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N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results F ocketal order malegra fxt plus 160 mg with amex erectile dysfunction in young males. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events F ocketal generic malegra fxt plus 160 mg online erectile dysfunction age. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled M onikesetal. Proton pump inhibitors Page 108 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results M onikesetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events M onikesetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled Placebo- controlled trials Peuraetal. E x cludedthosewithanactivegastric parallelgroup during the3monthsbeforethestudy. Proton pump inhibitors Page 111 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results Peuraetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events Peuraetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled A ctive-controlled trials vanZyletal. Historyof keyGE RD andpatientswhohadrecentlytakenorwerestillreceiving symptoms(oneepisode/monthforatleast3 PPI therapyoragentslikelytoaffectgastricacidsecretionor months)priortoentryintothestudy. Proton pump inhibitors Page 114 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results vanZyletal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events vanZyletal. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup Caos O f 497enrolledpatients,261patientscom pleted(Phase N R N R /N R /497/236(Phase1)/N R 2005 1)and205patientscom pleted(Phase2. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup D evault2007 IntheU S at143centers;twogroupsincluded-patients L A classification,% 4015screened,1026random iz edtotrm t, with healedE E from atrialof patientswith L A gradesC or GradeA 37% 1001ITT D E E whoweretreatedwith esom epraz ole40m g once GradeB38% dailyorlansopraz ole30m g oncedailyforup to8weeks. GradeC 20% Thesecondgroup of patientsincludedthosewith L A GradeD 4. Theyreceivedopen-labeltreatm entwith esom epraz ole40m g oncedailyforup to8weeks. Those whoseE E wasconsideredhealedonthebasisof an esophagogastroduodenoscopy(E GD )atweek4andwho reportednoheartburnoracidregurgitationsym ptom s during theprevious7dayswereeligibleforrandom iz ation intothism aintenancetrial. M eanage48years 41% fem ale 78% white 6% black 16% other J asperson 30patientsinGerm anywhoseesophagitishealedafter6- AllGrade4(Savary-M iller) 36treated,6didnotheal,30included. Proton pump inhibitors Page 118 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup L abenz etal2005 2766patients(63% m en;m eanage50years)were L A grade D iscontinuationsduetoadverseevents requiredtohaveE E [photographicallydocum entedat A:32. Proton pump inhibitors Page 119 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup L auritsenetal. A:38% (89%)random iz edform aintenance B:45% treatm ent. ITT = 1224(615 M eanage:49 C:14% esom epraz ole,609lansopraz ole). Proton pump inhibitors Page 120 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup R ichteretal. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup Thjodleifssonet 243patientsat21centersinE uropewith aprevious Grade0:77% 210/243com pletedoneyear;13 al. Proton pump inhibitors Page 122 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder Caos Primary endpoint: R elapseratesat5yrswere F air SupportedbyE isaiInc and 2005 11% forrabepraz ole20m g,23% forrabepraz ole J anssenPharm aceuticals 10m g and63% forplacebo(p<0. Secondary endpoints: D aytim eheartburnrelapse lowerwith both dosesof rabepraz olevplacebo (p<0. Symptomaticrelapse by 48 weeks: lansopraz ole30m g:0.

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Studies from Evidence Table 1 (H2H) Andrews purchase 160mg malegra fxt plus mastercard erectile dysfunction treatment orlando, 2001 No No Yes Attrition-yes buy 160 mg malegra fxt plus erectile dysfunction pump for sale, crossovers-no, adherence-no, High loss to follow up or contamination-no drop outs ranging from 14- 24% of each group. Assman, 1999 No details given No Yes Attrition: yes, but no details on reasons for No withdrawal, crossovers-no, adherence-yes, contamination-no Ballantyne C, 2006 NA- open label Yes Yes Attrition-208 (10. Not reported States used intention to treat, but not defined. Berger, 1996 No Yes Yes No Not clear Berne, 2005 Described as "double- No (465/469 analyzed) Yes Attrition yes, others no. No blind", but no details Statins Page 288 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Studies from Evidence Table 1 (H2H) Andrews, 2001 Poor-high early withdrawal rate, no reasons noted. LDL-c for Simva not as great as atorva and % meeting LDL-c also lower, possible that doses of simva not titrated properly? For safety - unknown what doses for serious adverse effects. Assman, 1999 Fair-poor-LDL no details on blinding, Poor-safety no details on dose related adverse effects. Ballantyne C, 2006 Fair (MERCURY II) Bays, 2005 Fair-Poor Berger, 1996 Fair Berne, 2005 Fair Statins Page 289 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Bertolini, 1997 Yes Not reported Yes, not much detail Yes Yes Yes Betterridge D, 2007 Yes NR Yes Yes NR NR (ANDROMEDA) Bevilacqua M, 2005 Method NR Not reported Yes Yes Yes No Binbrek A, 2006 Yes Yes Yes Yes No No (DISCOVERY-Alpha) Bots A, 2005 (Dutch Method NR NR Yes Yes Method NR Method NR DISCOVERY) Branchi, 2001 Yes Not reported Not enough detail given Yes Not reported Not reported Brown, 1998 Yes Not reported Yes Yes No No Calza L, 2008 Method NR NR Yes Yes NR NR Statins Page 290 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? Bertolini, 1997 Yes No Yes Attrition-reported but no details on reasons No for withdrawal. Crossovers-no, adherence to treatment-yes, contamination-no Betterridge D, 2007 Yes but method not Yes mITT Yes Attrition-52 (10. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Bertolini, 1997 Fair-LDL lowering Poor-safety (no details on serious adverse effects and dropouts). Betterridge D, 2007 Fair-LDL lowering Poor-safety (no details on (ANDROMEDA) serious adverse effects and dropouts). Bevilacqua M, 2005 Fair-LDL lowering Poor-safety (no details on serious adverse effects and dropouts). Binbrek A, 2006 Fair (DISCOVERY-Alpha) Bots A, 2005 (Dutch Fair DISCOVERY) Branchi, 2001 Fair-poor-LDL lowering unsure of blinding, comparable groups, study planned up to 6 months, but high drop out. Brown, 1998 Fair-LDL lowering equivalent doses not compared, treat to target. Safety-poor no details on reasons for withdrawal due to adverse effects or doses. Calza L, 2008 Poor to fair Statins Page 292 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Chan, 2004 Study states "blindly Study states Yes Yes Study states "blindly Study states "blindly randomized," but no "blindly randomized," but no randomized," but no details given. Clearfield M, 2006 Yes NR Yes Yes NR NR (PULSAR) Dart, 1997 Yes Not reported Yes Yes Yes Yes Davidson, 1997 Yes Not reported Yes Yes Yes Yes Deedwania P, 2007 Method NR NR Yes Yes NR NR Discovery-UK group, Method NR NA Yes Yes No No 2006 Faergeman O, 2008 Method NR NA Yes Yes No No (ECLIPSE) Statins Page 293 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? Chan, 2004 Study states "blindly Not clear Not reported Attrition - yes, crossovers - no, No (atorv: 5 withdrawals randomized," but no adherence - yes, contamination - no. Davidson, 1997 Yes Unsure Yes Attrition-yes, crossovers-no, adherence-yes, No contamination-no Deedwania P, 2007 Yes Modified ITT Yes Attrition-142 (15. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Chan, 2004 Poor to fair Clearfield M, 2006 Fair (PULSAR) Dart, 1997 Fair-LDL lowering Poor-safety (no details on serious adverse effects, dose and dropouts). Davidson, 1997 Fair-LDL lowering Poor-safety (no details on serious adverse effects and dropouts). Deedwania P, 2007 Fair Discovery-UK group, Fair 2006 Faergeman O, 2008 Fair (ECLIPSE) Statins Page 295 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Farnier, 2000 Yes Not reported Yes Yes Yes No Ferdinand, 2006 Method not reported Not reported Yes Yes No- open label No- open label Fonseca, 2005 Method not reported Not reported Yes Yes No- open label No- open label Gentile, 2000 Yes Not reported Yes Yes No No Statins Page 296 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? Farnier, 2000 No Yes Yes Attrition reported for adverse effects but no No details for other reasons for withdrawal. Fonseca, 2005 No- open label No- analyzed patients who Unable to determine Attrition yes, others no rosuva 8.

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Practical approach to vaccinations Informed consent: The obligation to inform vaccines follows national recommen- dations (in Germany: see STIKO 2004) 160 mg malegra fxt plus fast delivery erectile dysfunction operation. Patients should be informed about the risks and benefits of vaccines trusted malegra fxt plus 160mg erectile dysfunction va disability compensation, with particular attention to HIV-related vaccination problems. In some countries, written informed consent is required. For vaccine information statements in different languages see www. Timing: Vaccinations should be postponed when an acute infection is present; however, a mild afebrile infection is not relevant. Live vaccines such as MMR, varicella 496 Other Infections than HIV-1 or yellow fever must be given either simultaneously or at least four weeks apart from each other. After treatment with immunoglobulins, live vaccines should not be administered within the following three months (exception: yellow fever vaccine). That means that a past incomplete primary series can be completed independent of a time delay between the necessary shots (every shot counts! This strategy does not take into account that vaccinations might be repeated if prior doses were given at a time when the patient was significantly immunosuppressed. Route of application: Vaccination routes should follow the recommendations pro- vided by the manufacturer. High immunogenicity and few complications make intra- muscular injections the preferable application route (deltoid muscle, in infants also anterolateral thigh; gluteal applications are obsolete! Many vaccines can also be administered subcutaneously (see product information). In hemophiliacs, subcuta- neous vaccination followed by thorough compression (>2 minutes) usually allows vaccination without coadministration of clotting factors. Only a few vaccines have to be administered subcutaneously, including meningococcal polysaccharide, yellow fever, and some varicella vaccines. Intradermal rabies vaccination schedules, which are licensed in some countries, should not be administered to HIV+ patients due to reduced immunogenicity (Tantawichien 2001). Combination vaccines: In general, it is recommendable to combine vaccines to minimize patient discomfort (and sometimes costs). Documentation: Vaccinations should be documented in the patient’s medical records as well as in a vaccination card kept by the patient. For the latter, a WHO recommended form can be ordered either through WHO or national providers. Documentation includes the brand, manufacturer, and lot number of the vaccine. Details of selected vaccines in HIV+ patients Tetanus/Diphtheria/Pertussis: Following a primary series during childhood, life- long protection against tetanus/diphtheria should be maintained by boosters every 10 years. According to a Danish study (Kurtzhals 1992), protection against diph- theria is often insufficient. Depending on their CD4 T cells, patients have a reduced response to boosters and an accelerated antibody waning (Moss 2003). Combination vaccines including polio and/or pertussis are available and suitable. Recently, most countries recommend a single booster of acellular pertussis vaccine for adults. Since adult pertussis vaccine is only available as a combination vaccine (e. Pneumococcal: Even under ART, there is an increased risk of invasive pneumococ- cal infections (Jordano 2004) which can be reduced with the 23-valent pneumo- coccal vaccine PPSV23 (Grau 2005, Rodriguez-Barradas 2008). The vaccine response in patients under ART with CD4 cell counts >200/µl is similar to healthy individu- als (Falco 2006). However, a cohort study demonstrated that patients with VL >100,000/ml did not benefit independent of their immune status (Teshale 2008). Recent data indicate that pneumococcal conjugate vaccines (PCV) might induce a stronger and longer lasting protective effect (Nunes 2012). A placebo-controlled trial in Malawi showed an efficacy of 74% using PCV7 (French 2010). Therefore, most guidelines now recommend the combination of PCV and PPV. In the USA, unvac- cinated HIV+ patients first receive PCV13 (independent of their CD4 counts); if they Vaccinations and HIV 497 have CD4 T cell counts 200/µl, they should then be vaccinated after 8 weeks with PPV23. If CD4 T cell counts are lower, this vaccine might be considered, if patients are under ART and have low VL, or be postponed until the immune status recovers. Patients already vaccinated with PPV23 receive additional PPV13 after a time span of at least 12 months. PPV23 is repeated once after 5 years, then again when the patient is 65 years old (CDC 2012, Panel on OI 2015).

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