Augusto Afonso Guerra Júnior

Federal University of Minas Gerais, Cidade de Minas, Minas Gerais, Brazil

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Publications (56)13.76 Total impact

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    ABSTRACT: OBJECTIVE To analyze the cost-effectiveness of treatment regimens with cyclosporine or tacrolimus, five years after renal transplantation. METHODS This cost-effectiveness analysis was based on historical cohort data obtained between 2000 and 2004 and involved 2,022 patients treated with cyclosporine or tacrolimus, matched 1:1 for gender, age, and type and year of transplantation. Graft survival and the direct costs of medical care obtained from the National Health System (SUS) databases were used as outcome results. RESULTS Most of the patients were women, with a mean age of 36.6 years. The most frequent diagnosis of chronic renal failure was glomerulonephritis/nephritis (27.7%). In five years, the tacrolimus group had an average life expectancy gain of 3.96 years at an annual cost of R$78,360.57 compared with the cyclosporine group with a gain of 4.05 years and an annual cost of R$61,350.44. CONCLUSIONS After matching, the study indicated better survival of patients treated with regimens using tacrolimus. However, regimens containing cyclosporine were more cost-effective.
    Revista de saude publica 03/2015; 49(1):1-9. DOI:10.1590/S0034-8910.2015049005430 · 1.22 Impact Factor
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    ABSTRACT: Technologies: Medicines whose active ingredient is somatropin registered in Brazil. Indication: Hypopituitarism and Turner syndrome. Technologies characterization: Somatropin is human growth hormone produced by recombinant DNA technique. Question: What brand of recombinant human somatropin, currently incorporated by the Unified Health System (4 and 12 IU) and the general market (15, 16, 18, 30, 36 and 60 IU), presents itself more economically advantageous considering the indication, stability and the cost? Methods: The registered medicines in Brazil were obtained from the electronic database of the National Health Surveillance Agency (ANVISA). The stability of drugs and indications were obtained from the package inserts. The average body weight of patients with active process for somatropin was obtained in the Information System of the Pharmaceutical Assistance Management (SiGAF) and was used to calculate the consumption. To calculate the consumption and the wastage we considered the minimum and maximum dose recommended in Clinical Protocols and Therapeutic Guidelines of the Brazilian Ministry of Health. For the estimated cost of treatment analysis we considered the consumption and the Maximum Price of Sale to the Government with 0% tax obtained from the Drug Market Regulation Chamber on 11/20/2014. Results: Seven brands with 13 different presentations of human recombinant somatropin are currently available in the market. Aside from Eutropin® 4 IU that should be used right after reconstituted, all medicines have stability of 28 days. Hormotrop® is indicated only for Turner syndrome, but its formulation is similar to that of medicines indicated for hypopituitarism. Comparing all medicines, those incorporated by the SUS showed higher prices per IU (exception: Norditropin® 15 IU that showed the highest price). For children with hypopituitarism, the estimated average monthly somatropin wastage was 2.05 to 2.06 IU (4 IU stability of 28 days); 5.84 to 6.28 IU (IU 12); and 6.3 to 10.1 IU for presentations from 15 to 18 IU. For presentations of 30 IU or more the monthly average wastage was estimated to be 18.2 to 51.2 IU. Considering all registered medicines, those incorporated by SUS emerged from the fifth position of lower estimated average cost. For adults with hypopituitarism, the estimated average monthly somatropin wastage was 1.00 to 2.00 IU (4 IU - 28 days); 6.00 to 9, 00 IU (12 IU); and from 0.00 to 21.00 IU for presentations from 15 to 18 IU. For presentations of 30 IU or more the monthly average wastage was estimated to be 30.00 to 105.00 IU. Considering all registered medicines, those incorporated by SUS appeared from the first position of lower average estimated cost for the minimum dose, and from the fifth position for the maximum dose. For patients with Turner syndrome the estimated average monthly somatropin wastage was 2.65 to 2.08 IU (4 UI - 28 days); 6.08 to 6.86 IU (12 IU); and from 7.18 to 10.18 IU for presentations 15-18 IU. For presentations of 30 IU or more the monthly average wastage was estimated to be 14.29 to 30.08 IU. In a ranking with 13 placements, the medicines incorporated by SUS appeared from the eighth place of lower estimated average cost. The medicine Eutropin® 4 IU showed the highest wastage and the highest cost estimates for both diseases. Recommendations: Strictly speaking the use of Hormotrop® for hypopituitarism is off label. We emphasize the similarity between the formulation of this medicine and that of the others, and the fact that the indication update process stars with a requested by the registry holder, and not only on the existence of scientific evidence. With the results obtained for hypopituitarism and Turner syndrome we know that: (i) IU prices of medicines incorporated by SUS were the highest among all registered medicines (except for Norditropin® 15 IU); (ii) less wastage with presentations incorporated by SUS did not translate into better results of estimated mean treatment cost (presentations 15, 16 and 18 IU had lower or similar cost); and that (iii) the stability of Eutropin® 4 IU was responsible for it worst results of treatment cost and wastage. Thus, in order to obtain the medicine with lower cost and wastage, we recommend that the purchase of somatotropin be made considering price per IU, and to allow the participation of presentations of up to 18 IU. We also recommend the inclusion of technical criteria for the purchase somatropin, such as stability of 28 days. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Objective: To evaluate the lawful request of ziprasidone for treating trichotillomania and obesity. The drug is indicated, but it consists of a contingency measure, since social inclusion may have potencial to improve the overall state. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Technologies: Dutasteride and Abiraterone Indication: Prevention (dutasteride) and treatment (dutasteride or abiraterone) of prostate cancer. Characterization of the technologies: Dutasteride inhibits the conversion of testosterone to dihydrotestosterone, an androgen that is directly involved in the development of benign prostatic hyperplasia. Abiraterone is an inhibitor of androgens biosynthesis, which are hormones that stimulate the growth of prostate cancer cells. Question: Are dutasteride and abiraterone safe and effective for the prevention and treatment of prostate cancer? Search and analysis of scientific evidence: We searched Medline (via Pubmed), The Cochrane Library, LILACS and Centre for Reviews and Dissemination (CDR) databases for systematic reviews (SR) of clinical trials that assessed the use of abiraterone and dutasteride for the treatment of prostate cancer. We searched Health Technology Assessments (HTA) in sites of international agencies and the Brazilian Network for Health Technology Assessment. Quality of the evidence and strength of recommendation were evaluated using the GRADE system. Summary of results of selected studies: Four studies, two RS and two RCTs were selected. The RCT showed that dutasteride reduced by 38-66% cancer progression compared to placebo, with similar safety profile. Both RCTs have important limitations, such as funding by the manufacturer of dutasteride, considerable loss of follow up and no evaluation of survival. No ATS recommendations of dutasterida use in the treatment of prostate cancer were found. Regarding the prevention of prostate cancer, dutasteride was evaluated in a RS moderate quality, which showed favorable efficacy results, but with possible increase of disease progression. The fact resulted in the withdrawal of the license by the manufacturer of this therapeutic indication. High quality RS showed that the use of abiraterone and prednisone promotes 26% higher survival and 45% lower disease progression compared to placebo combined with prednisone in the treatment of metastatic castration-resistant prostate cancer. However the abiraterone presented unfavorable safety profile. ATS recommend abiraterone for the treatment of metastatic castration-resistant prostate cancer who had disease progression during or after failed therapy with docetaxel. However, other drugs such as cabazitaxel and mitoxantrone could be used after failure with docetaxel, and there is difficulty in choosing one therapy over another. Recommendations: For the initial stages of prostate cancer, surgery, radiation therapy, brachytherapy, and in some cases, vigilant observation are indicated. Dutasteride should not be used for prevention or treatment of prostate cancer, since the evidence evaluated is not sufficient to ensure a positive balance between the benefits and harms related to the technology use. Chemotherapy is indicated in more advanced stages of the disease and should be initiated quickly in patients with castration-resistant and metastatic cancer who are symptomatic, usually using docetaxel as first choice. After failure of first-line therapy, we weakly recommend the use of abiraterone and prednisone. For the treatment of patients who have resistant metastatic prostate cancer to castration, asymptomatic or mildly symptomatic who failed hormonal therapy and are chemotherapy-naive, we weakly recommend against the use of abiraterone and prednisone, due to lack of sufficient evidence to ensure greater effectiveness of abiraterone compared with docetaxel.
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    ABSTRACT: Strength of recommendations: Weak against the technology Technology: Valganciclovir Indication: Prevention of cytomegalovirus disease in solid organ transplant recipients Characterization of the technology: Valganciclovir is an antiviral drug, L-valyl ester (prodrug) of ganciclovir. It acts by inhibiting the viral DNA synthesis by a competitive inhibition of deoxyguanosine triphosphate incorporation to the viral DNA. Question: Is valganciclovir more effective and safer than other available therapies for cytomegalovirus prevention in solid organ transplant patients? Search and analysis of scientific evidence: We searched the Medline (via Pubmed), The Cochrane Library (via Bireme), Lilacs and the Centre for Reviews Dissemination (CRD). Systematic Reviews (SR) of clinical trials comparing valganciclovir to other antiviral drugs were included. Health Technologies Assessment (HTA) reports of international agencies were also searched. The quality of evidence and strength of recommendation were assessed using the GRADE system. Summary of results of selected studies: Seven SR were included and most of them presented low quality. None showed significantly superior efficacy of valganciclovir in cytomegalovirus prevention in solid organ transplants patients, when compared to therapeutic alternatives. In addition, its use, especially in 900mg/day dose, was statistically associated with the risk of leucopenia or neutropenia. We did not include any HTA. Recommendations: The strength of recommendation is weak against valganciclovir for cytomegalovirus prevention in solid organ transplants patients, considering the quality of the evidence and the higher cost of treatment compared to therapeutic alternatives. However, more transplant-specific studies are needed to evaluate its effectiveness in each type of solid organ transplant. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Technologies: Generic immediate release formulation of pramipexole Indication: Treatment of motor symptoms of Parkinson's disease. Technologies characterization: Pramipexole is a dopamine agonist that acts "replacing" dopamine, a neurotransmitter that is in decreased concentration in Parkinson's disease. Question: The generic drug pramipexole is safe and effective in the treatment of the motor symptoms of Parkinson's disease in comparison to the reference medicine (Sifrol®) and the similar medicine (Stabil®)? Search and analysis of scientific evidence: We performed a search for Brazilian official documents and reports that addressed the standards for registration of generic and similar medicines in the electronic sites of the National Health Surveillance Agency (from the Portuguese Agência Nacionald e Vigilância Sanitária - ANVISA) and international documents of the Food and Drug Administration (FDA), European Medicines Agency (EMA) sites and the World Health Organization (WHO). We conducted a search for scientific studies in Medline (via Pubmed), Centre for Reviews and Dissemination, The Cochrane Library, and LILACS. Summary of results of the selected studies: According to Law and resolutions of ANVISA the interchangeability between reference and generic, or similar medicines, is expected as they have to demonstrate biequivalence for the registration of the medicine in the Ministry of Health. ANVISA Resolutions regulated waiver from traditional bioequivalence studies for drugs considered to present high solubility and high permeability according to the Biopharmaceutics Classification System. In August 2014 pramipexole was included in the list of drugs eligible for biowaiver as it is considered of high absorption (greater than or equal to 85%) and of broad therapeutic index, i.e., the therapeutic dose is distant to the toxic dose. Furthermore, this drug has no reports of human absence of bioequivalence. In the United States of America pramipexole is eligible for biowaiver since 2010. The European agency has not released the list of drugs eligible for biowaiver, but considers drugs with high solubility and high permeability eligible for biowaiver, as well as the World Health Organization. After applying the eligibility criteria a scientific study was included. It is a narrative review in which the authors indicate that patients with Parkinson's disease should be treated with the brand name medicines. This study has important limitations regarding the method, as narrative reviews do not use a structured and reproducible search for studies, the authors can choose the ones that support their opinion. The peculiarities of patients with Parkinson's disease presented as an argument, such as reduced gastric motility, affect the effectiveness of generic, similar and reference medicines the same way. Recommendations: There is no legal and scientific support to justify the preference for brand name medicines with respect to pramipexole, since the Brazilian and foreign regulations point to the fact that there is no evidence of absence of bioequivalence between different formulations of immediate release pramipexole dichloridrate. In addition, we did not find high quality scientific evidence, according to the precepts of evidence-based medicine, which could point to differences in clinical outcomes between the formulations studied. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Intensity of recommendations: Weak in favor of the technology. Technology: Fluoxetine, sertraline and citalopram. Indication: Moderate or major depression. Characterization of the technology: Selective serotonin reuptake inhibitor (SSRI) antidepressants increase the amount of serotonin in the synaptic cleft, thus increasing synaptic stimulation and serotonergic activity in the body. Question: Are citalopram and sertraline more effective than fluoxetine for the treatment of major depression in adults? Search and analysis of scientific evidence: We searched Medline (via Pubmed), Centre for Reviews and Dissemination (CRD), The Cochrane Library and LILACS databases for systematic reviews (SR) of clinical trials that compared the efficacy and safety of fluoxetine, sertraline and citalopram for moderate or major depression. Quality of the evidence and strength of recommendation were evaluated using the GRADE system. We searched for Health Technology Assessments and therapeutic guides in international agencies and websites in the Brazilian Network for Health Technology Assessment. Summary of results of selected studies: We included seven SR, six with meta-analysis and one without. Assessing the effectiveness, the results of RS demonstrated a slight superiority of sertraline and fluoxetine front no statistically significant differences were observed between fluoxetine and citalopram. As for safety, most studies proved inconclusive or slightly favorable to fluoxetine. Compared to rates of noncompliance, the results were not statistically significant, we conclude that there is no difference between the drugs. Most RS showed evidence of low quality and all contributed to a weak recommendation in favor of sertraline. Four treatment guidelines were included. Their authors made no distinction between the SSRI medicines. Recommendations: Considering that most of the results had limitations and inconclusive data, it is recommended that further research is made, focusing on the comparison of SSRI drugs among themselves, expecting that new publications increase the strength and quality of evidence available for decision making. FULL CONTENT IN PORTUGUESE
  • Applied Health Economics and Health Policy 08/2014; DOI:10.1007/s40258-014-0113-x
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    ABSTRACT: Strength of recommendations: Weak in favor of Melatonin Technology: Melatonin Indication: Primary insomnia treatment Characterization of the technology: Capsules or tablets, used for primary insomnia treatment Question: Is Melatonin (MLT) effective for the treatment of primary insomnia? Search and analysis of scientific evidence: We searched the Medline (via Pubmed), The Cochrane Library (via Bireme), Lilacs and the Centre for Reviews Dissemination (CRD). Systematic Reviews (SR) of randomized controlled clinical trials comparing Melatonin or Ramelteon to placebo were included. The quality of evidence and strength of recommendation were assessed using the GRADE system. Summary of results of selected studies: 3 SR were selected which presented from low to moderated quality. The strength of recommendation for 2 of the 3 studies was weak in favor of MLT. The use it was associated with significant reduction of sleep latency. Total sleep time and sleep quality showed mixed results between nonsignificant and significant difference favoring the test drug when compared to placebo across studies. Melatonin showed little to none adverse effects. Recommendations: We weakly recommended the use of melatonin, considering that SR and Health Technology Assessment included in this advice demonstrated for patients with primary insomnia, melatonin showed statistically significant efficacy in reducing the time of sleep latency compared to placebo. For other outcomes evaluated - quality of sleep and total sleep time - the results were inconclusive, ranging from no significant difference to statistically significant. Regarding the safety profile, the studies found no adverse effects, but it should be noted that monitoring occurred only for short term use. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Technology: Testosterone Indication: Male sexual dysfunction Characterization of the technology: Testosterone is a steroid hormone that is naturally produced by the testicles and in much smaller amounts by the female ovaries and adrenal glands in both sexes. Testosterone is responsible for the development and maintenance of the normal masculine characteristics, and is also extremely important for sexual function and sexual performance. Question: Is testosterone effective and safe for treating men with sexual dysfunction? Search and analysis of scientific evidence: The Cochrane Library (via Bireme), Medline (via Pubmed), LILACS and Centre for Reviews and Dissemination (CRD) databases were searched. We attempted to find systematic reviews of clinical trials that compared testosterone with placebo or other therapeutic option for sexual dysfunction treatment. We also searched for Health Technologies Assessments (HTA) in national and international agencies websites. Studies published in English, Portuguese or Spanish were selected. Summary of results of selected studies: Two systematic reviews and seven randomized controlled trials were included. The reviews showed that in men with medium to low testosterone level the use of testosterone is moderately effective. However, these reviews had low and very low quality of evidence. The included randomized clinical trials showed each one different results due to the variability between the participant’s settings in each study. In addition, many results of clinical trials did not show statistical significance. No health technology assessment was found. Recommendations: Based on the available evidence of efficacy from the included studies, the lack of standardization in the definition of critical serum for the diagnosis of hypogonadism and the definition of appropriate dosage and the initial dose of testosterone replacement therapy, this technical report recommendation is weak in favor of the use of testosterone for the treatment of sexual dysfunction in men with hypogonadism. For men with normal testosterone levels, there is no indication for testosterone use. Of the included studies, few reported safety outcomes, therefore is not possible to conclude whether or not testosterone is safe in the treatment of sexual dysfunction in men. More studies on this subject are necessary to establish a more plausible recommendation on the use of testosterone for male sexual dysfunction treatment. FULL CONTENT IN PORTUGUESE
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    Felipe Ferré, Orozimbo Neto, Francisco de Assis Acurcio, Augusto Afonso Guerra Júnior
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    ABSTRACT: Strength of recommendation: Weak against the use of technology. Technology: Medicine and products based on Cannabis sativa. Indication: Treatment of Rett syndrome. Characterization of the technology: Enriched cannabidiol extracts with low delta-9-tetrahidrocanabinol (THC) content (up to 1%). Question: Medications based on Cannabis sativa are effective and safe for the treatment of epilepsy in patients with Rett syndrome compared with anticonvulsants available in SUS? Search and analysis of scientific evidence: We searched The Cochrane Library (via BIREME), Medline (via Pubmed), Lilacs, Centre for Reviews and Dissemination (CRD) and Tripdatabase databases aiming to find studies of Cannabis sativa treatment for Rett syndrome. We also selected Health Technology Assessments (HTA) on sites of international agencies and REBRATS. We also performed an additional search of clinical trials for the treatment of epilepsy with drugs containing known concentrations of cannabinoids extracted from Cannabis sativa. Summary of results of selected studies: No studies met the criteria for participant (patients diagnosed with Rett syndrome with episodes of epilepsy), intervention (medications based on Cannabis sativa), comparison (placebo drugs for epilepsy in Rett syndrome were identified - valproic acid, carbamazepine, clobazam, clonazepam, ethosuximide, phenytoin, phenobarbital, gabapentin, lamotrigine, primidone, topiramate, vigabatrin) and outcome (psychomotor improvement, reduction of seizures and adverse events). The four studies found in the supplementary search on the plant extract usage in the treatment of epilepsy had small sample, were of poor quality and inconclusive: two presented results in of favor the use of cannabidiol and two showed no differences among the groups. Recommendations: The intensity of the recommendation is weak against the use of medicine preparations of Cannabis sativa due to the lack of scientific evidence of efficacy and safety of plat extracts with high concentration of cannabidiol and low concentrations of delta-9-tetrahidrocanabinol. Because of the high concentration of THC, we strongly recommend against the use of the unpurified extract of Cannabis sativa. This position is guided by the possibility of the occurrence of adverse events such as deficits in cognitive development and seizure. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Technologies: Dutasteride and Abiraterone Indication: Prevention (dutasteride) and treatment (dutasteride or abiraterone) of prostate cancer. Characterization of the technologies: Dutasteride inhibits the conversion of testosterone to dihydrotestosterone, an androgen that is directly involved in the development of benign prostatic hyperplasia. Abiraterone is an inhibitor of androgens biosynthesis, which are hormones that stimulate the growth of prostate cancer cells. Question: Are dutasteride and abiraterone safe and effective for the prevention and treatment of prostate cancer? Search and analysis of scientific evidence: We searched Medline (via Pubmed), The Cochrane Library and LILACS databases for systematic reviews (SR) of clinical trials that assessed the use of abiraterone and dutasteride for the treatment of prostate cancer. We searched Health Technology Assessments (HTA) in sites of international agencies and the Brazilian Network for Health Technology Assessment. Quality of the evidence and strength of recommendation were evaluated using the GRADE system. Summary of results of selected studies: Four studies, two RS and two RCTs were selected. The RCT showed that dutasteride reduced by 38-66% cancer progression compared to placebo, with similar safety profile. Both RCTs have important limitations, such as funding by the manufacturer of dutasteride, considerable loss of follow up and no evaluation of survival. No ATS recommendations of dutasterida use in the treatment of prostate cancer were found. Regarding the prevention of prostate cancer, dutasteride was evaluated in a RS moderate quality, which showed favorable efficacy results, but with possible increase of disease progression. The fact resulted in the withdrawal of the license by the manufacturer of this therapeutic indication. High quality RS showed that the use of abiraterone and prednisone promotes 26% higher survival and 45% lower disease progression compared to placebo combined with prednisone in the treatment of metastatic castration-resistant prostate cancer. However the abiraterone presented unfavorable safety profile. ATS recommend abiraterone for the treatment of metastatic castration-resistant prostate cancer who had disease progression during or after failed therapy with docetaxel. However, other drugs such as cabazitaxel and mitoxantrone could be used after failure with docetaxel, and there is difficulty in choosing one therapy over another. Recommendations: For the initial stages of prostate cancer, surgery, radiation therapy, brachytherapy, and in some cases, vigilant observation are indicated. Dutasteride should not be used for prevention or treatment of prostate cancer, since the evidence evaluated is not sufficient to ensure a positive balance between the benefits and harms related to the technology use. For patients with castration-resistant metastatic cancer who are symptomatic, chemotherapy is indicated usually using docetaxel as first choice. After failure of first-line therapy, we weakly recommend the use of abiraterone and prednisone. For patients with castration-resistant metastatic cancer, asymptomatic or mildly symptomatic who failed hormonal therapy and are chemotherapy-naive, we weakly recommend against the use of abiraterone and prednisone, due to lack of sufficient evidence to ensure greater effectiveness of abiraterone compared with docetaxel.
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    ABSTRACT: Technologies: Pregabalin and vitamin B12 associated with uridine and cytidine (ETNA®) Indication: Treatment of diabetic neuropathic pain Technologies characterization: Pregabalin is an anticonvulsant indicated for the treatment of neuropathic pain in adults. Its mechanism of action is the reduction of calcium influx to regulate transmission of excitatory messages between nerve cells. ETNA ® is a combination of vitamin B12, uridine and cytidine nucleotides and it is indicated for the treatment of peripheral nerves diseases. Question: Are ETNA ® and pregabalin safe, effective and cost-effective options in the treatment of diabetic neuropathic pain, regarding the alternatives amitriptyline and gabapentin available at SUS? Search and analysis of scientific evidence: a search for systematic reviews and economic studies was performed in the databases The Cochrane Library (via Bireme), Medline (via Pubmed), LILACS and Centre for Reviews and Dissemination (CRD). Manual search was also conducted on the internet and in the references of the studies found. Health Technology Assessments (HTA) have been selected in international agencies and in Brazilian Network for Health Technology Assessment (REBRATS). Studies published in English, Portuguese or Spanish were selected. Summary of results of the selected studies: Nine studies were included, four systematic reviews, one clinical trial and four economic studies. Systematic reviews considering efficacy and safety of pregabalin evaluated the following outcomes: reduction in pain intensity, treatment response rate (≥50% on pain reduction), the Patient Global Impression of Change and adverse events. These reviews showed results in favor of pregabalin compared to placebo. The ETNA® Clinical trial showed results in favor of the intervention but compared to vitamin B12 alone. The results of cost-effectiveness for pregabalin considered as a measure of effectiveness the number of days with no pain or mild pain, the number of days with 30% and 50% reduction in pain and QALY gains. Only one cost-effectiveness study has not favored pregabalin. Recommendations: The treatment for neuropathic pain is contemplated in the therapeutic guideline for chronic disease, which recommends the use of amitriptyline in monotherapy as first choice or its association with gabapentin in cases of therapeutic failure with the monotherapy. The evidences appraised here allow recommending (weakly) the use of pregabalin in replacement of gabapentin only in cases of therapeutic failure of the schemes mentioned above, since no study included direct comparisons between pregabalin and amitriptyline or gabapentin, making it impossible to support the therapeutic superiority of pregabalin compared to other drugs already used in Brazil. The recommendation is against ETNA® use due to lack of studies with sufficient evidence of quality to ensure the efficacy and safety of this intervention and justify the expense.
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    ABSTRACT: Technologies: Pregabalin and vitamin B12 associated with uridine and cytidine (ETNA®) Indication: Treatment of diabetic neuropathic pain Technologies characterization: Pregabalin is an anticonvulsant indicated for the treatment of neuropathic pain in adults. Its mechanism of action is the reduction of calcium influx to regulate transmission of excitatory messages between nerve cells. ETNA ® is a combination of vitamin B12, uridine and cytidine nucleotides and it is indicated for the treatment of peripheral nerves diseases. Question: Are ETNA ® and pregabalin safe, effective and cost-effective options in the treatment of diabetic neuropathic pain, regarding the alternatives amitriptyline and gabapentin available at SUS? Search and analysis of scientific evidence: a search for systematic reviews and economic studies was performed in the databases The Cochrane Library (via Bireme), Medline (via Pubmed), LILACS and Centre for Reviews and Dissemination (CRD). Manual search was also conducted on the internet and in the references of the studies found. Health Technology Assessments (HTA) have been selected in international agencies and in Brazilian Network for Health Technology Assessment (REBRATS). Studies published in English, Portuguese or Spanish were selected. Summary of results of the selected studies: Nine studies were included, four systematic reviews, one clinical trial and four economic studies. Systematic reviews considering efficacy and safety of pregabalin evaluated the following outcomes: reduction in pain intensity, treatment response rate (≥50% on pain reduction), the Patient Global Impression of Change and adverse events. These reviews showed results in favor of pregabalin compared to placebo. The ETNA® Clinical trial showed results in favor of the intervention but compared to vitamin B12 alone. The results of cost-effectiveness for pregabalin considered as a measure of effectiveness the number of days with no pain or mild pain, the number of days with 30% and 50% reduction in pain and QALY gains. Only one cost-effectiveness study has not favored pregabalin. Recommendations: The treatment for neuropathic pain is contemplated in the therapeutic guideline for chronic disease, which recommends the use of amitriptyline in monotherapy as first choice or its association with gabapentin in cases of therapeutic failure with the monotherapy. The evidences appraised here allow recommending (weakly) the use of pregabalin in replacement of gabapentin only in cases of therapeutic failure of the schemes mentioned above, since no study included direct comparisons between pregabalin and amitriptyline or gabapentin, making it impossible to support the therapeutic superiority of pregabalin compared to other drugs already used in Brazil. The recommendation is against ETNA® use due to lack of studies with sufficient evidence of quality to ensure the efficacy and safety of this intervention and justify the expense. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Strength of Recommendations: Weak in favor of the technology Technology: Drug-Eluting Stent Indication: Increase in coronary luminal diameter and reducing restenosis stent for treatment of patients with coronary artery disease. Characterization of the technology: Tubular structures of metal, coated with a polymer and an antiproliferative agent. These structures are used to hold the arterial lumen open and prevent restenosis of the lesion and target vessel, by means of mechanical pressure and local administration of drugs. Question: Drug-eluting stents (DES) are more effective and safer than bare metal stents (BMS)? There are differences between the various DES? Search and analysis of scientific evidence: We searched the Medline and EMBASE and included observational studies comparing DES with each other or compared to BMS for treatment of patients with coronary artery disease. We searched Technology Assessments (HTA) studies in national and international agencies websites. Summary of results of selected studies: We selected four HTA and 34 observational studies, of which five were cohort studies and the remaining 19 registry studies published between 2005 and 2012, with mean follow-up ranging between six and 48 months. Among the selected observational studies, 27 studies (79.4%) were prospective. DES failed to reduce the mortality rate, incidence of myocardial infarction (MI) or stroke compared with BMS. There was a reduction in the rate of revascularization using sirolimus eluting stent (SES) compared to BMS. Regarding the comparison of DES with each other, there was no significant difference regarding mortality and MI. Diabetic patients were evaluated in SES vs. BMS and PES vs. BMS comparisons and there was no difference between groups for the primary outcomes. HTA studies recommended the use of DES if the cost of this technology is considered acceptable, by medical criteria and for the subgroup of patients considered at high risk of restenosis. Recommendations: Based on available evidence of effectiveness and safety and the results HTA found, we weakly recommend the use of drug eluting stents for patients with coronary artery disease who have complex lesion anatomy and for patients at high risk of being subjected to reintervention, such as diabetics. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Strength of Recommendations: Weak in favor of drug-eluting stents Technology: Drug-eluting stents Indication: Indicated to increase coronary luminal diameter and reduce stent restenosis of patients with coronary artery disease. Characterization of the technology: Metal Tubular structures, coated with a polymer and an antiproliferative agent, used to maintain the arterial lumen opened and to prevent restenosis of the lesion and the target vessel by mechanical pressure and local administration of drugs. Question: Drug-eluting stents (DES) are safer and more effective than bare metal stents (BMS)? There are differences between the various drug-eluting stents? Search and analysis of scientific evidence: We searched the Medline and EMBASE and included systematic reviews (SR) of randomized controlled trials (RCTs) comparing DES with each other or compared to BMS for treatment of patients with coronary artery disease. Summary of results of selected studies: 29 SR were selected and half of them had moderate to high quality. The strength of recommendation was weak for most studies. The use of DES was associated with a significant reduction of reintervention and major adverse cardiac events (combination of acute myocardial infarction, target lesion restenosis or need for reintervention or intra-stent thrombosis) compared to BMS. There was no difference in the risk of mortality, myocardial infarction and intra-stent thrombosis. After one year of follow-up, DES were associated with a higher risk of late and definitive thrombosis. Among DES, sirolimus and everolimus showed better results. The efficacy and safety profile for the subgroup of diabetic patients was similar to that observed for other patients. Recommendations: There was consistency between studies regarding the efficacy of DES compared to BMS, as assessed by the reduction of the reintervention rate. However, in robust outcomes such as death and myocardial infarction there was no difference between the various technologies compared. Considering the quality of the evidence, the results and the high cost of drug-eluting stents in Brazil, we recommend weakly the use of eluting stents for patients with coronary artery disease who have complex anatomy of the lesion and at high risk of reintervention, such as diabetics patients. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Technology: Drug Eluting Stents (DES) Indication: Myocardial revascularization in patients with coronary artery disease. Technology Characterization: DES are based on the principle of local administration, using the bare metal stents (BMS) as a platform to adduce the bioactive principle. The agents used in DES are highly lipophilic molecules and are distributed into the artery doing an immunosuppressive effect or antiproliferative effects on the smooth muscle cells of the artery. Question: Drug-eluting stents are more cost-effective than BMS? Search and analysis of evidence: We searched Medline (via Pubmed) and Embase. We searched for systematic reviews of economic studies and economic studies that compared DES with BMS. Were also selected Health Technology Assessments (HTA) from international agencies and from the Brazilian Network for Health Technology Assessment (Rede Brasileira de Avaliação de Tecnologias em Saúde - REBRATS). We selected studies published in english, portuguese or spanish, from 2009. Summary results of the selected studies: Nine economic studies and systematic review of economic studies considered as effectiveness measures survival, rate of re-intervention, restenosis rates and major adverse cardiovascular events. The studies were conducted in several countries, each with a specific context. In general, studies have shown that BMS were more cost-effective than DES in one year time horizon, but in long term and for high-risk patients, DES showed better cost-effectiveness ratio. Only one Brazilian study was included and it found that DES performed better than BMS, when considering the re-intervention as the effectiveness measure. Recommendations: In terms of cost-effectiveness and taking into account the Brazilian context, are needed studies considering all costs involved in the treatment, like the costs of the stent, stenting procedure, and complications treatment, the use of antiplatelet therapy and quality of life of patients. Also, is required the precise definition of clear intermediate and finalistic outcomes. So we can reach a conclusion about real cost-effectiveness of drug-eluting stents in Brazil. FULL CONTENT IN PORTUGUESE
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    ABSTRACT: Strength of Recommendations: Weak in favor of the technology Technology: Drug-Eluting Stent Indication: Increase in coronary luminal diameter and reducing restenosis stent for treatment of patients with coronary artery disease. Characterization of the technology: Tubular structures of metal, coated with a polymer and an antiproliferative agent. These structures are used to hold the arterial lumen open and prevent restenosis of the lesion and target vessel, by means of mechanical pressure and local administration of drugs. Question: Drug-eluting stents (DES) are more effective and safer than bare metal stents (BMS)? There are differences between the various DES? Search and analysis of scientific evidence: We searched the Medline and EMBASE and included observational studies comparing DES with each other or compared to BMS for treatment of patients with coronary artery disease. We searched Technology Assessments (HTA) studies in national and international agencies websites. Summary of results of selected studies: We selected four HTA and 34 observational studies, of which five were cohort studies and the remaining 19 registry studies published between 2005 and 2012, with mean follow-up ranging between six and 48 months. Among the selected observational studies, 27 studies (79.4%) were prospective. DES failed to reduce the mortality rate, incidence of myocardial infarction (MI) or stroke compared with BMS. There was a reduction in the rate of revascularization using sirolimus eluting stent (SES) compared to BMS. Regarding the comparison of DES with each other, there was no significant difference regarding mortality and MI. Diabetic patients were evaluated in SES vs. BMS and PES vs. BMS comparisons and there was no difference between groups for the primary outcomes. HTA studies recommended the use of DES if the cost of this technology is considered acceptable, by medical criteria and for the subgroup of patients considered at high risk of restenosis. Recommendations: Based on available evidence of effectiveness and safety and the results HTA found, we weakly recommend the use of drug eluting stents for patients with coronary artery disease who have complex lesion anatomy and for patients at high risk of being subjected to reintervention, such as diabetics.
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    ABSTRACT: Introduction: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti-TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. Methods: We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti-TNF agents before, and to relate outcome with RF and anti-CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager(r)5.1 for meta-analysis. Results: We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti-TNF treatment failure patients - ACR20/50/70 and EULAR response. We observed lower changes in Total Genant-modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF-36, FACIT-T and HAQ-DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti-CCP seropositive patients achieved ACR20 than RF/anti-CP negative patients in rituximab group. Conclusion: Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti-TNF treatment failure patients. RF and anti-CCP seam to influence treatment results, but this inference needs further research.
    Revista Brasileira de Reumatologia 06/2014; 54(3):220-230. · 0.99 Impact Factor
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    ABSTRACT: Introduction Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti–TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. Methods We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti–TNF agents before, and to relate outcome with RF and anti–CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager®5.1 for meta–analysis. Results We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti–TNF treatment failure patients ACR20/50/70 and EULAR response. We observed lower changes in Total Genant–modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF–36, FACIT–T and HAQ–DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti–CCP seropositive patients achieved ACR20 than RF/anti–CP negative patients in rituximab group. Conclusion Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti–TNF treatment failure patients. RF and anti–CCP seam to influence treatment results, but this inference needs further research.
    Revista Brasileira de Reumatologia 05/2014; 54(3):220–230. DOI:10.1016/j.rbr.2013.08.001 · 0.99 Impact Factor