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1.
Respir Res ; 24(1): 18, 2023 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-36653855

RESUMO

BACKGROUND: Epoprostenol AS (Veletri®), a thermostable epoprostenol formulation, provides better drug stability and improved clinical use compared to previous epoprostenol formulations. This study aims to expand clinical experience in the use of Veletri®, especially regarding tolerability, safety and survival. METHODS: Pulmonary arterial hypertension (PAH) patients at high risk despite pretreatment with at least double oral combination therapy and with clinical indication for epoprostenol (Veletri®) treatment were consecutively included in this prospective, open label, observational, non-interventional study. Clinical data were assessed at baseline, after 3 and 6 months. Adverse events (AEs) and serious adverse events (SAEs) were documented. Survival from initiation of Veletri® was assessed at last patient out. RESULTS: Fifteen patients (60 ± 13.7 years, WHO functional class III (n = 10) or IV (n = 5), severely impaired right ventricular function, mean pulmonary arterial pressure 54.8 ± 8.9 mmHg, mean pulmonary vascular resistance 4.4 ± 0.7 (median 3.8) Wood Units) were enrolled and treated with a mean dosage of 7.9 ± 3.9 (median 7.5) ng/kg/min. Eleven patients completed the study (treatment withdrawal n = 1, death n = 3). After a mean follow-up of 19.1 ± 13.5 (median 18.0) months, seven patients died and three were listed for lung transplantation. Seven AEs (nausea n = 3, diarrhea n = 1, flushing n = 2, headaches n = 1) and three SAEs (catheter infection n = 2, catheter occlusion n = 1) were related to Veletri®. The 1- and 2-year survival rates were 73.3% and 52.4%, respectively. CONCLUSIONS: The study showed that safety and tolerability of epoprostenol AS (Veletri®) was comparable to previous prostacyclin formulations and was feasible for most patients. The maximum tolerable dosage was lower than dosages reported in the literature. In future applications/trials the up-titration process should be pushing for higher dosages of epoprostenol in the occurrence of side effects, as the achievement of a high and effective dosage is crucial for the clinical benefit of the patients. Survival was as expected in these prevalent severely impaired patients. Trial registration The study was registered in the EUPAS registry (EUPAS32492).


Assuntos
Hipertensão Pulmonar , Hipertensão Arterial Pulmonar , Humanos , Epoprostenol/efeitos adversos , Anti-Hipertensivos/efeitos adversos , Hipertensão Arterial Pulmonar/diagnóstico , Hipertensão Arterial Pulmonar/tratamento farmacológico , Hipertensão Arterial Pulmonar/induzido quimicamente , Estudos Prospectivos , Hipertensão Pulmonar/diagnóstico , Hipertensão Pulmonar/tratamento farmacológico , Hipertensão Pulmonar/induzido quimicamente , Hipertensão Pulmonar Primária Familiar
2.
J Hypertens ; 41(2): 288-294, 2023 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-36583354

RESUMO

BACKGROUND: Treatment of severe inpatient hypertension (HTN) that develops during hospitalization is not informed by guidelines. Intravenous (i.v.) antihypertensives are used to manage severe HTN even in the absence of acute target organ damage; however they may result in unpredictable blood pressure (BP) reduction and cardiovascular events. Our goal was to assess the association between i.v. antihypertensives and clinical outcomes in this population. METHODS: This is a multihospital retrospective study of adults admitted for reasons other than HTN who develop severe HTN during hospitalization without acute target end organ damage. We defined severe HTN as BP elevation of systolic >180 or diastolic >110 mmHg. Treatment was defined as receiving i.v. antihypertensives within 3 h of BP elevation. We used overlap propensity score weighted Cox models to study the association between treatment and clinical outcomes during index hospitalization. RESULTS: Of 224 265 unique, nonintensive care unit hospitalizations, 20 383 (9%) developed severe HTN, of which 5% received i.v. antihypertensives and 79% were untreated within 3 h of severe BP elevation. In the overlap propensity weighted population, patients who received i.v. antihypertensives were more likely to develop myocardial injury (5.9% in treated versus 3.6% in untreated; hazard ratio [HR]: 1.6 [1.13, 2.24]). Treatment was not associated with increased risk of stroke (HR: 0.7 [0.3, 1.62]), acute kidney injury (HR: 0.97 [0.81, 1.17]), or death (HR: 0.86 [0.49, 1.51]). CONCLUSIONS: Intravenous antihypertensives were associated with increased risk of myocardial injury in patients who develop severe HTN during hospitalization. These results suggest that i.v. antihypertensives should be used with caution in patients without acute target organ damage.


Assuntos
Hipertensão , Hipotensão , Adulto , Humanos , Anti-Hipertensivos/efeitos adversos , Pressão Sanguínea , Estudos Retrospectivos , Hipotensão/induzido quimicamente
3.
J Am Heart Assoc ; 12(1): e028050, 2023 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-36583425

RESUMO

Background Anti-cancer vascular endothelial growth factor inhibitors (VEGFI) frequently induce a rise in blood pressure (BP). The most effective treatment of this BP rise is currently unknown, and risk factors and its association with survival remain inconclusive. Methods and Results Baseline characteristics and BP readings were retrospectively collected from oncology patients who received oral VEGFI treatment (sorafenib, sunitinib, pazopanib, regorafenib, lenvatinib, or cabozantinib). Risk factors for a clinically relevant BP rise (increase of ≥20 mm Hg in systolic BP or ≥10 mm Hg in diastolic BP) were investigated via logistic regression (relative), efficacy of antihypertensives via unpaired t-tests, and association of BP rise with survival via Cox regression analysis. In total, 162 (47%) of 343 included patients developed a clinically relevant BP rise ≥7 days after VEGFI treatment initiation. Both calcium channel blockers and renin-angiotensin system inhibitors effectively reduced systolic BP (-24.1 and -18.2 mm Hg, respectively) and diastolic BP (-12.0 and -11.0 mm Hg, respectively). Pazopanib therapy (odds ratio, 2.71 [95% CI, 1.35-5.42; P=0.005], compared with sorafenib) and estimated glomerular filtration rate <60 mL/min per 1.73 m2 (OR, 1.75 [95% CI, 0.99-3.18, P=0.054]) were risk factors for a BP rise, whereas a baseline BP ≥140/90 mm Hg associated with a lower risk (OR, 0.39 [95% CI, 0.25-0.62, P<0.001]). Only for renal cell carcinoma, BP rise was associated with a substantially improved median overall survival compared with no BP rise: 45.4 versus 20.3 months, respectively, P=0.003. Conclusions The type of VEGFI, baseline BP, and baseline estimated glomerular filtration rate determine the VEGFI-induced BP rise. Both calcium channel blockers and renin-angiotensin system inhibitors are effective antihypertensive treatments. Particularly in patients with renal cell carcinoma, a BP rise is associated with improved overall survival.


Assuntos
Carcinoma de Células Renais , Hipertensão , Neoplasias Renais , Humanos , Pressão Sanguínea , Hipertensão/induzido quimicamente , Hipertensão/tratamento farmacológico , Hipertensão/metabolismo , Fator A de Crescimento do Endotélio Vascular/farmacologia , Bloqueadores dos Canais de Cálcio/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/induzido quimicamente , Estudos de Coortes , Sorafenibe/efeitos adversos , Estudos Retrospectivos , Anti-Hipertensivos/efeitos adversos , Inibidores da Angiogênese/efeitos adversos , Neoplasias Renais/induzido quimicamente , Neoplasias Renais/tratamento farmacológico
4.
Circ Cardiovasc Qual Outcomes ; 16(1): e008997, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36484251

RESUMO

BACKGROUND: Discrete choice experiment is a survey method used to understand how individuals make decisions and to quantify the relative importance of features. Using discrete choice experiment methods, we quantified patient benefit-risk preferences for hypertension treatments, including pharmaceutical and interventional treatments, like renal denervation. METHODS: Respondents from the United States with physician-confirmed uncontrolled hypertension selected between treatments involving a procedure or pills, using a structured survey. Treatment features included interventional, noninterventional, or no hypertension treatment; number of daily blood pressure (BP) pills; expected reduction in office systolic BP; duration of effect; and risks of drug side effects, access site pain, or vascular injury. The results of a random-parameters logit model were used to estimate the importance of each treatment attribute. RESULTS: Among 400 patients completing the survey between 2020 and 2021, demographics included: 52% women, mean age 59.2±13.0 years, systolic BP 155.1±12.3 mm Hg, and 1.8±0.9 prescribed antihypertensive medications. Reduction in office systolic BP was the most important treatment attribute. The remaining attributes, in decreasing order, were duration of effect, whether treatment was interventional, number of daily pills, risk of vascular injury, and risk of drug side effects. Risk of access site pain did not influence choice. In general, respondents preferred noninterventional over interventional treatments, yet only a 2.3 mm Hg reduction in office systolic BP was required to offset this preference. Small reductions in office systolic BP would offset risks of vascular injury or drug side effects. At least a 20% risk of vascular injury or drug side effects would be tolerated in exchange for improved BP. CONCLUSIONS: Reduction in systolic BP was identified as the most important driver of patient treatment preference, while treatment-related risks had less influence. The results indicate that respondents would accept interventional treatments in exchange for modest reductions in systolic BP compared with those observed in renal denervation trials.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hipertensão , Lesões do Sistema Vascular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Masculino , Preferência do Paciente , Lesões do Sistema Vascular/tratamento farmacológico , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Rim , Pressão Sanguínea , Anti-Hipertensivos/efeitos adversos , Dor/tratamento farmacológico , Preparações Farmacêuticas , Resultado do Tratamento
5.
Expert Rev Pharmacoecon Outcomes Res ; 23(2): 251-265, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36576091

RESUMO

BACKGROUND: STN1013001 is an innovative latanoprost cationic emulsion for open-angle glaucoma/ocular hypertension (OAG/OHT) and ocular surface disease (OSD). METHODS AND FINDINGS: A 5-year, 7 health states, 1-year cycle early Markov model-supported cost-utility analysis (CUA) of STN1013001 vs. other latanoprost formulations (Latanoprost) followed the Italian National Health Service (INHS) perspective.One-way, probabilistic and scenario sensitivity analyses tested the uncertainty of the baseline results. Value of information analysis (VOIA) investigated the potential cost-effectiveness of collecting further evidence. RESULTS: Over 5 years, the Markov model-supported CUA predicts STN1013001 to be potentially highly cost-effective vs. Latanoprost (+€57.60 cost at €2020 values; +0.089 Quality-Adjusted Life Years).The Incremental Cost-Utility Ratio (€647.65) falls well below the lower limit of the acceptability range proposed for Italy (€25,000-€40,000).Sensitivity analyses confirmed the robustness of the baseline findings. VOIA highlighted that further information might only be cost-effective for OAG/OHT utilities and OSD-related disutility. CONCLUSION: STN1013001 is potentially highly cost-effective and strongly dominant vs. Latanoprost for OAG/OHT+OSD patients from the INHS perspective. These findings should be re-assessed using the data from the ongoing Phase III trial (NCT04133311) comparing the efficacy and safety of STN1013001 vs. Latanoprost and with future real-world CUAs upon the availability of STN1013001 on the Italian market.


Assuntos
Glaucoma de Ângulo Aberto , Hipertensão Ocular , Prostaglandinas F Sintéticas , Humanos , Glaucoma de Ângulo Aberto/tratamento farmacológico , Latanoprosta , Análise Custo-Benefício , Emulsões , Medicina Estatal , Pressão Intraocular , Prostaglandinas F Sintéticas/efeitos adversos , Anti-Hipertensivos/efeitos adversos , Hipertensão Ocular/tratamento farmacológico , Resultado do Tratamento
7.
BMC Cardiovasc Disord ; 22(1): 560, 2022 12 22.
Artigo em Inglês | MEDLINE | ID: mdl-36550424

RESUMO

BACKGROUND: Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. METHODS: The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. RESULTS: The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. CONCLUSION: The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).


Assuntos
Doenças Cardiovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Humanos , Anti-Hipertensivos/efeitos adversos , LDL-Colesterol , Combinação de Medicamentos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/tratamento farmacológico , Colesterol , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos
8.
Circ Cardiovasc Qual Outcomes ; 15(12): e008999, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36538586

RESUMO

BACKGROUND: Recent evidence suggests that sexual minority (eg, gay/lesbian, bisexual) adults might be at increased risk of hypertension compared with heterosexual adults. However, disparities by sexual identity in antihypertensive medication use among adults with hypertension have not been comprehensively examined. METHODS: We analyzed data from the Behavioral Risk Factor Surveillance System (2015-2019), to examine sexual identity differences in the prevalence of hypertension and antihypertensive medication use among adults. We ran sex-stratified logistic regression models to estimate the odds ratios of diagnosis of hypertension and antihypertensive medication use among sexual minority (ie, gay/lesbian, bisexual, and other) and heterosexual adults (reference group). RESULTS: The sample included 420 340 participants with a mean age of 49.7 (±17.0) years, of which 66.7% were Non-Hispanic White. Compared with heterosexual participants of the same sex, bisexual women (adjusted odds ratio, 1.19 [95% CI, 1.03-1.37]) and gay men (adjusted odds ratio, 1.18 [95% CI, 1.03-1.35]) were more likely to report having been diagnosed with hypertension. Among women with diagnosed hypertension, bisexual women had lower odds of current antihypertensive medication use (adjusted odds ratio, 0.71 [95% CI, 0.56-0.90]). Among men with diagnosed hypertension, gay men were more likely than heterosexual men to report current antihypertensive medication use (adjusted odds ratio, 1.39 [95% CI, 1.10-1.78]). Compared with heterosexual participants of the same sex, there were no differences in hypertension or antihypertensive medication use among lesbian women, bisexual men, and participants who reported their sexual identity as other. CONCLUSIONS: Clinical and public health interventions are needed to reduce the risk of hypertension among bisexual women and gay men. Bisexual women were at higher risk of untreated hypertension, which may be attributed to lower health care utilization due to fear of discrimination from health care providers and socioeconomic disadvantage. Future research is needed to better understand factors that may contribute to untreated hypertension among bisexual women with hypertension.


Assuntos
Hipertensão , Minorias Sexuais e de Gênero , Masculino , Adulto , Humanos , Feminino , Pessoa de Meia-Idade , Anti-Hipertensivos/efeitos adversos , Sistema de Vigilância de Fator de Risco Comportamental , Prevalência , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia
9.
Curr Hypertens Rev ; 18(2): 138-144, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36508272

RESUMO

BACKGROUND: The target blood pressure has changed many times in the guidelines in past years. However, there is always a question; is it good to lower blood pressure below 120/80 or not? Control of blood pressure in hypertension is very important in reducing hypertension-modified organ damage. So, the guidelines recommend combining more than one antihypertensive drug to reach the target blood pressure goal. RESULTS: Combination therapy is recommended by guidelines to reach the blood pressure goal. The guidelines recommend many combinations, such as the combination of angiotensin receptor blockers with either calcium channel blockers (CCB) or beta-blocker (BB). Angiotensin receptor blocker (ARB) combination with CCB has gained superiority over other antihypertension drug combinations because it reduces blood pressure and decreases the incidence of CV events and organ damage. BB combinations are recommended by guidelines in patients with ischemic events but not all hypertensive patients. Unfortunately, the new generation BB, for example, nebivolol, has a vasodilator effect, making it new hope for BB. CONCLUSION: Combination therapy is a must in treating the hypertensive patient. The new generation BBs may change the recommendations of guidelines because they have an effect that is similar to CCBs.


Assuntos
Antagonistas de Receptores de Angiotensina , Hipertensão , Humanos , Antagonistas de Receptores de Angiotensina/efeitos adversos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Pressão Sanguínea , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Antagonistas Adrenérgicos beta/efeitos adversos
10.
Artigo em Inglês | MEDLINE | ID: mdl-36561082

RESUMO

Hypertension is one of the leading causes of disability-adjusted life years and mortality, with approximately 15% prevalence worldwide. Most patients with hypertension from low- to high-income countries do not receive treatment. Among those who receive treatment, the majority remain undertreated and do not achieve their blood pressure goals. Therefore, new hypertension guidelines introduce more conscientious treatment strategies to maximize the probability of achieving the new strict blood pressure goals compared with the previous guidelines. Who should receive treatment for hypertension? Which antihypertensive medications have the strongest supporting data? Are generic and more affordable medications as effective as expensive brand medications? What are the different treatment strategies to maximize success in controlling blood pressure? Here, we briefly review pharmacotherapy for hypertension and provide answers to these questions as well as some other common questions regarding treatment of hypertension.


Assuntos
Inibidores da Enzima Conversora de Angiotensina , Hipertensão , Humanos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipertensão Essencial/tratamento farmacológico , Diuréticos/uso terapêutico , Antagonistas Adrenérgicos beta/uso terapêutico
11.
Vasc Health Risk Manag ; 18: 867-878, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36545494

RESUMO

Introduction: Hypertension is the most important modifiable risk factor for cardiovascular disease and a leading public health concern. Objectives: The primary aim was to compare sequential nephron blockade (SNB) versus dual renin-angiotensin system blockade (DRASB) plus bisoprolol in patients with resistant hypertension to observe reductions in systolic and diastolic blood pressure (SBP and DBP) levels after 20 weeks of treatment. Material and Methods: This trial was an open-label, prospective, randomized, parallel-group, clinical study with optional drug up-titration. Participants were evaluated during five visits at 28-day intervals. Results: The mean age was 55.5 years in the SNB and 58.4 years in the DRASB + bisoprolol group (p=NS). Significant office BP reductions were observed in both groups. SNB group, SBP decreased from 174.5±21.0 to 127.0±14.74 mmHg (p<0.0001), and DBP decreased from 105.3±15.5 to 78.11±9.28 mmHg (p<0.0001). DRASB group, SBP decreased from 178.4±21.08 to 134.4 ± 23.25 mmHg (p<0.0001) and DBP decreased from 102.7±11.07 to 77.33±13.75 mmHg (p<0.0001). Ambulatory blood pressure monitoring (ABPM) showed also significant SBP and DBP reductions in both groups (p<0.0001). Conclusion: In patients with RHTN adherent to treatment, SNB and DRASB plus bisoprolol showed excellent therapeutic efficacy, although SNB was associated with earlier SBP reduction.


Assuntos
Bisoprolol , Hipertensão , Humanos , Pessoa de Meia-Idade , Bisoprolol/efeitos adversos , Sistema Renina-Angiotensina , Anti-Hipertensivos/efeitos adversos , Monitorização Ambulatorial da Pressão Arterial , Estudos Prospectivos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Pressão Sanguínea , Néfrons
12.
N Engl J Med ; 387(26): 2401-2410, 2022 12 29.
Artigo em Inglês | MEDLINE | ID: mdl-36516076

RESUMO

BACKGROUND: Whether chlorthalidone is superior to hydrochlorothiazide for preventing major adverse cardiovascular events in patients with hypertension is unclear. METHODS: In a pragmatic trial, we randomly assigned adults 65 years of age or older who were patients in the Department of Veterans Affairs health system and had been receiving hydrochlorothiazide at a daily dose of 25 or 50 mg to continue therapy with hydrochlorothiazide or to switch to chlorthalidone at a daily dose of 12.5 or 25 mg. The primary outcome was a composite of nonfatal myocardial infarction, stroke, heart failure resulting in hospitalization, urgent coronary revascularization for unstable angina, and non-cancer-related death. Safety was also assessed. RESULTS: A total of 13,523 patients underwent randomization. The mean age was 72 years. At baseline, hydrochlorothiazide at a dose of 25 mg per day had been prescribed in 12,781 patients (94.5%). The mean baseline systolic blood pressure in each group was 139 mm Hg. At a median follow-up of 2.4 years, there was little difference in the occurrence of primary-outcome events between the chlorthalidone group (702 patients [10.4%]) and the hydrochlorothiazide group (675 patients [10.0%]) (hazard ratio, 1.04; 95% confidence interval, 0.94 to 1.16; P = 0.45). There were no between-group differences in the occurrence of any of the components of the primary outcome. The incidence of hypokalemia was higher in the chlorthalidone group than in the hydrochlorothiazide group (6.0% vs. 4.4%, P<0.001). CONCLUSIONS: In this large pragmatic trial of thiazide diuretics at doses commonly used in clinical practice, patients who received chlorthalidone did not have a lower occurrence of major cardiovascular outcome events or non-cancer-related deaths than patients who received hydrochlorothiazide. (Funded by the Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT02185417.).


Assuntos
Clortalidona , Hidroclorotiazida , Hipertensão , Idoso , Humanos , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Clortalidona/efeitos adversos , Clortalidona/uso terapêutico , Diuréticos/efeitos adversos , Diuréticos/uso terapêutico , Hidroclorotiazida/efeitos adversos , Hidroclorotiazida/uso terapêutico , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Inibidores de Simportadores de Cloreto de Sódio/efeitos adversos , Inibidores de Simportadores de Cloreto de Sódio/uso terapêutico , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/prevenção & controle
13.
Lancet ; 400(10367): 1927-1937, 2022 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-36356632

RESUMO

BACKGROUND: Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension. METHODS: PRECISION was a multicentre, blinded, randomised, parallel-group, phase 3 study, which was done in hospitals or research centres in Europe, North America, Asia, and Australia. Patients were eligible for randomisation if their sitting systolic blood pressure was 140 mm Hg or higher despite taking standardised background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: part 1 was the 4-week double-blind, randomised, and placebo-controlled part, in which patients received aprocitentan 12·5 mg, aprocitentan 25 mg, or placebo in a 1:1:1 ratio; part 2 was a 32-week single (patient)-blind part, in which all patients received aprocitentan 25 mg; and part 3 was a 12-week double-blind, randomised, and placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes. The study is registered on ClinicalTrials.gov, NCT03541174. FINDINGS: The PRECISION study was done from June 18, 2018, to April 25, 2022. 1965 individuals were screened and 730 were randomly assigned. Of these 730 patients, 704 (96%) completed part 1 of the study; of these, 613 (87%) completed part 2 and, of these, 577 (94%) completed part 3 of the study. The least square mean (SE) change in office systolic blood pressure at 4 weeks was -15·3 (SE 0·9) mm Hg for aprocitentan 12·5 mg, -15·2 (0·9) mm Hg for aprocitentan 25 mg, and -11·5 (0·9) mm Hg for placebo, for a difference versus placebo of -3·8 (1·3) mm Hg (97·5% CI -6·8 to -0·8, p=0·0042) and -3·7 (1·3) mm Hg (-6·7 to -0·8; p=0·0046), respectively. The respective difference for 24 h ambulatory systolic blood pressure was -4·2 mm Hg (95% CI -6·2 to -2·1) and -5·9 mm Hg (-7·9 to -3·8). After 4 weeks of withdrawal, office systolic blood pressure significantly increased with placebo versus aprocitentan (5·8 mm Hg, 95% CI 3·7 to 7·9, p<0·0001). The most frequent adverse event was mild-to-moderate oedema or fluid retention, occurring in 9%, 18%, and 2% for patients receiving aprocitentan 12·5 mg, 25 mg, and placebo, during the 4-week double-blind part, respectively. This event led to discontinuation in seven patients treated with aprocitentan. During the trial, a total of 11 treatment-emergent deaths occurred, none of which were regarded by the investigators to be related to study treatment. INTERPRETATION: In patients with resistant hypertension, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at week 4 with a sustained effect at week 40. FUNDING: Idorsia Pharmaceuticals and Janssen Biotech.


Assuntos
Monitorização Ambulatorial da Pressão Arterial , Hipertensão , Humanos , Antagonistas dos Receptores de Endotelina/uso terapêutico , Hipertensão/induzido quimicamente , Anti-Hipertensivos/efeitos adversos , Método Duplo-Cego , Resultado do Tratamento
14.
J Cardiovasc Pharmacol Ther ; 27: 10742484221136758, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36324213

RESUMO

OBJECTIVE: This study aimed to evaluate the effects of potential risk factors on antihypertensive treatment success. METHODS: Patients with hypertension who were treated with antihypertensive medications were included in this study. Data from the last visit were analyzed retrospectively for each patient. To evaluate the predictive models for antihypertensive treatment success, data mining algorithms (logistic regression, decision tree, random forest, and artificial neural network) using 5-fold cross-validation were applied. Additionally, study parameters between patients with controlled and uncontrolled hypertension were statistically compared and multiple regression analyses were conducted for secondary endpoints. RESULTS: The data of 592 patients were included in the analysis. The overall blood pressure control rate was 44%. The performance of random forest algorithm (accuracy = 97.46%, precision = 97.08%, F1 score = 97.04%) was slightly higher than other data mining algorithms including logistic regression (accuracy = 87.31%, precision = 86.21%, F1 score = 85.74%), decision tree (accuracy = 76.94%, precision = 70.64%, F1 score = 76.54%), and artificial neural network (accuracy = 86.47%, precision = 83.85%, F1 score = 84.86%). The top 5 important categorical variables (predictive correlation value) contributed the most to the prediction of antihypertensive treatment success were use of calcium channel blocker (-0.18), number of antihypertensive medications (0.18), female gender (0.10), alcohol use (-0.09) and attendance at regular follow up visits (0.09), respectively. The top 5 numerical variables contributed the most to the prediction of antihypertensive treatment success were blood urea nitrogen (-0.12), glucose (-0.12), hemoglobin A1c (-0.12), uric acid (-0.09) and creatinine (-0.07), respectively. According to the decision tree model; age, gender, regular attendance at follow-up visits, and diabetes status were identified as the most critical patterns for stratifying the patients. CONCLUSION: Data mining algorithms have the potential to produce predictive models for screening the antihypertensive treatment success. Further research on larger populations and longitudinal datasets are required to improve the models.


Assuntos
Anti-Hipertensivos , Hipertensão , Humanos , Anti-Hipertensivos/efeitos adversos , Estudos Retrospectivos , Mineração de Dados , Fatores de Risco , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia
15.
Open Heart ; 9(2)2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36396295

RESUMO

OBJECTIVES: To describe medical management in aortic dissection (AD) and to analyse the possible associations between antihypertensive, antithrombotic, anticoagulant and statin agents, respectively, and long-term survival. METHODS: From Swedish medical registers, all patients diagnosed with AD in 2006-2015 were identified. Filled prescriptions prior to admission and within 1 year from discharge in patients discharged and alive at 30 days were registered. Associations between pharmacological treatment and long-term survival were analysed using Cox proportional hazards models. RESULTS: Of 3951 patients hospitalised with acute AD, 3046 (77%) were discharged and alive at 30 days. In hospitalised patients, mean age was 66 years (SD 13), and 36% (n=1098) were women. Within 1 year from discharge, 96% (n=2939) had at least one antihypertensive drug. Beta blocker was the most commonly used drug type (90%, n=2741). Statin treatment (47%, n=1418) was associated with higher long-term survival; HR 0.74 (95% CI 0.63 to 0.87, p<0.001). The positive association between statins and long-term survival remained, in subgroup analysis, in medically managed patients (HR 0.72 (95% CI 0.60 to 0.86, p<0.001)), but not in patients undergoing surgical repair (HR 0.82 (95% CI 0.58 to 1.14, p=0.230)). Beta blockers were associated with favourable long-term survival in surgically managed patients (HR 0.58 (95% CI 0.35 to 0.97, p=0.038)) but not in medically managed patients (HR 0.93 (95% CI 0.72 to 1.12, p=0.057)). Neither antiplatelet therapy nor anticoagulants were associated with long-term survival. CONCLUSIONS: Statin treatment was associated with favourable long-term outcome in medically managed AD patients, whereas treatment with beta blocker was associated with higher survival only in surgically managed AD patients. Statin use as well as optimal antihypertensive therapy in the chronic stage of the disease need to be further analysed, preferably in randomised controlled trials.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Humanos , Feminino , Idoso , Masculino , Anti-Hipertensivos/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Resultado do Tratamento , /tratamento farmacológico , Modelos de Riscos Proporcionais , Antagonistas Adrenérgicos beta/efeitos adversos
16.
J Drugs Dermatol ; 21(11): 1249-1251, 2022 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-36342724

RESUMO

Epoprostenol (Flolan) is a last-resort intravenous medication for the treatment of severe pulmonary arterial hypertension (PAH). Cutaneous adverse events of Flolan are well-known by pulmonologists, though lacking in dermatologic literature. We report a near erythrodermic appearing, yet asymptomatic eruption lasting 10 years in a woman with end-stage PAH treated with long-term intravenous epoprostenol. Non-pruritic, blanching, erythematous papules coalescing to plaques surrounded by a hypopigmented halo encompassed her entire torso, as well as bilateral upper and lower extremities. Additional findings included bright red palms and soles associated with pain and tingling while walking. Laboratory workup revealed thrombocytopenia and a slightly elevated erythrocyte sedimentation rate (ESR); connective tissue disease markers were negative. Skin biopsies were, surprisingly, largely unremarkable without an inflammatory infiltrate. The patient was trialed on topical clobetasol ointment without effect. Her striking, yet asymptomatic and non-inflammatory eruption was thought due to long-term use of epoprostenol, a last-resort synthetic prostacyclin used to treat severe PAH. As her cutaneous findings were not bothersome, her dose of Flolan was not lowered and her lower extremity pain was treated with gabapentin. With this case, we aim to increase awareness of the impressive “Flolan rash”, a persistent erythematous eruption well-known by pulmonologists, yet scarcely described in dermatologic literature. Significant Finding: We report a striking, yet asymptomatic and non-inflammatory skin eruption lasting 10 years presumed due to long-term use of epoprostenol for end-stage pulmonary arterial hypertension. Meaning: Cutaneous adverse events of intravenous epoprostenol are well-known by pulmonologists, though lacking in dermatologic or primary care literature. The extensive body surface involvement, and near erythroderma, associated with Flolan necessitates awareness by patients, dermatologists, and other healthcare providers outside of the field of pulmonology. J Drugs Dermatol. 2022;21(11):1249-1251. doi:10.36849/JDD.6821.


Assuntos
Exantema , Hipertensão Pulmonar , Hipertensão Arterial Pulmonar , Humanos , Feminino , Epoprostenol/efeitos adversos , Hipertensão Pulmonar/induzido quimicamente , Hipertensão Pulmonar/tratamento farmacológico , Exantema/induzido quimicamente , Eritema/tratamento farmacológico , Dor/induzido quimicamente , Anti-Hipertensivos/efeitos adversos
17.
PLoS One ; 17(11): e0276781, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36350810

RESUMO

Hypertension appears to be one of the commonest comorbidities in COVID-19 patients, although whether hypertensive individuals have a higher risk of severe COVID-19 compared with non-hypertensives is unclear. It is also unclear whether the absolute level of systolic blood pressure, or the type of anti-hypertensive medication is related to this risk. Analyses were conducted using data from the UK Biobank and linked health records. Logistic regression models were fitted to assess the impact of hypertension, systolic blood pressure (SBP) and medications on the risk of severe COVID-19. 16,134 individuals tested positive for severe acute respiratory syndrome-coronavirus, 22% (n = 3,584) developed severe COVID-19 and 40% (n = 6,517) were hypertensive. Hypertension was associated with 22% higher odds of severe COVID-19 (Odds ratio (OR) 1.22; 95% confidence interval (CI) 1.12, 1.33), compared with normotension after adjusting for confounding variables. In those taking anti-hypertensive medications, elevated SBP showed a dose-response relationship with severe COVID-19 (150-159mmHg versus 120-129mmHg (OR 1.91; 95% CI 1.44, 2.53), >180+mmHg versus 120-129mmHg (OR 1.93; 95% CI 1.06, 3.51)). SBP <120mmHg was associated with greater odds of severe COVID-19 (OR 1.40; 95% CI 1.11, 1.78). Angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers were not associated with altered risk of severe COVID-19. Hypertension is an important risk factor for COVID-19. A better understanding of the underlying mechanisms is warranted in case of more severe strains or other viruses in the future.


Assuntos
COVID-19 , Hipertensão , Humanos , Anti-Hipertensivos/efeitos adversos , COVID-19/epidemiologia , Bancos de Espécimes Biológicos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Antagonistas de Receptores de Angiotensina/efeitos adversos , Reino Unido/epidemiologia , Estudos Retrospectivos
18.
Neurol India ; 70(5): 1793-1799, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36352567

RESUMO

Background and Objective: Current recommendations prescribe either nicardipine or labetalol as the first-line treatment for acute hypertension due to ease of use, availability, and low price. However, it is unclear if these drugs have different effectiveness and safety profiles. This systematic review and meta-analysis aimed to compare the efficacy and safety of labetalol and nicardipine in patients with acute stroke. Materials and Methods: MEDLINE via PubMed, Scopus, Embase, and Google Scholar databases were electronically searched for the eligible publications from inception until March 2022. All full-text journal papers in English which compared the efficacy of nicardipine with that of labetalol on lowering blood pressure (BP; or treating hypertension) in all subtypes of acute stroke were included. The Cochrane Collaboration tool was used to assess the risk of bias. Data were analyzed using specific statistical methods. Results: Following the abstract and full-text screening, this meta-analysis included five retrospective cohorts and one prospective pseudorandomized cohort. Nicardipine's effect on time at goal BP was significantly superior to that of labetalol in patients with acute stroke (0.275 standardized mean difference [SMD], 95% confidence interval [CI]: 0.112-0.438, P = 0.001). The incidence of adverse events was significantly higher in the nicardipine group than that in the labetalol group. The pooled odds ratio (OR) was 1.509 (95% CI: 1.077-2.113, I2 = 0.00%, P = 0.757). The quality of included studies was found to be low. Conclusion: More prospective, comparative trials are needed to investigate the efficacy of BP management as well as clinical outcomes in acute stroke patients receiving continuous labetalol and nicardipine infusions.


Assuntos
Hipertensão , Labetalol , Acidente Vascular Cerebral , Humanos , Labetalol/uso terapêutico , Labetalol/efeitos adversos , Nicardipino/uso terapêutico , Nicardipino/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Estudos Retrospectivos , Estudos Prospectivos , Pressão Sanguínea , Resultado do Tratamento , Hipertensão/tratamento farmacológico , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/diagnóstico
19.
Comput Math Methods Med ; 2022: 9317114, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36277012

RESUMO

Objective: The purpose is to investigate the influence of nifedipine, labetalol, and magnesium sulfate on blood pressure control, blood coagulation, and maternal and infant outcome in those suffering from pregnancy-induced hypertension (PIH). Methods: From January 2019 to April 2021, 100 participants with PIH in our center were randomly assigned to a control group and a research group. As a control, nifedipine combined with magnesium sulfate was administered. Nifedipine, labetalol, and magnesium sulfate were administered to the research group. The curative effect, blood pressure level, blood coagulation function, vascular endothelial function, and pregnancy comparisons were made between the two groups. Results: Based on the results of the study, the effective rate totaled 92.00%, while as for the control group, it was 80.0%, which indicates that there was a statistically significant difference between the effective rates of the research group and that of the control group, and the difference was statistically significant (P < 0.05). Blood pressure and blood coagulation function did not differ significantly between the two groups before treatment, and the difference was not statistically significant (P > 0.05). After treatment, both groups experienced a significant drop in systolic and diastolic blood pressure. After treatment, a higher PT index was found in the research group than in the control group. Likewise, the Fbg, D-D, and PLT were lower compared to those in the control group, and the difference was statistically significant (P < 0.05). Neither group had significantly different vascular endothelial function before treatment, and the difference was not statistically significant (P > 0.05). After treatment, the ET-1 of the two groups decreased, and the level of NO increased. There was a lower ET-1 in the research group than in the control group as well as a higher NO level in the research group than in the control group, and the difference was statistically significant (P < 0.05). Compared with the pregnancy outcome, in comparison to the controls, the research group had a higher vaginal delivery rate. Significantly, fewer cases of fetal distress, intrauterine asphyxia, and placental abruption were reported in the research group than in the control group, and the difference was statistically significant (P < 0.05). Conclusion: Nifedipine, in combination with magnesium sulfate and labetalol, is effective at treating PIH, reducing blood pressure, improving blood coagulation, preventing cardiovascular events and vascular endothelial function, and further improve the pregnancy outcome.


Assuntos
Hipertensão Induzida pela Gravidez , Hipertensão , Labetalol , Humanos , Feminino , Gravidez , Labetalol/efeitos adversos , Nifedipino/efeitos adversos , Hipertensão Induzida pela Gravidez/tratamento farmacológico , Hipertensão Induzida pela Gravidez/induzido quimicamente , Pressão Sanguínea , Sulfato de Magnésio/farmacologia , Sulfato de Magnésio/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Placenta , Coagulação Sanguínea
20.
Cancer Med ; 11 Suppl 1: 17-25, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36202605

RESUMO

Antiangiogenic tyrosine kinase inhibitors are the treatment of choice in radioiodine refractory-differentiated thyroid cancer (RR-DTC). Nevertheless, these therapies present class toxicities that may impact their feasibility and patient's quality of life. Their mechanism of action explains the high prevalence of hypertension associated with their use, which reaches 68% with lenvatinib. Moreover, up to 85% of patients treated in the SELECT clinical trial were receiving baseline antihypertensive treatment. These data support the need for prevention, detection, and early management of hypertension. Prevention can be accomplished by controlling cardiovascular risk factors (hypertension, diabetes, obesity, and dyslipidemia) and those associated with lifestyle (smoking, harmful alcohol consumption, and physical inactivity) and electrolyte disorders. It is necessary to achieve stabilization of cardiovascular diseases. Detection involves baseline measurement and monitoring of blood pressure and cardiac function. Treatment requires optimization of baseline blood pressure and early initiation of antihypertensive agents.


Assuntos
Adenocarcinoma , Antineoplásicos , Doenças Cardiovasculares , Hipertensão , Neoplasias da Glândula Tireoide , Adenocarcinoma/tratamento farmacológico , Anti-Hipertensivos/efeitos adversos , Antineoplásicos/efeitos adversos , Doenças Cardiovasculares/induzido quimicamente , Eletrólitos/uso terapêutico , Fatores de Risco de Doenças Cardíacas , Humanos , Hipertensão/induzido quimicamente , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Radioisótopos do Iodo/efeitos adversos , Compostos de Fenilureia/efeitos adversos , Inibidores de Proteínas Quinases/efeitos adversos , Qualidade de Vida , Quinolinas , Fatores de Risco , Neoplasias da Glândula Tireoide/tratamento farmacológico
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