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Only 1 patient discontinued glatiramer acetate but did so within the shortest amount of time (interferon ® ® beta-1a [Rebif ] 50% 50mg clomiphene fast delivery breast cancer 6 month follow up, 2 purchase 25mg clomiphene menstrual hygiene day. The main reason for discontinuation was lack of efficacy. There was little additional evidence regarding the comparative safety of interferons and glatiramer acetate based on data from observational and other non-randomized studies (Table 144, 173-175 34). While the types of adverse events reported in these studies and the rates of withdrawals due to adverse events were similar to those reported in controlled trials of these drugs, rates of other adverse events varied widely. These discrepant rates may have been the result of study design, as higher rates of flu-like syndrome, injection-site reactions, and fever were found in the trials, regardless of intervention. Tolerability outcomes of beta interferons compared with glatiramer acetate: trials compared with non-randomized studies Flu-like Injection-site Withdrawals due Intervention syndrome reaction Fever to AEs Non- Non- Non- Non- Trials RCTs Trials RCTs Trials RCTs Trials RCTs Interferon β-1a IM ® 62% 35% 9% 8% 20% 12% 4% 2% (Avonex ) Interferon β-1a SC ® 29% 6% 61% 6% 5% 3% 6% 8% (Rebif ) Interferon β-1b SC ® 42% 15% 59% 24% 33% 17% 8% 5% (Betaseron ) Glatiramer a 3% 0. Disease-modifying drugs for multiple sclerosis Page 72 of 120 Final Report Update 1 Drug Effectiveness Review Project Depression 176 A small (N=163) cohort study by Patten, et al used a Canadian reimbursement database to assess the incidence of depression in relapsing-remitting multiple sclerosis patients receiving any ® beta interferon (n=66) compared with glatiramer acetate (Copaxone ) (n=97). Specifically, the beta interferon-treated patients had slightly higher Expanded Disability Status Scale and depression scores and slightly lower quality of life scores at baseline. In addition, depression was common among multiple sclerosis patients, both at baseline (28. While glatiramer acetate-treated patients tended to have lower depression scores, there was no significant difference in depression score at 3-month follow-up between beta interferons and glatiramer acetate (40. This difference remained insignificant when any time points of follow-up were considered: 34. Cancer A cohort of patients in Israel with multiple sclerosis (type not specified) treated with beta ® interferons or glatiramer acetate (Copaxone ) was compared with healthy controls to assess the 177 incidence of cancer and the effect of beta interferon or glatiramer acetate use on cancer rates. This study found that baseline non-breast cancer incidence was lower in women with multiple sclerosis when compared with the general population and that use of either beta interferons or glatiramer acetate may increase the risk of developing cancer in women. However, this difference did not reach statistical significance and there was no significant risk difference for breast cancer in women or men. Larger studies could potentially validate a causal link between beta interferon or glatiramer acetate use and increased cancer risk, however based on the results of this study no such link can be proven or disproven. Lipoatrophy ® Evidence on the safety of glatiramer acetate (Copaxone ) from 5 non-comparative, non- 178-181 randomized studies was consistent with that from previously discussed trials. No additional serious adverse events were reported in any of these studies, with the exception of the risk of 182 potentially permanently disfiguring lipoatrophy with glatiramer acetate use. One long-term 170, 182 follow-up study and 1 small retrospective study found evidence of lipoatrophty. The small retrospective study found that 34 of 76 (45%) patients identified through chart review had evidence of lipoatrophy. Five of these cases were identified as severe, all cases occurred in women, and 4 withdrawals were attributed to lipoatrophy. The Miller study, which had the 170 longest follow-up of up to 22 years, found 33% of 18 patients had developed lipoatrophy. Overall, the observational studies agreed with the direct and placebo-controlled trials. Most patients experience at least 1 adverse event with the most common being injection site reactions and post-injection systemic reactions, however, treatment was generally well tolerated for years and treatment discontinuation due to an adverse event was uncommon. Lipoatrophy did appear to be a concern with long-term use. Natalizumab ® No studies compared natalizumab (Tysabri ) to another disease-modifying drug for multiple ® sclerosis. Two well-conducted trials compared natalizumab (Tysabri ) to placebo in patients Disease-modifying drugs for multiple sclerosis Page 73 of 120 Final Report Update 1 Drug Effectiveness Review Project 67, 68 with relapsing-remitting multiple sclerosis (Table 35). Patient population, natalizumab dose, 68 and study duration were similar in the 2 trials, however in 1 of these trials, interferon beta-1a ® IM (Avonex ) was used concomitantly in both groups. Adverse events were reported by most patients in these 2 trials, regardless of intervention. Combined data from both trials found that 97% of natalizumab patients and 98% of control patients reported some adverse event (P=0. Overall, rates of non-serious adverse events were similar in both trials (Table 35). Adverse events in natalizumab trials in patients with relapsing-remitting multiple sclerosis (natalizumab compared with control) Any adverse Injection-site Trial event Headache Depression Flu-like illness reactions Polman 95% vs. The exception was 2 cases of progressive multifocal leukoencephalopathy, a potentially fatal neurologic disorder, that were reported in patients enrolled in the SENTINEL trial and were possibly linked to natalizumab 68 use. No cases of progressive multifocal 67 leukoencephalopathy were reported in the AFFIRM trial. Further discussion of the association between natalizumab use and progressive multifocal leukoencephalopathy appears below.

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Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author discount clomiphene 100mg with amex pregnancy foods to avoid, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Sumatriptan Brandes generic 50mg clomiphene with mastercard breast cancer kills, 2007 85mg N=1441 NR Headache relief Study 1 Mean age (years) SNS: 65% vs S: 55% vs NS: SNS:40. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Sumatriptan Brandes, 2007 NR Study 1 Brandes, 2007 NR Study 2 Triptans Page 136 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Nasal Formulations: Sumatripan Diamond, 1998 5, 10, 20 mg N=1086 Relief at 1 Hour: Relief at 2hrs: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Nasal Formulations: Sumatripan Diamond, 1998 Clinical Disability scores at 2 hours: 5mg: 57%-No/Mild Impairment 10mg: 67%-No/Mild Impairment 20mg: 70%-No/Mild Impairment Placebo: 50%-No/Mild Impairment Triptans Page 138 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 5. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Peikert, 1999 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Peikert, 1999 Report of grade 0-1 for clinical disability: 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Salonen, 1994 1,5,10,20,40mg N=455 Results at Pain relief at 2 hrs: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Salonen, 1994 Clinical Disability at 2 hrs: Grade 0=no disability 5-40mg Sumatriptan: 0. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Dowson, 2003 0. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Dowson, 2003 Resumption of Normal Activities at 1 Hour: 0-90 days: 40. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Nasal Formulations: Zolmitripan Dodick, 2005 5mg N=1868 Relief at 1 Hour: Relief at 2 Hours: 40. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Nasal Formulations: Zolmitripan Dodick, 2005 No recurrance/requirement for rescue meds: Zolmitriptan: 2. Triptan compared with placebo: Triptans with none or few head-to-head trials Sample Size Age (mean yrs) Author, Year Drug/Dose Gender Results at 1 hour Results at 2 hours Gawel, 2005 5mg Nasal N=1044 Relief at 1 Hour: Relief at 2 hours: 41. Triptan compared with placebo: Triptans with none or few head-to-head trials Disability, Return to Author, Year Normal Function Gawel, 2005 Relief at 10 minutes: Z5: 15. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Eletriptan Difference of 19 yes Fair Pfizer, Ltd. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Cady Yes Study 1 Good Merck 2006 35 (1%) and USA Study 2 45 (11%) withdrawn post- randomizatio n due to not being treated, withdrew consent, or lost to follow- up Brandes NR 23 (<1%) Fair Pfizer 2005 withdrawn USA & post- Canada randomizatio n for not having an attack and/or recording necessary information in diary Triptans Page 152 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Goldstein Yes 18 (<1%) Good BMS 2005 withdrawn USA post- randomizatio n for not taking study medication to treat an attack Jelinski Yes 4 (<1%) GSK 2006 withdrawn Canada post- randomizatio n for not treating a migraine attack Mathew No; excluded No Fair NR 2007 30/347 (9%) who USA did not have 2-hour pain intensity data Triptans Page 154 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Tepper Yes 73 (10%) Good GSK 2006 withdrawn USA post- randomizatio n for not treating a migraine attack Winner Yes Study 1 Good NR 2006 58 (16%) USA Study 2 63(17%) withdrawn post- randomizatoi n for not treating a migraine attack Wendt NR NR Fair GSK 2006 USA Triptans Page 156 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 6. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Diener Yes 23 (10%) Good Bayer 2005 withdrawn HealthCare Germany post- randomizatio Diener n for not 2005 treating a Germany migraine (companion attack paper) Silberstein Yes 183 (14%) Good Pozen, Inc 2008 withdrawn and US post- GlaxoSmit randomizatio hKline n for not treating a migraine attack Tfelt-Hansen Yes 49 (32. Triptans compared with placebo controls: Assessment of internal validity Reporting of attrition, Author Allocation Groups Eligibility Outcome crossovers, Attrition: Year Randomization concealment similar at criteria assessors Care provider Patient adherence, and differential/hi Country adequate? Triptans compared with placebo controls: Assessment of internal validity Author Post- Year Intention-to-treat randomizatio Quality Country (ITT) analysis n exclusions Rating Funding Loder 2001 No; excluded No Fair Merck 88/472 (19%) who only treated 1 attack Pascual 2001 No; excluded No Fair Merck 32/481 (7%) for sumatriptan and 25/481 (5%) for rizatriptan in headache relief analysis Merck Yes No Good Merck Protocol 39- Unpublished Ahrens 1999 No; excluded 2/188 No Good Merck (1%) from rizatriptan and 5/185 (3%) from placebo groups that discontinued for "other" reasons Goadsby Yes No Fair NR 2008 Triptans Page 160 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Akpunonu 6mg Time to discharge: 60 NR NR NR 43 vs 66 1995 vs 96 min min Anonymous 1991 6mg, 8mg Relief: 51 vs 15 Relief: 73 vs 26 NR 30 Free: 45 vs 8 Bousser 6mg EARLY MORNING NR Relief: 71 vs 21 Relief: 78 vs 28 NR 1993 Free: 33 vs 10 Free: 44 vs 18 Cady 1991 (JAMA) 6mg Pooled results from 2 NR Relief: 70 vs 22 NR 10 studies Free: 49 vs 9 Cady 1993 6mg Relief: 54 vs 11 Relief: 80 vs 18 NR (Neurology) Cady 1998 6mg Sumatriptan naïve NR NR NR PRODUCTIVITY (any form); Only generalizable to patients that are working 8-hour shifts and have a migraine w/I the 1st 4 hours of a shift Cull 1997 S 6 mg Tx of recurrences NR NR NR Triptans Page 161 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Dahlof 1992 S 8 mg 8 mg NR NR NR 30 General well-being (MSEP): S>P Diener 1999 6mg NR NR Relief: 91. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Sumatriptan SC - pain outcomes Sumatriptan Earliest Author Dosage (mg) Notes 30-min outcomes 1-hour outcomes 2-hour outcomes relief (min) Winner, 2006 S 6mg Morning migraines NR NR Free: 48 vs 18 10 (Study 1) Winner, 2006 S 6mg Morning migraines NR NR Free: 57 vs 19 10 (Study 2) Wendt, 2006 S 4mg Acute migraine attacks Relief: 43 vs 18 Relief: 67 vs 25 Relief: 70 vs 22 10 in clinic Free: 10 vs 3 Free: 34 vs 7 Free: 50 vs11 Triptans Page 165 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 7. Triptan compared with placebo: Sumatriptan SC - pain outcomes 24-hr Earliest sustained! Triptan compared with placebo: Summary of quality-of-life results Sample size Age(years) Author Dose % Female Special characteristics Functional capacity Almotriptan Freitag, 2008 Almotriptan N=378 Functional disability and A vs Pla 12. Triptan compared with placebo: Summary of quality-of-life results Author QOL/Work-related outcomes Almotriptan Freitag, 2008 24 hour QOL social function domain p<0. Eletriptan Wells, 2000 Total Time Loss: Median Hours E40: 4.

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Last but not least clomiphene 100mg with mastercard pregnancy hemorrhoids, a wish for parenthood should be considered purchase 50mg clomiphene with visa womens health your best body meal plan. There are no absolute contraindications Illness Caution with Active hepatitis B Nevirapine, boosted PIs (beneficial: Tenofovir+ FTC) Active illicit drug use NNRTIs, ritonavir, cobicistat (possibly beneficial: raltegravir) Anemia AZT, possibly also 3TC Arterial hypertension Indinavir Cancer requiring chemotherapy Boosted PIs, boosted INIs (possibly beneficial: raltegravir) Chronic diarrhea, intestinal diseases Lopinavir, fosamprenavir, other PIs Diabetes mellitus PIs Kidney disease Tenofovir, atazanavir, elvitegravir/c Myocardial infarction Abacavir, ddI, PIs (potentially beneficial: nevirapine) Osteoporosis Tenofovir Pancreatitis ddI Polyneuropathy d4T, ddI Psychoses, other CNS illnesses Efavirenz, possibly rilpivirine 6. What to start with 183 Interactions with medications and drugs Interactions are important in when choosing regimens. Whereas interactions between antiretroviral drugs are well known, those with other medications are often less well characterized (see section on interactions). The urgent need for more research was demonstrated in a study investigating the interactions between ART and lipid lowering agents. In healthy volunteers, the measurement of plasma levels showed that levels of simvastatin were elevated by 3059% after concurrent dosing with riton- avir or saquinavir (Fichtenbaum 2002). Several cases of fatal rhabdomyolysis on sim- vastatin, atorvastatin and PIs such as atazanavir or lopinavir have been described (Review: Chauvin 2013). There are even case reports on pravastatin and rosuvastatin (Mikhail 2009, de Kanter 2011), so boosted PIs or INIs such as elvitegravir/c should be utilized with caution. The same applies to several HCV drugs such as daclatasvir. Many other drugs should be avoided in combination with particular antiretroviral drugs, as incalculable interactions may occur. Even drugs that seem unproblematic at first glance can have unfavorable effects. For example, the plasma levels of saquinavir can be reduced by half with administration of garlic capsules (Piscitelli 2002). One noteworthy interaction is between PIs and inhaled or intranasal corticosteroids. This interaction can result in adrenal insuffi- ciency and iatrogenic Cushing’s syndrome (Saberi 2013). Even a seemingly harmless agent such as vitamin C can influence plasma levels. A small study in healthy vol- unteers showed that vitamin C can significantly lower (14%) unboosted indinavir levels (Slain 2005). Coumarin derivative anticoagulants, such as warfarin can also be a problem; ritonavir can significantly lower plasma levels (Llibre 2002). Further typical problem drugs include migraine remedies, prokinetic drugs and sedatives/ hypnotics. One fatal case was described with ergotamine and ritonavir (Pardo 2003). The simultaneous administration of ART and PDE-5 inhibitors (sildenafil, vardenafil, tadalafil) can also be problematic. Drugs or alcohol can interact with ART (Neuman 2006, Mass 2006). For those in sub- stitution programs, the methadone requirement may be significantly increased by certain antiretroviral drugs, such as nevirapine and efavirenz (Clarke 2001). To a lesser extent, this is also true for ritonavir and nelfinavir. There is inconsistent data on lopinavir but it may also require dose adjustments. Raltegravir, seems to have no effects (Anderson 2010). Other interactions have even more dangerous consequences. Several deaths have been reported after simultaneous dosing with ritonavir and amphetamines or MDMA/ecstasy, the popular narcotic gamma hydroxybutyric acid (GHB) or “liquid ecstasy” (Henry 1998, Harrington 1999, Hales 2000). Ritonavir in particular inhibits the metabolism of amphetamines, ketamines or LSD (Antoniou 2002). Clinicians and patients are well advised to have an open conversation about drug use before starting therapy. Marijuana and THC appear to have a low potential for interactions (Kosel 2002). Amphetamines seem to be particularly dangerous and neurotoxic in HIV+ patients (Chana 2006). Many are described in the respective drug chapters and in the Interactions chapter. It is always recommended to check the package insert. Initiation of ART provides a good opportunity to re-evaluate exist- ing prescribed medications.

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