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By I. Brant. University of Natural Medicine. 2019.

Evaluation of eszopiclone (ESZ) in patients with obstructive sleep apnea (OSA) [abstract] buy suprax 200 mg line. Paper presented at: American Thoracic Society discount 200 mg suprax, 2005; 4 San Diego discount suprax 100 mg without a prescription, CA Roehrs T, Soubrane C, Roth T. Zolpidem modified-release objectively and subjectivatly improves sleep maintenance and retains the characteristics of standard zolpidem on sleep initiation and duration in elderly patients with primary 5 insomnia. Paper presented at: 19th Annual Meeting of Associated Professional Sleep Societies, 2005; Denver, Colorado. Zolpidem in the treatment of transient insomnia: a 4 double-blind, randomized comparison with placebo. Phase III outpatient trial of Ramelteon for the treatment of chronic insomnia in elderly patients. Roth T, Seiden S, Weigand S, Zhang J, Rieckhoff H, Sainati S. Phase III study to determine the efficacy of Ramelteon in elderly patients with chronic insomnia. Ramelteon (TAK-375), A Selective MT1/MT2- Receptor Agonist, Reduces Latency to Persistent Sleep in a Model of Transient 4 Insomnia Related to a Novel Sleep Environment. Sleep: Journal of Sleep and Sleep Disorders Research. Ruther E, Clarenbach P, Hajak G, Fischer W, Haase W. Impact on sleep quality and day-time wellbeing in comparison of (AO) flunitrazepam, triazolam and placebo. Ruther E, Clarenbach P, Hajak G, Fischer W, Haase W. Impact on Sleep Quality and Day-time Well-being in Comparison 1 to Flunitrazepam, Triazolam and Placebo. Influence of zopiclone on sleep quality and daytime well-being vs. Placebo-controlled sleep laboratory studies on the acute effects of zolpidem on objective and subjective 2 sleep and awakening quality in nonorganic insomnia related to neurotic and stress- related disorder. Insomnia Page 78 of 86 Final Report Update 2 Drug Effectiveness Review Project Trials Code Saugstad OD, Ramji S, Vento M. Resuscitation of depressed newborn infants with ambient air or pure oxygen: a meta-analysis. Savic MM, Obradovic DI, Ugresic ND, Cook JM, Sarma P, Bokonjic DR. Bidirectional effects of benzodiazepine binding site ligands on active avoidance 2 acquisition and retention: Differential antagonism by flumazenil and beta -CCt. Schadeck B, Chelly M, Amsellem D, Cohen A, Peraudeau P, Scheck F. Comparative efficacy of doxylamine (15 mg) and zolpidem (10 mg) for the 6 treatment of common insomnia. Patient-reported efficacy of eszopiclone (ESZ) in elderly patients with chronic insomnia [abstract]. Paper presented at: American Geriatrics Society AO conference 2004; Las Vegas, NV. Drug-alcohol interactions on psychomotor skills: 6 zopiclone and flunitrazepam. Serfaty M, Kennell-Webb S, Warner J, Blizard R, Raven P. Double blind randodmised placebo controlled trial of low dose melatonin for sleep disorders in 3 dementia. Zolpidem at supratherapeutic doses can cause drug abuse, dependence and withdrawal seizure. Journal of the Association of 4 Physicians of India. Sicard BA, Trocherie S, Moreau J, Vieillefond H, Court LA. Evaluation of zolpidem on alertness and psychomotor abilities among aviation ground personnel and 4 pilots. Sivertsen B, Omvik S, Pallesen S, Nordhus IH, Bjorvatn B. Sleep disorders in elderly patients who take hypnotics on a regular basis. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Zolpidem modified-release improves sleep induction, sleep maintenance, sleep duration, and quality of sleep without next-day 5 residual effects in adults with primary insomnia. Paper presented at: 19th Annual Meeting of Associated Professional Sleep Societies, 2005; Denver, Colorado. Effects of zolpidem modified- release formulation on next-day psychomotor and cognitive performance in a double-blind crossover study in healthy adult volunteers. Paper presented at: 19th 5 Annual Meeting of Associated Professional Sleep Societies, 2005; Denver, Colorado. Differential effects in humans after repeated administrations of zolpidem and triazolam. Suhner A, Schlagenhauf P, Hofer I, Johnson R, Tschopp A, Steffen R. Effectiveness and tolerability of melatonin and zolpidem for the alleviation of jet 4 lag. Double-blind study of new hypnotic zopiclone in comparison with inactive placebo. Insomnia Page 79 of 86 Final Report Update 2 Drug Effectiveness Review Project Trials Code Terzano MG, Parrino L, Boselli M, Spaggiari MC, Di Giovanni G, Smerieri A. Sensitivity of cyclic alternating pattern to prolonged pharmacotherapy: A 5-week 2 study evaluating zolpidem in insomniac patients. Terzano MG, Parrino L, Spaggiari MC, Palomba V, Rossi M, Smerieri A. CAP variables and arousals as sleep electroencephalogram markers for primary 6 insomnia. Zaleplon vs zopiclone: effects on car-driving performance. XI World 7 Congress of Psychiatry , Hamburg, August. Clinical study of triazolam on sleep disorders in psychiatric aspect. Clinical study on zolpidem, sleep-inducing agents, in the fields of internal medicine and psychosomatic medicine: double blind 1 comparative study with triazolam as reference drug. Clinical study on zolpidem, short-acting hypnotic, for chronic insomnia in the fields of internal medicine and psychosomatic medicine - double blind group comparative study with zopiclone as reference drug.

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Adverse events in head-to-head trials of beta blockers for hypertension Sample Trial Population Trial Interventions size duration characteristics Quality Yilmaz Nebivolol (neb) starting dose 46 6 weeks Baseline Fair 2008 of 2 200mg suprax. If after 2 weeks BP was normalized generic suprax 200 mg free shipping, amlodipine (5-10 mg daily) was added to treatment suprax 200 mg for sale. Beta blockers Page 491 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 20. Adverse events in head-to-head trials of beta blockers for hypertension Trial Results Yilmaz No AE reported 2008 Beta blockers Page 492 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 21. Safety of all head-to-head trials of beta blockers Sample Trial Indication size Duration P value Selective beta blockers Non-selective beta blockers ate bis met bet neb ace cart carv lab nad pen pin pro tim Overall adverse event incidence Fogari 1999 Hypertension 152 18 mos NS 13. Safety of all head-to-head trials of beta blockers Sample Trial Indication size Duration P value Selective beta blockers Non-selective beta blockers ate bis met bet neb ace cart carv lab nad pen pin pro tim Hypotension incidence Poole-Wilson 2003 Heart 3029 58 mos NS 11. The report is neither a usage guideline nor an endorsement or recommendation of any drug, use, or approach. Oregon Health & Science University does not endorse any guideline or recommendation developed by users of this report. Update 4: August 2006 Update 3: September 2005 Update 2: March 2004 Update 1: July 2003 Original Report: April 2002 The literature on this topic is scanned periodically. Lee, PharmD, BCPS Elizabeth Haney, MD Susan Carson, MPH Original authors: Mark Helfand, MD, MPH Cathy Kelley, PharmD Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Oregon Health & Science University Copyright © 2009 by Oregon Health & Science University Portland, Oregon 97239. Final Report Update 5 Drug Effectiveness Review Project The medical literature relating to this topic is scanned periodically. Prior versions of this report can be accessed at the DERP website. Statins Page 2 of 128 Final Report Update 5 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION.......................................................................................................................... How do statins and fixed-dose combination products containing a statin and another lipid-lowering drug compare in their ability to reduce low-density lipoprotein cholesterol?................... Are there doses for each statin or fixed-dose combination product containing a statin and another lipid-lowering drug that produce similar percent reduction in low-density lipoprotein cholesterol?............................................................................................................................................ Do statins or fixed-dose combination products containing a statin and another lipid- lowering drug differ in the ability to achieve National Cholesterol Education Program goals? How do statins and fixed-dose combination products containing a statin and another lipid-lowering drug compare in their ability to increase high-density lipoprotein cholesterol?............... Are there doses for each statin or fixed-dose combination product containing a statin and another lipid-lowering drug that produce similar percent increase in high-density lipoprotein cholesterol between statins? Is there a difference in the ability of a statin or fixed-dose combination product containing a statin and another lipid-lowering drug to achieve National Cholesterol Education Panel goals?..................................................................................................................................................... How do statins and fixed-dose combination products containing a statin and another lipid-lowering drug compare in their ability to reduce the risk of nonfatal myocardial infarction, coronary heart disease (angina), coronary heart disease mortality, all-cause mortality, stroke, hospitalization for unstable angina, or need for revascularization (coronary artery bypass graft, angioplasty, or stenting)? Are there differences in effectiveness of statins and fixed-dose combination products containing a statin and another lipid-lowering drug in different demographic groups or in patients with comorbid conditions (e. Are there differences in the harms of statins or fixed-dose combination products containing a statin and another lipid-lowering drug when used in the general population of adults? Are there differences in the harms of statins or fixed-dose combination products containing a statin and another lipid-lowering drug when used in special populations or with other medications (drug-drug interactions)? How do statins and fixed-dose combination products containing a statin and another lipid-lowering drug compare in their ability to reduce low-density lipoprotein cholesterol?................... Are there doses for each statin or fixed-dose combination product containing a statin and another lipid-lowering drug that produce similar percent reduction in low-density lipoprotein cholesterol?............................................................................................................................................ Do statins or fixed-dose combination product containing a statin and another lipid- lowering drug differ in the ability to achieve National Cholesterol Education Program goals? How do statins and fixed-dose combination products containing a statin and another lipid lowering drug compare in their ability to raise high-density lipoprotein cholesterol? Are there doses for each statin or fixed-dose combination product containing a statin and another lipid lower drug that produce similar percent increase in high-density lipoprotein cholesterol between statins? How do statins and fixed-dose combination products containing a statin and another lipid lowering drug compare in their ability to reduce the risk of nonfatal myocardial infarction, coronary disease (angina), coronary heart disease mortality, all-cause mortality, stroke, hospitalization for unstable angina, or need for revascularization (coronary artery bypass graft, angioplasty, or stenting)? Are there differences in effectiveness of statins and fixed-dose combination products containing a statin and another lipid lowering drug in different demographic groups or in patients with comorbid conditions (e. Are there differences in the harms of statins or fixed-dose combination products containing a statin and another lipid lowering drug when used in the general population of children?. Are there differences in the harms of statins or fixed-dose combination products containing a statin and another lipid lowering drug when used in special populations or with other medications (drug-drug interactions)? Percent reduction in low-density lipoprotein cholesterol with statins....................................... Doses of statins that result in similar percent reductions in low-density lipoprotein a cholesterol............................................................................................................................................ Percent reduction in low-density lipoprotein cholesterol with fixed-dose combination products................................................................................................................................................. Achieving target low-density lipoprotein cholesterol goals...................................................... Achievement of National Cholesterol Education Program low-density lipoprotein cholesterol goals of fixed-dose combination products............................................................................................. Outpatient and community-based placebo-controlled trials of statins with coronary heart disease endpoints.................................................................................................................................. Placebo-controlled trials in patients with diabetes................................................................. Inpatient trials of acute myocardial infarction or unstable angina (statins compared with placebo or usual care)........................................................................................................................... Studies of atherosclerotic progression that reported coronary heart disease outcomes...... Low-density lipoprotein cholesterol lowering in placebo-controlled trials of statins in children with familial hypercholesterolemia......................................................................................................... High-density lipoprotein cholesterol increases in placebo-controlled trials of statins in children with familial hypercholesterolemia......................................................................................................... Black box warnings for US Food and Drug Administration-approved drugs................... We also thank Trish Thieda, MA and Miranda Walker, MA for assistance with data abstraction and quality assessment of studies, and Theresa Nguyen for retrieval of articles and assistance with editing and formatting. Suggested citation for this report Smith MEB, Lee NJ, Haney E, Carson S. Drug class review: HMG-CoA reductase inhibitors (statins). These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Statins Page 6 of 128 Final Report Update 5 Drug Effectiveness Review Project INTRODUCTION In the United States, coronary heart disease and cardiovascular disease account for nearly 40% of all deaths each year. Coronary heart disease continues to be the leading cause of mortality and a significant cause of morbidity among North Americans.

Long-term fluvastatin reduces the hazardous effect of renal impairment on four-year atherosclerotic outcomes (a LIPS substudy) order 100mg suprax with mastercard. Effects of pravastatin in patients with serum total cholesterol levels from 5 discount suprax 200mg with mastercard. The Pravastatin Multinational Study Group for Cardiac Risk Patients buy 100 mg suprax amex. Effect of statins on risk of coronary disease: a meta- analysis of randomized controlled trials. Afilalo J, Duque G, Steele R, Jukema JW, de Craen AJM, Eisenberg MJ. Statins for secondary prevention in elderly patients: a hierarchical bayesian meta-analysis. Efficacy and safety of statin monotherapy in older adults: a meta-analysis. Journals of Gerontology Series A-Biological Sciences & Medical Sciences. Efficacy and tolerability of lovastatin in 459 African Americans with hypercholesterolemia. Comparison of rosuvastatin versus atorvastatin in South-Asian patients at risk of coronary heart disease (from the IRIS Trial). Lipid-altering efficacy and safety of simvastatin 80 mg/day: worldwide long-term experience in patients with Statins Page 97 of 128 Final Report Update 5 Drug Effectiveness Review Project hypercholesterolemia. Expanded clinical evaluation of lovastatin (EXCEL) study results IV. Additional perspectives on the tolerability of lovastatin. Expanded clinical evaluation of lovastatin (EXCEL) study design and patient characteristics of a double blind, placebo controlled study in patients with moderate hypercholesterolemia. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia. Expanded clinical evaluation of lovastatin (EXCEL) study results III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia. Efficacy and tolerability of lovastatin in 3390 women with moderate hypercholesterolemia. Expanded Clinical Evaluation of Lovastatin (EXCEL) study results two year efficacy and safety follow up. Hey-Hadavi JH, Kuntze E, Luo D, Silverman P, Pittman D, Lepetri B. Tolerability of atorvastatin in a population aged > or =65 years: a retrospective pooled analysis of results from fifty randomized clinical trials. Safety profiles for the HMG-CoA reductase inhibitors: treatment and trust. Systematic review and meta-analysis of clinically relevant adverse events from HMG CoA reductase inhibitor trials worldwide from 1982 to present. Meta-analysis of drug-induced adverse events associated with intensive-dose statin therapy. The safety of rosuvastatin as used in common clinical practice: a postmarketing analysis. Statins Page 98 of 128 Final Report Update 5 Drug Effectiveness Review Project 213. Garcia-Rodriguez LA, Gonzalez-Perez A, Stang MR, Wallander M-A, Johansson S. The safety of rosuvastatin in comparison with other statins in over 25,000 statin users in the Saskatchewan Health Databases. Garcia-Rodriguez LA, Masso-Gonzalez EL, Wallander M-A, Johansson S. The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care. The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. Impact of statin dosing intensity on transaminase and creatine kinase. FDA adverse effects reports on statin-associated rhabdomyolysis. Statin safety: an assessment using an administrative claims database. Gaist D, Rodriguez LA, Huerta C, Hallas J, Sindrup SH. Lipid-lowering drugs and risk of myopathy: a population-based follow-up study. Fibrates and statins in the treatment of hyperlipidaemia: an appraisal of their efficacy and safety. Comparison of the frequency of adverse events in patients treated with atorvastatin or simvastatin. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. Shepherd J, Vidt DG, Miller E, Harris S, Blasetto J. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Consistency of lipid-altering effects of ezetimibe/simvastatin across gender, race, age, baseline low density lipoprotein Statins Page 99 of 128 Final Report Update 5 Drug Effectiveness Review Project cholesterol levels, and coronary heart disease status: results of a pooled retrospective analysis. Effects of rosuvastatin on lipids, lipoproteins and apolipoproteins in the dyslipidaemia of diabetes. Bevilacqua M, Guazzini B, Righini V, Barrella M, Toscano R, Chebat E. Metabolic effects of fluvastatin extended release 80 mg and atorvastatin 20 mg in patients with type 2 diabetes mellitus and low serum high-density lipoprotein cholesterol levels: A 4-month, prospective, open-label, randomized, blinded - End point (probe) trial. Safety and efficacy of fluvastatin in hyperlipidemic patients with chronic renal disease. Gruer PJ, Vega JM, Mercuri MF, Dobrinska MR, Tobert JA.

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In the iPrEx Study cheap 100 mg suprax with visa, 2499 MSM from six countries received either TDF+FTC or placebo generic suprax 100mg visa. Apart from slightly more cases of nausea and weight loss in the active arm discount suprax 200 mg line, there were no differences. Of note, only in 3/34 patients of those infected in the active group was tenofovir or FTC detected in plasma. Protective effects were also proven in the Partners PrEP trial, a large trial involving 5000 heterosexual couples in Kenyia and Uganda, and the TDF2 trial (Thigpen 2011, Baeten 2012+2014). In the Partners PrEP trial, the placebo arm was stopped in July 2011 and the subjects re-randomized to tenofovir or TDF+FTC. In the Bangkok Tenofovir Study, daily oral TDF reduced the risk of HIV infection in people who inject drugs. Among 2413 par- ticipants, 1204 on TDF and 1209 on placebo, 17 and 33 participants became infected (incidence of 0. These results, however, have not been without their setbacks. In the FEM-PrEP Trial on African woman, 35 infections in the placebo arm were observed compared to 33 with TDF+FTC. Due to lack of efficacy, this large trial was discontinued in April 2011. The three-armed VOICE Trial investigating women from three African countries also showed no benefit with different interventions, neither with TDF gel, TDF tablets nor with TDF+FTC (Marrazzo 2013). The following table shows an overview of the ongoing large trials: 266 ART Table 12. However, adherence certainly has a strong influence. Simple truth: One can not expect a pro- tective effect if the patient doesn’t take the agent. Trials such as iPREX or PARTNERS PrEP showed a clear correlation between blood levels and infection risk. Protection was highest in volunteers with detectable tenofovir levels (Anderson 2012, Donnel 2012, Baeten 2014). In the Bangkok Tenofovir Study, the risk of HIV infection decreased as adherence improved, from 48. Adherence was poor in the FEM-PrEP trial, as the young women considered their risk of acquiring HIV infection as minimal. The VOICE trial also showed poor adherence as probably the application of gel was con- sidered inconvenient by participants. What has become clear however is that continuous PrEP is not always beneficial and that success depends on several factors: first, adherence, but also viral load of the infected sexual partner, other STDs, different biological factors, sexual behavior and sexual practices, to name just a few. Hormonal contraceptives seem to have no influ- ence on the transmission rates (McCoy 2012). Several studies suggested that tenofovir-based PrEP moderately but signifi- cantly reduces bone density and renal function (Mugwanya 2015, Mulligan 2015). And what about development and transmission of resistance in an unidentified HIV infection? Fortunately, drug resistance was rare in iPrEx on-study seroconverters, and only as low frequency minor variants (Liegler 2014). In PARTNERS PrEP, however, 5/26 seroconverters with detectable plasma drug levels had virus with resistance mutations associated with their PrEP regimen, mainly M184V (Lehman 2015). In early 2015, two randomized trials (PROUD and Ipergay) provided further evidence for the efficacy of PrEP in high-risk populations. In a pragmatic open-label trial, the PROUD Study, PrEP was evaluated in MSM in a real-world setting, and the use of public clinics, with minimal extra research funds, was key to its design (McCormack 2015). In total, 545 MSM reporting anal intercourse without condoms in the previ- ous 90 days were randomized to receive open-label daily TDF+FTC either immedi- ately (IMM) or after a deferral (DEF) period of 12 months. In October 2014 the DSMB recommended that all MSM in the deferral group be offered PrEP. Prevention of HIV infection 267 and 19 HIV infections had been observed in the IMM and DEF arm (1. In the French Ipergay trial, another strategy was evaluated for the first time, a so- called “on demand”, event-driven PrEP strategy. In total, 400 high risk adult MSM who reported anal sex without condoms were randomized to take two pills of TDF+FTC or placebo 2 to 24 hours before each sexual intercourse, then another pill 24 hours later and a fourth pill 48 hours after the first drug intake (Molina 2015). In November 2014, after a median follow-up of only 8. Sixteen patients had acquired HIV infection after enrollment, 14 in the placebo arm and 2 in the TDF/FTC arm. Taken together, PrEP represents a very effective and safe prevention strategy if the person is adherent. In July 2012, FDA approved TDF+FTC to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV+ partners. In July 2014, the WHO released guidelines recommending the offer of oral PrEP to high-risk populations http://www. In Europe, where TDF+FTC are not yet available for prevention, community organisations are currently calling stakeholders to make PrEP available and accessible. Evaluation of long-acting medications and alternative formulations for PrEP is under- way and may lead to the wider implementation and impact of PrEP. However, many questions remain that have not been answered by the above-men- tioned studies. Who should distribute it (walk-in clinics, doctors, phar- macists? Is the dose studied and the form (every day or before and after sex as “on-demand”) the best way? Other questions regarding long term toler- ance, safety during pregnancy, administration in young people or patients with hep- atitis B remain unanswered. References Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Anderson PL, Glidden DV, Liu A, et al, iPrEx Study Team. Emtricitabine-tenofovir concentrations and pre-expo- sure prophylaxis efficacy in men who have sex with men. Sexual transmission of HIV according to viral load and anti- retroviral therapy: systematic review and meta-analysis.

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