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FDA: Threat of Extreme Enhance in Incapacity Following MS Remedy Discontinuation


November 21, 2018

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

The Food and Drug Administration (FDA) has issued a safety communication regarding the potential for disease worsening following the discontinuation of the multiple sclerosis treatment fingolimod (Gilenya; Novartis), which in rare cases may result in permanent disability. Fingolimod, a sphingosine 1-phosphate receptor modulator, was initially approved in 2010 to treat relapsing forms of MS. 

From September 2010 to February 2018, the FDA has identified 35 cases of severe increased disability accompanied by the presence of new lesions on MRI that occurred 2 to 24 weeks after stopping treatment with fingolimod; most of the disease worsening was observed in the first 12 weeks. The increase in disability was reportedly more severe than typical MS relapses and appeared unrelated to the patients’ prior disease state.

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In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing. Corticosteroids were given as the initial treatment for all 35 patients. Some had partial recovery (N=17), some had permanent disability or no recovery (N=8), and others (N=6) returned to the level of disability before or during fingolimod treatment. 

Prior to starting fingolimod, healthcare professionals should inform patients about the potential risk of severe disability after discontinuing treatment. If stopped, patients should be monitored for signs of disease exacerbation via MRI and be treated appropriately. Patients should seek immediate medical attention if new or worsening MS symptoms develop upon discontinuing fingolimod. Symptoms may include weakness, increased difficulty using arms or legs, or changes in thinking, eyesight or balance. 

The FDA has added a new warning regarding this risk to the drug labeling and patient Medication Guide for Gilenya.

For more information visit FDA.gov.

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HCV Therapy Linked to Lowered Threat of Incident CVD Occasions

Both the incidence rate as well as risk factors for CVD events were assessed

Both the incidence rate as well as risk factors for CVD events were assessed

The risk of incident cardiovascular disease (CVD) events appears to be lower in hepatitis C virus (HCV) infection patients receiving direct-acting antiviral (DAA) regimens compared with those receiving older pegylated interferon-based therapy or no treatment at all, according to a study presented at the Liver Meeting 2018.

ERCHIVES (Electronically Retrieved Cohort of HCV Infected Veterans) was utilized to identify all patients who received HCV treatment for at least 7 weeks as well as a propensity-score matched group who did not receive treatment. Each group included 32,575 patients. Patients with HIV, HBV, or previously diagnosed CVD were excluded from the study. Both the incidence rate (per 1000 person-years) as well as risk factors for CVD events were assessed. 

“The incidence rate for CVD events/1,000 person-years (95% CI) among the treated was 19.10 (17.79, 20.50) vs. 32.37 (30.51, 34.33) among the untreated (P<.01),” the study authors reported. Results of the study also found that patients receiving DAA therapy had a lower risk of incident CVD events compared with those receiving pegylated interferon/ribavirin (HR: 0.68; 95% CI: 0.53, 0.88). Additionally, patients who achieved sustained virologic response (SVR) also had a lower risk of incident CVD events (HR: 0.76; 95% CI: 0.63, 0.92). “Kaplan-Meier curves demonstrated that untreated persons had a shorter CVD event-free survival during 30 months of follow-up compared with the treated persons,” the study authors added.

Results of this study determined that the likelihood of incident CVD events was not only reduced in HCV patients treated with DAA therapy, but also for patients who attained SVR.

Hormone injections scale back danger for early menopause from breast most cancers chemotherapy


Ultimate outcomes of SWOG Most cancers Analysis Community’s groundbreaking worldwide Prevention of Early Menopause Research (POEMS) medical trial are in, they usually present continued proof that girls who get injections of the hormone drug goserelin together with normal breast most cancers chemotherapy usually tend to turn out to be pregnant – with out creating detrimental unintended effects or shortening their lives.

“These five-year follow-up outcomes affirm our preliminary findings,” stated SWOG investigator Halle Moore, MD, lead researcher on the POEMS research and affiliate professor of medication at Cleveland Clinic. “Goserelin protects the ovaries from the consequences of chemotherapy, lowering the danger for early menopause. By getting these injections, extra girls grew to become pregnant with out negatively affecting their well being or their possibilities of surviving their most cancers.”

The outcomes are revealed within the present challenge of the Journal of the Nationwide Most cancers Institute. When the POEMS workforce introduced preliminary research outcomes on the 2014 American Society for Medical Oncology (ASCO) annual assembly, they gained worldwide consideration. POEMS is a singular collaboration, managed by SWOG, one in all 5 teams within the Nationwide Most cancers Institute’s Nationwide Medical Trials Community (NCTN), with assist from two different NCTN teams – ECOG-ACRIN Most cancers Analysis Group and the Alliance for Medical Trials in Oncology. The Worldwide Breast Most cancers Research Group, which incorporates the Australia New Zealand Breast Most cancers Trials Group, offered trial entry to sufferers around the globe.

The randomized, section III trial additionally obtained consideration for focusing not on the effectiveness of a most cancers remedy, however the affect that remedy has on the lives of most cancers survivors. In the US, virtually 49,000 girls beneath the age of 50 are recognized annually with invasive breast most cancers. Hormone-receptor detrimental breast most cancers is a much less frequent kind, which does not feed on estrogen or progesterone, and would not usually reply to medication that focus on these hormones.

Ovarian failure is one aspect impact of chemotherapy, one which carries a heavy burden for ladies, together with infertility, sexual dysfunction, and unsightly signs. To find out if ovarian failure might be prevented, the POEMS workforce launched their trial. Between 2004 and 2011, investigators randomized 218 premenopausal girls with hormone-receptor detrimental breast most cancers, putting them into two research teams. One group obtained normal chemotherapy remedy, and the opposite obtained normal chemotherapy plus goserelin.

Preliminary outcomes confirmed that 22 p.c of sufferers on normal remedy skilled ovarian failure whereas solely eight p.c who obtained goserelin did. As well as, these 2014 outcomes additionally confirmed that 12 p.c of sufferers on the usual arm obtained pregnant, whereas 22 p.c who obtained goserelin did.

The brand new outcomes, which embody 5 years of follow-up, present comparable results. On common, 23 p.c of girls who took goserelin grew to become pregnant in contrast with 12 p.c on the usual remedy. Importantly, girls who took goserelin skilled comparable, and even higher, survival charges in contrast with girls who obtained normal chemo. 5 years after remedy, 88 p.c of girls who took goserelin had been alive and disease-free in contrast with 79 p.c of girls who obtained normal chemo. Whereas variations in survival weren’t statistically important, 92 p.c of girls who took goserelin had been alive at 5 years in comparison with 83 p.c of management sufferers.

When the POEMS outcomes had been first issued, SWOG senior investigator Kathy Albain, MD, FACP, FASCO, of the Cardinal Bernardin Most cancers Middle of Loyola College Chicago, predicted they’d change the usual of look after breast most cancers. They usually have. The Nationwide Complete Most cancers Community Medical Apply Tips for Oncology and the St. Gallen Consensus Convention pointers already replicate the usage of goserelin for young women who hope to guard ovarian perform throughout chemotherapy for breast most cancers.

“Most cancers researchers got down to change the usual of care to be able to enhance, or lengthen, folks’s lives,” Moore stated. “Our remaining outcomes present a method to enhance high quality of life for younger girls with hormone-receptor detrimental breast most cancers. In the event that they wish to be moms, they’ll enhance their probabilities safely and successfully. I am pleased with this end result, and our worldwide workforce.”



Fluoroquinolones Tied to Elevated Threat for Arrhythmia, CV Mortality

Results showed fluoroquinolone use increased the risk for arrhythmia by 85%

Results showed fluoroquinolone use increased the risk for arrhythmia by 85%

Fluoroquinolone antibiotics appear to increase the risk for arrhythmia and cardiovascular mortality, according to a study published in the journal Drug Safety.

To investigate the risk of cardiovascular adverse effects associated with this antibiotic class, researchers conducted a systematic review, meta-analysis, and network meta-analysis using studies identified through a search of MEDLINE, EMBASE, and the Cochrane Library; 13 studies were selected for inclusion. “Outcomes were pooled using random effects models,” the authors explained. “Direct and indirect comparisons in network meta-analysis were performed using frequentist methods.”

Results showed fluoroquinolone use increased the risk for arrhythmia by 85% (odds ratio [OR] 1.85; 95% CI, 1.22–2.81) and cardiovascular mortality by 71% (OR 1.71; 95% CI, 1.39–2.09). Of the fluoroquinolones included in the analysis, moxifloxacin was found have the highest probability for cardiovascular adverse events (arrhythmia [P-score 0.99]; cardiovascular mortality [P-score 0.95]).

“Our findings show a significant association between fluoroquinolone use and an increased risk for arrhythmia and cardiovascular mortality,” the authors concluded. They added, “Further study is required to determine how to reduce the risk for fluoroquinolone-associated cardiac toxicity.”