Drugs In Brazil Research Articles

Retrospective application of ICH M7 to anti-hypertensive drugs in Brazil: Risk assessment of potentially mutagenic impurities

Potentially mutagenic impurities are likely to be formed in any drug substance, since their synthesis requires reactive intermediates which may also react with DNA. The ICH M7 guideline, which defines how to risk assess and control mutagenic impurities, was first published in 2014 and is not to be applied retrospectively; however, some impurities have been found above the permitted limits in drug products which were already on the market. This study assessed the implications of applying ICH M7 retrospectively to anti-hypertensive drugs marketed in Brazil by performing a risk assessment and establishing control strategies. The manufacturing processes of 15 drug substances were evaluated and 262 impurities were identified, from which 21% were classified as potentially mutagenic. Most of the impurities were identified below ICH M7 acceptable limits, except for impurities described in a pharmacopoeial monograph. Compendial specifications are defined based on scientific evidence and play an important role in setting quality and safety standards for pharmaceuticals, however there are opportunities for further alignment with ICH guidelines, aiming for a holistic assessment of the impurities profile to ensure the safety of medicines.

Case Report: Cross-reaction of phencyclidine in immunochromatographic tests for rapid drug detection using in silico analysis for investigation

Phencyclidine (PCP) is a dissociative drug previously used as an anesthetic agent but caused hallucinations due to its neurotoxic effects. A 49-year-old male farmer attempted suicide at home due to a massive intake of prescription drugs. Toxicological analysis was performed with an immunochromatography test and detected PCP (an uncommon drug in Brazil). Liquid chromatography-tandem mass spectrometry (LC-MS/MS) and in silico models were employed to elucidate this case. Despite the presence of midazolam, fentanyl and lidocaine in urine and serum samples by LC-MS/MS, these drugs and respective metabolites were not able to promote a cross-reaction with PCP as demonstrated by in silico models as well as our practical experience. In fact, doxepin, trimipramine and promethazine and their respective metabolites showed a high correlation interaction in the binding site of 2PCP, especially promethazine. Predicted results obtained on docking show a high correlation interaction between PCP and promethazine, indicating a possible cross-reaction in the immunochromatography test.

DA CRIMINALIZAÇÃO DE SUBSTÂNCIAS À POLÍTICA DE “GUERRA ÀS DROGAS”: UM SÉCULO DE PROIBICIONISMO NO BRASIL

Abstract In 1921, Decree 4,294 defined prohibitionism as the referential model of state response to drugs in Brazil. One century later, not only is the approach still enshrined in national legislation but also materialized in a complex institutional and bureaucratic network of governance and public policies. This paper examines the evolution of drug policies in Brazil over the past century, exploring how a web of normative, political, and institutional devices converged to entrench the hegemony of the prohibitionist approach in public responses to drugs. A systematic analysis of national and international legislation reveals that the prohibitionist enterprise was successful in Brazil due to two factors: i) as an ideational set, it was integrated into structuring discursive fields of Brazilian political culture, dialoguing with the stigmatization of marginalized populations and criminalization of their practices; and ii) as an ordering principle of public policy, it has demonstrated remarkable resilience and adaptability, incorporating elements of alternative models into its framework without compromising its fundamental structures. Political innovations implemented in Brazil since the 1990s (especially decriminalization and damage reduction models) have been able to neither shake the definition of drugs as a moral and criminal problem, nor prevent its instrumentalization as a policy of socio-spatial control of lower classes.

The myths that drive therapeutic inertia in multiple sclerosis: a cost-effectiveness analysis of high-efficacy drugs in Brazil.

The myths that drive therapeutic inertia in multiple sclerosis: a cost-effectiveness analysis of high-efficacy drugs in Brazil.

HTA99 Expert Validation on Proposed Framework for Differentiated HTA Criteria for Rare Disease Drugs in Brazil

HTA99 Expert Validation on Proposed Framework for Differentiated HTA Criteria for Rare Disease Drugs in Brazil

Abstract 11768: Regression of Inflammation by Cardiac Magnetic Resonance in Chronic Chagasic Patients Treated With Benznidazole

Introduction: Chagas disease (CD) is a neglected disease caused by Trypanosoma cruzi ( T. cruzi ), and benznidazole (BZN) is the most prescribed trypanocidal drug in Brazil in function of its best tolerability profile. While treatment with this drug is effective in acute disease, there is no consensus on its effectiveness in adults with chronic infection. Although it is now accepted that treatment directed against T. cruzi is necessary to avoid the long-term sequelae of the disease, the lack of reliable markers for assessment of treatment efficacy is a major obstacle to evaluating new drugs. Hypothesis: the objective of this study is to determine if BZN treatment reduces cardiac inflammation/fibrosis as assessed by magnetic resonance imaging (MRI), using parametric mapping techniques. Methods: Prospective, multi-center study of chronic CD patients underwent MRI T1 and T2 mapping and extracellular volume measurement (ECV) using the modified Look-Locker inversion recovery (MOLLI) sequence, undergoing treatment with BZN, at a dose of 300 mg/kg daily divided into two doses and taken for 60 days. Absolute change T1 and T2 mapping, ECV, left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV) and left ventricle ejection fraction (LVEF) were analyzed from baseline to 6-month follow-up. Results: 53 patients (females 83%, 53.9 ± 11.9 years old) were studied. LVEDV (149 ± 27ml vs 147 ± 29ml, p = 0.52), LVESV (66 ± 29 vs 64 ± 15, p = 0.65) and LVEF (55 ± 11% vs 57 ± 8%, p = 0,28) did not change between baseline and post treatment. Native T1 time showed reduced values among anterior (1030 ± 41ms vs 1011 ± 52ms, p = 0.011), septal (1052 ± 53ms vs 1006 ± 38ms, p = 0.000) and lateral (1042 ± 55ms vs 1019 ± 44ms, p = 0.003) LV walls. T2 mapping showed reduction in LV septal wall (53 ± 4ms vs 52 ± 3ms, p = 0.005). ECV showed significant reduction from baseline to 6-month follow-up (29.9 ± 3,3% vs 28.2 ± 3.5%, p = 0.0001). Conclusions: For the first time, we observe favorable changes in CMR ECV, T1 and T2 mapping induced by benznidazole therapy in chronic Chagas disease patients. These findings suggest that there may be an opportunity to decrease fibrosis/inflammation in chronic CD patients with the use of this therapeutic approach.

Consensus on the therapeutic management of atopic dermatitis ‒ Brazilian Society of Dermatology: an update on phototherapy and systemic therapy using e-Delphi technique

This publication is an update of the “Consensus on the therapeutic management of atopic dermatitis – Brazilian Society of Dermatology” published in 2019, considering the novel, targeted-oriented systemic therapies for atopic dermatitis. The initial recommendations of the current consensus for systemic treatment of patients with atopic dermatitis were based on a recent review of scientific published data and a consensus was reached after voting. The Brazilian Society of Dermatology invited 31 experts from all regions of Brazil and 2 international experts on atopic dermatitis who fully contributed to the process. The methods included an e-Delphi study to avoid bias, a literature search and a final consensus meeting. The authors added novel approved drugs in Brazil and the indication for phototherapy and systemic therapy for AD. The therapeutical response to systemic treatment is hereby reported in a suitable form for clinical practice and is also part of this updated manuscript.

HTA6 Balancing National Financial Stability with Commercial Expectations of Return on R&D Investment: A Review of Price Discounts for the Reimbursement of Oncology Drugs in Brazil

With Brazil becoming a key reference country in Latin America, pricing discussions at the country level have regional implications. Bargaining behavior in pricing and negotiations for oncology products in Brazil is leading to more price discounts and subsequent sub-optimal revenue goals for manufacturers. This study aims to investigate the common price discounts applied to innovative oncology drugs in Brazil.

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis

Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries. All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall survival (OS) benefit, added therapeutic benefit, and prices were compared. Fifty-six FDA-approved cancer drugs with matching indications received a MA at the Brazilian Health Regulatory Agency (Anvisa) after a median of 522 days following US approval (IQR: 351-932). Earlier authorisation in Brazil was associated with availability of RCT (median: 506 vs 760 days, p=0.031) and evidence of OS benefit (390 vs 543 days, p=0.019) at FDA approval. At Brazilian marketing authorisation, a greater proportion of cancer drugs had main RCTs (75% vs 60.7%) and OS benefit (42.9% vs 21.4%) than that in the US. Twenty-eight (50%) drugs did not demonstrate added therapeutic benefit over drugs for the same indication in Brazil. Median approved prices of new cancer drugs were 12.9% lower in Brazil compared to the US (adjusted by Purchasing Power Parity). However, for drugs with added therapeutic benefit median prices were 5.9% higher in Brazil compared to the US, while 17.9% lower for those without added benefit. High-quality clinical evidence accelerated the availability of cancer medicines in Brazil. The combination of marketing and pricing authorisation in Brazil may favour the approval of cancer drugs with better supporting evidence, and more meaningful clinical benefit albeit with variable degree of success in achieving lower prices compared to the US. None.

The role of competition in determining the prices of generic drugs in Brazil

Resumo O objetivo deste artigo é analisar o papel da concorrência nos mercados relevantes (MR) selecionados e sua influência no diferencial de preços entre medicamentos genéricos e de referência. Trata-se de um estudo de caso sobre 268 apresentações comerciais de medicamentos, classificados em MR em 2001 e 2016. Os dados para obtenção do grau de concentração foram provenientes da base de dados utilizada por Hasenclever (2002) e do Anuário Estatístico do Mercado Farmacêutico de 2016. Os preços praticados em 2019 foram retirados de dez sites de farmácias e drogarias. Os resultados indicam que a margem de 35% sob o preço do medicamento de referência imposta ao preço-fábrica para a entrada do genérico no mercado é baixa em relação ao diferencial de preços médios praticados no varejo. Além disso, notou-se que, quanto maior o número de fornecedores, maior tendia a ser o diferencial de preços entre medicamentos genéricos e de referência.

Sales trends of psychotropic drugs in the COVID-19 pandemic: A national database study in Brazil.

Background: The social restrictions among coronavirus disease 2019 (COVID-19) pandemic have posed a thoughtful risk to mental health and have implications in the use of drugs, including antidepressants, anxiolytics and other psychotropics. Objective: This study analyzed the sales data of the psychotropics prescribed in Brazil, in order to verify the change in consumption trends of these drugs during the COVID-19 pandemic. Methods: This interrupted time-series analyzed psychotropic sales data, between January 2014 and July 2021, using the National System of Controlled Products Management from The Brazilian Health Regulatory Agency. The monthly mean DDDs per 1,000 inhabitants per day of psychotropic drugs was evaluated by analysis of variance (ANOVA) followed by Dunnett Multiple Comparisons Test. The changes in monthly trends in the use of the psychotropic studied were evaluated by Joinpoint regression. Results: During the period studied, clonazepam, alprazolam, zolpidem and escitalopram were the most sold psychotropic drugs in Brazil. According to Joinpoint regression, an upward trend was observed in sales during the pandemic of pregabalin, escitalopram, lithium, desvenlafaxine, citalopram, buproprion and amitriptyline. An increase in psychotropic consumption was noted throughout the pandemic period, with the maximum consumption (2.61 DDDs) occurring in April 2021, with a downward trend in consumption that accompanied the drop in the number of deaths. Conclusions: The increase in sales, mainly of antidepressants during the COVID-19 pandemic, draws attention to issues related to the mental health of the Brazilian population and on the need for greater monitoring in the dispensing of these drugs.

Lenalidomide Maintenance and Measurable Residual Disease in a Real-World Multiple Myeloma Transplanted Population Receiving Different Treatment Strategies Guided by Access to Novel Drugs in Brazil

Despite recent advances in multiple myeloma (MM), the incorporation of novel agents and measurable residual disease (MRD) monitoring in low-income countries remains a challenge. Although lenalidomide maintenance (M-Len) after autologous stem cell transplantation (ASCT) has been associated with improved outcomes and MRD has refined the prognosis of complete response (CR) cases, until now, there have been no data on the benefits of these approaches in Latin America. Here, we evaluate the benefits of M-Len and MRD using next-generation flow cytometry (NGF-MRD) at Day + 100 post-ASCT (n = 53). After ASCT, responses were evaluated based on the International Myeloma Working Group criteria and NGF-MRD. MRD was positive in 60% of patients with a median progression-free survival (PFS) of 31 months vs. not reached (NR) for MRD-negative cases (p = 0.05). The patients who received M-Len continuously had a significantly better PFS and overall survival (OS) than those without M-Len (median PFS: NR vs. 29 months, p = 0.007), with progression in 11% vs. 54% of cases after a median follow-up of 34 months, respectively. In a multivariate analysis, MRD status and M-Len therapy emerged as independent predictors of PFS (median PFS of M-Len/MRD- vs. no M-Len/MRD+ of NR vs. 35 months, respectively; p = 0.01). In summary, M-Len was associated with improved survival outcomes in our real-world MM cohort in Brazil, with MRD emerging as a useful reproducible tool to identify patients at an earlier risk of relapse. The inequity in drug access remains a hurdle in countries with financial constraints, with a negative impact on MM survival.

Evaluation of bacterial diversity in a swine manure composting system contaminated with veterinary antibiotics (VAs).

Composting has become an alternative for the treatment of organic effluents, due to its low cost, easy handling, and a great capacity for treating swine manure. As it is a biological process, many microorganisms are involved during the composting process and act in the degradation of organic matter and nutrients and also have the ability to degrade contaminants and accelerate the transformations during composting. The objective of this work was to identify microorganisms present in the swine effluent composting system, under the contamination by most used veterinary drugs in Brazil. The composting took place for 150days, there was an addition of 200 L of manure (these 25 L initially contaminated with 17 antibiotics) in 25kg of eucalyptus wood shavings. The microorganisms were measured at times (0 until 150days) and were identified by the V3-V4 regions of the 16S rRNA for Bacteria, by means of next-generation sequencing (NSG). The results show seven different bacterial phyla (Proteobacteria, Bacteroidetes, Firmicutes, Acidobacteria, Actinobacteria, Spirochaetota and Tenericutes) and 70 bacterial genera (more than 1% significance), of which the most significant ones were Pseudomonas, Sphingobacterium, Devosia, Brucella, Flavisolibacter, Sphingomonas and Nitratireductor. The genus Brucella was found during mesophilic and thermophilic phases, and this genus has not yet been reported an in article involving composting process. With the results obtained, the potential for adaptation of the bacterial community was observed, being under the influence of antibiotics for veterinary use.

Effectiveness and Safety of Ustekinumab for Moderate to Severely Active Crohn's Disease: Results from an Early Access Program in Brazil.

This prospective, observational, open-label study aimed to provide access to ustekinumab prior to market authorization and assess its safety and effectiveness in patients with Crohn's disease (CD) refractory to anti-tumor necrosis factor-α and conventional drugs in Brazil. Patients with a diagnosis of moderate-to-severe active CD for ≥3 months before screening received ustekinumab in a single intravenous induction dose (~6 mg/kg) at week 0, and a 90 mg maintenance dose, subcutaneously, every 8 or 12 weeks, from week 8 through to 80. Serious adverse events (SAE), adverse drug reactions (ADR), clinical response (per CD Activity Index and Harvey Bradshaw Index (HBI) scores), remission (per HBI scores), biomarkers (C-reactive protein (CRP) and fecal calprotectin (FC)) and endoscopic improvement rate over 80 weeks were assessed. Patients with a mean age of 39.9 years were assessed. Discontinuation rate was low (23%) and most adverse events were mild (68.7%). The SAE rate was 21% (mostly infections/infestations or gastrointestinal disorder), and ADR rate was 44%. The CD Activity Index and HBI scores decreased (by 74% and 81%, respectively) with 50% of patients showing normalized CRP and FC, and 63% achieved endoscopic improvement. Ustekinumab was fairly safe, well tolerated and effective in a Brazilian cohort of CD patients.

Lucy is back in Brazil with a new dress

Lucy in the Sky with Diamonds, a John Lennon song that was a hit in the 1960s, was born amidst a social context enlightened by lysergic acid diethylamide (LSD). In Brazil, both the drug and the song were very popular at the time, although it gradually mitigated. Nevertheless, while the song remains out of the spotlight, LSD derivatives are currently gaining attention with the rising of the new psychoactive substances (NPS). With this new presentation, the drug is returning to Brazil after a few decades and herein we report and discuss the first cases of an LSD prodrug seized in our country. Nine suspected blotter paper samples were seized by the Sao Paulo State Police in different cities of the State. Gas chromatography-mass spectrometry (GC-MS), attenuated total reflection Fourier transform infrared spectroscopy (ATR-FTIR) and liquid chromatography coupled with electrospray ionization-mass spectrometry (LC-ESI-MS) analyses were utilized to confirm the identity of the LSD derivative. The compound was identified as 4-acetyl-N,N-diethyl-7-methyl-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (ALD-52 or 1A-LSD) and no other active substance was detected in all samples. The identity of the unknown compound found in seized blotter papers has been successfully confirmed as an LSD prodrug, ALD-52, which was not controlled by Brazilian legislation. The arrival of a new type of designer drug in Brazil is in support by other reports, although those are still scarce and should not be overlooked. Altogether, these findings indicate the rising of a new NPS strategy that merits proper discussion.

Judicialización de medicamentos huérfanos en Brasil: la justiciabilidad de un objeto políticamente “no palatable”Judicialization of orphan drugs in Brazil: the justiciability of a politically unpalatable issue

Abstract Occasionally, elected officials invite the judiciary to resolve those particularly challenging problems for which there are no solutions or that they would rather not address. The access to orphan drugs in Brazil is a problem of such type. With the aim of illustrating how the judicial enforcement of social rights can favor vulnerable groups, this article deploys original data through a case study on the most prominently judicialized orphan drug in Brazil, reliant on quantitative as well as qualitative primary sources. Thus, it advances a twofold argument. First, when the exercise of a social right is associated with a politically unpalatable controversy, meaning one that does not foster enough political interest in a solution, despite embodying a pressing policy problem, elected officials are less likely to address it. Second, the expansion of judicial power would be defensible against the backdrop of an issue of such type. The empirical analysis yields new insights into normative debates concerning social rights judicial enforcement. When politically disadvantaged groups learn to use the constitutional framework to advance their interests by presenting rights claims, in the long term it can generate information about the scope of a legislative inertia, give a voice to silenced actors, and reallocate resources to care for urgent needs of minoritarian groups.

Applications of NIR spectroscopy and chemometrics to illicit drug analysis: An example from inhalant drug screening tests

The “loló” stands out among the most used inhalant drugs in Brazil. This drug is a non-specific blend of organic solvents, traditionally composed of ether and chloroform. Reports in the literature and forensic practice have revealed changes in the composition profile of this drug, based on availability of acquisition. This diversity has an effect on the efficiency of the preliminary tests used to detect illicit substances in situations that require rapid response time from the criminal investigations, such as arrests in the act. Considering the diversity of volatile substances with potential use as inhalant drugs and the limited detection abilities of preliminary exams routinely used by forensic laboratories, this present work applied NIR spectroscopy associated with chemometric models to detect the presence of organic solvents in samples of “loló”. Initially, the chemical profile of the seized samples was surveyed in the geographic region of study (Paraiba State, Brazilian northeast), and from the observation of the prevalent substances, classification models were produced using samples made in the laboratory and samples from real apprehensions. Then, an analysis protocol was developed, based on SIMCA models, to detect the predominant solvents in the regional composition profile (dichloromethane, trichloroethene and chloroform). The proposed analysis protocol obtained an overall accuracy of 94.7% in detecting halogenated hydrocarbons in suspect samples and 100% accuracy in characterizing the composition of samples composed exclusively of the studied halogenated hydrocarbons and their binary mixtures. Considering that the colorimetric tests used in the routine of forensic laboratories do not detect many components, the proposed method was technically and economically viable in preliminary tests for samples seized as suspicious of being "loló".

Use of Paper Microdevices in the Identification and Quantification of Cocaine in Seized Street Samples

The growing consumption of illicit drugs in Brazil is becoming increasingly problematic for society. It is therefore critical to develop technologies to combat drug trafficking that allow for rapid, non-invasive evaluation of drug samples. Microfluidics is a technology that manipulates and studies small amounts of fluids, using structures with dimensions from ten to hundreds of micrometers (microdevices). The main advantages of microfluidic approaches are its low cost, speed, and ability to provide results in loco. Here, paper microfluidics were developed to perform the modified Scott test to calculate the cocaine hydrochloride content in seized samples of cocaine (n = 30) and crack (n = 30). A smartphone with the Photometrix® app was used to construct a model for quantifying the samples. A factorial model was developed to optimize microfluidic analytical parameters such as spot size (6, 8 and 10 mm), reagent content (50, 75, and 100% cobalt thiocyanate II), cocaine hydrochloride concentration (4, 6 and 8 mg mL-1) and response time (or analyte detection; t = 0, 0.5 1, 12 and 24 h). After experimental planning, a diameter of ΜPADs = 8 mm - [Co(SCN)2] = 100% and a 1 h response time were identified as the best conditions. We observed that the cocaine hydrochloride concentration did not influence the model. A sample concentration of 15 mg mL-1 was used to quantify cocaine hydrochloride in street samples apprehended by the Forensic Police of Espírito Santo state (with n = 60). The quantification curve constructed to determine the cocaine hydrochloride concentration showed a determination coefficient, R2, of 0.98246 and RMSEC (root mean squares error calibration - mean square error of the calibration) of 0.39480, with a LOD and LOQ of 0.09 and 0.30 mg mL-1, respectively. For the crack samples, the cocaine hydrochloride concentrations ranged from 2.5 to 60.8 wt% with an average purity content of 21.3 ± 13.3 wt%. For the seized cocaine samples, variation in hydrochloride content from 1.2 to 22.6 wt% was observed with a mean percentage of 14.19 ± 6.92 wt%. Finally, chemometric tools such as principal component analysis were used to assess the similarity among the samples.

In the name of public health: misoprostol and the new criminalization of abortion in Brazil.

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the cause, but rather the consequence of misoprostol’s double life. In the last section, it draws on an outlier judgment of the case law to chart a regulatory future for misoprostol and its supply in the informal sector as a site of harm reduction and safe abortion in public health policy.

UTILIZATION OF ANTIHYPERTENSIVE DRUGS AS MONOTHERAPY AND COMBINED THERAPY IN BRAZIL: A POPULATION BASED STUDY

Objective: Our objective was to describe the use of antihypertensive drugs in Brazil with a focus on the combination of two drugs. Design and method: Secondary data analysis from the National Survey on Access Use and Promotion of Rational Use of Medicines (PNAUM 2014), a nationwide cross-sectional population-based study, focused on the use of medicines in Brazil with a total of 41,433 interviews. The sample consists of all antihypertensive drugs cited as used to treat hypertension. The I Brazilian Positioning about Combination of Antihypertensive Drugs 2013 was used as a criteria to identify the combinations as Preferential: ACEI (Angiotensin-converting enzyme inhibitors) + CCB (Calcium channel blockers), ACEI + Diuretic, ARB (Angiotensin II receptor blockers) + CCB (dihydropyridine derivates), ARB + Diuretic; Acceptable: Diuretic + BB (beta-Blockers), CCB (dihydropyridine derivates) + BB, CCB + Diuretic, RI (Renin inhibitor)+ Diuretic, RI + CCB, Diuretic Thiazide + Potassium-sparing Agent; Less usual: ACEI + BB, ARB + BB and Unusual combinations: CCB (non-dihydropyridine derivates) + BB, ACEI + ARB, ACEI + RI, ARB + RI, Antiadrenergic agents, centrally acting + BB. The Statistical Analysis System (SAS) version 9.4 was used. Results: A total of 45 antihypertensive drugs was related. Diuretics (47.2% 95%CI 45.5–48.8), ACEI (38.1% 95%CI 36.4–39.8) and ARB (37.1% 95%CI 35.5–38.7) were the most used drugs, regardless the treatment as monotherapy or combined therapy. As monotherapy the three classes cited was the most used, however in a different percentage: ACEI (37.1% 95%CI 35.0–39.4), ARB (28.1% 95%CI 26.1–30.2) and Diuretics (14.5% 95%CI 12.9–16.1). Considering people under therapy with two drugs and the I Brazilian Positioning about Combination of Antihypertensive Drugs criteria, the preferential combinations represented 66.3% (95%CI 63.8–68.8), acceptable 19.2% (95%CI 17.1–21.2), less usual 10.1% (95%CI 8.5–11.8), unusual combinations 1.4% (95% CI 0.9–1.9) and other combinations 3.0% (95%CI 1.9–4.1). The most preferential combinations were ARB + Diuretic 30.3% (95%CI 27.8–32.8) and ACEI + Diuretic 28.0% (95%CI 25.5–30.5). In general, Brazil is using antihypertensives according to the guidelines of hypertension. Conclusions: In general, Brazil is using antihypertensives according to the guidelines of hypertension.