I170 E2V/DNG: contraceptive efficacy and safety data

2009 ◽  
Vol 107 ◽  
pp. S42-S42
Author(s):  
J.T. Jensen ◽  
L. Speroff
Keyword(s):  
Safety Data ◽  
Efficacy And Safety ◽  
Contraceptive Efficacy

scholarly journals Immunotherapy in hepatocellular carcinoma: evaluation and management of adverse events associated with atezolizumab plus bevacizumab

2021 ◽  
Vol 13 ◽  
pp. 175883592110311
Author(s):  
Chiun Hsu ◽  
Lorenza Rimassa ◽  
Hui-Chuan Sun ◽  
Arndt Vogel ◽  
Ahmed O. Kaseb
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Treatment Options ◽  
Healthcare Providers ◽  
Safety Data ◽  
Standard Of Care ◽  
Antiangiogenic Agents ◽  
Efficacy And Safety ◽  
First Line

In light of positive efficacy and safety findings from the IMbrave150 trial of atezolizumab plus bevacizumab, this novel combination has become the preferred first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). Several additional trials are ongoing that combine an immune checkpoint inhibitor with another agent such as a multiple kinase inhibitor or antiangiogenic agent. Therefore, the range of first-line treatment options for unresectable HCC is likely to increase, and healthcare providers need succinct information about the use of such combinations, including their efficacy and key aspects of their safety profiles. Here, we review efficacy and safety data on combination immunotherapies and offer guidance on monitoring and managing adverse events, especially those associated with atezolizumab plus bevacizumab. Because of their underlying liver disease and high likelihood of portal hypertension, patients with unresectable HCC are at particular risk of gastrointestinal bleeding, and this risk may be exacerbated by treatments that include antiangiogenic agents. Healthcare providers also need to be alert to the risks of proteinuria and hypertension, colitis, hepatitis, and reactivation of hepatitis B or C virus infection. They should also be aware of the possibility of rarer but potentially life-threatening adverse events such as pneumonitis and cardiovascular events. Awareness of the risks associated with these therapies and knowledge of adverse event monitoring and management will become increasingly important as the therapeutic range broadens in unresectable HCC.

Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis

2021 ◽  
pp. 112067212110143
Author(s):  
Itay E Gabbay ◽  
Mordechai Goldberg ◽  
Felicity Allen ◽  
Zhiheng Lin ◽  
Christine Morley ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Failure Rate ◽  
Open Angle Glaucoma ◽  
Safety Data ◽  
Angle Closure ◽  
Efficacy And Safety ◽  
Antihypertensive Medications ◽  
Uk National Health Service ◽  
The Uk ◽  
Comparative Audit

Purpose: To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Methods: Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. Results: The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months ( p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively ( p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). Conclusion: XEN45 implantation is effective and safe at 36 months’ follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

World Health Organization recommendations for multidrug-resistant tuberculosis: should different standards be applied?

2017 ◽  
Vol 21 (12) ◽  
pp. 1211-1213 ◽  
Author(s):  
V. Cox ◽  
J. Furin
Keyword(s):  
World Health Organization ◽  
Safety Data ◽  
Evaluation Process ◽  
Multidrug Resistant ◽  
World Health ◽  
Efficacy And Safety ◽  
Assessment Development ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Health Organization

The World Health Organization uses a Grading of Recommendations Assessment, Development, and Evaluation process to make recommendations for treating multidrug-resistant tuberculosis. Even with this standardized approach, there have been discrepancies between recommendations for newer drugs such as bedaquiline and delamanid and the shorter regimen. This may be because newer drugs are novel chemical entities and may merit closer scrutiny. Here, we explore the problematic nature of this supposition, arguing that although the newer drugs have been used in fewer individuals, they may have more robust efficacy and safety data than many of the second-line drugs used in the shorter regimen.

scholarly journals Updated efficacy and safety data of dabrafenib (D) and trametinib (T) in patients (pts) with BRAF V600E–mutated anaplastic thyroid cancer (ATC)

2018 ◽  
Vol 29 ◽  
pp. viii645-viii646 ◽  
Author(s):  
B. Keam ◽  
R.J. Kreitman ◽  
Z.A. Wainberg ◽  
M.E. Cabanillas ◽  
D.C. Cho ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Safety Data ◽  
Anaplastic Thyroid Cancer ◽  
Braf V600e ◽  
Efficacy And Safety

scholarly journals Comparison of efficacy and safety profiles of epidural analgesia and opioid analgesia in Chinese patients with thoracic trauma: A preliminary report

2021 ◽  
Vol 19 (12) ◽  
pp. 2683-2689
Author(s):  
Xiaoping Yang ◽  
Danjie Zhang ◽  
Deling Kong ◽  
Jin Zhang ◽  
Bingwen Dang
Keyword(s):  
Epidural Analgesia ◽  
Thoracic Trauma ◽  
Rating Scale ◽  
Safety Data ◽  
Chinese Patients ◽  
Opioid Analgesia ◽  
Efficacy And Safety ◽  
Chi Square ◽  
Before And After ◽  
The Difference

Purpose: To compare the efficacy and safety profiles of epidural analgesia (EA) and opioid analgesia (OA) in Chinese patients with thoracic trauma (TT). Methods: Patients with confirmed diagnosis of thoracic trauma were given either EA (via a catheter) or slow-release OA. The following efficacy variables were assessed in the two treatment groups: pain score, and changes in cytokine and catecholamine levels from baseline after treatment. Moreover, respiratory parameters were determined before and after treatment. The safety associated with each anesthesia was also evaluated. Quantitative data were analyzed either with Student’s t-test or MannWhitney test, while  categorical data were analyzed using Fisher exact or Chi-square test, based on data size. Results: A total of 200 patients completed the study (100 patients in each group). Pain, as assessed by verbal rating scale (VRS), was slightly lower in patients after treatment with EA, when compared to the patients treated with OA. However, the difference was not statistically significant (p < 0.05). Maximum inspiratory force (cmH2O) and tidal volume (liters) were slightly improved in patients  treated with EA, when compared to OA-treated patients, although the difference was not statistically significant (p < 0.05). Moreover,  the two treatments produced comparable levels of cytokines and catecholamines. Conclusion: The efficacy and safety data for EA and OA in Chinese non-obese patients with TT indicate numerically favorable outcome for EA, when compared to OA. Keywords: Epidural analgesia, Opioid analgesia, Chinese patients, Thoracic trauma

scholarly journals Efficacy and safety of netakimab, a novel anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial

2021 ◽  
Vol 97 (4) ◽  
pp. 80-91
Author(s):  
Luis Puig ◽  
Andrey L. Bakulev ◽  
Muza M. Kokhan ◽  
Alexey V. Samtsov ◽  
Vladislav R. Khairutdinov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Monoclonal Antibody ◽  
Plaque Psoriasis ◽  
Safety Data ◽  
Interleukin 17 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Severe Plaque Psoriasis ◽  
To Receive

Background. Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate to severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 trial. Aim. To evaluate the efficacy and safety of two NTK regimens vs. placebo in moderate to severe plaque psoriasis. Methods. PLANETA is the ongoing randomized double-blind placebo-controlled clinical trial. 213 patients with moderate to severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8, and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8, and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a 75% or greater reduction from baseline in psoriasis area and severity index (PASI 75) at week 12. Results. A total of 77.7%, 83.3%, and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W, and placebo groups, respectively (P 0.0001, Fishers exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity. Conclusion. Treatment with NTK results in high rates of sustained clinical response in patients with moderate to severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming.

Efficacy and safety of intravenous pamidronate for parathyroid hormone-dependent hypercalcemia in hospitalized patients

2021 ◽  
Author(s):  
Rachel Chava Rosenblum ◽  
Orit Twito ◽  
Liat Barzilay-Yoseph ◽  
Erez Ramaty ◽  
Noa Klein ◽  
...  
Keyword(s):  
Parathyroid Hormone ◽  
Serum Calcium ◽  
Medical Center ◽  
Tertiary Care ◽  
Laboratory Data ◽  
Safety Data ◽  
Kidney Injury ◽  
Efficacy And Safety ◽  
Retrospective Case ◽  
Tertiary Care Medical Center

Abstract Context Bisphosphonates are effective for hypercalcemia of malignancy (HOM). Efficacy and safety data for bisphosphonates in parathyroid hormone-related hypercalcemia (PTHRH) are rare, including pamidronate, which is not indicated for this condition. Objective To evaluate the efficacy and safety of pamidronate for moderate-to-severe PTHRH. Design Retrospective case-control study. Setting Tertiary care medical center. Patients Adults hospitalized with serum calcium levels ≥12mg/dL, 29/10/2013–17/12/2019. Interventions Etiology was categorized as PTHRH or PTH-independent. Clinical and laboratory data of PTHRH patients treated with pamidronate (PTHRH-Pam+) were compared to pamidronate-untreated counterparts (PTHRH-Pam-). Results Thirty-four patients with 37 hospitalizations for PTHRH (pamidronate-treated and untreated) met the inclusion criteria. Pamidronate was given in 24/37 cases (64.8%). Admission serum calcium levels for the PTHRH-Pam+ group were higher than for PTHRH-Pam- (14.4mg/dL vs. 13.0mg/dL, p=0.005). Median total pamidronate dose was 60mg (range 30–180mg) in the treated group. Serum calcium decreased 3.5mg/dL for PTHRH-Pam+ vs. 1.6mg/dL for PTHRH-Pam- (p=0.003). No PTHRH-Pam+ patients developed hypocalcemia or acute kidney injury. Nadir serum phosphorus levels were lower in the PTHRH-Pam+ vs. PTHRH-Pam- group (1.7mg/dL vs. 2.4mg/dL, respectively, p=0.005). Three PTHRH-Pam+ patients developed severe hypophosphatemia; all resolved with intravenous and oral supplementation. Seventeen patients underwent parathyroidectomy, of whom 10 received pamidronate within 28 days preoperatively. Post-operatively, 4 developed hypocalcemia and 3 hypophosphatemia. Conclusions This study demonstrates that pamidronate is effective and safe for treating PTHRH, while ensuring close laboratory monitoring of calcium and phosphorus metabolism. Larger, prospective studies are needed to establish the role of pamidronate and other potent bisphosphonates in moderate-to-severe PTHRH.

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