Asthma Symptom Control Using a Combination of Mometasone Furoate/Formoterol (MF/F): Grouped Analysis of Three Clinical Trials

2010 ◽  
Vol 125 (2) ◽  
pp. AB194
Author(s):  
M. White ◽  
H. Nolte ◽  
E. Meltzer ◽  
R. Nathan
2007 ◽  
Vol 41 (9) ◽  
pp. 1397-1410 ◽  
Author(s):  
Leslie Hendeles ◽  
Christine A Sorkness

Objective: To evaluate data on anti-immunoglobulin E (anti-IgE) therapy for asthma. Data Sources: Information was selected from PubMed from 1989 to May 2007 using the search term omalizumab and included randomized, controlled trials. These studies evaluated asthma treatment with omalizumab and focused on its efficacy, tolerability, and cost-effectiveness in this population. Study Selection and Data Extraction: All randomized clinical trials were reviewed (23 were identified and 19 were included; 3 were not relevant and 1 contained duplicative data). Other articles using the search words anti-IgE therapy and cost-effectiveness were evaluated; relevant information was extracted. Data Synthesis: IgE-dependent mechanisms play an important role in the development and maintenance of airway inflammation in asthma. Omalizumab is a subcutaneously administered monoclonal anti-IgE antibody that reduces unbound IgE concentrations and promotes down-regulation of IgE receptors. Results from clinical trials in adults, adolescents, and children with poorly controlled IgE-mediated asthma have shown that omalizumab improves symptom control and allows patients to be managed with lower doses of inhaled corticosteroids (ICS). It has been well tolerated in clinical trials lasting as long as 52 weeks, but injection-site reactions are common (45% in omalizumab group vs 43% in placebo group) and anaphylaxis has occurred in 0.2% of patients. A consensus expert panel has recommended that omalizumab should be considered for patients 12 years of age or older with allergic asthma who are inadequately controlled on guideline-based therapy and require maintenance therapy with systemic corticosteroids or high-dose ICSs, or who have poor adherence to ICS therapy. Conclusions: Anti-IgE therapy provides an effective and generally safe approach to the treatment of patients with IgE-mediated asthma who are not adequately controlled by conventional guideline-based medications. However, the potential benefit must be weighed against the cost and inconvenience of this new therapy.


CNS Spectrums ◽  
2005 ◽  
Vol 10 (S11) ◽  
pp. 1-15 ◽  
Author(s):  
Dan L. Zimbroff ◽  
Michael H. Allen ◽  
John Battaglia ◽  
Leslie Citrome ◽  
Avrim Fishkind ◽  
...  

Acute agitation is a common psychiatric emergency often treated with intramuscular (IM) medication when rapid control is necessary or the patient refuses to take an oral agent. Conventional IM antipsychotics are associated with side effects, particularly movement disorders, that may alarm patients and render them unreceptive to taking these medications again. Ziprasidone (Geodon®) is the first second-generation, or atypical, antipsychotic to become available in an IM formulation. Ziprasidone IM was approved by the Food and Drug Administration in 2002 for the treatment of agitation in patients with schizophrenia. In October 2004, a roundtable panel of physicians with extensive experience in the management of acutely agitated patients met to review the first 2 years of experience with this agent. This monograph, a product of that meeting, discusses clinical experience to date with ziprasidone IM and offers recommendations on its use in various settings.In clinical trials, patients treated with ziprasidone IM demonstrated significant and rapid (within 15-30 minutes) reduction in agitation and improvement in psychotic symptoms, agitation, and hostility to an extent greater than or equal to that attained with haloperidol IM. Tolerability of ziprasidone IM was superior to that of haloperidol IM, with a lower burden of movement disorders. Clinical trials have also shown that ziprasidone IM can be administered with benzodiazepines without adverse consequences. Transition from IM to oral ziprasidone has been well tolerated, with maintenance of symptom control. The most common adverse events associated with ziprasidone IM were insomnia, headache, and dizziness in fixed-dose trials and insomnia and hypertension in flexible-dose trials. No consistent pattern of escalating incidence of adverse events with escalating ziprasidone doses has been observed. Changes in QTc interval associated with ziprasidone at peak serum concentrations are modest and comparable to those seen with haloperidol IM. Results of randomized clinical trials of ziprasidone IM have been corroborated in studies in real-world treatment settings involving patients with extreme agitation or a recent history of alcohol or substance abuse. In these circumstances, clinically significant improvement was seen within 30 minutes of ziprasidone IM administration, without regard to the suspected underlying etiology of agitation. Agents with a good safety/tolerability profile, such as ziprasidone IM, may be more cost effective long term than older agents, due to reduced incidence of acute adverse effects (eg, acute dystonia) that often require extended periods of observation. Additional trials of ziprasidone IM in agitated patients in a variety of clinical settings are warranted to generate comparative risk/benefit data with conventional agents and other second-generation antipsychotics.


2009 ◽  
Vol 124 (4) ◽  
pp. 397-401 ◽  
Author(s):  
M A Khan ◽  
A S Abou-Halawa ◽  
A A Al-Robaee ◽  
A A Alzolibani ◽  
H A Al-Shobaili

AbstractBackground:Many patients with allergic rhinitis are reluctant to use daily intranasal steroids for prolonged periods. A self-adjusted regimen which delivers reasonable control of allergic rhinitis may be more acceptable to such patients.Objectives:To compare the efficacy of daily use of mometasone furoate nasal spray, versus a self-adjusted regimen, in patients with chronic allergic rhinitis, in terms of symptom control and nasal volume change.Setting:Ambulatory visits in an office setting.Patients and methods:Sixty patients with chronic allergic rhinitis were randomised: 30 were prescribed mometasone furoate nasal spray once daily for six weeks, while 30 were prescribed the same spray daily for one week, every alternate day for one week and then on a self-adjusted regimen for four weeks. Patients kept a symptom diary documenting sneezing, rhinorrhoea, nasal blockage and nasal itching. Acoustic rhinometry was used to measure the total nasal cavity volume at the first visit and at the end of the treatment period.Results:The total nasal score on treatment days showed an improvement in both groups, compared with baseline measurements. There was no significant difference in total nasal scores between the two groups, except on days 10 (p = 0.043), 20 (p = 0.008), 23 (p = 0.19), 30 (p = 0.008) and 37 (p = 0.000), when the daily group's total nasal score was significantly lower than the self-adjusted group's total nasal score, and on day 8 (p = 0.004), when the self-adjusted group's total nasal score was significantly lower than the daily group's total nasal score. Total nasal cavity volume significantly increased in both groups (p = 0.0001), with no statistically significant difference between the groups.Conclusions:Self-adjusted dosage of mometasone furoate nasal spray gives reasonable control of allergic rhinitis (albeit with some ‘breakthrough’ symptoms). Patients should learn how to control these symptoms with the least number of steroid doses.


2020 ◽  
Vol 35 (1) ◽  
pp. S26
Author(s):  
Marysol Almestica ◽  
Cassandra Deering-Rice ◽  
Christopher Reilly

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Melissa J Benson ◽  
Sarah V Abelev ◽  
Susan J Connor ◽  
Crispin J Corte ◽  
Lewis J Martin ◽  
...  

Abstract Background Medicinal cannabis (MC) is an increasingly utilized treatment option for various refractory diseases. While robust clinical evidence supporting MC efficacy in inflammatory bowel disease (IBD) is lacking, many IBD patients report using MC to obtain symptomatic relief. Understanding this use and associated outcomes may help inform future clinical trials. Methods A cross-sectional anonymous online survey was conducted involving Australians with IBD. It examined attitudes and experiences with MC in relation to IBD management. The survey included validated sub-questionnaires assessing quality of life, medication adherence, IBD severity, and functional impairment. Results A total of 838 responses were obtained. Results showed 25.3% (n = 212) of respondents were current or previous users of MC (18.1% current, 7.2% previous). Half of the current users also consumed cannabis recreationally although less frequently than for medicinal purposes. Cannabis consumption was via smoking (joints 34.2%; water pipe/bongs 14.5%) or as an oral liquid (19.7%) with products obtained from recreational dealers (44.6%), friends/family (26.1%), or self-grown (9.8%). Only 3 respondents reported using legally accessed products. Clinical ratings of IBD severity did not differ according to cannabis use although users reported more hospitalizations, less engagement with specialist services, and lower medication adherence. IBD symptoms reported as positively affected by cannabis included abdominal pain, stress, sleep, cramping, and anxiety. Most users (92.7%) endorsed cannabis as effective in symptom management. Cannabis-using ulcerative colitis patients reported better quality of life than nonusers on some measures. Conclusion Many patients in Australia are using illicit MC to manage their IBD. Further clinical trials are required to validate, or refute, patient claims around MC efficacy for symptom control in IBD.


2004 ◽  
Vol 25 (5) ◽  
pp. 502-514 ◽  
Author(s):  
Theresa Charrois ◽  
Stephen Newman ◽  
Don Sin ◽  
Ambikaipakan Senthilselvan ◽  
Ross T. Tsuyuki

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2635-2635
Author(s):  
Ricarda Selder ◽  
Masa Pandurevic ◽  
Mandy-Deborah Möller ◽  
Johannes Waldschmidt ◽  
Milena Pantic ◽  
...  

Abstract Introduction: Tumor boards have become a crucial institution in oncology practice to provide paramount interdisciplinary cancer treatment, stream-line patient (pt) entries and to ensure treatment according to clinical pathways (CP). We initiated a weekly MM-TB at our institution in 6/2012. Participating experts are hematologist-oncologists, pathologists/cytogenetic specialists, orthopedists, radiotherapists, immunologists/rheumatologists and, if needed, nephrologists, cardiologists and others. Pt applications to be discussed are centrally organized through our CCCF, with the TB advice being centrally stored within our electronic pt information system. Recommended TB advice is made according to best current literature/knowledge and international CP. The development of mandatory CCCF-CP and transparency of decision making are key quality criteria. Methods: This first analysis focused on a) discussed TB questions, b) given recommendations, c) pt characteristics, d) pts’, referring- and participating-physicians' satisfaction with the TB, e) inclusion of these challenging-to-treat pts in clinical trials (CT) and f) PFS/OS of TB pts as compared to the literature (Kumar SK. Leukemia 2012). Grades of recommendations were assigned using the GRADE criteria (Engelhardt M. Haematologica 2014) and meticulously assessed, as well as whether TB recommendations were pursued. Pts’, referring- and participating-physicians' satisfaction with the TB was evaluated via standardized questionnaires, the aimed sample size being n=100 for consecutive pts and ~n=30 each for participating and referring physicians. Results: From 6/2012-5/2014, 483 pts have been discussed within 90 MM-TB sessions, substantially increasing these from 2011 to 2012, 2013 and 2014 by 12-fold. Of the entire MM cohort seen at our institution, 60% of these challenging-to-treat pts were discussed within the TB in 2012, increasing to 71% in 2013. We have currently assessed 200 TB-protocols for pt characteristics, clinical outcome and adherence to TB decisions. Of those, 2% were presented for explicit diagnosis-finding, 17% had newly diagnosed MM, 41% relapsed/refractory MM and 40% had attained stable disease or better with their last-line therapy and were discussed to resolve their ongoing treatment. Expectedly, most pts (89%) were discussed for their next-line treatment, 43% due to strains with comorbidities, symptom control, side effects, diagnosis finding and MM-staging, and 11% due to various other reasons (multiple entries possible). Mean treatment lines of pts discussed in the TB was 2 (range 0-10), deciding on their 3rd-line-treatment. Within the TB cohort, 70% were presented once, but 30% several times (mean 2, range 2-4). Of these multiple presentations, most pts had relapsed or refractory MM, this rate further increasing towards the 3rd and 4th TB-presentation. The adherence to TB-recommendations was excellent with 93% of decisions being pursued. Reasons for adapted approaches were practicable issues or disagreement of the pt, family or referring physician. Of currently 80/100 interviewed pts, 95% were entirely satisfied with their care, treating oncologists/MM-expert team and very supportively perceived the MM-TB. Of note, 94% considered their cancer care ideally achieved by the TB, 92% that their local physician profited greatly and 88% that their personal preferences were also accounted for. Of 30 interviewed participating physicians, 97% considered themselves well-educated and their time well-spent. Of currently 18 referring physicians, 73% were unconditionally satisfied with all TB-diagnostics and -therapies, with the university centers' cooperation and 65% acknowledged no information loss. Of 288 pts assessed for their CT suitability, 28% were suggested by the TB to be included, with 53% actually being able to enter therein. Thus, 15% of our MM-TB cohort could be included in a CT, which is considerable since these were challenging-to-treat pts who had received extensive prior therapies and showed several comorbidities. This also confirms current CT accrual rates for cancer pts of 5-15%, which can be increased with well-structured TB. Conclusions: Our preliminary results suggest that this MM-TB is a highly relevant exchange platform and allows physicians from different disciplines to intensely and rewardingly collaborate for state-of-the-art cancer care. Disclosures No relevant conflicts of interest to declare.


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