Burden of Asthma and Role of 2.5 µg Tiotropium Respimat® as an Add-On Therapy: A Systematic Review of Phase 2/3 Trials.

Abstract:

INTRODUCTION:Tiotropium, a long-acting muscarinic antagonist, is approved for maintenance treatment of asthma in patients at least 6 years of age in the USA. We systematically reviewed published evidence on the efficacy and safety of 2.5 µg tiotropium Respimat® add-on therapy to inhaled corticosteroid (ICS) with or without additional controller medication(s) in children, adolescents, and adults with asthma. METHODS:We searched PubMed from inception until October 3, 2018, for phase 2 and 3 randomized controlled trials (RCTs) evaluating the effects of 2.5 µg tiotropium Respimat® on lung function parameters in patients with asthma. We extracted adjusted mean differences for lung function data and adverse events (AEs) from relevant articles. RESULTS:Overall, 11 RCTs (three phase 2 and eight phase 3 studies) including 3244 patients (2.5 µg tiotropium Respimat®, n = 1642; placebo, n = 1602) met the predefined inclusion criteria. Once-daily 2.5 µg tiotropium Respimat® improved lung function parameters, including peak and trough forced expiratory volume in 1 s and peak and trough forced vital capacity, versus placebo. Overall, the safety profile of 2.5 µg tiotropium Respimat® was comparable to that of placebo, with the most commonly reported AEs being asthma worsening, reduction in peak expiratory rate, nasopharyngitis, and respiratory tract infections. CONCLUSION:On the basis of the results of phase 2 and 3 studies, 2.5 µg tiotropium Respimat® as add-on to ICS therapy was safe and associated with consistent improvements in lung function in patients with asthma of varying severities across different age groups. FUNDING:Development of the manuscript was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI).

journal_name

Adv Ther

journal_title

Advances in therapy

authors

Mansfield L,Duong-Quy S,Craig T

doi

10.1007/s12325-019-01062-w

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

2587-2599

issue

10

eissn

0741-238X

issn

1865-8652

pii

10.1007/s12325-019-01062-w

journal_volume

36

pub_type

杂志文章
  • Treatment of nonresectable hepatocellular carcinoma: review of the literature and meta-analysis.

    abstract::Many doubts surround the numerous forms of nonsurgical treatment of nonresectable hepatocellular carcinoma (HCC). Our study aimed to reach reliable conclusions on the actual efficacy of these treatments. We examined 85 studies involving a total of 6746 patients: 6113 were treated; the remaining 633 were not. We applie...

    journal_title:Advances in therapy

    pub_type: 杂志文章,meta分析

    doi:

    authors: Malaguarnera M,Trovato G,Restuccia S,Giugno I,Franzé CM,Receputo G,Siciliano R,Motta M,Trovato BA

    更新日期:1994-11-01 00:00:00

  • Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): A Multicenter Post-marketing Surveillance Study.

    abstract:INTRODUCTION:Phase IV post-marketing surveillance studies are needed to evaluate the real-world safety and effectiveness of drug products. This study aimed to evaluate the safety and effectiveness of biosimilar etanercept (Altebrel, AryoGen Co., Iran) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01611-8

    authors: Gharibdoost F,Salari AH,Salesi M,Ebrahimi Chaharom F,Mottaghi P,Hosseini M,Sahebari M,Nazarinia M,Mirfeizi Z,Shakibi M,Moussavi H,Karimifar M,Mowla K,Karimzadeh H,Anjidani N,Jamshidi A

    更新日期:2021-01-11 00:00:00

  • Mifepristone treatment of olanzapine-induced weight gain in healthy men.

    abstract:INTRODUCTION:Antipsychotic medications are associated with significant weight gain, type 2 diabetes mellitus, dyslipidemia, and increased cardiovascular risk. Suggested mechanisms of weight gain from antipsychotic medication include antagonism of histamine and serotonin receptors, and effects on the hypothalamic-pituit...

    journal_title:Advances in therapy

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/s12325-009-0070-1

    authors: Gross C,Blasey CM,Roe RL,Allen K,Block TS,Belanoff JK

    更新日期:2009-10-01 00:00:00

  • Metabolic Effects of Aripiprazole and Olanzapine Multiple-Dose Treatment in a Randomised Crossover Clinical Trial in Healthy Volunteers: Association with Pharmacogenetics.

    abstract:INTRODUCTION:Aripiprazole and olanzapine are atypical antipsychotics. Both drugs can induce metabolic changes; however, the metabolic side effects produced by aripiprazole are more benign. The aim of the study was to evaluate if aripiprazole and olanzapine alter prolactin levels, lipid and glucose metabolism and hepati...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01566-w

    authors: Koller D,Almenara S,Mejía G,Saiz-Rodríguez M,Zubiaur P,Román M,Ochoa D,Navares-Gómez M,Santos-Molina E,Pintos-Sánchez E,Abad-Santos F

    更新日期:2020-12-05 00:00:00

  • Outcomes and costs of patients with persistent asthma treated with beclomethasone dipropionate hydrofluoroalkane or fluticasone propionate.

    abstract:OBJECTIVE:Examine outcomes and costs of patients with persistent asthma who initiated treatment with beclomethasone dipropionate hydrofluoroalkane (BDP-HFA) or fluticasone propionate (FP). METHODS:MedStat's Commercial Claims and Encounters database (July 1, 2002-June 30, 2007) was utilized. Patients (n=13,968) were in...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-009-0056-z

    authors: Lage MJ,Gross GN,Brewster C,Spalitto A

    更新日期:2009-08-01 00:00:00

  • Cost-effectiveness of the 21-gene breast cancer assay in Mexico.

    abstract:INTRODUCTION:The 21-gene breast cancer assay (Oncotype DX(®); Genomic Health, Inc.) is a validated diagnostic test that predicts the likelihood of adjuvant chemotherapy benefit and 10-year risk of distant recurrence in patients with hormone-receptor-positive, human epidermal growth receptor 2-negative, early-stage brea...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-015-0190-8

    authors: Bargalló-Rocha JE,Lara-Medina F,Pérez-Sánchez V,Vázquez-Romo R,Villarreal-Garza C,Martínez-Said H,Shaw-Dulin RJ,Mohar-Betancourt A,Hunt B,Plun-Favreau J,Valentine WJ

    更新日期:2015-03-01 00:00:00

  • Susceptibility to various oral antiseptics of Porphyromonas gingivalis W83 within a biofilm.

    abstract::The origin of chronic periodontal disease is strongly related to the nature and physiology of the subgingival bacterial biofilm, of which Porphyromonas gingivalis is a main protagonist. This study was conducted in vitro, to test the susceptibility of the W83 strain of P gingivalis to several oral antiseptics, bearing ...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/BF02877764

    authors: Bercy P,Lasserre J

    更新日期:2007-11-01 00:00:00

  • Evaluation of a new formulation of epoprostenol sodium in Japanese patients with pulmonary arterial hypertension (EPITOME4).

    abstract:INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of ep...

    journal_title:Advances in therapy

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s12325-013-0029-0

    authors: Tamura Y,Ono T,Fukuda K,Satoh T,Sasayama S

    更新日期:2013-05-01 00:00:00

  • Attitudes of physiotherapists and physiotherapy students toward euthanasia: a comparative study.

    abstract::This interventional study was undertaken to assess the impact of physiotherapy education on the knowledge and attitudes of physiotherapists (PTs) and physiotherapy students (PSs) toward euthanasia. The study, which was conducted during the period between 2004 and 2005, included a total of 494 participants (311 PTs; 18...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/BF02850001

    authors: Cavlak U,Aslan UB,Gurso S,Yagci N,Yeldan I

    更新日期:2007-01-01 00:00:00

  • Identification of Patient Needs and Preferences in Pigmented Villonodular Synovitis (PVNS) Using a Qualitative Online Bulletin Board Study.

    abstract:INTRODUCTION:Pigmented villonodular synovitis (PVNS), also known as giant-cell tumour of the tendon sheath (GCTT), is a rare, benign proliferative tumour affecting the inner lining of synovial joints and tendon sheets. Information on treatment needs of PVNS patients to inform drug development is currently scarce. We co...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01364-4

    authors: Cook NS,Landskroner K,Shah B,Walda S,Weiss O,Pallapotu V

    更新日期:2020-06-01 00:00:00

  • A Longitudinal Study of the Association of Opioid Use with Change in Pain Interference and Functional Limitations in a Nationally Representative Cohort of Adults with Osteoarthritis in the United States.

    abstract:INTRODUCTION:Real-world data are sparse on longitudinal associations of opioid use with pain interference with activities (PIA) and daily function with osteoarthritis (OA) in the USA. METHODS:Data from the 2010-2015 Medical Expenditure Panel Surveys were analyzed for community-dwelling adults with OA. Opioid use patte...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-019-01200-4

    authors: Shah D,Zhao X,Wei W,Gandhi K,Dwibedi N,Webster L,Sambamoorthi U

    更新日期:2020-02-01 00:00:00

  • Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia.

    abstract::Permixon, the lipidosterolic extract of Serenoa repens, is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years. One hundred fifty-five men with clinically diagnosed B...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1007/BF02853175

    authors: Pytel YA,Vinarov A,Lopatkin N,Sivkov A,Gorilovsky L,Raynaud JP

    更新日期:2002-11-01 00:00:00

  • Pregabalin for alcohol dependence: a critical review of the literature.

    abstract:INTRODUCTION:Alcohol dependence represents a severe pathological disorder associated with a significant rate of morbidity and mortality. To date, limited pharmacological agents exist to treat this disorder, and there is a growing interest for new therapies. In this context, pregabalin represents a promising strategy. P...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-012-0061-5

    authors: Guglielmo R,Martinotti G,Clerici M,Janiri L

    更新日期:2012-11-01 00:00:00

  • The Case for the Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials: A Methodologic Overview.

    abstract:INTRODUCTION:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome meas...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审

    doi:10.1007/s12325-019-00920-x

    authors: Contesse MG,Valentine JE,Wall TE,Leffler MG

    更新日期:2019-05-01 00:00:00

  • Enhancement of Retinal Function and of Neural Conduction Along the Visual Pathway Induced by Treatment with Citicoline Eye Drops in Liposomal Formulation in Open Angle Glaucoma: A Pilot Electrofunctional Study.

    abstract:INTRODUCTION:To evaluate the retinal function and the relative neural conduction along the visual pathway after treatment with citicoline in liposomal formulation (CLF) eye drops in patients with open angle glaucoma (OAG). METHODS:Twelve OAG patients (mean age ± standard deviation 52.58 ± 11.39 years, intraocular pres...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-019-0897-z

    authors: Parisi V,Oddone F,Roberti G,Tanga L,Carnevale C,Ziccardi L,Manni G

    更新日期:2019-04-01 00:00:00

  • Prevalence of diagnosed adult immune thrombocytopenia in the United Kingdom.

    abstract:INTRODUCTION:Data regarding the prevalence of immune thrombocytopenia (ITP) is limited, and is derived from North American population-based analyses. Therefore, the authors conducted the first study outside the United States (US) using the United Kingdom (UK) General Practice Research Database (GPRD) to estimate the ad...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-011-0084-3

    authors: Bennett D,Hodgson ME,Shukla A,Logie JW

    更新日期:2011-12-01 00:00:00

  • Acceptance of Intanza® 9 μg intradermal influenza vaccine in routine clinical practice in Australia and Argentina.

    abstract:INTRODUCTION:Intanza® 9 μg (Sanofi Pasteur SA, Lyon, France), a split virion trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available as a vaccination for adults aged 18 to 59 years old, as of the 2010 southern hemisphere influenza season. METHODS:This study was des...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-011-0042-0

    authors: Eizenberg P,Booy R,Naser N,Mason G,Stamboulian D,Weber F

    更新日期:2011-08-01 00:00:00

  • Hypericum perforatum versus fluoxetine in the treatment of mild to moderate depression.

    abstract::In a randomized, controlled, double-blind trial, 70 patients (mean age, 49.7 years) suffering from mild to moderate depression received one tablet of either St. John's Wort (Hypericum perforatum) extract (Calmigen) or fluoxetine hydrochloride (Prozac) twice a day for 6 weeks. Efficacy was determined according to the 1...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1007/BF02850017

    authors: Behnke K,Jensen GS,Graubaum HJ,Gruenwald J

    更新日期:2002-01-01 00:00:00

  • Angiotensin-Converting Enzyme Inhibition: Beyond Blood Pressure Control-The Role of Zofenopril.

    abstract::The extensive use of angiotensin-converting enzyme inhibitors (ACEIs) as antihypertensive agents and the huge amount of data collected in clinical trials and post-marketing studies has allowed the extending of the indication of ACEIs beyond blood pressure control. Current guidelines recommend ACEIs in symptomatic pati...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审

    doi:10.1007/s12325-020-01455-2

    authors: Borghi C,Omboni S

    更新日期:2020-10-01 00:00:00

  • Caregivers' and Physicians' Perspectives on Alpha-Mannosidosis: A Report from Italy.

    abstract::Alpha-mannosidosis is a rare lysosomal storage disorder that generally presents in early childhood. It is a progressive, highly heterogeneous disease that is difficult to recognize, and a diagnosis is usually reached after referrals to multiple specialists. It is important to understand the challenges faced by patient...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01574-w

    authors: Verrecchia E,Sicignano LL,Massaro MG,Rocco R,Silvestri G,Rossi S,Manna R

    更新日期:2020-11-24 00:00:00

  • The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries.

    abstract:INTRODUCTION:New biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin's lymphoma, and...

    journal_title:Advances in therapy

    pub_type: 杂志文章,多中心研究

    doi:10.1007/s12325-017-0522-y

    authors: Gulácsi L,Brodszky V,Baji P,Rencz F,Péntek M

    更新日期:2017-05-01 00:00:00

  • Effectiveness of Perindopril/Indapamide Single-Pill Combination in Uncontrolled Patients with Hypertension: A Pooled Analysis of the FORTISSIMO, FORSAGE, ACES and PICASSO Observational Studies.

    abstract:INTRODUCTION:Our objective was to determine the effectiveness of a perindopril/indapamide (Per/Ind) single-pill combination (SPC) in a broad range of patient profiles, including subgroups with varying hypertension severity, age and cardiovascular risk profiles. METHODS:Patient data from four large prospective observat...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01527-3

    authors: Dézsi CA,Glezer M,Karpov Y,Brzozowska-Villatte R,Farsang C

    更新日期:2020-11-05 00:00:00

  • Adalimumab Reduces Extraintestinal Manifestations in Patients with Crohn's Disease: A Pooled Analysis of 11 Clinical Studies.

    abstract:INTRODUCTION:Extraintestinal manifestations (EIMs) in patients with Crohn's disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate ...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-018-0678-0

    authors: Louis EJ,Reinisch W,Schwartz DA,Löfberg R,Robinson AM,Berg S,Wang AW,Maa JF,Huang B,Pappalardo B

    更新日期:2018-04-01 00:00:00

  • Sirukumab: A Potential Treatment for Mood Disorders?

    abstract::Convergent evidence indicates that abnormalities in the innate immune system may be pertinent to the pathogenesis, phenomenology, and possible treatment of several mental disorders. In keeping with this view, the targeting of interleukin-6 with the human monoclonal antibody sirukumab may represent a possible treatment...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审

    doi:10.1007/s12325-016-0455-x

    authors: Zhou AJ,Lee Y,Salvadore G,Hsu B,Fonseka TM,Kennedy SH,McIntyre RS

    更新日期:2017-01-01 00:00:00

  • Real-World Impact of Cardiovascular Disease and Anemia on Quality of Life and Productivity in Patients with Non-Dialysis-Dependent Chronic Kidney Disease.

    abstract:INTRODUCTION:Patients with chronic kidney disease (CKD) have an increased risk of comorbid conditions, including cardiovascular disease (CVD). Anemia is prevalent in the CKD population and worsens as kidney function declines, resulting in a diminished quality of life and increased morbidity/mortality. The purpose of th...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-017-0566-z

    authors: Covic A,Jackson J,Hadfield A,Pike J,Siriopol D

    更新日期:2017-07-01 00:00:00

  • Management of Dyslipidemia in Individuals with Low-to-Moderate Cardiovascular Risk: Role of Nutraceuticals.

    abstract::Cardiovascular diseases (CVDs) are the leading cause of premature deaths globally and in Ukraine. Dyslipidemia is a recognized risk factor for the development of CVD. Therefore, early detection and appropriate management of dyslipidemia are essential for the primary prevention of CVDs. However, currently, there is a l...

    journal_title:Advances in therapy

    pub_type: 杂志文章,评审

    doi:10.1007/s12325-020-01490-z

    authors: Dolzhenko MM,Barnett OY,Grassos C,Dragomiretska NV,Goloborodko BI,Ilashchuk TO,Zuiev KO,Karpenko OV,Kolesnikova OV,Kolesnyk TV,Talaieva TV,Vakaliuk IP,Tiabut TD,Mesnikova IL,Zinych OV

    更新日期:2020-11-01 00:00:00

  • Persistence and Adherence to ICS/LABA Drugs in UK Patients with Asthma: A Retrospective New-User Cohort Study.

    abstract:INTRODUCTION:Asthma is associated with significant economic burden. Inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) combination therapies are considered mainstays of treatment. We describe real-world use of ICS/LABAs by comparing treatment persistence and adherence among patients with asthma in the Unit...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-020-01344-8

    authors: Parimi M,Svedsater H,Ann Q,Gokhale M,Gray CM,Hinds D,Nixon M,Boxall N

    更新日期:2020-06-01 00:00:00

  • Effects of nonsteroidal ophthalmic drops on epithelial healing and pain in patients undergoing bilateral photorefractive keratectomy (PRK).

    abstract::The present study, which was designed as a prospective, double-masked, randomized, controlled, single-site study, was conducted to compare the effects of 3 approved ophthalmic nonsteroidal anti-inflammatory drugs-nepafenac ophthalmic suspension 0.1% (Nevanac; Alcon Laboratories, Inc., Fort Worth, Tex), ketorolac trome...

    journal_title:Advances in therapy

    pub_type: 杂志文章,随机对照试验

    doi:10.1007/BF02877774

    authors: Durrie DS,Kennard MG,Boghossian AJ

    更新日期:2007-11-01 00:00:00

  • An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice.

    abstract:INTRODUCTION:In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SA...

    journal_title:Advances in therapy

    pub_type: 杂志文章

    doi:10.1007/s12325-009-0063-0

    authors: Goossens LM,Riemersma RA,Postma DS,van der Molen T,Rutten-van Mölken MP

    更新日期:2009-09-01 00:00:00

  • Efficacy and acceptability of nedocromil sodium 2% and olopatadine hydrochloride 0.1% in perennial allergic conjunctivitis.

    abstract::In this 2-week, randomized, crossover study, ophthalmic solutions of nedocromil sodium 2% and olopatadine hydrochloride 0.1% were compared for effectiveness and acceptability in 28 patients with perennial allergic conjunctivitis and previous olopatadine experience. Patients received nedocromil twice daily or olopatadi...

    journal_title:Advances in therapy

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1007/BF02853155

    authors: Alexander M,Allegro S,Hicks A

    更新日期:2000-05-01 00:00:00