American Society of Hematology, Dec. 7 to 10
The annual meeting of the American Society of Hematology was held from Dec. 7 to 10 in San Diego and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems.
In one study, Kristin A. Shimano, M.D., of the University of California, San Francisco, Benioff Children's Hospital, and colleagues found that for pediatric patients with newly diagnosed immune thrombocytopenia (ITP) within three months of diagnosis, eltrombopag leads to a more durable platelet response during weeks six 6 to 12 of treatment compared with standard treatments.
The authors evaluated the use of eltrombopag (a thrombopoietin receptor agonist approved for persistent or chronic ITP) during the new-diagnosis phase and compared the responses between patients treated with eltrombopag and standard therapies (intravenous immunoglobulin, prednisone, and anti-D globulin).
The researchers found that compared with those treated with standard therapies, a greater proportion of patients treated with eltrombopag had a platelet count of more than 50,000 during weeks 6 through 12 of the study without requiring a rescue therapy.
"This has a huge potential to change our approach to the management of newly diagnosed pediatric ITP," Shimano said. "For patients with moderate bleeding or significant impact on quality of life due to their ITP, eltrombopag may be a good option to get the platelets to a more hemostatic level during the time that they have active ITP."
Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Novartis, which manufactures eltrombopag and funded the study.
In another study, Rushad Patell, M.D., of Harvard Medical School in Boston, and colleagues found that the use of glucagon-like peptide-1 (GLP-1) receptor agonists leads to a significant reduction in the risk for blood clots among patients with type 2 diabetes.
The authors compared patients who newly started a GLP-1 receptor agonist for type 2 diabetes to patients being prescribed another antidiabetic medication to assess rates of blood clots at one year.
The researchers observed a 20 percent reduction in venous thromboembolism rates at 12 months. This benefit was seen across patients with different body mass index at the time of starting the study and included a breakdown for the two different types of blood clots (pulmonary embolism and deep vein thrombosis) when evaluated individually.
"This was the first time this medication has been shown to impact venous thromboembolism to our knowledge," Patell said. "If these results are confirmed, they suggest that the use of these medications can have benefits beyond what has already been shown and can now include a reduction of blood clots."
Two authors disclosed financial ties to the pharmaceutical and biotechnology industries.
Jenny Paredes, Ph.D., of the City of Hope National Medical Center in Duarte, California, and colleagues found that increasing dietary fiber intake is beneficial for the intestinal microbiome of allogeneic hematopoietic cell transplantation (allo-HCT) patients and could lead to an increase in overall survival and a reduction in acute graft-versus-host disease (GVHD).
The authors assessed a preclinical mouse model of GVHD with defined diet fiber concentrations and also analyzed the dietary patterns of allo-HCT patients.
The investigators found that dietary fiber intake in allo-HCT patients (days −7 to −30) positively correlated with higher overall survival, lower acute GVHD cumulative incidence, and lower gastrointestinal-GVHD cumulative incidence (landmark analysis to 24 months). In addition, fiber consumption positively correlated with microbial alpha-diversity, relative abundance of butyrate producers, and production of short chain fatty acids (SCFAs).
In the murine model of GVHD post allo-HCT, the researchers determined that a diet rich in fiber (12 percent cellulose) increased survival to GVHD, led to a higher relative abundance of butyrate producers, and modulated gene expression associated with higher epithelial homeostasis and lower T-cell mediated inflammation (single cell sequencing).
"Although follow-up studies on the strategies that can be used to increase dietary fiber in allo-HCT patients are in course, we would like to recommend reevaluating the nutritional plans and meals for allo-HCT patients and including multiple options of high fiber foods for every meal and beverage," Paredes said. "Increasing fiber consumption by 10 to 20 grams per day, based on our results, would lead to a more diverse microbiome, an increase in SCFA production, and consequently, to better overall survival (the Recommended Dietary Allowance for dietary fiber by the U.S. Department of Agriculture is 25 to 30 grams per day)."
One author disclosed financial ties to the pharmaceutical and biotechnology industries.
ASH: Blinatumomab + Chemo Aids Survival in B-Cell Acute Lymphoblastic Leukemia
THURSDAY, Dec. 12, 2024 (HealthDay News) -- For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
ASH: Reduced-Dose Anticoagulants Not Noninferior for Recurrent VTE
FRIDAY, Dec. 6, 2024 (HealthDay News) -- Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
ASH: Auto-HCT Not Beneficial for Mantle Cell Lymphoma With Undetectable Residual Disease
FRIDAY, Dec. 6, 2024 (HealthDay News) -- Autologous hematopoietic cell transplant is not beneficial for patients with mantle cell lymphoma in first complete remission with undetectable minimal residual disease, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego.
ASH: Complications Common With Controlled Ovarian Hyperstimulation in Sickle Cell Anemia
THURSDAY, Nov. 14, 2024 (HealthDay News) -- Many individuals with sickle cell anemia undergoing controlled ovarian hyperstimulation with oocyte cryopreservation have complications, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego.
ASH: GLP-1 RA Use Tied to Lower Rate of Venous Thromboembolism in Diabetes
THURSDAY, Nov. 14, 2024 (HealthDay News) -- For patients with type 2 diabetes mellitus, glucagon-like peptide 1 receptor agonist use is associated with a lower risk for venous thromboembolism, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego.
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ASH: GLP-1 RA Use Tied to Lower Rate of Venous Thromboembolism in Diabetes
For patients with type 2 diabetes mellitus (T2DM), glucagon-like peptide 1 receptor agonist (GLP-1 RA) use is associated with a lower risk for venous thromboembolism (VTE), according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego.
Cho Han Chiang, M.D., from Mount Auburn Hospital in Cambridge, Massachusetts, and colleagues examined whether GLP-1 RA use would reduce the risk for VTE among patients with T2DM in a retrospective, propensity score-matched multicenter database analysis. Patients who received GLP-1 RAs were compared to those who received dipeptidyl peptidase-4 (DPP-4) inhibitors; after propensity score matching, the final analysis included two cohorts of 168,428 patients each.
The researchers found that the incidence of VTE was 11.0 versus 12.9 events per 1,000 patient-years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively, with an 18 percent lower risk for VTE for those receiving GLP-1 RAs (hazard ratio [HR], 0.82). Compared with those on DPP-4 inhibitors, patients receiving GLP-1 RAs had a lower risk for pulmonary embolism and deep venous thrombosis (HRs, 0.78 and 0.85, respectively). In a subgroup analysis, the differences in VTE rates were similar for patients with and without obesity (HRs, 0.80 and 0.82, respectively).
"These results support the hypothesis that use of GLP-1 RA can lead to a reduction in VTE risk," the authors write. "Further studies are needed to elucidate the mechanisms and causality underlying the association between GLP-1 RA use and reduction of VTE risk, and whether these findings extend to patients using GLP-1 RA for weight control without T2DM."
Two authors disclosed ties to the pharmaceutical industry.
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COVID-19 Hospitalization Equivalent to Coronary Artery Disease for MACE Risk
Hospitalization for COVID-19 represents a coronary artery disease risk equivalent, contributing to an increased risk for major adverse cardiovascular events (MACE), according to a study published online Oct. 9 in Arteriosclerosis, Thrombosis, and Vascular Biology.
James R. Hilser, from the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues identified 10,005 COVID-19 cases between Feb. 1, 2020, and Dec. 31, 2020, from the U.K. Biobank and examined the long-term (>1,000 days) risk for MACE compared to 217,730 population controls and 38,860 propensity score-matched controls during the same period.
The researchers found that COVID-19 cases at all levels of severity had an increased risk for MACE (hazard ratio, 2.09), with a higher risk for cases hospitalized for COVID-19 (hazard ratio, 3.85). Hospitalization for COVID-19 represented a coronary artery disease risk equivalent, with even higher incident MACE risk among cases without a history of cardiovascular disease than in patients with cardiovascular disease without COVID-19 (hazard ratio, 1.21). There was a significant genetic interaction between the ABO locus and hospitalization for COVID-19; the risk for thrombotic events was higher in those with non-O blood types versus blood type O.
"This increased risk of heart attack and stroke continued three years after COVID-19 infection. Remarkably, in some cases, the increased risk was almost as high as having a known cardiovascular risk factor such as type 2 diabetes or peripheral artery disease," Hilser said in a statement.
Several authors disclosed ties to the biopharmaceutical industry; one author is co-inventor on patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics.
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Risk for Venous Thromboembolism Up for Those With Sickle Cell Trait
Individuals with sickle cell trait (SCT) have an increased risk for venous thromboembolism (VTE), according to a study published online Sept. 12 in Blood Advances.
Keng-Han Lin, Ph.D., from 23andMe in Sunnyvale, California, and colleagues leveraged data from the 23andMe Research cohort (4,184,082 participants) to calculate the ancestry-independent risk for VTE associated with SCT. A meta-analysis of three genetic ancestry groups (European [3,183,142 participants], Latine [597,539 participants], and South Asian [41,257 participants]) was used to calculate odds ratios.
The researchers found that 2.25 percent of participants from the full cohort reported a history of VTE. In a meta-analysis, the risk for VTE was increased 1.45-fold among individuals with SCT versus non-SCT carriers, similar to the full cohort estimate. In SCT, the risk for pulmonary embolism (PE) was higher than that of isolated deep vein thrombosis (DVT; odds ratios, 1.95 versus 1.04). Carriers of factor V Leiden had a 3.30-fold increased risk for VTE versus noncarriers, with a higher risk for isolated DVT versus PE (odds ratios, 3.59 and 2.72, respectively).
"Our study also provides high-powered data to confirm the PE-predominant pattern of VTE in SCT carriers. These data may inform clinical practice guidelines, future research, and public health initiatives in SCT," the authors write.
Several authors are employed by and hold stock or stock options in 23andMe.
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Interactive Map Highlights PAD Amputation Hotspots in the U.S.
A new interactive map has been created by the American Heart Association (AHA) to illustrate the risk for leg, foot, or toe amputations due to peripheral artery disease (PAD) in different regions of the United States.
Mississippi has the highest risk for lower limb amputation, followed by Texas, Louisiana, Alabama, and South Carolina, the Non-Traumatic Lower Extremity Amputations by Congressional District Heat Map shows.
"Increasing knowledge surrounding peripheral artery disease and the potential complication of lower limb amputation is vital, especially considering many people who are at high risk don't even know what PAD is," said investigator Marc Bonaca, M.D., chair of cardiovascular research with the University of Colorado School of Medicine.
Annually, about 150,000 leg amputations occur in the United States due to PAD or other health problems, researchers said.
For the new map, developed by the AHA and other organizations, researchers used 2017 and 2018 data from Medicare and the U.S. Census Bureau to track rates of leg and foot amputations. Rural residents, the poor, and Black and Native American people have the greatest risk for amputation, researchers found.
PAD affects as many as 12 million people in the United States, and Black people are twice as likely to develop the condition, researchers said.
"Much of the amputation data we are seeing is not surprising, yet the map helps us confirm and illustrate what we suspected in terms of where the biggest issues are," Bonaca said in an AHA news release. "When patients with PAD and their health teams advocate for themselves, we can share a firm message that this is a public health issue, and it is preventable."
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Skin of Color Has More Adverse Events From Sclerotherapy
Patients with skin of color may experience more adverse events from sclerotherapy, according to a study published online July 26 in the Journal of the American Academy of Dermatology.
Michelle Lazar, from the Boston University School of Medicine, and colleagues characterized the incidence of common adverse events following sclerotherapy in various Fitzpatrick Skin Types. The analysis included data from 134 patient visits for sclerotherapy (treated with 0.5 to 1 percent Polidocanol).
The researchers identified 12 adverse events across all visits, resulting in an 8.96 percent adverse event rate. Adverse events included blistering (six events), postinflammatory hyperpigmentation (PIH; five events), induration (three events), superficial thrombophlebitis (one event), and ulcer (one event). There was no evidence of acute deep venous thrombosis in Doppler ultrasound in the patient with superficial thrombophlebitis. Overall, the majority of the adverse events occurred in Fitzpatrick Skin Types of III or higher, while all PIH adverse events occurred in patients with Fitzpatrick Skin Types of IV or higher.
"Our data highlights that sclerotherapy is safe in populations with skin of color, though they do experience PIH at a higher rate as compared to those with lighter skin tones," the authors write.
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Oversight of DOAC Prescribing Beneficial for A-Fib, VTE Patients
Direct oral anticoagulant (DOAC) prescribing oversight for off-label prescribing is beneficial while patients are prescribed DOAC, according to a study published online July 30 in Thrombosis and Haemostasis.
Grace C. Herron, from the Frankel Cardiovascular Center at the University of Michigan in Ann Arbor, and colleagues evaluated data from the Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry to better characterize when off-label DOAC dosing is occurring and examine the effectiveness of prescribing oversight. The number of alerts generated in response to dosing deviations from the U.S. Food and Drug Administration instructions for atrial fibrillation (AF) and venous thromboembolism (VTE) was examined.
The researchers found that off-label dosing was relatively common among a sample of 789 to 1,022 annual AF patients and 381 to 484 annual VTE patients prescribed a DOAC in the MAQI2 registry. From 2018 to 2022, there were 569 and 162 alerts for AF and VTE patients, respectively. In AF patients, alerts occurred more frequently during follow-up than at initial prescribing (78.2 versus 21.8 percent), while in VTE patients, alerts were more common at initial prescribing (59.9 versus 40.1 percent). Overall, 19.3 and 14.8 percent of AF and VTE alerts, respectively resulted in contact to the prescriber; when the prescriber was contacted, it led to an intervention about 75 percent of the time, with a change in DOAC dosing the most common intervention.
"Oversight of DOAC prescribing using a registry-based approach is effective in identifying errors and initiating the chain of events prompting prescribers to correct errors," the authors write.
Several authors disclosed ties to the biopharmaceutical industry.
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ISTH Issues Clinical Practice Guideline for the Treatment of Hemophilia
In a clinical practice guideline issued by the International Society on Thrombosis and Haemostasis and published online June 13 in the Journal of Thrombosis and Haemostasis, recommendations are presented for the treatment of congenital hemophilia.
Suely M. Rezende, M.D., Ph.D., from the Universidade Federal de Minas Gerais in Belo Horizonte, Brazil, and colleagues developed an evidence-based clinical practice guideline for hemophilia treatment. Thirteen questions were selected by a multidisciplinary panel: 11 addressed the treatment of hemophilia A and two addressed hemophilia B treatment.
For hemophilia A, the panel addressed questions relating to prophylactic and episodic treatment with factor VIII concentrates, bypassing agents, nonfactor therapy (emicizumab) (with and without inhibitors), as well as immune tolerance induction. Questions on prophylactic and episodic treatment of bleeding events with factor IX concentrates were addressed for hemophilia B. For all 13 recommendations, agreement was reached. For severe and moderately severe hemophilia A and B without inhibitors, prophylaxis is strongly recommended over episodic treatment of bleeding events. Prophylaxis with emicizumab or with factor VIII concentrates is recommended for hemophilia A, and prophylaxis with purified plasma-derived factor IX or standard or extended half-life recombinant factor IX concentrates is recommended for hemophilia B without inhibitors.
"With hemophilia management being complex, our guideline provides clarity, guiding treatment decisions with evidence-based insight, yet highlighting the importance of making treatment decisions consistent with patients' individual risks, values, and preferences," Rezende said in a statement.
Several authors disclosed ties to the pharmaceutical industry.
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Xylitol Linked to Incident Major Adverse Cardiovascular Event Risk
Xylitol is associated with incident major adverse cardiovascular event (MACE) risk, according to a study published online June 6 in the European Heart Journal.
Marco Witkowski, M.D., from the Lerner Research Institute at the Cleveland Clinic, and colleagues performed untargeted metabolomics studies on overnight fasting plasma samples in a discovery cohort of 1,157 sequential stable patients undergoing elective diagnostic cardiac evaluations. Subsequent isotope dilution liquid chromatography tandem mass spectrometry (LC-MS/MS) analyses were performed on an independent validation cohort comprising 2,149 participants. The effect of xylitol on platelet responsiveness and thrombus formation in vivo was examined in complementary isolated human platelet, platelet-rich plasma, whole blood, and animal model studies. Finally, the effects of xylitol consumption were examined on platelet function in 10 healthy volunteers.
The researchers found that circulating levels of a polyol tentatively assigned as xylitol were associated with incident MACE risk in the initial untargeted metabolomics study (discovery cohort). The association of xylitol with incident MACE risk was confirmed in stable isotope dilution LC-MS/MS analyses (third versus first tertile adjusted hazard ratio, 1.57). Xylitol-enhanced multiple indices of platelet reactivity and in vivo thrombosis formation at levels observed in fasting plasma were seen in complementary mechanistic studies. Xylitol-sweetened drinks markedly raised plasma levels in interventional studies, and enhanced multiple functional measures of platelet responsiveness in all individuals.
"Our studies suggest that xylitol will likely confer heightened thrombosis potential in the same vulnerable patients that it is marketed towards and intended to protect," the authors write.
Several authors disclosed ties to the biopharmaceutical industry; several authors are named coinventors on pending and issued patents relating to cardiovascular diagnostics and therapeutics.
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Robotic-Assisted Total Knee Arthroplasty Has Fewer Complications
WEDNESDAY, May 15, 2024 (HealthDay News) -- Robotic-assisted total knee arthroplasty (rTKA) is associated with fewer complications but higher average total cost than conventional TKA (cTKA), according to a study recently published online in Archives of Orthopaedic and Trauma Surgery.
Vikram A. Aggarwal, from University of Texas Southwestern Medical Center in Dallas, and colleagues used data from the National Inpatient Sample Database Healthcare Cost and Utilization Project (2016 to 2019) to examine differences in cost and outcomes for patients undergoing rTKA and cTKA.
The researchers found that compared with cTKA patients, rTKA patients had lower average length of stay (1.91 days) and higher average total cost ($67,133.34). Benefits were seen for fewer complications, including reduced periprosthetic infection (odds ratio [OR], 0.027), periprosthetic dislocation (OR, 0.117), periprosthetic mechanical complication (OR, 0.315), pulmonary embolism (OR, 0.358), transfusion (OR, 0.366), pneumonia (OR, 0.468), deep vein thrombosis (OR, 0.479), and blood loss anemia (OR, 0.728). Findings persisted even after propensity matching.
"Identifying patient-specific factors that place them at risk for increased complications with cTKA as opposed to rTKA could provide surgeons insight on the method of TKA that maximizes patient outcomes while minimizing health care cost," the authors write.
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Leukocyte Glucose Index, Arteriovenous Fistula Failure Linked in ESKD
MONDAY, April 22, 2024 (HealthDay News) -- For patients with end-stage kidney disease (ESKD), a high preoperative leukocyte glucose index (LGI) is associated with arteriovenous fistula (AVF) failure, according to a study published online April 1 in the Journal of Clinical Medicine.
Adrian Vasile Muresan, Ph.D., from the George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures in Romania, and colleagues examined the impact of LGI on long-term primary patency of AVF following initiation of dialysis in 158 patients with ESKD. AVF failure, defined as the impossibility of performing chronic dialysis due to severe restenosis or AVF thrombosis, was examined as the primary end point.
The researchers found that the prevalence rates of atrial fibrillation and diabetes were higher in patients with AVF failure, and they had a higher LGI value. In a receiver operating characteristic analysis, the strongest association with the outcome was seen for LGI, with an area under the curve of 0.729 and an optimal cutoff of 0.95 (sensitivity and specificity of 72.4 and 68 percent, respectively). Patients in the highest versus the lowest tertile of LGI had a significantly higher incidence of AVF failure in Kaplan-Meier survival analyses. The risk for AVF failure during follow-up was significantly higher for patients with higher baseline LGI values (hazard ratio, 1.48); the association was independent of age and sex, cardiovascular risk factors, and preoperative vascular mapping determinations (hazard ratios, 1.65, 1.63, and 3.49, respectively).
"LGI can be used as a potential biomarker to identify patients from risk groups that require more careful monitoring of AVF in order to improve the management and care of patients with ESKD," the authors write.
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Atopic Dermatitis Tied to Higher Venous Thromboembolism Risk
WEDNESDAY, May 31, 2023 (HealthDay News) -- Atopic dermatitis (AD) in adulthood is associated with an increased risk for venous thromboembolism (VTE), according to a study published online May 31 in JAMA Dermatology.
Tai-Li Chen, M.D., from Taipei Veterans General Hospital in Taiwan, and colleagues examined the risk for incident VTE among patients with AD. The analysis included 284,858 matched participants (142,429 participants with AD newly diagnosed between 2003 and 2017).
The researchers found that 0.7 percent of participants in the AD group and 0.6 percent in the non-AD cohort developed VTE, with incidence rates of 1.05 and 0.82 per 1,000 person-years, respectively. Compared with adults without AD, adults with AD had a significantly increased risk for incident VTE (hazard ratio, 1.28). Specifically, AD was associated with higher risks for deep vein thrombosis (hazard ratio, 1.26) and pulmonary embolism (hazard ratio, 1.30).
"The results of this cohort study suggest that AD in adulthood is associated with an increased risk of VTE; however, the absolute risk difference of VTE between adults with and without AD appears small," the authors write. "Nevertheless, cardiovascular examination and imperative management may be considered for adults with AD who present with symptoms suggestive of VTE. Future research is warranted to elucidate the pathophysiology underlying the association between AD and VTE."
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Low Risk of Recurrent Thrombotic Events After COVID-19-Linked VTE
TUESDAY, May 23, 2023 (HealthDay News) -- Patients with COVID-19-associated venous thromboembolism (VTE) have low risk of recurrent thrombotic events, and the risk is similar to that seen in patients with VTE provoked by hospitalization for other acute medical illness, according to a study published online April 26 in Research and Practice in Thrombosis and Haemostasis.
Walter Ageno, M.D., from the University of Insubria in Varese, Italy, and colleagues conducted a study involving a prospective cohort of 278 COVID-19 patients with VTE enrolled between 2020 and 2021 and a comparison cohort of 300 non-COVID-19 patients with VTE associated with hospitalization for other acute medical illnesses. Patients were followed for a minimum of 12 months after discontinuation of treatment.
The researchers found that compared with controls, patients with VTE secondary to COVID-19 more often had pulmonary embolism without deep vein thrombosis (83.1 versus 46.2 percent) and had a lower prevalence of chronic inflammatory disease (1.4 versus 16.3 percent) and VTE history (5.0 versus 19.0 percent). The two groups had a similar median duration of anticoagulant treatment (194 and 225 days) and proportion of patients who discontinued anticoagulation (78.0 and 75.0 percent). The rates of thrombotic events after discontinuation did not differ between the groups (1.5 and 2.6 per 100 patient-years).
"The low number of events seen in our study after discontinuation of therapy suggests that anticoagulant treatment for a limited period of three to six months is generally adequate for the majority of patients with COVID-19-associated venous thromboembolism," Ageno said in a statement.
Two authors disclosed ties to the pharmaceutical industry.
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FDA Approves First Pill to Treat Moderate-to-Severe Crohn Disease
FRIDAY, May 19, 2023 (HealthDay News) -- Patients with Crohn disease have a new treatment option, following U.S. Food and Drug Administration approval of Rinvoq (upadacitinib).
Rinvoq is meant to treat adults with moderately to severely active Crohn disease who have not had success with tumor necrosis factor blockers. The daily pill is the first oral treatment for this group of patients.
The medication was previously approved for several other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, according to the website of pharmaceutical company AbbVie.
Researchers evaluated its safety and effectiveness in two randomized trials in 857 patients with the disease. Participants received either 45 mg of Rinvoq or a placebo daily for 12 weeks. More patients treated with the medication achieved remission than those treated with the placebo, the FDA said in a news release. Also, more people treated with the medication had improvement in intestinal inflammation, which was assessed with a colonoscopy.
The FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 or 30 mg once daily or a placebo for a year. More of those on the maintenance treatment achieved remission and reduced intestinal inflammation than those on the placebo. Side effects of the medication were upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache.
The drug is not recommended for use with other Janus kinase inhibitors, biological therapies for Crohn disease, or strong immunosuppressants, including azathioprine and cyclosporine. Among the risks are serious infections, death, cancer, major adverse cardiovascular events, and thrombosis.
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Doctor died from rare reaction to AstraZeneca Covid jab
Dr Stephen Wright, 32, an NHS clinical psychologist and frontline health worker, suffered from a combination of a brainstem infarction, bleed on the brain and vaccine-induced thrombosis, an inquest at London’s Southwark coroner’s court heard.
He was in one of the earliest groups of people to be given the jab, and died 10 days after it was administered. The coroner Andrew Harris said it was a “very unusual and deeply tragic case”, but noted that the inquest’s conclusion was not “blaming AstraZeneca”.
Dr Mark Howard, a consultant pathologist and medical examiner at King’s College hospital, said scientists and medical experts were not aware of the vaccine’s possible deadly side effects when Wright received the jab as it was so early in its rollout, but even at later stages there would have been no way of predicting this “rare and unintended consequence”...Read More
What's the proper way to roll out a vaccine and prevent cases like this?
Nirmatrelvir Cuts Risk for Post-COVID-19 Condition
MONDAY, March 27, 2023 (HealthDay News) -- Treatment with nirmatrelvir during the acute phase of COVID-19 may reduce the risk for postacute adverse health outcomes, according to a study published online March 23 in JAMA Internal Medicine.
Yan Xie, Ph.D., from the Department of Veterans Affairs St. Louis Health Care System, and colleagues examined whether treatment with nirmatrelvir in the acute phase of COVID-19 is associated with a reduced risk for post-COVID-19 condition (PCC). The analysis included 35,717 veterans who had a severe acute respiratory syndrome coronavirus 2 positive test result between Jan. 3, 2022, and Dec. 31, 2022, with at least one risk factor for severe COVID-19 who were treated with oral nirmatrelvir within five days after the positive test, and 246,076 who tested positive during the study period and received no COVID-19 antiviral or antibody treatment.
The researchers found that nirmatrelvir was associated with a reduced risk for PCC (relative risk, 0.74; absolute risk reduction at 180 days [ARR], 4.51 percent), including a reduced risk for 10 of 13 postacute sequelae (components of PCC) in the cardiovascular system (dysrhythmia and ischemic heart disease), coagulation and hematologic disorders (pulmonary embolism and deep vein thrombosis), fatigue and malaise, acute kidney disease, muscle pain, neurologic system disorders (neurocognitive impairment and dysautonomia), and shortness of breath. Furthermore, nirmatrelvir was also associated with a lower risk for postacute death (hazard ratio, 0.53; ARR, 0.65 percent) and postacute hospitalization (hazard ratio, 0.76; ARR, 1.72 percent). Regardless of vaccination or booster status, or primary infection versus reinfection, nirmatrelvir was associated with a reduced risk for PCC.
"These findings suggest that the salutary benefit of nirmatrelvir may extend to the postacute phase of COVID-19," the authors write.
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Use of Vena Cava Filters in VTE Patients Is Safe, Effective
THURSDAY, March 16, 2023 (HealthDay News) -- Inferior vena cava filters (VCFs) are a safe and effective way to treat venous thromboembolism (VTE), according to a study published online Feb. 23 in the Journal of Vascular and Interventional Radiology.
Matthew S. Johnson, M.D., from Indiana University School of Medicine in Indianapolis, and colleagues assessed the safety and effectiveness of VCFs. The analysis included 1,421 participants (mean 62.7 years old; 53.3 percent male) who were treated at 54 U.S. sites between Oct. 10, 2015, and March 31, 2019.
The researchers found that primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12 months) and effectiveness (composite composed of procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12 months in situ or one month postretrieval) were met. Procedural AEs were uncommon and usually minor, although one patient died during VCF removal. Strut perforation >5 mm was seen in 31 of 201 patients' computed tomography scans (15.4 percent), but only three were deemed clinically significant. VCF-related AEs were rare (0.5 percent). VTE events (none fatal) occurred in 6.5 percent of patients postfilter, including DVT (5.2 percent), PE (1.6 percent), and/or caval thrombotic occlusions (1.1 percent). In patients receiving prophylactic placement, no PE occurred.
"Now that the study is complete, we now have a roadmap for better filter utilization," a coauthor said in a statement. “We need to solidify a clearer set of practice guidelines for venous thromboembolic disease, based on its symptoms, location, and complications."
Several authors disclosed financial ties to the medical device industry.
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Common Sugar Substitute Negatively Impacts Cardiovascular Risk
THURSDAY, March 9, 2023 (HealthDay News) -- Erythritol is associated with incident major adverse cardiovascular event risk and enhances platelet reactivity and thrombosis formation, according to a study published online Feb. 27 in Nature Medicine.
Marco Witkowski, M.D., from the Lerner Research Institute at the Cleveland Clinic, and colleagues examined the commonly used sugar substitute erythritol and atherothrombotic disease risk among patients undergoing cardiac risk assessment and healthy volunteers.
The researchers found that circulating levels of multiple polyol sweeteners, especially erythritol, were associated with incident risk for major adverse cardiovascular events in initial untargeted metabolomics studies in 1,157 patients undergoing cardiac risk assessment (discovery cohort). This association was confirmed in targeted metabolomics analyses in independent validation cohorts of stable patients (2,149 U.S. patients and 833 European patients) undergoing elective cardiac assessment (fourth versus first quartile adjusted hazard ratios, 1.80 and 2.21, respectively). Erythritol enhanced platelet reactivity in vitro and formation of thrombosis in vivo at physiological levels. In eight healthy volunteers, erythritol ingestion induced marked and sustained increases in plasma erythritol levels well above thresholds associated with heightened platelet reactivity and thrombosis potential.
"Our study shows that when participants consumed an artificially sweetened beverage with an amount of erythritol found in many processed foods, markedly elevated levels in the blood are observed for days -- levels well above those observed to enhance clotting risks," a coauthor said in a statement.
Several authors disclosed financial ties to the pharmaceutical industry; one author is a co-inventor on pending and issued patents held by the Cleveland Clinic relating to cardiovascular diagnostics and therapeutics. The LipidCardio Study was partially funded by Sanofi-Aventis.
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