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A second systematic review buy discount shuddha guggulu 60 caps, published by Pinelli and colleagues in 2008 buy shuddha guggulu 60caps free shipping, also compared 81 exenatide to placebo and insulin in terms of adverse events. In a meta-analysis of the 5 included studies on exenatide, the pooled odds ratios for nausea was 9. Another systematic review of GLP-1 receptor agonists, including exenatide and 82 liraglutide, was also included. This study combined trials of both exenatide and liraglutide into one meta-analysis and found, similar to our results, an increased risk of gastrointestinal side effects with exenatide and liraglutide. This is similar to the findings of our meta-analyses. Detailed Assessment of Liraglutide: Harms Active-control trials Among the 3 studies comparing liraglutide to glimepiride, total withdrawals in the liraglutide 58-60 group ranged from 7% to 35% compared with 0% to 39% in the glimepiride group. Withdrawals due to adverse events for the liraglutide group ranged from 5% to 12% and were 0% to 6% in the comparison glimepiride group. Nausea, vomiting, and diarrhea were frequent adverse events among liraglutide-treated subjects. Rates of these symptoms were higher in the liraglutide group than in groups using glimepiride. In the LEAD-2 study, 35% to 44% of participants on liraglutide reported nausea, vomiting, or diarrhea, compared to 17% of participants on glimepiride. Vomiting was reported in 5% to 7% of participants on liraglutide, compared to 1% on glimepiride. Diarrhea was reported in 8% to 15% of participants on liraglutide, compared to 4% on glimepiride. There was a trend toward increase side 59 gastrointestinal side effects with the increased dose of liraglutide. In the LEAD-3 study, 27% to 29% of participants on liraglutide reported nausea, compared to 8% of participants on glimepiride. Vomiting was reported in 9% to 12% in the liraglutide group, compared to 4% in the glimepiride group. Diarrhea was reported in 16% to19% in the liraglutide group, compared to 60 9% in the glimepiride group. The majority of the symptoms of nausea occurred in the first weeks of therapy. In both the LEAD-2 and the LEAD-3 study groups, by week 4 less than 10% of subjects in the liraglutide groups reported nausea. Overall hypoglycemia rates were lower in the liraglutide groups than in the glimepiride 58-60 group. Minor hypoglycemia occurred in 3% to 12% of the participants in the liraglutide groups, and 15% to 24% of the participants in the glimepiride groups. There were no reports of major hypoglycemic events in any of the participants in these studies. Two participants in the LEAD-2 study developed pancreatitis; 1 was in the liraglutide 1. Two participants in the LEAD-3 study developed pancreatitis; both were in the liraglutide arms of the study. A weak association between 59, 60 development of pancreatitis and treatment with liraglutide could not be excluded. In the 1 active-control trial comparing liraglutide 1. This was in large part secondary to a higher incidence of nausea, dyspepsia, vomiting, and diarrhea in the liraglutide arm of the study (nausea: liraglutide 14% compared with insulin glargine 1%; dyspepsia: liraglutide 7% compared with insulin glargine 2%; vomiting: liraglutide 7% compared with insulin glargine 0. Rates of minor hypoglycemia were similar between the 2 groups (liraglutide 27. There were no reports of pancreatitis in this study. In the active-control trial comparing liraglutide to rosiglitazone, the incidence of serious 84 adverse events was similar between treatment arms (rosiglitazone 3%, liraglutide 3-5%). Nausea was more common in the liraglutide groups compared to rosiglitazone, although the occurrence of nausea decreased over time in the liraglutide treatment arms. No other cases of pancreatitis were reported in the study. In the active-control trial comparing liraglutide to sitagliptin, the incidence of serious 41 adverse events was similar between treatment arms (3% to 4%). Gastrointestinal complaints, particularly nausea, was more common in the liraglutide arms of the study than in the sitagliptin arm (incidence of nausea: liraglutide 21-27%, sitagliptin 5%). The median duration of nausea was 8 days with liraglutide 1.

Head-to-head trials of beta blockers for heart failure Author Study Year Design Country Setting Eligibility criteria Exclusion criteria Galatius RCT Patients who fulfilled all standard indications for BB treatment Patients who had contraindications for BB treatment; and those who 2004 in patients with systolic CHF had been admitted buy cheap shuddha guggulu 60caps, had attended an emergency room purchase shuddha guggulu 60 caps with mastercard, or who had been Denmark treated in the heart failure clinic for acute decompensation within 2 weeks prior to randomization. Patients were excluded from data Poor Quality analysis if they died before two months of follow-up. Lombardo RCT Caucasion patients aged > 35 years w/ CHF, LV ejection SBP <90mm Hg; DBP <60mm Hg; HR <50 bpm; cerebral vascular 2006 fraction < 40%, NYHA class II-III, stable clinical condition during accidents w/in previous 6 months; heart or vascular surgery or MI w/in prior 4 weeks. Beta blockers Page 307 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 11. Head-to-head trials of beta blockers for heart failure Author Allowed other Age Year Interventions (drug, medications/ Method of outcome assessment Gender Country regimen, duration) interventions and timing of assessment Ethnicity Galatius Bisopolol started at 1. Ethnicity: 100% Nebivolol (neb) started at 6-minute walk test Caucasion 1. X 6 months Beta blockers Page 308 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 11. Head-to-head trials of beta blockers for heart failure Number Number Author Other population screened/ Author withdrawn/ Year characteristics eligible/ Year lost to fu/ Country (diagnosis, etc) enrolled Country analyzed Galatius NYHA class III-IV=19. NR/70/70 Lombardo 2/0/70 2006 NYHA function class 2. Head-to-head trials of beta blockers for heart failure Author Year Method of adverse effects Adverse effects Country Outcomes assessment? Beta blockers Page 310 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 11. Head-to-head trials of beta blockers for heart failure Author Withdrawals due to Year adverse events (%, Country adverse n/enrolled n) Galatius 0 2004 Denmark Poor Quality Lombardo 2. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Randomization Allocation Groups similar at Country described? Quality assessments of head-to-head trials of beta blockers for heart failure Author Eligibility Outcome Care Patient Year criteria assessors provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Sanderson Valvular heart disease as the etiology of LV dysfunction, active Yes Yes Yes Yes 1999 myocarditis, unstable angina, a documented history of sustained China ventricular tachycardia or symptomatic nonsustained ventricular tachycardia or second- or third degree atrioventricular block; chronic obstructive lung diseases, asthma, long-term alcohol or drug abuse or chronic renal failure (serum creatine >200 mmol/liter), hepatic hematological, neurological or collagen vascular disease Kukin Obstructive valvular disease, acute myocardial infarction within 6 weeks, Yes N/A - open N/A - open N/A - open 1999 or active angina study study study Metra Unstable angina,acute myoardial infarction, or a coronary Yes Yes Yes Yes 2000 revascularization procedure within 3 months; history of alcohol abuse; primary valve disease; congenital heart disease; systolic blood pressure <90 mm Hg; concomitant disease that might adversely influence prognosis or impair exercise capacity; contraindications to b-blocker therapy; concomitant treatment with other b-blockers, a-antagonists, calcium antagonists or antiarrhythmic agents (except amiodarone) Beta blockers Page 313 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Maintenance of Reporting of attrition, Year Intention-to-treat comparable crossovers, adherence, Loss to follow-up: Country (ITT) analysis groups and contamination differential/high Score Sanderson Unclear Unclear Attrition reported; Others NR Fair 1999 NR China Kukin No NR Attrition reported; Others None Fair 1999 NR Metra No NR Attrition reported; Others None Fair 2000 NR Beta blockers Page 314 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Sanderson NR Yes 12 weeks 1999 China Kukin SKB Yes 6 months 1999 Metra CARIPLO funds University of Brescia Yes 44 months 2000 Beta blockers Page 315 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Randomization Allocation Groups similar at Country described? Metoprolol European Trial (COMET) Beta blockers Page 316 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Eligibility Outcome Care Patient Year criteria assessors provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Metra Patients with an acute ischemic event or a coronary revascularization Yes Yes Yes Yes 2002 procedure within 3 months; a history of alcohol abuse; primary valve US, Italy disease or congenital heart disease; frequent ventricular premature beats and/or runs of ventricular tachycardia; contraindications to beta-blocker therapy; concomitant treatment with other beta-blockers, a-antagonists, calcium antagonists or antiarrhythmic agents (except amiodarone) Poole-Wilson Recent change in treatment within 2 weeks before randomization; Yes Yes Yes Yes 2003 requirement for intravenous inotropic therapy; current treatment with non- Europe dihydropyridine calcium channel blockers (diltiazem, verapamil); amiodarone (>200 mg per day); class-I antiarrhythmic drugs; unstable Carvedilol Or angina; myocardial infarction; coronary revascularisation or stroke within Metoprolol the previous 2 months; uncontrolled hypertension (SBP >170 mm Hg or European Trial DBP >105 mm Hg); hemodynamically significant valvular disease; (COMET) symptomatic and sustained ventricular arrhythmias within the past 2 months note adequately treatment with antiarrhythmic drugs or implantation of an automatic defibrillator; pregnancy; women with childbrearing potential on inadequate contraception; known drug or alcohol misuse; poor compliance; any other serious systemic disease; contraindication to beta blockers Beta blockers Page 317 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Maintenance of Reporting of attrition, Year Intention-to-treat comparable crossovers, adherence, Loss to follow-up: Country (ITT) analysis groups and contamination differential/high Score Metra No NR Attrition reported; Others None Fair 2002 NR US, Italy Poole-Wilson Yes NR 31. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Metra NR Yes 9-12 months 2002 US, Italy Poole-Wilson F Hoffman La Roche and GlaxoSmithKline; Yes 58 months 2003 first author has served as a consultant to or Europe received travel expenses, payment for speaking at meetings or funding for Carvedilol Or research from one or more of the major Metoprolol pharmaceutical companies European Trial (COMET) Beta blockers Page 319 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Randomization Allocation Groups similar at Country described? Beta blockers Page 320 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Eligibility Outcome Care Patient Year criteria assessors provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Galatius Patients who had contraindications for BB treatment; and those who had Yes No No No 2004 been admitted, had attended an emergency room, or who had been treated in the heart failure clinic for acute decompensation within 2 weeks prior to randomization. Patients were excluded from data analysis if they died before two months of follow-up. Lombardo SBP <90mm Hg; DBP <60mm Hg; HR <50 bpm; cerebral vascular Yes No No No 2006 accidents w/in previous 6 months; heart or vascular surgery or MI w/in Italy previous 3 months; serious valvular conditions that required surgery; atrioventricular conduction abnormalites; milignancies; serious liver, kidney, connective tissue, respiratory, or hematologic disease; history of allergy; intolerance to ACE inhibitors; unstable angina, DM; digitalis intolerance; BMI >30; excercise tolerance limited by other disorders; pregnancy. Beta blockers Page 321 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Maintenance of Reporting of attrition, Year Intention-to-treat comparable crossovers, adherence, Loss to follow-up: Country (ITT) analysis groups and contamination differential/high Score Galatius No; excluded 3 NR Yes NR Poor 2004 patients that died No prior to completing 2 No months of treatment No Lombardo Yes Yes Yes NR Fair 2006 No Italy No No Beta blockers Page 322 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 12. Quality assessments of head-to-head trials of beta blockers for heart failure Author Year Country Funding Control group standard of care Length of follow-up Galatius Danish Pharmacy Foundation, Merck Sharp Yes 10. Outcomes in head-to-head trials of beta blockers for heart failure Sample Worsening Trial Interventions* size Duration Baseline EF Mortality heart failure Sanderson Carvedilol 51 12 weeks 26% NR NR 1999 Metoprolol Fair Kukin Carvedilol 67 6 months 18-19% NR car=3/37(8. Outcomes in head-to-head trials of beta blockers for heart failure Change in EF following Trial NYHA Class Exercise capacity treatment Sanderson # patients at NYHA class I/II/III/IV Improvement in 6-min walk(feet) Mean EF at Week 12 (% 1999 car car=72(6. Outcomes in head-to-head trials of beta blockers for heart failure Trial Quality of life Sanderson Minnesota QOL mean reduction in symptom 1999 score (%) car=9. Randomized controlled trials of beta blockers for arrhythmia Author Year Study design Country Setting Eligibility criteria Exclusion criteria Head-to-head trials Katritsis RCT Patients subjected to cardioversion of Terminal illness, age > 80 years, left ventricular 2003 multicenter persistent AF (> 7 days) ejection fraction <30, concomitant treatment with class I or III antiarrhythmic drugs, amiodarone use Fair quality within 3 months before randomization, previous treatment with bisoprolol or carvedilol, and contraindications to beta blockade, such as conduction disturbances, asthma, or severe chronic obstructive pulmonary artery disease Beta blockers Page 327 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 14. Randomized controlled trials of beta blockers for arrhythmia Author Allowed other Method of outcome Age Year Interventions (drug, regimen, medications/ assessment and timing of Gender Country duration) interventions assessment Ethnicity Head-to-head trials Katritsis Bisoprolol 10 mg daily (or 5 mg No restrictions, with Clinic visits at months 1, 3, Mean 2003 daily if LVEF < 40%) exception of class I 6 and 12 age=65. Randomized controlled trials of beta blockers for arrhythmia Number Author Number screened/ withdrawn/ Year Other population characteristics eligible/ lost to fu/ Country (diagnosis, etc) enrolled analyzed Outcomes Head-to-head trials Katritsis Heart rate=71. Randomized controlled trials of beta blockers for arrhythmia Author Year Method of adverse Adverse effects Withdrawals due to adverse events Country effects assessment?

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A new NNRTI alone is often not sufficient (Abgrall 2007 generic 60 caps shuddha guggulu amex, Khaykin 2008) buy shuddha guggulu 60caps with mastercard. The two INSTIs raltegravir and elvitegravir/c were of similar potency in patients with virological failure (most patients were on PI-based regimens). In 145, a double-blinded ran- domized study, patients were randomized to elvitegravir QD or raltegravir BID with a fully active boosted PI plus a third agent. The proportion of subjects maintained HIV-1 RNA <50 copies/mL through week 96 were 48% and 45% (Elion 2013). Dolutegravir seems to be even more potent, as shown by the large SAILING trial, a double-blinded non-inferiority study in 715 patients with virological failure and resistance to two or more classes of antiretroviral drugs. Patients received dolute- gravir 50 mg QD or raltegravir 400 mg BID, with investigator-selected background therapy. At week 48, 71% patients on dolutegravir had HIV-RNA less than 50 copies/ml, versus 64% patients on raltegravir. Superiority of dolutegravir versus raltegravir was concluded. Of note, significantly fewer patients had virological failure with INSTI RAMs on dolutegravir (treatment-emergent integrase-inhibitor resistance on dolutegravir (four vs 17 patients). Dolutegravir seems to have the highest poten- tial in pre-treated patients with PI-failing regimens (see next chapter). Virological failure with INSTI-based regimens Failure of an INSTI-based regimen in first-line is a rare event. With elvitegravir or raltegravir, the risk seems to be around 1–2%. If these regimens fail, a rapid switch is recommended, in order to preserve the efficacy of dolutegravir. Dolutegravir remains effective in patients with limited INSTI RAMs (see Salvage Chapter). In the case of concomitant NRTI resistance mutations, a boosted PI should be consid- ered. Can HIV infection be treated in a similar fashion to mycobacterias, with a sequence of intense induction therapy followed by less toxic (and less expensive) maintenance therapy? The idea is appealing, and has circulated almost since the existence of com- bination ART. Between 1998 and 2003, the answer was clearly that maintenance therapies do not work. Three randomized studies (Trilège, ADAM, ACTG 343) destroyed any hope that ART might be reduced to two or even one drug. By today’s standards, one could object that outdated agents such as saquinavir, indinavir or nelfinavir were used (Havlir 1998, Reijers 1998, Flander 2002). In the last few years better drugs have been licensed. In particular, lopinavir and darunavir with high resistance barriers cast a different light on the negative image of maintenance therapies. Randomized studies already exist for lopinavir/r and darunavir/r, but other boosted PIs such as atazanavir/r have also been investigated as PI/r monotherapy (see Table 8. Nunes 2009 60 LPV/r versus 96 80 vs 87% (ITT, VL <80) (KalMo) 2 NRTIs+LPV/r Campo 2009 155 LPV/r versus 96 60 vs 63% (ITT), but low-level viremia (M03-613) CBV+EFV more frequently Pulido 2008 205 LPV/r versus 48 85 vs 90% (ITT), Non-inferiority shown, (OK04 Study) 2 NRTIs+LPV/r but more frequent low viremia Meynard 2010 186 LPV/r versus ART- 48 84 vs 88% (ITT), Non-inferiority not (KALESOLO) continuitation shown, more frequent low viremia Gutmann 2010 60 LPV/r versus ART- 24 21% VF on Mono. Especially those with continuitation low CD4 nadir, study discontinued. Cahn 2011 80 LPV/r versus ART- 48 98 vs 95% (LOCV, VL <200) continuitation Clumeck 2011 256 DRV/r versus 96 78 vs 82% (ITT), Non-inferiority not clearly (MONET) 2 NRTIs+DRV/r shown completely Valentin 2012 225 DRV/r versus 96 84 vs. In the OK04 study with lopinavir/r, even a reduc- tion of lipoatrophy rates was achieved. The observation period was extended to four years (Cameron 2007, Pulido 2008). However, other studies failed to show any effect on lipoatrophy (Bernadino 2013). In MONARK, bone density improved after a switch to darunavir/r monotherapy (Guarladi 2014). However, some patients on lopinavir/r show low levels of viremia, especially in combination with low CD4 T cells. They tend to show poor compliance (Campo 2007, Pulido 2008, Gutmann 2010). The same was observed with therapy-naïve patients (see above). For darunavir, the results of two large randomized studies MONET and MONOI with identical design are published (Clumeck 2011, Valentin 2012). In MONET, non-infe- riority of the monotherapy could not completely be shown after 96 weeks, at least regarding the primary endpoints (Clumeck 2011). In total, 82% of patients were below 50 copies/ml in the standard arm at week 96, compared to 78% on darunavir monotherapy.

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