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Discontinuation due to adverse events was also less with losartan (P<0 purchase cleocin gel 20 gm with visa acne in hair. Harms 34 In ELITE cheap cleocin gel 20 gm with visa acne scar removal cream, persisting increase in serum potassium and hypotension were not significantly different between treatment groups (P>0. In ELITE II rates of worsening heart failure were similar between groups (25% both groups). Other adverse events were not reported for this trial. Hypotension and congestive heart failure were not significantly different between groups. Subgroup analyses 34 In ELITE the decrease in mortality with losartan was generally consistent across different subgroups, including age, ejection fraction, and New York Heart Association functional class. The exception was a similar mortality in women (9/118 with losartan compared with 8/122 with 34 captopril; P value not reported). Among patients on prior beta-blocker therapy, however, more events occurred with losartan than with captopril for the composite outcomes of all-cause mortality and hospital admissions (P=0. There was no interaction between treatment and beta-blocker subgroups for the primary outcome of all-cause mortality (P>0. Event rates were higher for both losartan and captopril in patients not on beta-blockers. Losartan compared with enalapril (monotherapy and combination therapy) (n=5) 26, Five small trials compared losartan with enalapril, all in populations with stable heart failure. Several of these studies involved patients stabilized on an 26, 32 29, 30, 35 ACE-I, while others included only subjects with no recent use of ACE-Is or AIIRAs. The largest of the 5 trials included only 166 26 26, 32, 35 patients. The 3 parallel-group studies were all of monotherapy, while 1 cross-over 30 study (N=20) included a placebo, monotherapy with either losartan or enalapril, and a combination group. The other cross-over study included a placebo arm, both drugs as 29 monotherapy, and both monotherapies combined with aspirin. Three of these studies were of 26, 30 32 29, 35 fair quality and 2 were of poor quality. The quality of the body of evidence for the outcomes of quality of life and exercise capacity were assessed as low due to concerns regarding risk of bias and small sample sizes. Other outcomes were not assessed for quality as no more than 1 study examined other relevant outcomes. Exercise capacity improved with both losartan and enalapril, with no significant 26, 29, 32 difference between monotherapy treatment groups. Symptoms also improved in 1 study, with no significant difference between monotherapy groups, although the incidence of 26 pulmonary rales increased more with losartan 50 mg than with enalapril 20 mg daily (P<0. In that same study, the dyspnea-fatigue index improved with lisinopril 25 mg only (P=0. Minor increases in serum creatinine, 26 32 blood urea nitrogen, and potassium were reported with enalapril compared with losartan, but were not considered clinically significant. Cough was only reported in 1 study, with no 26 significant differences between enalapril and losartan 25 and 50 mg daily. Subgroups There were no significant interactions between treatment and subgroups based on age, sex, and 26, 32 New York Heart Association functional class in 2 studies examining subpopulations. Telmisartan compared with enalapril (monotherapy plus diuretic) (n=1) 28 The REPLACE (the replacement of angiotensin converting enzyme inhibition) trial involved patients with stable heart failure on a diuretic and enalapril 10 mg twice daily who were then randomized to continuation of enalapril 10 mg twice daily or to various telmisartan dosages (10, 20, 40, 60 mg daily). There was no significant difference within any treatment group at 12 weeks of follow-up, nor were there any significant differences between any telmisartan group and enalapril for exercise duration, New York Heart Association classification, or quality of life. Rates of 1 or more adverse events were reported as similar across treatment groups (overall rate of 54%), but group-specific rates were not reported. Cough was more common with enalapril, but not significantly different from rates with telmisartan (P=0. Telmisartan compared with ramipril (monotherapy and combination therapy) (n=1) A large, double-blind, non-inferiority, randomized, good-quality trial (N=25 620) compared ramipril 10 mg daily, telmisartan 80 mg daily, and combination therapy in patients with vascular disease or diabetes with end-organ damage but without symptomatic heart failure (ONTARGET, 31 The Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial). At a median follow-up of 56 months, telmisartan was not inferior to ramipril for the prespecified primary outcome of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure (relative risk, 1.

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Triptan compared with placebo: Sumatriptan SC pain outcomes………………… buy cheap cleocin gel 20gm online acne yellow pus. purchase cleocin gel 20gm otc acne gel..... Triptan compared with placebo: Summary of quality-of-life results………………….. Triptan compared with placebo: Summary of disintegrating drug results……………. Triptan compared with placebo: Summary of early treatment results………………. Prior versions of this report can be accessed at the DERP website. Triptans Page 2 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Bomhof Multicenter single-dose RCT Not stated 618 39 years I H S criteria 6-month history of migraine; 1-8 1999 conducted in Europe of 84% female 18-65 men and reports per month; no evidence naratriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Bomhof H. O cva, cardiovascular disease, Merck, co-investigator Permitted NR 1999 significant ecg abnormality, history or (maker of rizatriptan) drug or alcohol use, past use of study drugs Carpay 1997 Known narcotic/alcohol abuse Glaxo NR 142/124/124 ergotamine abuse pregnancy, breast-feeding history of ECG evidence of ischaemic heart disease significant concomitant disease significant psychiatric illness known hypersensitivity to/intolerance of sumatriptan current use of fluarizine Triptans Page 4 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Bomhof 96 (did not take study 1999 medication) Carpay 1997 NR/NR Triptans Page 5 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Charlesworth Multicentre, DB, Double- 42 centers in 1547 Mean age=19. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Charlesworth History of basilar, ophthalmoplegic AstraZeneca NR 1547/1383/1372 2003 migraine reported non-migraine > 10 days/month 6 months before study pregnancy, lactation, inadequate conception in women ischaemic heart disease, arrhythmias/cardiac accessory uncontrolled hypertension, use of monoamine oxidase-A inhibitors, methylergometrine within 2 weeks of study clinically significant abnormal laboratory result recent history of drug/alcohol abuse known hypersensitivity/adverse reaction to study treatments/triptans existing serious medical condition participation in another clinical study at same time of this study risk of transmitting Hep B/HIV Colman, 2001 Subjects could not have uncontrolled Pharmacia Rescue medications NR/NR/1255 Spierings, hypertension, defined as a diastolic allowed at 2 hours 2001 blood pressure higher than 95 mm Hg or a systolic blood pressure higher than 160 mm Hg, or clinically significant disease affecting any system but especially the cardiovascular or gastrointestinal tract Triptans Page 7 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Charlesworth 66/8 2003 Colman, 2001 NR/NR Spierings, 2001 Triptans Page 8 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Diez Multicenter, randomized, open, NR 436 Mean age: 36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Diez Complex forms of migraine, pregnancy, Almirall Prodesfarma Rescue medication NR/436/372 2007 lactation, hypersensitivity to any permitted (NSAIDs) component of the study medications, history signs or symptoms of ischemic heart disease, cerebrovascular accidents, transient ischemic attack or peripheral vascular disease. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Diez 54/10 2007 DowsonDowson 32(14. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gallagher Multicenter, multiple-dose Not stated 1212 39 years IHS criteria; 1 For women, use of reliable 1999, 2000 analysis of DB RCT, 6 month 85% female year history of contraception. Patients who had study; conducted in Europe of race/ethnicity migraine 2 or more migraines included in zolmitriptan vs. Garcia-Ramos Multicenter, single-attack, DB Not stated 548 Mean age=36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gallagher H/o ischemic heart disease, arrhythmia, Zeneca, co-investigator Some permitted NR 1999, 2000 hypertension, some types of migraine; drug or alcohol abuse, abnormal lab tests Garcia-Ramos 1) Coronary artery disease, heart failure, Pfizer Rescue medication 563 screened/548 2003 uncontrolled hypertension or abnormal allowed by 4 hours post- randomized/483 treated an UK/Latin ECG; dose (excluding any other attack America 2) frequent migraine or concommitant triptan, ergotamine, or nonmigrainous headache (<6 per month), ergotamine-like substance) Fair quality migraine variants (e. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gallagher 233 who had only 1 1999, 2000 headache Garcia-Ramos 65 not treated/4 2003 withdrawn/1 (0. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Geraud Multicenter, single-dose DB Outpatient 1311 38 years IHS criteria; 1 Average of 1-6 attacks per 2000 RCT conducted in Europe and 85% female year history of month for the 6 months Australia of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Geraud H/o ischemic heart disease, arrhythmias, Maker of zolmitriptan, co- Permitted NR 2000 uncontrolled hypertension, use of investigator psychoactive drugs, history of drug or alcohol abuse; certain types of migraine; any condition that could interfere with efficacy assessments, pregnant or breastfeeding Goadsby Hemiplegic or basilar migraine, tension- Almirall Prodesfarma Rescue medication (other NR/NR/1298 2007 type headache >4 days/month, inability than triptans) was to distinguish between tension-type and permitted migraine headache, history of ischaemic heart disease, severe or uncontrolled hypertension, cerebrovascular disease, peripheral artery disease, moderate to severe renal or hepatic disease, pregnancy, lactation, history of abuse of analgesics or ergot derivatives or triptans, allergy or sensitivity to sulfonamides or triptans Goadsby, 2000 >6 migraine attacks per month, frequent Pfizer, Ltd. Rescue medication NR/NR/857 Jackson, 1998 tension-type headaches, recent history allowed after 2 hours of alcohol or other substance misuse, serious allergic reactions to drugs, use of any experimental drug within the past month, pregnant or breastfeeding women, severely limited gastrointestinal absorption, any medical condition that might interfere with the interpretations of the study results, coronary artery disease, heart failure, uncontrolled hypertension, and receiving medication specifically contraindicated with sumatriptan Triptans Page 16 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Geraud 253; 225 did not take 2000 medication, 28 were lost to follow-up Goadsby 122/NR 2007 Goadsby, 2000 157/849 (18. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gruffyd-JonesGruffydd-Jones Multicentre, randomized, open, NRMulticenter, double-dummy Not stated 1787401 Age range=18-42 years IHS criteriaMale or female Average of 1-6 attacks perHistory of migraine for at least 2001 RCT conducted in 21 countries 86% female 18-65 men and month for 2 months preceding of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gruffyd-JonesGruffydd-Jones Pregnancy, lactating, inadequateNR Astra-Zeneca, funderNR Most prohibitedRescue medication: 414/401/388NR 2001 contraception in females, ischemic heart disease, arrhythmias, cardiac accessory pathway disorders, hypertension, use of MAO inhibitors, recent history of alcohol or drug abuse, abnormal clinical lab result, STDs, hepatitis B. Havanka History suggestive of cardiovascular or Glaxo, co-investigator Prophylactic medications NR 2000 cerebrovascular disease; hypertension; stopped 1 week before the pregnant or lactating; history of drug or study; rescue drugs not alcohol or ergotamine abuse; use of permitted MAO inhibitors, SSRIs, lithium, or flunarizine. Triptans Page 19 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gruffydd-JonesGruffyd-Jones 620, many because109/30% 2001 they did not have 6 attacks Havanka NR 2000 Triptans Page 20 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1.

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Resistance muta- tions of elvitegravir and raltegravir overlap to a great extent (Garrido 2012) cleocin gel 20 gm line skin care 29 year old. No viro- logic response was observed in a small clinical study with patients who switched from elvitegravir to raltegravir (DeJesus 2007) cheap 20gm cleocin gel fast delivery acne under skin. Major interactions with elvitegravir are not expected, at least not with NRTIs, darunavir, tipranavir, fosamprenavir or etravirine. However, dose adjustments with lopinavir/r and atazanavir/r may be necessary. The dose of maraviroc must be halved (Ramanathan 2011). There are no clinically relevant interactions between boosted elvitegravir and H2-receptor antagonists or proton pump inhibitors. However, staggered antacid administration by 2 hours is recommended (Ramanathan 2013) In September 2014, elvitegravir as single agent was approved for use with a protease inhibitor coadministered with ritonavir plus other antiretrovirals. The approval was based upon results from the Phase III Study 145 (see above). Raltegravir (RAL, Isentress) is a strand transfer inhibitor and was the first integrase inhibitor on the market (Hazuda 2000). Raltegravir has a wide range of efficacy for R5 and X4 tropic viruses, and inhibits HIV-2 replication. During a 10-day monotherapy, viral load declined by two logs (Markowitz 2006). The encouraging results of an early Phase II study in extensively pre-treated patients (Grinsztejn 2007) were confirmed by two large Phase III studies which led to approval of raltegravir. In BENCHMRK-1 and -2, a total of 699 pretreated patients with triple- 6. Overview of antiretroviral agents 103 class resistance were randomized to raltegravir 400 mg BID or placebo, each combined with an optimized background therapy (Cooper 2008, Steigbigl 2008). After 16 weeks, 79% (versus 43%) of patients showed a viral load below 400 copies/ml. Even in patients initially without an active substance in their background therapy in geno- typic assays, the success rate reached 57% (versus 10%). The effects were sustained beyond 144 weeks (Eron 2010). Raltegravir has also been effective in treatment-naïve patients. The encouraging data from an early Phase II study (Markowitz 2009) were confirmed by a large Phase III study in which 563 patients received either raltegravir or efavirenz (Lennox 2009): at week 48, rates of patients achieving undetectable plasma viremia (<50 copies/ml) were 86% and 82%, respectively. Tolerability was better and the effects were main- tained over five years (Rockstroh 2013). In September 2009, raltegravir was approved for first-line therapy. In ACTG 5237, raltegravir was superior to the two boosted PIs atazanavir and darunavir (Landovitz 2014). Tolerability of raltegravir has so far been excellent. In BENCHMRK, raltegravir side effects were comparable to placebo. Apart from some anecdotal reports of rhab- domyolysis, hepatitis, rash and insomnia (Gray 2009, Santos 2009, Dori 2010, Tsukada 2010), frequently appearing side effects with raltegravir have not been seen. Raltegravir seems to be safe, including in those with hepatitis coinfections (Rockstroh 2012). In patients with renal impairment, no dosage adjustment is required. Expected autoimmune diseases observed in animal testing have so far not been clinically confirmed (Beck-Engeser 2010). There is limited data for pediatric or pregnant patients (Taylor 2011). Due to its excellent tolerability, raltegravir is currently being evaluated in the setting of nuke-sparing strategies (see below). The fact that viral load decreased more rapidly in the first weeks in patients taking raltegravir compared to those taking efavirenz led to some speculations about higher potency (Murray 2007). Several experimental studies looked at strategies aimed at achieving viral eradication with raltegravir intensification (see chapter on Eradication).

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