoming an important aspect of the microcharacterization of solids in materials science, however relatively stringent requirements exist on the specimen thickness under which one can obtain EELS data due to the adverse effects of multiple inelastic scattering.1,2 This study was initiated to determine the limitations on quantitative analysis of EELS data due to specimen thickness.

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