scholarly journals Current and Emerging Pharmacotherapeutic Options for Smoking Cessation

2013 ◽  
Vol 7 ◽  
pp. SART.S8108 ◽  
Author(s):  
Kristin V. Carson ◽  
Malcolm P. Brinn ◽  
Thomas A. Robertson ◽  
Rachada To-A-Nan ◽  
Adrian J. Esterman ◽  
...  
Keyword(s):  
Developing Countries ◽  
Smoking Cessation ◽  
Clinical Practice ◽  
Chronic Disease ◽  
Developed Countries ◽  
Mental Illnesses ◽  
Current Clinical Practice ◽  
Efficacy And Safety ◽  
First Line ◽  
Marginalized Groups

Tobacco smoking remains the single most preventable cause of morbidity and mortality in developed countries and poses a significant threat across developing countries where tobacco use prevalence is increasing. Nicotine dependence is a chronic disease often requiring multiple attempts to quit; repeated interventions with pharmacotherapeutic aids have become more popular as part of cessation therapies. First-line medications of known efficacy in the general population include varenicline tartrate, bupropion hydrochloride, nicotine replacement therapy products, or a combination thereof. However, less is known about the use of these products in marginalized groups such as the indigenous, those with mental illnesses, youth, and pregnant or breastfeeding women. Despite the efficacy and safety of these first line pharmacotherapies, many smokers continue to relapse and alternative pharmacotherapies and cessation options are required. Thus, the aim of this review is to summarize the existing and developing pharmacotherapeutic and other options for smoking cessation, to identify gaps in current clinical practice, and to provide recommendations for future evaluations and research.

Generic imatinib therapy among Jordanians: An observational assessment of safety and efficacy in routine clinical practice.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18548-e18548
Author(s):  
Abdallah Awidi ◽  
Salah Y. Abbasi ◽  
Kamal Hosni Al-Rabi ◽  
Khalid Kheirallah
Keyword(s):  
Clinical Practice ◽  
Middle Eastern ◽  
Primary Objective ◽  
Routine Clinical Practice ◽  
Imatinib Therapy ◽  
Efficacy And Safety ◽  
Observational Assessment ◽  
First Line ◽  
Optimal Response ◽  
Prospective Study Design

e18548 Background: Generic imatinib therapy is being globally considered due to cost considerations. Evidence about its efficacy and safety in developing country settings, however, is scarce. Methods: The efficacy and safety of generic imatinib among Jordanian patients diagnosed with chronic myeloid leukemia (CML) was assessed utilizing an observational, multicenter, prospective study design. All patients (N = 91) were adults with CML treated with generic imatinib, mainly 400 mg/day, who either received generic imatinib (n = 33) as first-line therapy “first-line patients “or switched from patented imatinib to generic imatinib “switched patients” (n = 58). The primary objective was to measure proportions (95% Confidence Interval (CI)) of optimal response for first-line and switched patients at 12 months of treatment with generic imatinib, as defined in the 2009 ELN guidelines (CCyR [no Ph+ metaphases], or MMR [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale]) and assessed by complete blood counts, fluorescence in situ hybridization and real-time quantitative PCR. Results: A total of 84.8% (n = 28/33) of the first-line patients achieved complete hematologic response (CHR) within 3 months of starting generic imatinib therapy (100% after 6 months). Out of the 23 evaluable first-line patients, [(87%, 95% CI = 73% - 100%), (n = 20)] in the per-protocol population (60.6 %, 95% CI = 51% - 86%) of the 33 patients in the intention-to-treat (ITT) population) achieved an optimal response at 12 months. All 58 switched patients had CHR at enrollment. Out of the 55 evaluable switched patients, [(96.4%, 95% CI = 91%-100%), (n = 53)] in the PP population (91.4%, 95% CI = 83%-98%) of the 58 patients in the ITT population) gained or maintained an optimal response at 12 months after switching to generic imatinib therapy. Most (84.7%, n = 144 out of 170) adverse events (AEs) were mild. Frequencies of drug-related AEs were similar to patented imatinib. Conclusions: Efficacy and safety of generic imatinib among middle eastern population in routine clinical practice is comparable to that of patented imatinib, and to that of the global population. Clinical trial information: NCT02977312.

scholarly journals Varenicline for Smoking Cessation: a Review

2016 ◽  
Vol 12 (3) ◽  
pp. 215-220
Author(s):  
G P Rauniar ◽  
A Mishra ◽  
D P Sarraf
Keyword(s):  
Smoking Cessation ◽  
Tobacco Use ◽  
Nicotinic Acetylcholine Receptors ◽  
Acetylcholine Receptors ◽  
Smoking Prevalence ◽  
Meta Analysis ◽  
Developed Countries ◽  
First Line ◽  
The World ◽  
Quitting Smoking

Tobacco use is the leading cause of preventable death and disability in the world. Although gradually declining in most developed countries, the prevalence of tobacco use has increased among developing countries. Nicotine is an addictive chemical that is inhaled from the tobacco present in the cigarettes. It acts on neuronal nicotinic acetylcholine receptors within the ventral tegmental area of the brain, causing dopamine release in the nucleus accumbens which reinforces nicotine-seeking behavior. Reward through the dopaminergic system is a common thread among many drugs of addiction. According to the National Anti-Tobacco Communication Campaign Strategy for Nepal smoking prevalence in Nepal is higher (38.4%) than the smoking prevalence in the world (29%). Smoking attributable annual deaths in Nepal is estimated at nearly 14,000 (9,000 male deaths and 5,000 female deaths) for population aged 35 and over. First-line pharmacotherapies for smoking cessation are varenicline, sustained-release bupropion and various forms of nicotine replacement therapy (i.e., patch, gum, lozenge, inhaler, nasal spray). These drugs can be used as monotherapy or combination therapy for the treatment of smoking cessation. After studying the outcome of many clinical trials and meta-analysis, it is concluded that cigarette smokers taking varenicline have the most success quitting smoking as compared with those taking other first-line pharmacotherapies for treating smoking cessation.  Health Renaissance 2014;12(3): 215-220

scholarly journals Efficacy and safety of TDF/FTC-containing, first-line HAART in clinical practice: 3-year data from the German outpatient cohort

2010 ◽  
Vol 13 ◽  
pp. P12-P12
Author(s):  
J van Lunzen ◽  
G Fätkenheuer ◽  
T Lutz ◽  
S Klauke ◽  
S Mauss ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Efficacy And Safety ◽  
First Line

scholarly journals First Line Treatment with Hydroxyurea in Patients with Policitemia Vera: Evaluation of Efficacy in the Current Clinical Practice Beyond ELN Criteria

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 43-44
Author(s):  
Roberto Latagliata ◽  
Massimo Breccia ◽  
Ambra Di Veroli ◽  
Giulia Benevolo ◽  
Elena M Elli ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Board Of Directors ◽  
Research Funding ◽  
Current Clinical Practice ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Definition Of ◽  
Wbc Count ◽  
First Line Treatment

Introduction Hydroxyurea (HU) is worldwide used in the current clinical practice as first line treatment in high risk patients with Polycythemia Vera (PV). However, its efficacy has been seldom evaluated in the real-life setting. Aims The present study aims to address the role of Complete Peripheral Recovery (CPR) as useful response criteria in PV patients treated with HU in a large cohort of unselected patients. Methods After IRB approval, data of 846 PV patients, revised according to WHO2008/2016 and followed in 21 European Hematology Centers, were retrospectively collected. Definition of CPR during HU treatment included all the following criteria: hematocrit (Ht) level ≤45% (≤3 phlebotomies per year allowed), white blood cells (WBC) count ≤10 x109/l, platelets (PLT) count ≤ 400 x109/l. Spleen size and symptoms were not considered in the definition of CPR. Event-free survival (EFS), considering as event evolution into blast phase (BP) or myelofibrosis (MF) and death from any cause, was calculated from HU start to last contact/event by Cox analysis with age≥70y. Overall survival (OS) was calculated from the start of HU to last contact/death (log-rank p). Results Among the 846 patients of the entire cohort, 724 (85.5%) were treated with HU after a median time from PV diagnosis of 2.6 months [interquartile range (IQR) 0.5 - 19.6]: the main clinical features of these 724 patients at diagnosis are reported in the Table 1. Starting doses of HU, available in 709 patients, were <500 mg/day in 42 (5.9%), 500 mg/day in 371 (52.3%), 750 mg/day in 39 (5.5%), 1000 mg/day in 219 (30.9%) and >1000 mg/day in 38 (5.4%). Twenty-five patients were not evaluable for response to HU. Among the remaining 699 patients, 426 (60.9%) achieved a CPR after a median time from HU start of 4.9 months (IQR 2.1 - 15.7) while 273 (39.1%) never achieved a CPR. Among the 426 patients who achieved CPR, 115 (26.9%) needed a treatment period >12 months before obtaining the CPR. The main baseline clinical features of patients achieving or not CPR are reported in the Table 1: female sex, older age at diagnosis and at HU start, lower WBC count, no phlebotomies need and no palpable spleen were all associated in univariate analysis with CPR achievement. During HU treatment, a thrombotic episode occurred in 36 patients achieving CPR (8.4%) compared to 16 patients without CPR (5.8%) (p=0.162). Among 426 patients achieving CPR, 20 (4.6%) evolved in MF and 10 (2.3%) evolved in BP: among 273 patients without CPR, 20 (7.3%) evolved in MF and 9 (3.3%) evolved in BF (p=0.134 and 0.451, respectively). Ten-year EFS was 79.2% [95%Confidence Interval (CI) 72.1 - 84.8] in patients achieving CPR compared to 67.3% (95%CI 56.9 - 75.7) in patients without CPR (p=0.001) (Fig. 1). Ten-year OS was 80.5% (95%CI 73.9 - 87.1) in patients achieving CPR compared to 74.4% (95%CI 65.6 - 83.2) in patients without CPR (p=0.116). Conclusions In the current clinical practice, HU is effective in inducing CPR in about two thirds of patients with PV treated front-line. CPR is more frequently achieved by patients with lower disease burden, including lower WBC count, and less frequent PHL need and palpable spleen. Notably, >25% of responding patients achieved CPR after >12 months from HU start, suggesting the need for a long period of HU therapy before efficacy evaluation. The clinical importance of CPR is highlighted by a significantly longer EFS in patients achieving this type of response. Disclosures Breccia: Abbvie: Consultancy; Bristol-Myers Squibb/Celgene: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Benevolo:Amgen: Honoraria; Celgene: Honoraria; Novartis: Honoraria. Cavazzini:Pfize: Honoraria; Incyte: Honoraria; Novartis: Honoraria. Heidel:Novartis: Consultancy, Honoraria, Research Funding. Crugnola:Novartis: Honoraria; Celgene: Honoraria; Janssen: Honoraria; BMS: Honoraria. Pane:AbbVie: Consultancy, Other: Travel Expenses, Speakers Bureau; Amgen: Consultancy, Other: Travel Expenses, Speakers Bureau; Daiichi Sankyo: Consultancy, Other: Travel Expenses; Jazz Pharmaceuticals: Consultancy, Other: travel expenses, Speakers Bureau; Novartis pharma SAS: Consultancy, Other: Travel Expenses, Research Funding, Speakers Bureau; Janssen: Other: Travel Expenses; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Cuneo:Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Astra Zeneca: Honoraria; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Krampera:Janssen: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Semenzato:Abbvie: Honoraria; Roche: Honoraria; Takeda: Honoraria. Cavo:Jannsen, BMS, Celgene, Sanofi, GlaxoSmithKline, Takeda, Amgen, Oncopeptides, AbbVie, Karyopharm, Adaptive: Consultancy, Honoraria. Palumbo:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Palandri:Novartis: Consultancy, Honoraria.

scholarly journals Efficacy and safety of TDF/FTC-containing first-line HAART in clinical practice – 2-year data from the German Outpatient Cohort

2008 ◽  
Vol 11 (Suppl 1) ◽  
pp. P12
Author(s):  
J van Lunzen ◽  
G Fätkenheuer ◽  
T Lutz ◽  
S Klauke ◽  
S Mauss ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Efficacy And Safety ◽  
First Line

scholarly journals Eltrombopag in immune thrombocytopenia: efficacy review and update on drug safety

2018 ◽  
Vol 9 (6) ◽  
pp. 263-285 ◽  
Author(s):  
Jose Ramon Gonzalez-Porras ◽  
Jose Maria Bastida
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Immune Thrombocytopenia ◽  
Autoimmune Disorder ◽  
Efficacy And Safety ◽  
First Line ◽  
Platelet Production ◽  
Thrombopoietin Receptor ◽  
Current Guidelines

Immune thrombocytopenia (ITP) is an autoimmune disorder that induces a decrease in the number of circulating platelets due to spleen destruction and inability of megakaryocytes to restore normal counts. Immunosuppressive therapy with glucocorticoid drugs constitutes the first line of treatment. However, lack of response to these agents is not uncommon, and the management of refractory patients is a matter of controversy. In fact, day-to-day clinical practice shows that, in spite of the current guidelines, splenectomy, which is currently considered a suitable second-choice therapy, is being replaced by treatment with thrombopoietin receptor agonists. These boost platelet production by megakaryocytes. The use of one of these, namely eltrombopag, has been permitted for ITP patients refractory to first-line drugs or splenectomy, for the last 10 years. This review summarizes the experience reported using eltrombopag in ITP, paying attention to efficacy and safety. Results from clinical trials will be discussed, and studies performed in the course of daily clinical practice will also be reviewed, as these are useful to assess the potential of the drug in real-world settings. The management of adverse events and the use of eltrombopag in particular situations will also be covered. The experience reported so far permits us to suggest that eltrombopag efficiently induces recovery of platelet counts. Furthermore, recent papers have demonstrated that a sustained response after discontinuation, initially thought to be problematic, may be possible in a nonnegligible number of cases. The safety profile is satisfactory, although patients presenting with thromboembolism risk factors should be treated with caution until the eltrombopag-associated prothrombotic risk is fully established. In summary, although larger studies are still needed to clarify some issues, eltrombopag may be a useful alternative tool for ITP patients refractory to conventional medical management or splenectomy.

scholarly journals Efficacy and safety of palbociclib and ribociclib in patients with estrogen and/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0253722
Author(s):  
Sushmita Rath ◽  
Prahalad Elamarthi ◽  
Pallavi Parab ◽  
Seema Gulia ◽  
Ravindra Nandhana ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Progesterone Receptor ◽  
Metastatic Breast ◽  
Routine Clinical Practice ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Cox Regression Analysis ◽  
Line Setting

Background There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. Methods This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. Results The study included 101 female patients with median age of 57 (IQR 48–62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5–41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5–43.7) months, median PFS and OS were 5.98 (95%CI 4.96–7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3–4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25–0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20–0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008–0.206, p = 0.000) with OS. Conclusion Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.

scholarly journals SERUM CORTISOLAS A PROGNOSTIC FACTOR OF EARLY STROKE

2020 ◽  
pp. 1-7
Author(s):  
R. Murugaraj ◽  
V. Padma ◽  
Rameez Raja
Keyword(s):  
Risk Factors ◽  
Developing Countries ◽  
Clinical Practice ◽  
Brain Infarction ◽  
Developed Countries ◽  
Neurological Injury ◽  
Cortisol Response ◽  
Hemorrhage Risk ◽  
Dexamethasone Suppression ◽  
Early Stroke

Stroke is a common neurological disorder in clinical practice causing death in the developing countries as well as developed countries. Stroke is defined as an acute neurological injury occurring due to vascular pathological processes which manifest either as brain infarction or hemorrhage. Risk factors can never explain the timing and activity of the occurrence of stroke. But we can prevent the onset of stroke by reducing the risk factors. A stress response occurs after stroke which causes increased levels of cortisol and catecholamines1 .This has been known since the 1950s. There is also a dysregulation of the hypothalamo-pituitary-adrenal (HPA) system which is shown by a failure of the dexamethasone suppression of cortisol levels in stroke. This cortisol response to stroke has been identified in both cerebral infarction as well as in intracerebral hemorrhage2 of any cause.

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