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1.
Lancet ; 395(10234): 1444-1451, 2020 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-32234534

RESUMEN

BACKGROUND: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. METHODS: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. FINDINGS: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months. INTERPRETATION: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. FUNDING: Medtronic.


Asunto(s)
Hipertensión/cirugía , Riñón/inervación , Riñón/cirugía , Adulto , Antihipertensivos/normas , Australia/epidemiología , Austria/epidemiología , Teorema de Bayes , Presión Sanguínea/fisiología , Canadá/epidemiología , Femenino , Alemania/epidemiología , Grecia/epidemiología , Humanos , Hipertensión/diagnóstico , Hipertensión/etnología , Irlanda/epidemiología , Japón/epidemiología , Riñón/fisiopatología , Masculino , Persona de Mediana Edad , Placebos/efectos adversos , Estudios Prospectivos , Simpatectomía/métodos , Resultado del Tratamiento , Reino Unido/epidemiología , Estados Unidos/epidemiología
2.
Medicine (Baltimore) ; 99(17): e19769, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32332617

RESUMEN

INTRODUCTION: High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure. METHODS/DESIGN: This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales). DISCUSSION: This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).


Asunto(s)
Antihipertensivos/normas , Determinación de la Presión Sanguínea/normas , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Determinación de la Presión Sanguínea/métodos , Restricción Calórica/métodos , Análisis por Conglomerados , Dieta Hiposódica/métodos , Ejercicio Físico/fisiología , Femenino , Humanos , Hipertensión/psicología , Estilo de Vida , Masculino , Persona de Mediana Edad , Factores de Riesgo , Automanejo/métodos , Automanejo/psicología , Cumplimiento y Adherencia al Tratamiento/psicología , Resultado del Tratamiento
3.
Glob Heart ; 14(3): 327-333, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31451241

RESUMEN

BACKGROUND: Widespread access to good quality antihypertensive medicines is a critical component for reducing premature cardiovascular disease (CVD) mortality. Poor-quality medicines pose serious health concerns; however, there remains a knowledge gap about the quality of cardiovascular medicines available in low- and middle-income countries. OBJECTIVES: The aim of this study was to determine the quality of generic antihypertensive medicines available in the retail market of a developing country. METHODS: Samples of the 2 most commonly prescribed classes of antihypertensive medicines were collected from 3 states in 3 different geopolitical zones in Nigeria following a semirandom sampling framework. Medicine samples were purchased by mystery shoppers from 22 pharmacy outlets from 6 local government areas across the 3 states. Medicine quality was determined by measuring the amount of stated active pharmaceutical ingredient using high-performance liquid chromatography with photodiode array detection and classified according to their compliance to the specified pharmacopeia tolerance limits for each antihypertensive drug. RESULTS: Amlodipine and lisinopril were identified as the most commonly prescribed antihypertensive drugs in Nigeria. In total, 361 samples from 22 pharmacies were collected and tested. In total, 24.6% of amlodipine and 31.9% of lisinopril samples were of substandard quality and significantly more samples purchased in rural (59 of 161, 36.7%) compared with urban (32 of 200, 16%) outlets were found to be of substandard quality (p < 0.001). No falsified samples of either amlodipine or lisinopril were detected. There was large variation in price paid for the antihypertensive medicines (range ₦150 to ₦9,750). Of the 24 pharmacy outlets surveyed, 46% stated that patients did not always require a prescription and 21% had previously reported a medicine as falsified or substandard. CONCLUSIONS: More than one-quarter of some commonly prescribed antihypertensive medicines available in Nigeria may be of substandard quality. Enhanced quality assurance processes in low- and middle-income countries, such as Nigeria, are needed to support optimum management.


Asunto(s)
Amlodipino/normas , Antihipertensivos/normas , Medicamentos Genéricos/normas , Lisinopril/normas , Amlodipino/química , Antihipertensivos/química , Composición de Medicamentos/normas , Medicamentos Genéricos/química , Humanos , Lisinopril/química , Nigeria , Farmacias/estadística & datos numéricos , Salud Rural , Salud Urbana
4.
Biol Pharm Bull ; 42(4): 547-551, 2019 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-30726781

RESUMEN

Valsartan products, commonly used to treat high blood pressure and heart failure, have been recalled in many countries due to the presence of an impurity, N-nitrosodimethylamine (NDMA), in the recalled products. We present and evaluate a GC-MS-based analytical method for the determination of NDMA levels and attempt an investigation of NDMA concentrations in valsartan drug substances and associated products. The limit of detection and limit of quantification for the method were estimated to be 0.1 and 0.5 µg/g, respectively, when testing a 0.5-g sample. A good trueness (99%) with a small relative standard deviation (1.9%) was obtained for a valsartan product spiked with NDMA at a concentration of 1.0 µg/g. Additionally, a valsartan drug substance and the associated product, which were previously determined to have NDMA contamination, were analyzed by the method. The NDMA content by our method was very close to previously determined values. Finally, six samples, including valsartan drug substances and associated, commercially available products in Japan, all of which were derived from the company implicated in the NDMA contamination, were analyzed by our method, revealing that none of these samples contained detectable concentrations of NDMA. Overall, the data indicate that the present method is reliable and useful for determination of NDMA in valsartan drug substances and associated products.


Asunto(s)
Antihipertensivos/análisis , Dimetilnitrosamina/análisis , Contaminación de Medicamentos/prevención & control , Valsartán/análisis , Métodos Analíticos de la Preparación de la Muestra , Antihipertensivos/normas , Cromatografía de Gases y Espectrometría de Masas , Japón , Límite de Detección , Comprimidos , Valsartán/normas
5.
Circ J ; 83(3): 622-629, 2019 02 25.
Artículo en Inglés | MEDLINE | ID: mdl-30760655

RESUMEN

BACKGROUND: SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal denervation (RDN) with standard pharmacologic therapy for treatment of uncontrolled hypertension (HTN). Methods and Results: Patients enrolled had uncontrolled HTN, defined as office systolic blood pressure (SBP) ≥160 mmHg and 24-h ambulatory SBP ≥135 mmHg, on ≥3 antihypertensive drugs of maximally tolerated dose for at least 6 weeks prior to enrollment. Randomization was 1:1 to RDN or maintenance of current medical therapy (control). Patients were followed every 6 months post-randomization for up to 36 months. There were 22 patients randomized to RDN and 19 to control, and 11 patients were crossed over and received RDN at 6 months post-randomization. For the RDN group (n=22), office SBP reduction was -32.8±20.1 mmHg and office DBP reduction was -15.8±12.6 mmHg at 36 months post-procedure, both P<0.001. For the combined RDN and crossover group (n=33), office SBP reduction was -26.7±18.9 mmHg and office DBP reduction was -12.7±11.8 mmHg at 30 months post-procedure, both P<0.001. There were no procedural-, device- or treatment-related safety events through 36 months. CONCLUSIONS: SYMPLICITY HTN-Japan is the first randomized controlled trial to evaluate RDN in an Asian population. Despite the small number of enrollments, results show patients who received RDN therapy maintained SBP reduction out to 36 months.


Asunto(s)
Antihipertensivos/uso terapéutico , Desnervación/métodos , Hipertensión/terapia , Riñón/inervación , Adulto , Anciano , Antihipertensivos/normas , Desnervación/normas , Femenino , Estudios de Seguimiento , Humanos , Japón , Riñón/fisiopatología , Persona de Mediana Edad , Resultado del Tratamiento
6.
PLoS One ; 14(2): e0211567, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30759124

RESUMEN

BACKGROUND: As the burden of noncommunicable diseases grows, access to safe medical therapy is increasing in importance. The aim of this study was to develop a method for evaluating the quality of antihypertensive drugs and to examine whether this prevalence varies by socioeconomic variables. METHODS: We conducted a cross-sectional survey of registered pharmacies in 6 local government areas (LGAs) in Lagos State, Nigeria. In each LGA, we sampled 17 pharmacies from a list of all registered pharmacies derived from the Pharmacists Council of Nigeria. We assessed drug quality based on (1) the level of active pharmaceutical ingredients (APIs), which identified falsely labeled drug samples; and (2) the amount of impurities, which revealed substandard drug samples in accordance with the international pharmacopoeia guidelines. Good-quality drugs met specifications for both API and impurity. RESULTS: Of the 102 drug samples collected, 30 (29.3%) were falsely labeled, 76 (74.5%) were substandard,78 (76.5%) were of poor quality and 24 (23.5%) were of good quality.Among the falsely labeled drugs, 2 samples met standards set for purity while 28 did not. Among the 76 substandard drug samples, 28 were also falsely labeled. Of the falsely labeled drugs, 17 (56.7%) came from LGAs with low socioeconomic status, and 40 (52.6%) of the substandard drug samples came from LGAs with high socioeconomic status. Most of the good-quality drug samples, 14 (58.3%), were from LGAs with low socioeconomic status. Eighteen (60%) of the falsely labeled samples, 37 (48.7%) of the substandard samples, and 15 (62.5%) of the good-quality drug samples were from manufacturers based in Asia. The average price was 375.67 Nigerian naira (NGN) for falsely labeled drugs, 383.33 NGN for substandard drugs, and 375.67 NGN for good-quality drugs. The prevalence of falsely labeled and substandard drug samples did not differ by LGA-level socioeconomic status (P = .39) or region of manufacturer (P = .24); however, there was a trend for a difference by price (P = .06). CONCLUSION: The prevalence of falsely labeled and substandard drug samples was high in Lagos. Treatment of noncommunicable diseases in this setting will require efforts to monitor and assure drug quality.


Asunto(s)
Antihipertensivos/normas , Nifedipino/normas , Farmacias/normas , Control de Calidad , Antihipertensivos/uso terapéutico , Comercio , Estudios Transversales , Humanos , Nifedipino/uso terapéutico , Nigeria , Enfermedades no Transmisibles/tratamiento farmacológico , Factores Socioeconómicos
7.
J Pharm Biomed Anal ; 165: 325-337, 2019 Feb 20.
Artículo en Inglés | MEDLINE | ID: mdl-30579233

RESUMEN

Ambrisentan is a highly selective endothelin-A receptor antagonist for the treatment of pulmonary arterial hypertension (PAH). The analysis of the process-related impurities will help not only to optimize the process parameters but also to develop reasonable analytical methods and set the quality standard for a quality control strategy in pharmaceutical manufacturing. During the manufacture of ambrisentan, five unknown impurities were detected in pilot batches ranging from 0.05% to 0.15% by HPLC. All of these impurities were isolated and synthesized successfully and were identified and characterized by LC-MS, HRMS, ESI-MS/MS(Q-Tof), 1D-NMR (1H, 13C, DEPT) and 2D-NMR (COSY, HSQC, HMBC) techniques. The formation mechanisms that yield these impurities are discussed for the first time. Quality control strategies to deal with these impurities are developed to obtain bulk drug of ICH-grade quality.


Asunto(s)
Antihipertensivos/análisis , Contaminación de Medicamentos , Fenilpropionatos/análisis , Piridazinas/análisis , Control de Calidad , Antihipertensivos/química , Antihipertensivos/normas , Cromatografía Líquida de Alta Presión/métodos , Cromatografía Liquida/métodos , Espectroscopía de Resonancia Magnética/métodos , Fenilpropionatos/química , Fenilpropionatos/normas , Piridazinas/química , Piridazinas/normas , Espectrometría de Masa por Ionización de Electrospray/métodos , Espectrometría de Masas en Tándem/métodos
8.
Ned Tijdschr Geneeskd ; 1622018 10 18.
Artículo en Holandés | MEDLINE | ID: mdl-30379497

RESUMEN

According to the 2011 Dutch guideline on Cardiovascular risk management 1 in 5 hypertensive patients are eligible for blood pressure lowering treatment. The Dutch guideline recommends striving for a systolic blood pressure (SBP) of < 140 mmHg in adult patients who have no cardiovascular disease or diabetes mellitus, while the recent American guideline now recommends an SBP target value of < 130 mmHg for all adult patients. An important reason for using a stricter SBP target value are the results of randomised studies and meta-analyses that looked at the effect of intensive antihypertensive therapy on the risk of mortality and cardiovascular disease. Based on the literature, there appears to be sufficient evidence that intensive antihypertensive therapy (SBP target value of < 130 mmHg) is useful in patients with cardiovascular disease and in patients with high cardiovascular risk. Currently, there is insufficient evidence that intensive antihypertensive therapy is useful in patients who have diabetes mellitus or who are over 80 years old.


Asunto(s)
Antihipertensivos/normas , Hipertensión/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Anciano de 80 o más Años , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus/fisiopatología , Humanos , Hipertensión/complicaciones , Países Bajos , Estándares de Referencia
9.
Am J Trop Med Hyg ; 98(6): 1643-1652, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29611498

RESUMEN

The World Health Organization has warned that substandard and falsified medical products (SFs) can harm patients and fail to treat the diseases for which they were intended, and they affect every region of the world, leading to loss of confidence in medicines, health-care providers, and health systems. Therefore, development of analytical procedures to detect SFs is extremely important. In this study, we investigated the quality of pharmaceutical tablets containing the antihypertensive candesartan cilexetil, collected in China, Indonesia, Japan, and Myanmar, using the Japanese pharmacopeial analytical procedures for quality control, together with principal component analysis (PCA) of Raman spectrum obtained with handheld Raman spectrometer. Some samples showed delayed dissolution and failed to meet the pharmacopeial specification, whereas others failed the assay test. These products appeared to be substandard. Principal component analysis showed that all Raman spectra could be explained in terms of two components: the amount of the active pharmaceutical ingredient and the kinds of excipients. Principal component analysis score plot indicated one substandard, and the falsified tablets have similar principal components in Raman spectra, in contrast to authentic products. The locations of samples within the PCA score plot varied according to the source country, suggesting that manufacturers in different countries use different excipients. Our results indicate that the handheld Raman device will be useful for detection of SFs in the field. Principal component analysis of that Raman data clarify the difference in chemical properties between good quality products and SFs that circulate in the Asian market.


Asunto(s)
Antihipertensivos/normas , Bencimidazoles/normas , Compuestos de Bifenilo/normas , Fraude , Farmacopeas como Asunto/normas , Espectrometría Raman/instrumentación , Comprimidos/normas , Tetrazoles/normas , China , Computadoras de Mano , Fraude/prevención & control , Humanos , Indonesia , Japón , Mianmar , Análisis de Componente Principal , Control de Calidad , Organización Mundial de la Salud
10.
Am J Health Syst Pharm ; 75(5): 309-315, 2018 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-29472513

RESUMEN

PURPOSE: Results of a study to determine the stability of an extemporaneously compounded minoxidil oral suspension under various temperature and stress conditions are reported. METHODS: Commercially available minoxidil tablets (10 mg) were crushed to a fine powder, and predetermined amounts of 2 suspending vehicles were added to produce a 1-mg/mL suspension, which was stored in glass bottles at room temperature (25 ± 2 °C) or in a refrigerator (4 ± 2 °C). To simulate daily patient use, 5 days weekly 1 bottle of the suspension was removed from refrigerated storage and shaken and 0.5 mL of the contents discarded. At each specified time point, samples were analyzed in duplicate (n = 6 for each test condition) using a validated high-performance liquid chromatography method. Samples were visually observed and their pH measured at each time point. Microbiological studies were performed on day 0 and at week 24. RESULTS: The mean percentage of initial minoxidil concentration remaining in all refrigerated samples exceeded 90% throughout the 24-week study, with no change in appearance, pH, microbial activity, odor, or redispersibility. During storage at room temperature, the suspension exhibited a color change at week 4, with slight sedimentation after 6 weeks, although minoxidil recovery exceeded 90% for 10 weeks. CONCLUSION: An extemporaneously compounded minoxidil oral suspension was stable for 24 weeks when stored in a refrigerator. This suspension can be used for up to 3 weeks when stored at room temperature.


Asunto(s)
Antihipertensivos/análisis , Antihipertensivos/normas , Composición de Medicamentos/normas , Minoxidil/análisis , Minoxidil/normas , Administración Oral , Cromatografía Líquida de Alta Presión/métodos , Cromatografía Líquida de Alta Presión/normas , Composición de Medicamentos/métodos , Estabilidad de Medicamentos , Almacenaje de Medicamentos/métodos , Almacenaje de Medicamentos/normas , Suspensiones
12.
JAMA Netw Open ; 1(5): e181617, 2018 09 07.
Artículo en Inglés | MEDLINE | ID: mdl-30646139

RESUMEN

Importance: Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (-10.7, -9.7, and -6.6 mm Hg, respectively). Objectives: To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care. Design, Setting, and Participants: Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015. Interventions: A home BP telemonitoring intervention with pharmacist management or usual care. Main Outcomes and Measures: Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit. Results: Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was -2.5 mm Hg (95% CI, -6.3 to 1.2 mm Hg; P = .18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of -1.0 mm Hg (95% CI, -3.2 to 1.2 mm Hg; P = .37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months. Conclusions and Relevance: This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases. Trial Registration: ClinicalTrials.gov Identifier: NCT00781365.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/normas , Servicios Comunitarios de Farmacia/normas , Hipertensión/tratamiento farmacológico , Anciano , Antihipertensivos/normas , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Monitoreo Ambulatorio de la Presión Arterial/instrumentación , Monitoreo Ambulatorio de la Presión Arterial/métodos , Quimioterapia/métodos , Quimioterapia/normas , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/clasificación , Masculino , Persona de Mediana Edad , Minnesota , Relaciones Profesional-Paciente , Telemetría/métodos , Telemetría/normas
13.
J Hypertens ; 36(2): 395-401, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-28957849

RESUMEN

OBJECTIVE: Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality. METHODS: Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. RESULTS: A total of 1185 samples were assessed, of which 70.0% were generic (n = 830). Among the generic drugs, the percentage of poor-quality drugs was 24.3% (n = 202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2 to 111.3%; the majority (81.7%) of the poor-quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. CONCLUSION: In this study from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.


Asunto(s)
Antihipertensivos/normas , Países en Desarrollo/estadística & datos numéricos , Medicamentos Genéricos/normas , Medicamentos de Baja Calidad , África del Sur del Sahara , Antihipertensivos/economía , Comercio , Medicamentos Genéricos/economía , Humanos
15.
Am J Respir Crit Care Med ; 196(8): e32-e47, 2017 10 15.
Artículo en Inglés | MEDLINE | ID: mdl-29028375

RESUMEN

BACKGROUND: Health disparities have a major impact in the quality of life and clinical care received by minorities in the United States. Pulmonary arterial hypertension (PAH) is a rare cardiopulmonary disorder that affects children and adults and that, if untreated, results in premature death. The impact of health disparities in the diagnosis, treatment, and clinical outcome of patients with PAH has not been systematically investigated. OBJECTIVES: The specific goals of this research statement were to conduct a critical review of the literature concerning health disparities in PAH, identify major research gaps and prioritize direction for future research. METHODS: Literature searches from multiple reference databases were performed using medical subject headings and text words for pulmonary hypertension and health disparities. Members of the committee discussed the evidence and provided recommendations for future research. RESULTS: Few studies were found discussing the impact of health disparities in PAH. Using recent research statements focused on health disparities, the group identified six major study topics that would help address the contribution of health disparities to PAH. Representative studies in each topic were discussed and specific recommendations were made by the group concerning the most urgent questions to address in future research studies. CONCLUSIONS: At present, there are few studies that address health disparities in PAH. Given the potential adverse impact of health disparities, we recommend that research efforts be undertaken to address the topics discussed in the document. Awareness of health disparities will likely improve advocacy efforts, public health policy and the quality of care of vulnerable populations with PAH.


Asunto(s)
Antihipertensivos/normas , Política de Salud , Disparidades en Atención de Salud , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Sociedades Médicas , Estados Unidos , Adulto Joven
18.
Dtsch Med Wochenschr ; 141(24): 1764-1769, 2016 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-27903027

RESUMEN

Pulmonary hypertension (PH) is characterized by an increase in PAPmean > 25 mmHg associated with a reduced life expectancy. Recent advances in the management of these patients provided the basis for the updated recommendations of the 2015 joint guidelines of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS) on the diagnosis and treatment of pulmonary hypertension. The updated version includes important modifications with regards to hemodynamic definitions, clinical classification and diagnostic assessment of patients with PH. In addition, risk stratification and PH treatment were profoundly modified, introducing novel drugs and improved treatment strategies such as early combination therapy. Finally, the new ESC /ERS guidelines provide formal recommendations for the management of PH due to left heart or chronic lung disease and chronic thromboembolic pulmonary hypertension, and define criteria for specialized PH expert centers.


Asunto(s)
Antihipertensivos/administración & dosificación , Determinación de la Presión Sanguínea/normas , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/terapia , Guías de Práctica Clínica como Asunto , Neumología/normas , Antihipertensivos/normas , Europa (Continente) , Medicina Basada en la Evidencia , Humanos , Sociedades Médicas , Resultado del Tratamiento
19.
Dtsch Med Wochenschr ; 141(24): 1778-1782, 2016 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-27825176

RESUMEN

Recently, the updated European Guidelines on the Diagnosis and Treatment of Pulmonary Hypertension (PH) have been published. The practical implementation of the guidelines considering country-specific aspects, current data and individual features is essential for clinical patient care. In order to accomplish this, in June 2016 the 2nd Cologne Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany. To this end, 10 working groups were initiated, each of which was dedicated to one specific topic. This article summarizes some of the results that were obtained by interdisciplinary consensus.


Asunto(s)
Antihipertensivos/administración & dosificación , Determinación de la Presión Sanguínea/normas , Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/terapia , Guías de Práctica Clínica como Asunto , Neumología/normas , Antihipertensivos/normas , Medicina Basada en la Evidencia , Alemania , Humanos , Sociedades Médicas , Resultado del Tratamiento
20.
Diabetes Educ ; 42(6): 739-747, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27621092

RESUMEN

PURPOSE: The purpose of this study was to determine the use of clinical-guideline-recommended antihypertensive regimens among Mexican Americans (MAs) and non-Hispanic blacks and whites with type 2 diabetes and hypertension. METHODS: A secondary data analysis based on National Health and Nutrition Examination Survey 2003-2012 cohort data included 1857 noninstitutionalized civilian MA, black, and white adults with type 2 diabetes and hypertension. Unadjusted and adjusted 2-way analysis of variance models evaluated whether there was a difference in the use of recommended antihypertensive regimens across race/ethnic group. RESULTS: There was no difference in the use of recommended regimens across race/ethnic group (MAs, 79.1%; blacks, 81.7%; whites, 82.3%). Similarly, there was no difference between blood pressure goal levels and the use of recommended therapies across race/ethnicity (P = .632). Mexican Americans were least likely and blacks most likely to be on 3 or more antihypertensive drug classes (16.8% vs 28%). Furthermore, MAs were least likely to be on recommended add-on therapies such as calcium channel blockers and diuretics. CONCLUSION: Racial/ethnic medication use disparities were observed when looking at the number of antihypertensive drug classes per patient regimen, and add-on therapy use was evaluated. Along with lifestyle modifications, frequent antihypertensive regimen reassessment is necessary.


Asunto(s)
Antihipertensivos/uso terapéutico , Diabetes Mellitus Tipo 2/complicaciones , Adhesión a Directriz/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Hipertensión/tratamiento farmacológico , Adulto , Afroamericanos/estadística & datos numéricos , Antihipertensivos/normas , Diabetes Mellitus Tipo 2/etnología , Grupo de Ascendencia Continental Europea/estadística & datos numéricos , Femenino , Humanos , Hipertensión/etnología , Masculino , Americanos Mexicanos/estadística & datos numéricos , Persona de Mediana Edad , Encuestas Nutricionales , Guías de Práctica Clínica como Asunto , Estados Unidos
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