Abstract 1122‐000115: Coiling of Wide‐Necked Ruptured Aneurysms: A Subset Analysis of the SMART Registry

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Alejandro M Spiotta ◽  
B. Keith Woodward ◽  
Min S Park ◽  
Richard J Bellon ◽  
Osama O Zaidat
Keyword(s):  
Adverse Events ◽  
Ruptured Aneurysm ◽  
Anterior Communicating Artery ◽  
Serious Adverse Events ◽  
Neck Width ◽  
Safety Outcome ◽  
Ruptured Aneurysms ◽  
Average Patient ◽  
Progressive Occlusion

Introduction : The purpose of this study was to assess the 1‐year clinical outcomes of wide‐necked ruptured aneurysms treated with coiling. Methods : Data on patients with a wide‐necked ruptured aneurysm were extracted from a prospective multicenter registry (SMART) that enrolled patients with intracranial aneurysm or other neurovascular abnormality who underwent coiling. A wide neck was defined as a neck width of at least 4 mm or as a dome‐to‐neck ratio (largest diameter / neck width) of less than 2. Enrollment was not limited by Hunt and Hess grade. The primary safety outcome was device‐related serious adverse events within 24 hours, and the primary effectiveness outcome was retreatment through follow‐up. Results : Of the 995 adults enrolled in the SMART registry, 144 had a wide‐necked ruptured aneurysm (Table). Average patient age was 59.3 years (SD 14.3), and 74.3% were female. Lesion locations were internal carotid artery, 31.3%; anterior communicating artery, 31.9%; middle communicating artery, 10.4%; and posterior circulation, 26.4%. Aneurysm sizes were small, 27.1%; medium, 54.2%; large, 18.1%; and giant, 0.7%. The most common aneurysm type was saccular (88.8%, 127/143). Coiling was stent assisted in 10.4% of patients and balloon assisted in 36.1% of patients. The rate of device‐related serious adverse events within 24 hours was 3.5%. The rate of retreatment through follow‐up was 20.6% (20/97). At 1 year, 82.6% (76/92) of patients had a Raymond–Roy Occlusion Classification of I or II, 32.6% (30/92) had progressive occlusion, and 46.7% (43/92) had stable occlusion. The 1‐year all‐cause mortality rate was 12.5%. At 1‐year follow‐up, 58.3% (42/72) of patients had a modified Rankin Scale score of 0 to 2. Conclusions : Treatment of wide‐necked ruptured aneurysms with coiling has acceptable occlusion and retreatment rates at 1‐year follow‐up.

Woven EndoBridge (WEB) device in the treatment of ruptured aneurysms

2020 ◽  
pp. neurintsurg-2020-016405 ◽  
Author(s):  
Patrick P Youssef ◽  
David Dornbos III ◽  
Jeremy Peterson ◽  
Ahmad Sweid ◽  
Amanda Zakeri ◽  
...  
Keyword(s):  
Adverse Events ◽  
Intracranial Aneurysms ◽  
Anterior Communicating Artery ◽  
Safety And Efficacy ◽  
Ruptured Aneurysms ◽  
Primary Treatment Modality ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

BackgroundWide-necked bifurcation aneurysms (WNBAs) present unique challenges for endovascular treatment. The Woven EndoBridge (WEB) device is an intrasaccular braided device, recently approved by the FDA for treatment of WNBAs. While treatment of intracranial aneurysms with the WEB device has been shown to yield an adequate occlusion rate of 85% at 1 year, few data have been published for patients with ruptured aneurysms.ObjectiveTo present a multi-institutional series depicting the safety and efficacy of using the WEB device as the primary treatment modality in ruptured intracranial aneurysms.MethodsA multi-institutional retrospective analysis was conducted, assessing patients presenting with aneurysmal subarachnoid hemorrhage treated with the WEB between January 2014 and April 2020. Baseline demographics, aneurysm characteristics, adverse events, and long-term outcomes (occlusion, re-treatment, functional status) were collected. A descriptive analysis was performed, and variables potentially associated with aneurysm recurrence or re-treatment were assessed.ResultsForty-eight patients were included. Anterior communicating artery aneurysms were the most common (35.4%) location for treatment, followed by middle cerebral artery (20.8%) and basilar apex (16.7%). Procedural success was noted in 95.8% of patients, and clinically significant periprocedural adverse events occurred in 12.5%. After a median follow-up of 5.5 months, 54.2% of patients had follow-up angiographic imaging. Complete occlusion was seen in 61.5% of cases with adequate occlusion in 92.3%. Re-treatment was required in only 4.2% of patients during the study period. Tobacco use was significantly higher in patients with aneurysm recurrence (88.9% vs 35.7%; p=0.012). No other characteristics were associated with recurrence/re-treatment. At 30 days, 81.1% were functionally independent (modified Rankin Scale score ≤2).ConclusionTreatment of acutely ruptured aneurysms with the WEB device demonstrates both safety and efficacy on par with rates of conventional treatment strategies.

Abstract 1122‐000087: Long‐Term Outcomes of Anterior Communicating Artery Aneurysm Treated with Coiling: Subset Analysis of SMART Registry

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Clemens M Schirmer ◽  
Richard J Bellon ◽  
Bradley N Bohnstedt ◽  
Reade A DeLeacy ◽  
Min S Park ◽  
...  
Keyword(s):  
Adverse Events ◽  
Scale Score ◽  
Unruptured Aneurysm ◽  
Anterior Communicating Artery ◽  
Modified Rankin Scale ◽  
Serious Adverse Events ◽  
Large Aneurysm ◽  
Small Aneurysm

Introduction : The purpose of this study was to assess the long‐term clinical outcomes of anterior communicating artery (ACoA) aneurysm treated with coiling. Methods : Data on patients with an ACoA aneurysm were extracted from a prospective multicenter registry (SMART) that enrolled patients with intracranial aneurysms or other neurovascular abnormalities who underwent coiling. The primary effectiveness outcome was retreatment through follow‐up, and the primary safety outcome was procedural device‐related serious adverse events within 24 hours. Results : Of the 995 adults enrolled in the SMART registry, 230 had an ACoA aneurysm (Table). The average patient age was 59.1 years (SD 12.5), and 62.6% were female. A modified Rankin Scale score of 0 to 2 was present in 89.6% of patients. Most aneurysms were small (93.9%) and saccular (87.8%). The aneurysm was wide necked in 57.7% of patients and was ruptured in 35.7%. Coiling was stent assisted in 39.1% of patients and balloon assisted in 14.8%. Retreatment through follow‐up occurred in 8.1% (15/185) of patients—6.8% (12/176) of patients with a small aneurysm, 33.3% (3/9) of patients with a large aneurysm, 4.0% (5/126) of patients with an unruptured aneurysm, 16.9% (10/59) of patients with a ruptured aneurysm, 9.9% (9/91) of patients with unassisted coiling, 5.6% (4/71) of patients with stent‐assisted coiling, and 7.4% (2/27) of patients with balloon‐assisted coiling. Procedural device‐related serious adverse events within 24 hours occurred in 5.2% of patients—5.1% (11/216) of patients with a small aneurysm, 7.1% (1/14) of patients with a large aneurysm, 6.1% (9/148) of patients with an unruptured aneurysm, 3.7% (3/82) of patients with a ruptured aneurysm, 3.6% (4/111) of patients with unassisted coiling, 5.6% (5/90) of patients with stent‐assisted coiling, and 11.8% (4/34) of patients with balloon‐assisted coiling. No deaths occurred within 24 hours of the procedure. At 1 year, 91.8% (167/182) of patients had a Raymond–Roy Occlusion Classification of Class I or II. From immediately after the procedure to 1 year, progressive occlusion was observed in 29.1% (53/182) of patients, and stable occlusion was observed in 56.6% (103/182) of patients. At 1 year, the all‐cause mortality rate was 4.3%, and at a 1‐year follow‐up, a modified Rankin Scale score of 0 to 2 was present in 86.2% (112/130) of patients. Conclusions : Coiling of ACoA aneurysm was safe and had durable 1‐year results.

scholarly journals Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures

2021 ◽  
Author(s):  
Douglas M. Sidle ◽  
Pablo Stolovitzky ◽  
Ellen M. O'Malley ◽  
Randall A. Ow ◽  
Nathan E. Nachlas ◽  
...  
Keyword(s):  
Adverse Events ◽  
Nasal Obstruction ◽  
Large Population ◽  
Inferior Turbinate ◽  
Nasal Valve ◽  
Serious Adverse Events ◽  
Vas Scores ◽  
Nasal Implant ◽  
Nasal Valve Collapse

AbstractThe aim of the study is to report outcomes after treatment of nasal valve collapse with a bioabsorbable nasal implant. It involves two prospective, multicenter, post-market studies evaluating long-term effectiveness of the LATERA implant for severe to extreme nasal obstruction. Participants underwent implant alone or with concomitant inferior turbinate reduction (ITR) and/or septoplasty. Outcome measures included the change from baseline Nasal Obstruction Symptom Evaluation (NOSE) scores, NOSE responder rates, visual analog scale (VAS) scores, and adverse events. A total cohort of 277 participants (109 implants only, 67 implants + ITR, 101 implants + septoplasty + ITR) enrolled at 19 U.S. centers was available for analysis with 177 participants (69 implants only, 39 implants + ITR, 69 implants + septoplasty + ITR) available at 2 years. The mean changes from baseline in NOSE scores and VAS scores were statistically significant (p < 0.001) at all follow-up periods. The baseline NOSE score of 77.8 ± 13.6 was improved to 24.2 ± 23.6 at 24 months. Greater than 90% of participants were NOSE responders across all follow-up periods, 6.1% withdrew for lack of treatment effect. The baseline VAS score of 66.7 ± 18.8 was improved to 21.1 ± 23.9 at 24 months. There were no serious adverse events related to the device or implant procedure. Implant retrieval rate was 4.0% (22/543 implants). Nonserious adverse events were mild to moderate in severity, typically occurred within 6 months of implant, and resolved or were stable. Significant reductions in NOSE and VAS scores and high responder rates from our large population of patients with nasal obstruction who had nasal valve implants confirm sustained effectiveness at 24 months after treatment. The studies are registered on www.clinicaltrials.gov (NCT02952313 and NCT02964312).

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

scholarly journals Efficacy and safety of combined endoscopic cyanoacrylate injection and balloon-occluded retrograde transvenous occlusion (BRTOcc) of gastrorenal shunts in patients with bleeding gastric fundal varices

2020 ◽  
Author(s):  
Fateh Bazerbachi ◽  
Akira Dobashi ◽  
Swarup Kumar ◽  
Sanjay Misra ◽  
Navtej S Buttar ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastric Varices ◽  
High Rate ◽  
Efficacy And Safety ◽  
Cyanoacrylate Glue ◽  
Serious Adverse Events ◽  
Gastroesophageal Varices ◽  
Life Threatening ◽  
Glue Embolization

Abstract Background Endoscopic cyanoacrylate (glue) injection of fundal varices may result in life-threatening embolic adverse events through spontaneous gastrorenal shunts (GRSs). Balloon-occluded retrograde transvenous occlusion (BRTOcc) of GRSs during cyanoacrylate injection may prevent serious systemic glue embolization through the shunt. This study aimed to evaluate the efficacy and safety of a combined endoscopic–interventional radiologic (BRTOcc) approach for the treatment of bleeding fundal varices. Methods We retrospectively analysed the data of patients who underwent the combined procedure for acutely bleeding fundal varices between January 2010 and April 2018. Data were extracted for patient demographics, clinical and endoscopic findings, technical details, and adverse events of the endoscopic–BRTOcc approach and patient outcomes. Results We identified 30 patients (13 [43.3%] women; median age 58 [range, 25–92] years) with gastroesophageal varices type 2 (53.3%, 16/30) and isolated gastric varices type 1 (46.7%, 14/30) per Sarin classification, and median clinical and endoscopic follow-up of 151 (range, 4–2,513) days and 98 (range, 3–2,373) days, respectively. The median volume of octyl-cyanoacrylate: Lipiodol injected was 7 (range, 4–22) mL. Procedure-related adverse events occurred in three (10.0%) patients, including transient fever, non-life-threatening pulmonary glue embolism, and an injection-site ulcer bleed. Complete gastric variceal obturation was achieved in 18 of 21 patients (85.7%) at endoscopic follow-up. Delayed variceal rebleeding was confirmed in one patient (3.3%) and suspected in two patients (6.7%). Although no procedure-related deaths occurred, the overall mortality rate was 46.7%, primarily from liver-disease progression and co-morbidities. Conclusion The combined endoscopic–BRTOcc procedure is a relatively safe and effective technique for bleeding fundal varices, with a high rate of variceal obturation and a low rate of serious adverse events.

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Predictors of Recurrence, Progression, and Retreatment in Basilar Tip Aneurysms: A Location-Controlled Analysis

2018 ◽  
Vol 16 (4) ◽  
pp. 435-444 ◽  
Author(s):  
Isaac Josh Abecassis ◽  
Rajeev D Sen ◽  
Jason Barber ◽  
Rakshith Shetty ◽  
Cory M Kelly ◽  
...  
Keyword(s):  
Risk Factors ◽  
Primary Outcome ◽  
Hazard Ratio ◽  
Anterior Communicating Artery ◽  
Multivariate Modeling ◽  
Ruptured Aneurysms ◽  
Endovascular Interventions ◽  
Kaplan Meier ◽  
Event Rates

Abstract BACKGROUND Endovascular treatment of intracranial aneurysms is associated with higher rates of recurrence and retreatment, though contemporary rates and risk factors for basilar tip aneurysms (BTAs) are less well-described. OBJECTIVE To characterize progression, retreatement, and retreated progression of BTAs treated with microsurgical or endovascular interventions. METHODS We retrospectively reviewed records for 141 consecutive BTA patients. We included 158 anterior communicating artery (ACoA) and 118 middle cerebral artery (MCA) aneurysms as controls. Univariate and multivariate analyses were used to calculate rates of progression (recurrence of previously obliterated aneurysms and progression of known residual aneurysm dome or neck), retreatment, and retreated progression. Kaplan–Meier analysis was used to characterize 24-mo event rates for primary outcome prediction. RESULTS Of 141 BTA patients, 62.4% were ruptured and 37.6% were unruptured. Average radiographical follow-up was 33 mo. Among ruptured aneurysms treated with clipping, there were 2 rehemorrhages due to recurrence (6.1%), and none in any other cohorts. Overall rates of progression (28.9%), retreatment (28.9%), and retreated progression (24.7%) were not significantly different between surgical and endovascular subgroups, though ruptured aneurysms had higher event rates. Multivariate modeling confirmed rupture status (P = .003, hazard ratio = 0.14) and aneurysm dome width (P = .005, hazard ratio = 1.23) as independent predictors of progression requiring retreatment. In a separate multivariate analysis with ACoA and MCA aneurysms, basilar tip location was an independent predictor of progression, retreatment, and retreated progression. CONCLUSION BTAs have higher rates of progression and retreated progression than other aneurysm locations, independent of treatment modality. Rupture status and dome width are risk factors for progression requiring retreatment.

Efficacy, Safety and Tolerability Of Valsartan Plus HCTZ in Patients With Essential Hypertension: A Multicentre Observational Study in Bangladesh

1970 ◽  
Vol 3 (1) ◽  
pp. 37-44
Author(s):  
MN Islam
Keyword(s):  
Adverse Event ◽  
Essential Hypertension ◽  
Adverse Events ◽  
Global Assessment ◽  
Paired Comparison ◽  
Additional Treatment ◽  
Serious Adverse Events ◽  
Published Evidence ◽  
Bangladeshi Population

Background: Valsartan is an established drug for treatment of essential hypertension. It blocks the action of Angiotensin II irrespective of its sources. A large proportion of patients need additional treatment with two or more drugs of different pharmacological classes for achieving target blood pressure. Published evidence demonstrated synergistic effect of Thiazides with ARB. Coadministration of valsartan and Hydrochlorothiazide has the potential to reverse the untoward effect of each other. Current study aimed at evaluating the efficacy, safety and tolerability of Valsartan plus Hydrochlorothiazide combination, and thus validating the regimen in the treatment of essential hypertension in Bangladeshi population, a population significantly different from Caucasian population where most studies were done. Methods: Current study is a prospective interventional study involving 404 Adult, patients, with Stage I (SBP 140-159 mmHg/DBP 90-99 mmHg) or Stage II (SBP≥160 mmHg/DBP ≥100 mmHg) essential hypertension or patients uncontrolled on current mono-therapy or other combination therapy. Valsartan plus HCTZ 80/12.5 mg once daily tablet were prescribed to continue till the following visit or for the remainder of the study. In case of inadequate control increment in dose was made on the following visit. Patients were assessed at baseline, at 4th weeks, 12th week and 24th week. One of the major outcome parameter set for the study was the percentage of participant having BP controlled that is a SBP <140 mmHg and DBP <90 mmHg or a reduction >10 mmHg for DBP and/ or >20 mmHg SBP versus baseline values at 24 weeks. At final follow-up, in addition to repetition of the baseline measurements and examinations, data on Safety of the drug was collected by enquiring and recording all adverse events or serious adverse events. Global assessment of efficacy and tolerability of treatment was also done by both the physicians and patients on a 4-point scale. Result: The percentage of participant having BP controlled at the end of the trial was 91%. Besides, Significant reduction in mean SBP and mean DBP was also evident (P<.001) through paired comparison from baseline to end of the study. Average reduction of 32.4 ± 19.5 mmHg was seen in systolic BP and 17.4 ± 9.3 mmHg in diastolic BP. Global assessment based on both physician and patients reported greater satisfaction with the efficacy of treatment modality. Total adverse event reported by only six (1.5%) participants. Of the six cases three of the adverse effect was reported at 3rd visit and another three were reported at 4th visit. Total five dropouts (1.24%) were reported of which 1 in 3rd visit and 4 in 4th visit. Among the dropout patient three were withdrawn from the study and two didn’t attend the final follow-up. Global assessment of safety and tolerability based on both physician and patient’s opinion reveals greater satisfaction level with the safety and tolerability of combination treatment. Conclusion: The combination of valsartan and hydrochlorothiazide is an effective treatment for patients with essential hypertension. The combination is also effective in patients not responding to monotherapy with either agent. The drug is found to be well tolerated with minimal adverse event during the course of treatment. Key words: Valsartan; Hydrochlorothiazide; Hypertension. DOI: 10.3329/cardio.v3i1.6425Cardiovasc. j. 2010; 3(1): 37-44

scholarly journals Navigating the Quagmire: Comparison and Interpretation of COVID-19 Vaccine Phase 1/2 Clinical Trials

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 746
Author(s):  
Luca Tudor Giurgea ◽  
Matthew James Memoli
Keyword(s):  
Adverse Events ◽  
Protective Efficacy ◽  
Phase 1 ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Safety Studies ◽  
Antibody Titers ◽  
Public Health Strategies

Vaccines against Coronavirus Disease 2019 Originated-19) have been developed with unprecedented rapidity, many utilizing novel strategies. As of November 2020, a series of publications have outlined the results of phase 1/2 studies of nine different vaccines planned to move forward to phase 3 trials. The results are encouraging, demonstrating a paucity of severe or serious adverse events and robust induction of antibody titers. Determination of the vaccine candidates with the highest protective efficacy and best adverse event profiles will be essential in refining public health strategies. However, differences in study design and reporting of data make comparisons of existing phase 1/2 studies difficult. With respect to safety, studies have variable follow-up times and may use different definitions for adverse events. Immunogenicity outcomes are even more inconsistent, with variations in timepoints and critical differences in the types of antibodies studied as well as methodological differences in assays. Furthermore, the correlates of protection in COVID-19 are not known. Harmonization of phase 3 trial designs and use of objective and meaningful clinical outcomes will be crucial in streamlining future global responses to the pandemic.

A Nationwide Investigation of a Possible Protamine Drug-Product Defect

1992 ◽  
Vol 26 (5) ◽  
pp. 643-644 ◽  
Author(s):  
Carlos R. Herrera ◽  
Thaddeus H. Grasela ◽  
Cynthia A. Walawander
Keyword(s):  
Coronary Artery ◽  
Adverse Events ◽  
Coronary Artery Bypass ◽  
Response Rate ◽  
Artery Bypass ◽  
Drug Surveillance ◽  
Surveillance Network ◽  
Serious Adverse Events ◽  
Telephone Interviews

OBJECTIVE: To follow-up a report submitted to FDA Spontaneous Reporting System, we investigated the hypothesis that there was not a striking increase in unexpected deaths within four hours after elective coronary artery bypass surgery associated with protamine sulfate use. DESIGN: Surveys were mailed to clinical pharmacists at 521 hospitals participating in the Drug Surveillance Network. Questionnaires were to be completed with the assistance of cardiac surgeons and anesthesiologists. Hospitals responding with a suspected problem with protamine were contacted via telephone. RESULTS: Surveys were received from clinical pharmacists at 380 hospitals (73 percent response rate) and 29 hospitals reported the occurrence of potential problems associated with protamine during coronary artery bypass graft surgery. Telephone interviews of the positive responders yielded six cases of possible myocardial decomposition potentially associated with protamine. There was no association with a specific distributor, however, and none of the hospitals reported a dramatic increase in serious adverse events around the time of index cases. CONCLUSIONS: There was no evidence of a widespread public health problem with protamine and a product recall was not necessary. The high response rate and the ability to follow-up with telephone interviews suggests that the Drug Surveillance Network is an effective mechanism for investigating possible outbreaks of serious adverse events in the hospital setting.

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