PRE-THERAPEUTIC NUTRITIONAL STATUS FOLLOW-UP FOR PREDICTING SEVERE ADVERSE EVENTS IN PATIENTS WITH CERVICAL CANCER TREATED BY CHEMO-RADIOTHERAPY

2017 ◽  
Author(s):  
Ester Miralpeix
Keyword(s):  
Cervical Cancer ◽  
Adverse Events ◽  
Nutritional Status ◽  
Severe Adverse Events

scholarly journals Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization

2018 ◽  
Vol 28 (4) ◽  
pp. 406-415 ◽  
Author(s):  
Sven Schmidt ◽  
Joerg Franke ◽  
Michael Rauschmann ◽  
Dieter Adelt ◽  
Matteo Mario Bonsanto ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Walking Distance ◽  
Pivotal Trial ◽  
Significant Difference ◽  
Patient Reported ◽  
Severe Adverse Events ◽  
Us Fda ◽  
Foraminal Height

OBJECTIVESurgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS.METHODSUnder approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany. Patients had moderate to severe LSS at 1 or 2 adjacent segments from L-3 to L-5. Outcomes were evaluated up to 2 years postoperatively, including Oswestry Disability Index (ODI) scores, the presence of secondary surgery or lumbar injections, neurological status, and the presence of device- or procedure-related severe adverse events. The composite clinical success (CCS) was defined as combining all 4 of these outcomes, a success definition validated in a US FDA pivotal trial. Additional secondary end points included visual analog scale (VAS) scores, Zürich Claudication Questionnaire (ZCQ) scores, narcotic usage, walking tolerance, and radiographs.RESULTSThe overall follow-up rate was 91% at 2 years. There were no significant differences in patient-reported outcomes at 24 months (p > 0.05). The CCS was superior for the D+ILS arm (p = 0.017). The risk of secondary intervention was 1.75 times higher among patients in the DA group than among those in the D+ILS group (p = 0.055). The DA arm had 228% more lumbar injections (4.5% for D+ILS vs 14.8% for DA; p = 0.0065) than the D+ILS one. Patients who underwent DA had a numerically higher rate of narcotic use at every time point postsurgically (16.7% for D+ILS vs 23% for DA at 24 months). Walking Distance Test results were statistically significantly different from baseline; the D+ILS group had > 2 times the improvement of the DA. The patients who underwent D+ILS had > 5 times the improvement from baseline compared with only 2 times the improvement from baseline for the DA group. Foraminal height and disc height were largely maintained in patients who underwent D+ILS, whereas patients treated with DA showed a significant decrease at 24 months postoperatively (p < 0.001).CONCLUSIONSThis study showed no significant difference in the individual patient-reported outcomes (e.g., ODI, VAS, ZCQ) between the treatments when viewed in isolation. The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure.Clinical trial registration no.: NCT01316211 (clinicaltrials.gov)

scholarly journals Tolerability of Omalizumab in Asthma as a Major Compliance Factor: 10-Year Follow Up

2018 ◽  
Vol 6 (10) ◽  
pp. 1839-1844 ◽  
Author(s):  
Mona Al-Ahmad ◽  
Jasmina Nurkic ◽  
Ahmed Maher ◽  
Nermina Arifhodzic ◽  
Edin Jusufovic
Keyword(s):  
Adverse Events ◽  
Treatment Efficacy ◽  
Real Life ◽  
Drop Out ◽  
Uncontrolled Asthma ◽  
Increased Risk ◽  
Asthma Patients ◽  
Severe Adverse Events

BACKGROUND: There is a lack of data related to real life, long-term safety, tolerability and compliance of omalizumab treatment in asthma patients beyond 6 years. AIM: Study aimed to assess safety, tolerability, compliance and all reasons for treatment discontinuation during 10 years on omalizumab. SUBJECT AND METHODS: This is a retrospective, observational study of uncontrolled asthma patients receiving omalizumab for the last 10 years. All data were collected from patients’ files (demographics, adverse events, comorbidities, compliance index, reasons for discontinuation of omalizumab). Reactions to omalizumab were classified as local and systemic, and their severity as mild, moderate or severe. Reactions were either immediate (minutes to hours after drug administration) or delayed (after days). Compliance to omalizumab, defined as Compliance index (CI), was calculated by comparing milligrams of given to milligrams of prescribed dose/ per year. RESULTS: Out of 35 patients receiving omalizumab, 15 drop out at different time points mostly due to treatment efficacy or appearance of new comorbidities. Patients who continue for the next ten years had mild to moderate adverse events related to omalizumab. There was no increased risk of severe adverse events during 10 years on omalizumab. Patient’s treatment tolerability, despite mild to moderate adverse events, is in favour of compliance. CONCLUSION: Compliance with omalizumab mildly decreased over 10 years but was not affected by severe adverse events of treatment or new comorbidities. Although, omalizumab is safe medicine appearance of new comorbidities has to be closely followed up.

scholarly journals Prognostic value of longitudinal assessment of hepatorenal function and nutritional status in patients undergoing valvular heart surgery

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
Y K Tse ◽  
H L Li ◽  
S Y Yu ◽  
M Z Wu ◽  
Q W Ren ◽  
...  
Keyword(s):  
Heart Failure ◽  
Adverse Events ◽  
Nutritional Status ◽  
Risk Stratification ◽  
Temporal Changes ◽  
Valvular Surgery ◽  
All Cause Mortality ◽  
Sts Score ◽  
Hepatorenal Function

Abstract Background Hepatorenal dysfunction and malnutrition are frequent extracardiac consequences of valvular heart disease (VHD) and have emerged as prominent drivers of adverse prognosis in selected valvular interventions. Nonetheless, data in a general VHD population is sparse, and their interaction and changes following valvular surgery remain unexplored. Purpose We aim to characterise the temporal changes, interaction, and prognostic implications of hepatorenal dysfunction and malnutrition before and after valvular surgery. Methods Baseline and temporal changes in hepatorenal dysfunction (assessed by the modified model for end-stage liver disease [MELD-XI] score) and nutritional status (assessed by Controlling Nutritional Status [CONUT] score) were correlated with adverse events (composite of all-cause mortality and hospitalisation for heart failure) using Cox proportional hazards model, adjusted with clinical and echocardiographic covariates, medications, type of valvular procedure, and cardiac surgery risk-stratification models (EuroSCORE II and STS score). Results Our study included 909 patients who underwent valvular surgery. At baseline, 216 (24%) and 554 (61%) had hepatorenal dysfunction (MELD-XI &gt;12.43) and malnutrition (CONUT ≥2), respectively. MELD-XI scores were modestly correlated with CONUT scores (R=0.36, p&lt;0.001), with concomitant hepatorenal dysfunction and malnutrition present in 177 (19%) patients. Over a median follow-up of 4.1 years, 101 (11%) patients died and 119 (13%) were hospitalised for heart failure. There was a stepwise increase in mortality (χ2 89.1, p&lt;0.001) and adverse events (χ2 92.9, p&lt;0.001) from patients with normal hepatorenal function and nutrition to concomitant hepatorenal dysfunction and malnutrition (Figure 1). This association remained consistent in fully adjusted models. MELD-XI and CONUT scores significantly improved the discriminatory accuracy of EuroSCORE II (area under the curve [AUC]: 0.80 vs 0.73, p&lt;0.001) and STS score (AUC: 0.79 vs 0.72, p=0.004) for all-cause mortality. In patients with MELD-XI and CONUT scores 1 year after surgery (n=707), ΔMELD-XI (follow-up MELD-XI minus baseline MELD-XI score) and ΔCONUT scores were significantly associated with adverse events (HR 1.08, 95% CI 1.03–1.14, p=0.001 for ΔMELD-XI; HR 1.18, 95% CI 1.02–1.35, p=0.02 for ΔCONUT). Patients remaining with hepatorenal dysfunction and malnutrition experienced worse survival (log-rank χ2 65.2, p&lt;0.001) and adverse events (log-rank χ2 90.4, p&lt;0.001) (Figure 2). Conclusions In patients undergoing valvular surgery, hepatorenal function and nutritional status at baseline, and their temporal changes, are strongly linked to clinical outcomes. These results highlight the role of hepatorenal and nutritional assessment for risk-stratification in valvular surgery. FUNDunding Acknowledgement Type of funding sources: None. Figure 1 Figure 2

Low-income minority women at risk for cervical cancer: a process to improve adherence to follow-up recommendations

2001 ◽  
Vol 116 (6) ◽  
pp. 608-616 ◽  
Author(s):  
Virginia A Cardin ◽  
Richard M Grimes ◽  
Zhi Dong Jiang ◽  
Nancy Pomeroy ◽  
Luther Harrell ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
At Risk ◽  
Low Income ◽  
Minority Women

Three-year follow-up of women who participated in a prison cervical cancer screening intervention

2005 ◽  
Author(s):  
Ruth Elwood Martin ◽  
Greg Hislop ◽  
Veronika Moravan ◽  
Garry Grams ◽  
Betty Calam
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening

Safety_and_Pharmacokinetics_of_Dapivirine_Delivery.7

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Adverse Events ◽  
Hiv Transmission ◽  
Plasma Concentrations ◽  
Vaginal Fluid ◽  
Time Curve ◽  
Vaginal Microbicides ◽  
Intravaginal Rings ◽  
Lower Genital Tract ◽  
The Matrix

Vaginal microbicides for the prevention of HIV transmission maybe an important option for protecting women from infection.Incorporation of dapivirine, a lead candidate nonnucleoside reversetranscriptase inhibitor, into intravaginal rings (IVRs) for sustainedmucosal delivery may increase microbicide product adherence andefficacy compared with conventional vaginal formulations. Twentyfourhealthy HIV-negative women 18–35 years of age were randomlyassigned (1:1:1) to dapivirine matrix IVR, dapivirine reservoir IVR,or placebo IVR. Dapivirine concentrations were measured in plasmaand vaginal fluid samples collected at sequential time points over the33-day study period (28 days of IVR use, 5 days of follow-up). Safetywas assessed by pelvic/colposcopic examinations, clinical laboratorytests, and adverse events. Both IVR types were safe and well toleratedwith similar adverse events observed in the placebo and dapivirinegroups. Dapivirine from both IVR types was successfully distributedthroughout the lower genital tract at concentrations over 4 logs greaterthan the EC50 against wild-type HIV-1 (LAI) in MT4 cells. Maximumconcentration (Cmax) and area under the concentration–time curve(AUC) values were significantly higher with the matrix than reservoirIVR. Mean plasma concentrations of dapivirine were ,2 ng/mL.These findings suggest that IVR delivery of microbicides is a viableoption meriting further study.Key Words: dapivirine, HIV, intravaginal ring, microbicide,pharmacokinetics, prevention

scholarly journals O06 Baseline predictors of methotrexate-related adverse events in methotrexate-naïve patients with RA

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Ahmad A Sherbini ◽  
James M Gwinnutt ◽  
Kimme L Hyrich ◽  
Suzanne M M Verstappen ◽  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Health Assessment ◽  
Prevalence Rates ◽  
Clinical Predictors ◽  
Research Support ◽  
Related Data ◽  
Increased Risk ◽  
One Year

Abstract Background/Aims  Methotrexate (MTX) is the most common treatment for rheumatoid arthritis (RA). The prevalence of adverse events (AEs) associated with MTX treatment for RA have been studied extensively, but there are limited data on the predictors of these AEs. This study aims to summarise the prevalence rates of MTX AEs, including gastrointestinal (GI), neurological, mucocutaneous, and elevated alanine transaminase (ALT) enzyme, and to identify baseline demographic and clinical predictors of these AEs. Methods  The Rheumatoid Arthritis Medication Study (RAMS) is a UK multi-centre prospective cohort study of patients with RA starting MTX for the first time. Relevant demographic, medication, clinical and disease related data were collected at baseline. AEs were reported at six and twelve months follow-ups. The prevalence rates of AEs were calculated based on the proportions of patients who reported having had an AE within one year of follow-up. The associations between candidate baseline predictors and AEs were assessed using multivariable logistic regression. Results  A total of 2,089 patients were included with a mean age of 58.4 (standard deviation: 13.5) years, 1390 (66.5%) were women. 1,814 and 1,579 patients completed the 6 and 12 months follow-up visits, respectively. The prevalence rates of the AEs within one year of follow-up were: GI = 777 (40.6%), mucocutaneous = 441 (23.1%), neurological = 487 (25.5%), elevated ALT (&gt; upper limit of normal [ULN]) = 286 (15.5%). Younger age and being a woman were associated with increased risk of GI AEs, (age: OR 0.97 per year increase in age, 95% CI 0.98, 1.00; male sex: OR 0.58 vs female, 95% CI 0.46, 0.74) (Table 1). Higher baseline Health Assessment Questionnaire (HAQ) score was an independent predictor of GI, mucocutaneous, and neurological AEs. Furthermore, having ALT &gt;1xULN at baseline or history of diabetes was associated with increased risk of subsequent ALT elevation during the study follow-up. Conclusion  In patients with RA starting MTX, GI AEs were the most commonly reported AEs during the first year of follow-up. The identified predictors of AEs may facilitate discussions between clinicians and patients prior to commencing MTX, and may lead to increased adherence and consequently improved effectiveness. Disclosure  A.A. Sherbini: None. J.M. Gwinnutt: Grants/research support; BMS. K.L. Hyrich: Member of speakers’ bureau; Abbvie. Grants/research support; Pfizer, UCB, BMS. S.M.M. Verstappen: Consultancies; Celltrion. Member of speakers’ bureau; Pfizer. Grants/research support; BMS.

OP270 Why The Haute Autorité de Santé Rejects the Widespread Use Of “Mini-Bypass”/One Anastomosis Gastric Bypass For Obesity In France

2020 ◽  
Vol 36 (S1) ◽  
pp. 4-4
Author(s):  
Jean-Charles Lafarge ◽  
Denis-Jean David ◽  
Cédric Carbonneil
Keyword(s):  
Esophageal Cancer ◽  
Gastric Bypass ◽  
Adverse Events ◽  
Severe Obesity ◽  
One Anastomosis Gastric Bypass ◽  
Close Monitoring ◽  
Efficacy And Safety ◽  
Multicenter Rct ◽  
Nutritional Complications

IntroductionOne anastomosis gastric bypass (OAGB) has become a widespread technique over the last few years in France, without any prior assessment and despite existing controversies among bariatric surgeons. An older bypass technique for treating obesity, the Roux-en-Y gastric bypass (RYGB), is available and reimbursed, having been assessed and approved for use in 2005. In 2019, the French Haute Autorité de Santé (HAS) assessed OAGB for the treatment of severe and massive obesity. This assessment, the first in the world, was undertaken for OAGBs carried out with a 200- or 150-centimeter biliopancreatic-limb (BP-limb) length.MethodsA systematic review (SR) of the literature and consultation of a working group consisting of both healthcare professionals (clinician and surgeons) and patients were carried out. The primary aim of our assessment was to determine whether the OAGB technique can replace RYGB. The efficacy and safety profile of OAGB was compared with RYGB in adult patients with massive, severe obesity. Complications and postoperative follow up specific to OAGB were identified.ResultsThe three selected randomized controlled trials (RCTs) could not confirm the superiority or the non-inferiority of OAGB, compared with RYGB, on the selected efficacy endpoints of weight loss, resolution of comorbidities, and quality of life. Adverse events reported for OAGB included severe nutritional complications and bile reflux that could potentially lead to lower esophageal cancer. In one RCT, the frequency of serious adverse events in the OAGB group was almost two times higher than in the RYGB group.ConclusionsHAS considered that OAGB carried out with a longer (200 centimeter) BP-limb is not a validated technique for the surgical treatment of massive, severe obesity. Thus, it cannot be considered an alternative to RYGB. There were insufficient data available on OAGB performed with a 150-centimeter BP-limb. Thus, HAS recommended undertaking a multicenter RCT to assess the efficacy and safety of OAGB. Patients who have already undergone OAGB should receive the same follow up as patients who have received RYGB, including close monitoring for nutritional complications and lower esophageal cancer and an endoscopic examination five years after surgery.

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