DOCSLIB.ORG

Safety and Efficacy of Tamsulosin, Alfuzosin Or Silodosin As

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Safety and Efficacy of Tamsulosin, Alfuzosin Or Silodosin As 148 Central European Journal of Urology O R I G I N A L P A P E R FUNCTIONAL UROLOGY Safety and efficacy of tamsulosin, alfuzosin or silodosin as monotherapy for LUTS in BPH – a double-blind randomized trial Chikka Moga Siddaiah Manohar, Mahadevappa Nagabhushana, Vilvapathy Senguttuvan Karthikeyan, Ramachandra Pudakalkatti Sanjay, Ananth Janardhan Kamath, Ramaiah Keshavamurthy Insititute of Nephro Urology, Bangalore, India Citation: Manohar CS, Nagabhushana M, Karthikeyan VS, et al. Safety and efficacy of tamsulosin, alfuzosin or silodosin as monotherapy for LUTS in BPH – a double blind randomized trial. Cent European J Urol. 2017; 70: 148-153. Article history Introduction Currently alpha1-adrenoceptor blockers (AB) are widely used as first-line therapy to improve Submitted: Oct. 11, 2016 lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). We compared the Accepted: Feb. 5, 2017 efficacy and safety profile of tamsulosin, alfuzosin and silodosin in LUTS due to BPH. Published online: June 7, 2017 Material and methods Consecutive consenting male patients (N = 269) undergoing medical management of BPH with AB from February 2012 to October 2015 were enrolled. Patients were randomized to a 0.4 mg tamsulosin (group T), 10 mg alfuzosin (group A) or a 8 mg silodosin (group S) by double-blind randomiza- tion. All patients were assessed for improvements and post-void residual urine (PVR) and for adverse drug events (ADE). Results IPSS showed significant improvement in Group S at the first week (11.7 ±4.18, p = 0.027) and at 3 months (7.97 ±3.84, p = 0.020). QOL showed significant improvement at 1 (2.2 ±0.76, p = 0.020), 4 (1.47 ±0.63, p <0.001) and 12 (1.2 ±0.66, p <0.001) weeks in Group S. The mean Qmax improvement Corresponding author was the maximum (13.76 ±2.44, p = 0.028) in Group S at 1 week. Reduction in PVR was the maximum Vilvapathy Senguttuvan in Group S, but it was not statistically significant. Adverse drug events (ADE) were observed in 20.07% Karthikeyan (54/269) patients and distribution was similar in the three groups with decreasing incidence with progres- Insititute of Nephro Urology sion of time. Victoria Hospital Campus 560002 Bangalore, India Conclusions Silodosin is the most efficacious AB with rapid onset of action. Silodosin also improves the phone: +91 903 640 24 12 quality of life in patients with LUTS due to BPH and objectively improves maximum flow rate. However, [email protected] silodosin has more adverse events when compared to tamsulosin and alfuzosin. Key Words: benign prostatic hyperplasia ‹› alpha 1-adrenoceptor blocker ‹› tamsulosin ‹› alfuzosin ‹› silodosin INTRODUCTION Autopsy studies in Asian and Caucasian men showed an overall prevalence of BPH in 74.8% of men. Al- Benign prostatic hyperplasia (BPH) results in lower pha 1-adrenoceptor blockers (AB) are currently the urinary tract symptoms (LUTS) and is common in recommended first-line therapies for benign pros- 50% of men past the age of 60 years. BPH causes tatic hyperplasia (BPH) [2]. They have high effica- resistance to urinary flow due to the increase in cy, are less expensive and have fewer adverse events prostate capsule tone in prostates <30 cc [1]. LUTS (ADE) in the treatment of LUTS [1, 3, 4]. They act is caused by increased prostatic smooth muscle con- principally by blocking α1A-adrenoreceptors, which traction due to the sympathetic hyperactivity of al- is most prevalent in the prostatic smooth muscle pha 1-adrenoceptors. LUTS are bothersome and in- and produce relaxation in the smooth muscle terfere with quality of life (QoL) of aging males [2]. component of the prostate [4]. Multiple drugs are Cent European J Urol. 2017; 70: 148-153 doi: 10.5173/ceju.2017.924 149 Central European Journal of Urology available and each drug has its own advantages Study population and disadvantages. Tamsulosin is the most wide- ly used AB, alfuzosin is used in sexually active All consecutive consenting male patients with BPH males and silodosin is a newer agent with greater aged more than 50 years, LUTS with mild to moder- α-1A receptor selectivity. We compared the safety ate International Prostate Symptom Score (IPSS), and efficacy of the three drugs namely tamsulosin, Maximum flow rate (Qmax) <15 ml/sec on uroflow- alfuzosin and silodosin. metry (UFR), prostate size measuring 25–50 cm3 and post void residue (PVR) <100 ml on trans ab- MATERIAL AND METHODS dominal ultrasound (US) were eligible for the study after obtaining a written informed consent. The ex- This was a hospital-based, double-blind, random- clusion criteria were the following: use of AB within ized trial, performed in 269 patients undergoing 2 weeks/ 5-alpha reductase inhibitors (5ARI) within medical management of BPH in the Department 6 months or phytotherapy, active urinary tract in- of Urology, in a tertiary care institute, in South In- fection (UTI), bladder outlet obstruction due to any dia. After obtaining approval from the Institute Re- other cause like urethral stricture, bladder neck search Council and Ethics committee, the study was stenosis or diagnosed to have vesical calculus, ure- conducted from February 2012 to October 2015. thral or bladder diverticulum, neurogenic bladder, Figure 1. Flow of study participants through the study. 150 Central European Journal of Urology prostatic or bladder cancer, significant orthostatic ables were summarized using mean, standard er- hypotension (OH), post-prostatectomy and renal ror, median, interquartile range, and percentages impairment (serum creatinine >2 mg/dl). based on the characteristics of the variable. One- way ANOVA and the Kruskal-Wallis test were used Randomization, allocation concealment as appropriate for the analysis of continuous vari- and blinding ables based on the normality of the distribution. Chi-Square test was used for categorical variables. Patients were randomized to receive oral tamsu- The P value of <0.05 was considered statistically losin 0.4 mg or alfuzosin 10 mg or silodosin 8 mg significant. by block randomization (block size of 10) performed using Microsoft Excel 2010. Allocation concealment RESULTS was performed using opaque sealed envelopes. Randomization and sealed envelopes were done For the purpose of tabulation and analysis, the by a person independent of the investigators. En- groups were denoted as: Group T receiving 0.4 mg velopes were opened in the outpatient department of oral tamsulosin, group A receiving 10 mg of al- by a nursing staff not involved in the research. The fuzosin and Group S receiving 8 mg of silodosin. drug was placed in a sealed envelope with the code. The baseline patient characteristics like age, dura- The patient and the investigators who assessed the tion of symptoms, prostate weight, Qmax, and PVR outcomes were also blinded. Hence, the study was were comparable (Table 1). double-blind. At the end of the study, the groups were decoded and analyzed (Figure 1). IPSS and QoL Intervention The mean IPSS scores at baseline were compara- ble between the three groups (Table 1; p = 0.337). A standard protocol was used for all our patients. At follow-up at first week (11.7 ±4.18, p = 0.027 Patients were evaluated with detailed history re- and at 3 months (7.97 ± 3.84, p = 0.020) the maxi- garding LUTS. Clinical and digital rectal examina- mum improvement was observed in Group S and tion was done. LUTS was assessed using the IPSS this was statistically significant. At end of the questionnaire (English and native language Kanna- first month, the maximum improvement was seen da) including QoL. UFR, ultrasound of the kidney, in Group S; however, it did not reach statistical sig- ureters, bladder (KUB) and prostate, with PVR, nificance (9.43 ±3.89, p = 0.077). The mean QoL serum prostate specific antigen (PSA), blood urea, serum creatinine, blood pressure (BP) in supine and standing position and electrocardiogram were Table 1. Baseline characteristics done in all patients at the beginning of the study. Group T Group A Group S Parameter P value Follow-up was done at 1,4 and 12 weeks with LUTS N = 89 N = 87 N = 93 assessment using IPSS, QoL, Qmax using UFR and Age, years 58.47 56.90 59.10 0.451 US for PVR and side effects of each drug and BP Mean ±SD ±6.16 ±10.26 ±8.79 in supine and standing positions. Eight patients IPSS 16.27 16.23 14.27 0.337 each in groups T and A and five patients in group S Mean ±SD ±6.07 ±6.48 ±5.33 opted out due to side effects. Mild: Moderate IPSS, N 18:71 14:73 21:72 0.544 QoL 2.40 2.37 2.47 0.465 Study endpoints Mean ±SD ±0.86 ±0.89 ±0.82 Prostate weight, cc 33.82 37.76 35.18 0.342 The primary endpoints were improvement in IPSS Mean ±SD ±11.38 ±12.10 ±11.20 LUTS scores, QoL, Qmax and PVR from baseline Voided volume, cc 162.36 165.67 159.78 0.654 at 1,4 and 12 weeks. The secondary endpoints were Mean ±SD ±45.46 ±39.51 ±43.41 ADE to the drugs. Qmax, ml/sec 11.75 12.69 12.13 0.381 Mean ±SD ±2.64 ±2.58 ±2.62 PVR, cc 44.74 41.88 53.61 Statistical analysis 0.218 Mean ±SD ±27.14 ±19.33 ±29.00 Serum creatinine, mg/dl 1.45 1.56 1.39 Statistical analysis was performed using SPSS ver- 0.260 sion 19 for Windows (IBM Corporation, Armonk, Mean ±SD ±0.89 ±0.24 ±0.78 PSA ng/ml 2.8 3.1 2.7 New York). The normality of the data was initially 0.129 assessed using a Box and Whisker plot.
Load more

Recommended publications
  • Appendix A: Potentially Inappropriate Prescriptions (Pips) for Older People (Modified from ‘STOPP/START 2’ O’Mahony Et Al 2014)
    Appendix A: Potentially Inappropriate Prescriptions (PIPs) for older people (modified from ‘STOPP/START 2’ O’Mahony et al 2014) Consider holding (or deprescribing - consult with patient): 1. Any drug prescribed without an evidence-based clinical indication 2. Any drug prescribed beyond the recommended duration, where well-defined 3. Any duplicate drug class (optimise monotherapy) Avoid hazardous combinations e.g.: 1. The Triple Whammy: NSAID + ACE/ARB + diuretic in all ≥ 65 year olds (NHS Scotland 2015) 2. Sick Day Rules drugs: Metformin or ACEi/ARB or a diuretic or NSAID in ≥ 65 year olds presenting with dehydration and/or acute kidney injury (AKI) (NHS Scotland 2015) 3. Anticholinergic Burden (ACB): Any additional medicine with anticholinergic properties when already on an Anticholinergic/antimuscarinic (listed overleaf) in > 65 year olds (risk of falls, increased anticholinergic toxicity: confusion, agitation, acute glaucoma, urinary retention, constipation). The following are known to contribute to the ACB: Amantadine Antidepressants, tricyclic: Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Nortriptyline, Trimipramine and SSRIs: Fluoxetine, Paroxetine Antihistamines, first generation (sedating): Clemastine, Chlorphenamine, Cyproheptadine, Diphenhydramine/-hydrinate, Hydroxyzine, Promethazine; also Cetirizine, Loratidine Antipsychotics: especially Clozapine, Fluphenazine, Haloperidol, Olanzepine, and phenothiazines e.g. Prochlorperazine, Trifluoperazine Baclofen Carbamazepine Disopyramide Loperamide Oxcarbazepine Pethidine
    [Show full text]
  • Study Protocol and Statistical Analysis Plan
    Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 RANDOMIZED CONTROLLED PILOT STUDY USING PROPRANOLOL TO DECREASE GENE EXPRESSION OF STRESS-MEDIATED BETA- ADRENERGIC PATHWAYS IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS Version 3.0 Principal Investigator: Jennifer M. Knight, MD Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226 Telephone: 414-955-8908 Fax: 414-955-6285 Email: [email protected] Co-Investigator: J. Douglas Rizzo, MD, MS CIBMTR Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-0700 Fax: 414-805-0714 Email: [email protected] Co-Investigator: Parameswaran Hari, MD, MS Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-4600 Fax: 414-805-4606 Email: [email protected] Consultant Steve W. Cole, PhD and Statistician: UCLA-David Geffen School of Medicine 10833 LeConte Ave 11-934 Factor Bldg Los Angeles, CA 90095-1678 Telephone: 310-267-4243 Email: [email protected] 1 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 Sponsor: Medical College of Wisconsin Funding Sponsor: This project has an offer of sponsorship from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. 2 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 PROTOCOL SYNOPSIS Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients Principal Investigator: Jennifer M. Knight, MD Study Design: This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma.
    [Show full text]
  • Avoid the Stop and Go of BPH Start and Stay on RAPAFLO® for BPH Symptom Relief
    Avoid the Stop and Go of BPH Start and Stay on RAPAFLO® for BPH Symptom Relief Using RAPAFLO® RAPAFLO® is available only by prescription and is approved to treat male urinary symptoms due to BPH, also called an enlarged prostate. RAPAFLO® should not be used to treat high blood pressure. Important Safety Information Who should not take RAPAFLO® (silodosin) capsules? Do not take RAPAFLO® if you: • have certain kidney problems. • have certain liver problems. Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information in pocket. Have BPH symptoms? What they may mean Enlarged prostate— uncomfortable but not uncommon Your doctor has diagnosed you with having BPH, benign prostatic hyperplasia, also known as an enlarged prostate. As men age, having BPH is not unusual. In fact, BPH is the most common prostate problem for men over 50. It affects about 50% of men aged 51-60 and up to 90% of men over 80. The prostate is about But it can grow to the size of a walnut the size of a baseball. in younger men. BLADDER The prostate is located below the bladder and surrounds the urethra, the tube that carries urine from the bladder. BPH symptoms occur when the “smooth” muscle of the prostate squeezes the urethra. This, in turn, can affect your bladder URETHRA control. Unfortunately, there is little you can do PROSTATE to avoid BPH. 2 Is BPH linked to prostate cancer? No. While many men share this belief, BPH is not linked to prostate cancer, and men with BPH are not more likely to get prostate cancer.
    [Show full text]
  • Medication Dental Watch List Risk for Reflux Risk for Caries
    Risk for Stomatitis Risk for Xerostomia Generic and Trade Name Medication Dental Watch List Risk for Reflux Risk for Caries Abilify Celexa Exenatide Itraconazole Naproxen Sinequan Acamprosate Cetirizine Famotidine Ketorolac Neurontin Sporanox Accutane Chantix Feldene Kytril Nexium Strattera Actiq Chlorpromazine Felodipine Lamivudine Nifedipine Subutex Adalat Cholestryramine Fentanyl Lansoprazole Nitro-Bid Sulfamethoxazole Advair Cialis Fentanyl (transmucosal) Levalbuterol Nitro-Dur Sulfasalazine Aldomet Citalopram Flexeril Levbid Nitroglycerin Sulfatrim Alendronate Clarithromycin Flonase Levocarnitine Nitrostat Sumatriptan Alfuzosin Claritin Flovent Levocetirizine Nortriptyline Tacrine Aliskiren Clomipramine Fluoxetine Levodopa Oxybutynin Tadalafil Alprazolam Clonidine Fluticasone Lexapro Pamelor Tegretol Amitriptyline Clozapine Fluvoxamine Lioresal Pentasa Tekturna Anafranil Clozaril Fosamax Lisdexamfetamine Pepcid Tenex Antivert Cognex Fosinopril Lisinopril Periactin Thorazine Aripiprazole Combivir Gabapentin Lithium Piroxicam Tofranil Asacol Copegus Gemfibrozil Locholest Plaquenil Toprol Aspirin Cozaar Granisetron Loperamide Plendil Toradol Atarax Cyclobenzaprine Guanfacine Lopid Prevacid Trexall Atomoxetine Cymbalta Haldol Lopressor Prevalite UroXatral Atrovent Cyproheptadine Haloperidol Loratadine Prinivil Varenicline Azulfidine Cytotec Hydroxychloroquine Losartan ProAmatine Vasotec Baclofen Darifenacin Hydroxyzine Luvox Procardia Versed Biaxin Diflunisal Hyoscyamine Meclizine Propranolol Vistaril Budesonide Ditropan Ibuprofen Mesalamine
    [Show full text]
  • 2021 Step Therapy Criteria
    SelectHealth Advantage 2021 Step Therapy Criteria Step Therapy Group Drug Name Criteria ACNE ADAPAL/BEN P Previous trial on at least ONE: AZELEX Generic topical acne treatment TRETINOIN ACTONEL RISEDRON SOD Previous trial on: RISEDRONATE alendronate ADAPALENE ADAPALENE Previous use of non-micronized tretinoin TAZAROTENE ANTICONVULSANT APTIOM Previous trial on at least TWO of the following: SPRITAM carbamezapine, divalproex, epitol, ethosuximide, felbamate, lamotrigine, XCOPRI levetiracetam, oxcarbazepine, phenytoin, tiagabine, topiramate, valproic acid, zonisamide ANTIDEPRESSION APLENZIN Previous trial on at least TWO of the following: EMSAM bupropion, citalopram, escitalopram, fluoxetine, fluvoxamine, maprotiline, FETZIMA mirtazapine, paroxetine, sertraline, venlafaxine, desvenlafaxine PEXEVA TRINTELLIX VIIBRYD ANTIPSYCHOTIC ARISTADA Previous trial on at least ONE of the following: ASENAPINE aripiprazole, clozapine, fluoxetine-olanzapine, haloperidol, olanzapine, FANAPT quetiapine, risperidone, ziprasidone LATUDA PALIPERIDONE SECUADO VRAYLAR BELSOMRA BELSOMRA Previous trial on at least ONE of the following: zaleplon, zolpidem, eszopiclone BUDESONIDE BUDESONIDE TAB Previous trial of ONE of the following: Mesalamine, Pentasa CADUET AMLOD/ATORVA Previous trial on at least ONE of the following: atorvastatin, lovastatin, pravastatin, simvastatin AND Previous trial on: amlodipine Updated 8/25/2021 1 SelectHealth Advantage 2021 Step Therapy Criteria Step Therapy Group Drug Name Criteria CAPEX CAPEX Previous trial on: clobetasol shampoo OR ciclopirox
    [Show full text]
  • Department of Health
    DEPARTMENT OF HEALTH National Drug Policy - Pharmaceutical Management Unit 50 National Formulary Committee Philippine National Drug Formulary EssentialEssential MedicinesMedicines ListList Volume I, 7th Edition ( 2008 ) Published by: The National Formulary Committee National Drug Policy ‐ Pharmaceutical Management Unit 50 DEPARTMENT OF HEALTH Manila, Philippines All rights reserved 2008 The National Formulary Committee National Drug Policy‐Pharmaceutical Management Unit 50 (NDP‐PMU 50) Department of Health San Lazaro Cmpd., Rizal Ave., Sta. Cruz, Manila, Philippines 1003 ISBN 978‐971‐91620‐7‐0 Any part or the whole book may be reproduced or transmitted without any alteration, in any form or by any means, with permission from DOH provided it is not sold commercially. ii PHILIPPINE NATIONAL DRUG FORMULARY Volume I, 7th Edition 2 0 0 8 Francisco T. Duque III, MD, MSc Secretary of Health Alexander A. Padilla Undersecretary of Health, Office for External Affairs Robert Louie P. So, MD Program Manager, NDP-PMU 50 Dennis S. Quiambao, MD Proj. Mgmt. Operating Officer & Coordinator (PMOOC) NDP-PMU 50 NATIONAL FORMULARY COMMITTEE Estrella B. Paje-Villar, MD, DTM & H Chairperson Jose M. Acuin, MD, MSc Alma L. Jimenez, MD Alejandro C. Baroque II, MD Marieta B. de Luna, MD Bu C. Castro, MD Nelia P. Cortes-Maramba, MD Dina V. Diaz, MD Yolanda R. Robles, PhD Pharm Mario R. Festin, MD, MS, MHPEd Isidro C. Sia, MD BFAD Representative SECRETARIAT Luzviminda O. Marquez, RPh, RMT Mary Love C. Victoria, RPh Michael D. Junsay, RPh Ermalyn M. Magturo iii Republic of the Philippines DEPARTMENT OF HEALTH OFFICE OF THE SECRETARY 2/F Bldg. 1, San Lazaro Cmpd., Rizal Avenue, Sta.
    [Show full text]
  • Silodyx, INN-Silodosin
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Silodyx 4 mg hard capsules Silodyx 8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silodyx 4 mg hard capsules Each hard capsule contains 4 mg silodosin. Silodyx 8 mg hard capsules Each hard capsule contains 8 mg silodosin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Silodyx 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm). Silodyx 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. 4.2 Posology and method of administration Posology The recommended dose is one capsule of Silodyx 8 mg daily. For special patient populations, one capsule of Silodyx 4 mg daily is recommended (see below). Elderly No dose adjustment is required in the elderly (see section 5.2). Renal impairment No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min). A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR ≥ 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient’s response. The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2). Hepatic impairment No dose adjustment is required for patients with mild to moderate hepatic impairment.
    [Show full text]
  • New Zealand Data Sheet 1. Product Name
    NEW ZEALAND DATA SHEET 1. PRODUCT NAME Norvir 100 mg tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg ritonavir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White film-coated oval tablets debossed with the corporate Abbott "A" logo and the Abbott-Code “NK”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications NORVIR is indicated for use in combination with appropriate antiretroviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of HIV-1 infection in adults and children aged 12 years and older. For persons with advanced HIV disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and AIDS defining clinical events for patients who received ritonavir. Median duration of follow-up in this study was 6 months. The clinical benefit from ritonavir for longer periods of treatment is unknown. For persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks duration (see section 5.1 Pharmacodynamic properties). 4.2 Dose and method of administration General Dosing Guidelines Prescribers should consult the full product information and clinical study information of protease inhibitors if they are co-administered with a reduced dose of ritonavir. The recommended dose of NORVIR is 600 mg (six tablets) twice daily by mouth, and should be given with food. NORVIR tablets should be swallowed whole and not chewed, broken or crushed. NORVIR DS 29 April 2020 Page 1 of 37 Version 35 Paediatric population Ritonavir has not been studied in patients below the age of 12 years; hence the safety and efficacy of ritonavir in children below the age of 12 have not been established.
    [Show full text]
  • Treatment Options for Motor and Non-Motor Symptoms of Parkinson’S Disease
    biomolecules Review Treatment Options for Motor and Non-Motor Symptoms of Parkinson’s Disease Frank C. Church Department of Pathology and Laboratory Medicine, The University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] Abstract: Parkinson’s disease (PD) usually presents in older adults and typically has both motor and non-motor dysfunctions. PD is a progressive neurodegenerative disorder resulting from dopamin- ergic neuronal cell loss in the mid-brain substantia nigra pars compacta region. Outlined here is an integrative medicine and health strategy that highlights five treatment options for people with Parkinson’s (PwP): rehabilitate, therapy, restorative, maintenance, and surgery. Rehabilitating begins following the diagnosis and throughout any additional treatment processes, especially vis-à-vis consulting with physical, occupational, and/or speech pathology therapist(s). Therapy uses daily administration of either the dopamine precursor levodopa (with carbidopa) or a dopamine ago- nist, compounds that preserve residual dopamine, and other specific motor/non-motor-related compounds. Restorative uses strenuous aerobic exercise programs that can be neuroprotective. Maintenance uses complementary and alternative medicine substances that potentially support and protect the brain microenvironment. Finally, surgery, including deep brain stimulation, is pursued when PwP fail to respond positively to other treatment options. There is currently no cure for PD. In conclusion, the best strategy for treating PD is to hope to slow disorder progression and strive to achieve stability with neuroprotection. The ultimate goal of any management program is to improve the quality-of-life for a person with Parkinson’s disease.
    [Show full text]
  • Guideline for Preoperative Medication Management
    Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented.
    [Show full text]
  • First Dose Efficacy of Alfuzosin Once Daily in Men with Symptomatic Benign Prostatic Hyperplasia
    ADULT UROLOGY FIRST DOSE EFFICACY OF ALFUZOSIN ONCE DAILY IN MEN WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA LEONARD S. MARKS, CLAUS G. ROEHRBORN, MARC GITTELMAN, DANIEL KIM, JOHN FORREST, AND SHARON JACOBS ABSTRACT Objectives. To evaluate the onset of action of alfuzosin once daily (OD) as determined by uroflowmetry early after initial dosing. Alfuzosin OD is an extended-release formulation of a uroselective, alpha1-adrenorecep- tor-blocking agent (alpha-blocker) used in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Methods. This was a randomized, placebo-controlled, two-way Latin square crossover study. Forty-nine patients were selected for this study on the basis of their symptomatic improvement during previous treatment with alpha-blockers and significant decreases in urinary flow rate when that treatment was withdrawn. Results. Our analysis showed that significant increases in the maximal urinary flow rate (Qmax) in 34 assessable patients occurred as soon as 8 hours after the initial dose of medication and persisted for at least 4 days. The ⌬Qmax for alfuzosin 10 mg OD was 3.2 mL/s and for placebo it was 1.1 mL/s. The difference of means for the assessable population was 2.1 (95% confidence interval 0.8 to 3.4, P ϭ 0.002). The overall incidence of adverse events was low. Only dizziness, experienced by 3 patients treated with alfuzosin compared with 1 patient treated with placebo, appeared to be related to the study drug. Conclusions. Together, our findings suggest that alfuzosin OD exhibits a urodynamically measurable effect on bladder outlet obstruction due to benign prostatic hyperplasia in men with lower urinary tract symptoms within hours of the first administration.
    [Show full text]
  • Comparison of Different Alpha-Blocker Combinations in Male Hypertensives with Refractory Lower Urinary Tract Symptoms
    대한남성과학회지：제 29 권 제 3 호 2011년 12월 Korean J Androl. Vol. 29, No. 3, December 2011 http://dx.doi.org/10.5534/kja.2011.29.3.242 Comparison of Different Alpha-blocker Combinations in Male Hypertensives with Refractory Lower Urinary Tract Symptoms Keon Cheol Lee1, Jong Gu Kim2, Sung Yong Cho1, Joon Sung Jeon1, In Rae Cho1 Department of Urology, 1Inje University Ilsanpaik Hospital, Goyang, 2Happy Urology Clinic, Ansan, Korea =Abstract= Purpose: We compared the efficacy and safety profiles of dose increase, traditional combination methods, and combining different alpha blockers in hypertensive males with lower urinary tract symptom (LUTS) refractory to an initial dose of 4 mg doxazosin. Materials and Methods: Between 2000 and 2005, 374 male patients with LUTS and hypertension unresponsive to 4 weeks of 4 mg doxazosin were enrolled. The subjects were randomly classified into 3 groups, 8 mg/day of doxazosin (D group), 4 mg of doxazosin plus 0.2 mg/day of tamsulosin (DT group), and 4 mg doxazosin plus 5 mg/day finasteride (DF group). Patients were evaluated based on their International Prostate Symptom Score (IPSS), quality of life (QOL), uroflowmetry and blood pressure (BP) and adverse events (AEs) at the baseline and 3 and 12 months after treatment. Results: The 269 patients (71.9%) were followed for at least 1 year (D group n=84, DT group n=115, and DF group n=70). The clinical parameters before and after initial 4 mg/day doxazosin were not different among the 3 groups. IPSS improvement after 3 months and maximal flow rate (Qmax) improvement after 3 and 12 months were significantly higher in the D and DT groups than the DF group (p＜0.05).
    [Show full text]