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1.
N Engl J Med ; 386(13): 1221-1229, 2022 03 31.
Artículo en Inglés | MEDLINE | ID: mdl-35172072

RESUMEN

BACKGROUND: The risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) decreases substantially among patients who have recovered from coronavirus disease 2019 (Covid-19). However, it is unknown how long protective immunity lasts. Current guidelines recommend vaccination of recovered patients even though data regarding vaccine effectiveness in such cases are still limited. METHODS: In this retrospective cohort study, we reviewed electronic medical records from a large health care organization in Israel to assess reinfection rates in patients who had recovered from SARS-CoV-2 infection before any vaccination against Covid-19. We compared reinfection rates among patients who had subsequently received the BNT162b2 vaccine (Pfizer-BioNTech) and those who had not been vaccinated between March 1 and November 26, 2021. We used a Cox proportional-hazards regression model with time-dependent covariates to estimate the association between vaccination and reinfection after adjustment for demographic factors and coexisting illnesses. Vaccine effectiveness was estimated as 1 minus the hazard ratio. In a secondary analysis, we evaluated the vaccine effectiveness of one dose as compared with two doses. RESULTS: A total of 149,032 patients who had recovered from SARS-CoV-2 infection met the eligibility criteria. Of these patients, 83,356 (56%) received subsequent vaccination during the 270-day study period. Reinfection occurred in 354 of the vaccinated patients (2.46 cases per 100,000 persons per day) and in 2168 of 65,676 unvaccinated patients (10.21 cases per 100,000 persons per day). Vaccine effectiveness was estimated at 82% (95% confidence interval [CI], 80 to 84) among patients who were 16 to 64 years of age and 60% (95% CI, 36 to 76) among those 65 years of age or older. No significant difference in vaccine effectiveness was found for one dose as compared with two doses. CONCLUSIONS: Among patients who had recovered from Covid-19, the receipt of at least one dose of the BNT162b2 vaccine was associated with a significantly lower risk of recurrent infection.


Asunto(s)
Vacuna BNT162 , COVID-19 , Reinfección , Adolescente , Adulto , Anciano , Vacuna BNT162/uso terapéutico , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/uso terapéutico , Humanos , Persona de Mediana Edad , Reinfección/prevención & control , Estudios Retrospectivos , SARS-CoV-2 , Eficacia de las Vacunas , Vacunas/uso terapéutico , Adulto Joven
2.
N Engl J Med ; 387(9): 790-798, 2022 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-36001529

RESUMEN

BACKGROUND: The oral protease inhibitor nirmatrelvir has shown substantial efficacy in high-risk, unvaccinated patients infected with the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Data regarding the effectiveness of nirmatrelvir in preventing severe coronavirus disease 2019 (Covid-19) outcomes from the B.1.1.529 (omicron) variant are limited. METHODS: We obtained data for all members of Clalit Health Services who were 40 years of age or older at the start of the study period and were assessed as being eligible to receive nirmatrelvir therapy during the omicron surge. A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of nirmatrelvir treatment with hospitalization and death due to Covid-19, with adjustment for sociodemographic factors, coexisting conditions, and previous SARS-CoV-2 immunity status. RESULTS: A total of 109,254 patients met the eligibility criteria, of whom 3902 (4%) received nirmatrelvir during the study period. Among patients 65 years of age or older, the rate of hospitalization due to Covid-19 was 14.7 cases per 100,000 person-days among treated patients as compared with 58.9 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.27; 95% confidence interval [CI], 0.15 to 0.49). The adjusted hazard ratio for death due to Covid-19 was 0.21 (95% CI, 0.05 to 0.82). Among patients 40 to 64 years of age, the rate of hospitalization due to Covid-19 was 15.2 cases per 100,000 person-days among treated patients and 15.8 cases per 100,000 person-days among untreated patients (adjusted hazard ratio, 0.74; 95% CI, 0.35 to 1.58). The adjusted hazard ratio for death due to Covid-19 was 1.32 (95% CI, 0.16 to 10.75). CONCLUSIONS: Among patients 65 years of age or older, the rates of hospitalization and death due to Covid-19 were significantly lower among those who received nirmatrelvir than among those who did not. No evidence of benefit was found in younger adults.


Asunto(s)
Antivirales , Tratamiento Farmacológico de COVID-19 , COVID-19 , Lactamas , Leucina , Nitrilos , Prolina , Adulto , Anciano , Antivirales/uso terapéutico , COVID-19/virología , Hospitalización , Humanos , Lactamas/uso terapéutico , Leucina/uso terapéutico , Persona de Mediana Edad , Nitrilos/uso terapéutico , Prolina/uso terapéutico , SARS-CoV-2 , Resultado del Tratamiento
3.
N Engl J Med ; 385(26): 2413-2420, 2021 12 23.
Artículo en Inglés | MEDLINE | ID: mdl-34879190

RESUMEN

BACKGROUND: The emergence of the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 and the reduced effectiveness over time of the BNT162b2 vaccine (Pfizer-BioNTech) led to a resurgence of coronavirus disease 2019 (Covid-19) cases in populations that had been vaccinated early. On July 30, 2021, the Israeli Ministry of Health approved the use of a third dose of BNT162b2 (booster) to cope with this resurgence. Evidence regarding the effectiveness of the booster in lowering mortality due to Covid-19 is still needed. METHODS: We obtained data for all members of Clalit Health Services who were 50 years of age or older at the start of the study and had received two doses of BNT162b2 at least 5 months earlier. The mortality due to Covid-19 among participants who received the booster during the study period (booster group) was compared with that among participants who did not receive the booster (nonbooster group). A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of booster status with death due to Covid-19, with adjustment for sociodemographic factors and coexisting conditions. RESULTS: A total of 843,208 participants met the eligibility criteria, of whom 758,118 (90%) received the booster during the 54-day study period. Death due to Covid-19 occurred in 65 participants in the booster group (0.16 per 100,000 persons per day) and in 137 participants in the nonbooster group (2.98 per 100,000 persons per day). The adjusted hazard ratio for death due to Covid-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% confidence interval, 0.07 to 0.14; P<0.001). CONCLUSIONS: Participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 than participants who did not receive a booster.


Asunto(s)
Vacuna BNT162 , COVID-19/mortalidad , Inmunización Secundaria , Eficacia de las Vacunas/estadística & datos numéricos , Anciano , Vacuna BNT162/inmunología , COVID-19/prevención & control , Femenino , Humanos , Israel/epidemiología , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales
4.
Am Heart J ; 272: 1-10, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38458372

RESUMEN

BACKGROUND: The increasing burden of atrial fibrillation (AF) emphasizes the need to identify high-risk individuals for enrolment in clinical trials of AF screening and primary prevention. We aimed to develop prediction models to identify individuals at high-risk of AF across prediction horizons from 6-months to 10-years. METHODS: We used secondary-care linked primary care electronic health record data from individuals aged ≥30 years without known AF in the UK Clinical Practice Research Datalink-GOLD dataset between January 2, 1998 and November 30, 2018; randomly divided into derivation (80%) and validation (20%) datasets. Models were derived using logistic regression from known AF risk factors for incident AF in prediction periods of 6 months, 1-year, 2-years, 5-years, and 10-years. Performance was evaluated using in the validation dataset with bootstrap validation with 200 samples, and compared against the CHA2DS2-VASc and C2HEST scores. RESULTS: Of 2,081,139 individuals in the cohort (1,664,911 in the development dataset, 416,228 in the validation dataset), the mean age was 49.9 (SD 15.4), 50.7% were women, and 86.7% were white. New cases of AF were 7,386 (0.4%) within 6 months, 15,349 (0.7%) in 1 year, 38,487 (1.8%) in 5 years, and 79,997 (3.8%) by 10 years. Valvular heart disease and heart failure were the strongest predictors, and association of hypertension with AF increased at longer prediction horizons. The optimal risk models incorporated age, sex, ethnicity, and 8 comorbidities. The models demonstrated good-to-excellent discrimination and strong calibration across prediction horizons (AUROC, 95%CI, calibration slope: 6-months, 0.803, 0.789-0.821, 0.952; 1-year, 0.807, 0.794-0.819, 0.962; 2-years, 0.815, 0.807-0.823, 0.973; 5-years, 0.807, 0.803-0.812, 1.000; 10-years 0.780, 0.777-0.784, 1.010), and superior to the CHA2DS2-VASc and C2HEST scores. The models are available as a web-based FIND-AF calculator. CONCLUSIONS: The FIND-AF models demonstrate high discrimination and calibration across short- and long-term prediction horizons in 2 million individuals. Their utility to inform trial enrolment and clinical decisions for AF screening and primary prevention requires further study.


Asunto(s)
Fibrilación Atrial , Humanos , Fibrilación Atrial/epidemiología , Fibrilación Atrial/complicaciones , Femenino , Masculino , Persona de Mediana Edad , Medición de Riesgo/métodos , Reino Unido/epidemiología , Incidencia , Factores de Riesgo , Anciano , Adulto
5.
Telemed J E Health ; 2024 Jul 05.
Artículo en Inglés | MEDLINE | ID: mdl-38966964

RESUMEN

Objective: Patient satisfaction is an imperative factor in integrating telehealth services as a treatment modality in health care systems. Here, we compared patient satisfaction from telehealth versus in-person health care visits in a large heterogeneous population. Methods: We conducted a retrospective cohort study of patients making telehealth or in-person primary care visits between January 2021 and August 2022. Patient satisfaction with both service types was evaluated using a validated survey. Logistic regression models were employed to assess the association between type of visit (in-person/telehealth) and patient satisfaction (satisfied/unsatisfied) while accounting for sociodemographic and clinical characteristics. Results: Of the 247,087 surveys included in the study, 86,580 (35%) were answered following telehealth visits. Telehealth visitors were more satisfied than in-person visitors in aspects related to doctor-patient interactions, such as "courtesy and respect," "attentive listening," and "coherent explanations" (aOR = 1.17, 95% CI: 1.14-1.21; aOR = 1.16, 95% CI: 1.12-1.19; aOR = 1.15, 95% CI: 1.12-1.18, respectively), and less satisfied in aspects related to indirect services, such as adherence to appointment scheduling, effort required on the part of the patient, and staff cooperation (aOR = 0.95, 95% CI: 0.93-0.97; aOR = 0.89, 95% CI: 0.87-0.91; aOR = 0.85, 95% CI: 0.83-0.87, respectively). Importantly, considerably more telehealth visits were delayed (44%) than in-person visits (27%). Adjustment for this factor further strengthened the observed association between telehealth services and patient satisfaction. Conclusions: While telehealth was associated with high levels of satisfaction in doctor-patient interaction, improvements are still needed in indirect services. Addressing issues related to staff cooperation and streamlining processes to reduce delays could improve overall patient satisfaction with telehealth.

6.
Sex Transm Dis ; 50(10): 680-684, 2023 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-37255258

RESUMEN

BACKGROUND: The current Mpox outbreak presents unique vaccination challenges in vulnerable populations. Understanding factors associated with vaccine uptake in vulnerable populations is required for a successful vaccination campaign. METHODS: This population-based cohort study was conducted in Clalit Health Services and included all individuals eligible for the Modified Vaccinia Ankara vaccine. Cox proportional hazards models were used to assess the characteristics associated with uptake of the first vaccine dose. RESULTS: Attendance to a primary healthcare clinic in the Tel Aviv district, repeated sexually transmitted infection screening, and the recent purchase of HIV-PrEP or PDE5 inhibitors were associated with higher vaccine adherence, whereas previous nonadherence with recommended vaccines, low sociodemographic status, and history of HIV were associated with lower adherence. CONCLUSIONS: These findings highlight the need for proactive patient and healthcare provider-oriented educational campaigns to curb vaccine hesitancy, and may help direct resources toward underserved populations, hence increasing equality in vaccine enrollment.


Asunto(s)
Infecciones por VIH , Mpox , Vacuna contra Viruela , Vacunas , Humanos , Estudios de Cohortes , Vacunación , Poblaciones Vulnerables , Mpox/prevención & control
7.
Diabetes Obes Metab ; 25(4): 961-964, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36507900

RESUMEN

AIMS: Higher doses of the glucagon-like peptide-1 agonist semaglutide and, more recently, tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 agonist showed a significant reduction in body weight in patients with type 2 diabetes mellitus. However, their comparative value for money for this indication is unclear. Therefore, we aimed to establish which provides better value for money. MATERIALS AND METHODS: We calculated the cost needed to treat to achieve a 1% reduction in body weight using high-dose tirzepatide (15 mg) versus semaglutide (2.4 mg). The body weight reductions were extracted from published results of SURMOUNT-1 and STEP 1 trials, respectively. In addition, we performed a scenario analysis to mitigate the primary differences between the two study populations. Drug costs were based on US GoodRx prices as of October 2022. RESULTS: Using tirzepatide resulted in a weight loss of 17.8% (95% CI: 16.3%-19.3%) compared with 12.4% (95% CI: 11.5%-13.4%) for semaglutide. The total cost of 72 weeks of tirzepatide was estimated at $17 527 compared with $22 878 for 68 weeks of semaglutide. Accordingly, the cost needed to treat per 1% of body weight reduction with tirzepatide is estimated at $985 (95% CI: $908-$1075) compared with $1845 (95% CI: $1707-$1989) with semaglutide. Scenario analysis confirmed these findings. CONCLUSIONS: Tirzepatide provides better value for money than semaglutide for weight reduction.


Asunto(s)
Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Hemoglobina Glucada , Pérdida de Peso , Péptidos Similares al Glucagón/uso terapéutico , Peso Corporal , Péptido 1 Similar al Glucagón/uso terapéutico , Receptor del Péptido 1 Similar al Glucagón/uso terapéutico
8.
N Engl J Med ; 388(18): 1726, 2023 May 04.
Artículo en Inglés | MEDLINE | ID: mdl-37133606
9.
12.
N Engl J Med ; 387(26): 2480-2481, 2022 12 29.
Artículo en Inglés | MEDLINE | ID: mdl-36577109

Asunto(s)
COVID-19 , Humanos
13.
Int J Equity Health ; 15: 33, 2016 Feb 24.
Artículo en Inglés | MEDLINE | ID: mdl-26911329

RESUMEN

BACKGROUND: The global economic crisis imposes severe restrictions on healthcare budgets, limiting the coverage of new interventions, even when they are cost-effective. Our objective was to develop a tool that can assist decision-makers in comparing the impact of medical intervention alternatives on the entire target population, under a pre-specified budget constraint. METHODS: We illustrated the tool by using a target population of 1,000 patients, and a budget constraint of $1,000,000. We compared two intervention alternatives: the current practice that costs $1,000 and adds 0.5 quality-adjusted-life-years (QALYs) per patient and a new technology that costs 100 % more, and provides 20 % more QALYs per patient. We also developed a formula for defining the maximum premium price for a higher-cost/higher-effectiveness intervention that can justify its adoption under a constrained budget. RESULTS: Using the new therapy will add 300 QALYs, compared to 500 QALYS when using the lower-cost, lower-effective intervention, despite a favorable incremental cost-effectiveness ratio (ICER) of $10,000. The maximum price for the higher-efficacy therapy that will preserve the target population outcomes is 20 % higher than the lower-cost therapy. CONCLUSIONS: Although an intervention associated with higher costs and higher efficacy may have an acceptable ICER, it could provide inferior outcomes in the target population under budget constraints, depending on the relative effectiveness and costs of the interventions. The cost premium that can be justified for a higher-efficacy intervention is directly correlated to its effectiveness premium. Using the proposed tool may assist decision-makers in improving overall healthcare outcomes, especially in times of economic downturn.


Asunto(s)
Análisis Costo-Beneficio , Costos de la Atención en Salud/tendencias , Salud Pública/economía , Costo de Enfermedad , Equidad en Salud/normas , Humanos , Años de Vida Ajustados por Calidad de Vida
14.
Front Pharmacol ; 15: 1357673, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38567348

RESUMEN

Background and aim: Heart failure with preserved ejection fraction (HFpEF) is associated with an increased risk of heart failure (HF) hospitalizations and cardiovascular death (CVD). Both dapagliflozin and sacubitril-valsartan have recently shown convincing reductions in the combined risk of CVD and HF hospitalizations in patients with HF and mildly reduced ejection fraction (HFmrEF) or HFpEF. We aimed to investigate the cost-per-outcome implications of dapagliflozin vs sacubitril-valsartan in the treatment of HFmrEF or HFpEF patients. Methods: We compared the annualized cost needed to treat (CNT) to prevent the composite outcome of total HF hospitalizations and CVD with dapagliflozin or sacubitril-valsartan. The CNT was estimated by multiplying the annualized number needed to treat (aNNT) by the annual cost of therapy. The aNNT was calculated based on data collected from the DELIVER trial for dapagliflozin and a pooled analysis of the PARAGLIDE-HF and PARAGON-HF trials for sacubitril-valsartan. Costs were based on 2022 US prices. Scenario analyses were performed to attenuate the differences in the studies' populations. Results: The aNNT with dapagliflozin in DELIVER was 30 (95% confidence interval [CI]: 21-62) versus 44 (95% CI: 25-311) with sacubitril-valsartan in a pooled analysis of PARAGLIDE-HF and PARAGON-HF, with an annual cost of $4,951 and $5,576, respectively. The corresponding CNTs were $148,547.13 (95% CI: $103,982.99-$306,997.39) for dapagliflozin and $245,346.77 (95% CI: $139,401.58-1,734,155.60) for sacubitril-valsartan for preventing the composite outcome of CVD and HF hospitalizations. The CNT for preventing all-cause mortality was lower for dapagliflozin than sacubitril-valsartan $1,128,958.15 [CI: $401,077.24-∞] vs $2,185,816.71 [CI: $607,790.87-∞]. Conclusion: Dapagliflozin provides a better monetary value than sacubitril-valsartan in preventing the composite outcome of total HF hospitalizations and CVD among patients with HFmrEF or HFpEF.

15.
Nat Med ; 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38749475

RESUMEN

Comparative evidence for the effects of bariatric metabolic surgery (BMS) and glucagon-like peptide-1 receptor agonists (GLP-1RA) on cardiovascular outcomes is limited. Here, in an observational, retrospective cohort study, we compared the incidence of congestive heart failure (CHF) in adults living with obesity and diabetes without history of CHF (primary CHF) treated with BMS versus GLP-1RA. The population cohort comprised members of Clalit Health Services with no prior history of ischemic heart disease, ischemic stroke or CHF. During the time period of 2008-2021, patients who underwent their first BMS were matched 1:1 with patients who initiated treatment with GLP-1RA, based on clinical characteristics. The study included 2,205 matched pairs of patients (64.5% female), followed for a median of 6.6 years and up to 12 years. Primary incidence of CHF occurred in 26 (1.2%) patients treated with BMS and in 90 patients treated with GLP-1RA (4.1%) (adjusted hazard ratio 0.43, 95% confidence interval 0.27-0.68). Further adjustment for weight reduction did not significantly diminish this association (hazard ratio adjusted for weight reduction 0.48, 95% confidence interval 0.28-0.82), indicating that the differential effect was not mediated through the relative advantage of BMS in maximal weight reduction. In this study, BMS was associated with a stronger reduction in primary incidence of CHF compared with treatment with GLP-1RA. With the increasing use of highly potent next-generation GLP-1RAs, further comparative long-term studies are warranted.

16.
JAMA Netw Open ; 7(6): e2415392, 2024 Jun 03.
Artículo en Inglés | MEDLINE | ID: mdl-38848064

RESUMEN

Importance: Evidence regarding the relative effectiveness of bariatric metabolic surgery (BMS) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) in reducing mortality and major adverse cardiovascular events (MACEs) is limited. Objective: To compare all-cause mortality and nonfatal MACEs associated with BMS vs GLP-1RAs for adults with obesity and diabetes and without known cardiovascular disease. Design, Setting, and Participants: This observational, retrospective cohort study was based on data obtained from the electronic medical records of Clalit Health Services (Clalit), the largest health care organization in Israel. The study included 6070 members aged 24 years or older, who had diabetes and obesity and no prior history of ischemic heart disease, ischemic stroke, or congestive heart failure. Patients who underwent BMS and patients who received GLP-1RAs from January 1, 2008, through December 31, 2021, were matched 1:1 by age, sex, and clinical characteristics. Follow-up ended December 31, 2022. Exposures: Initiation of BMS or GLP-1RAs. Main Outcomes and Measures: The primary outcome was all-cause mortality, assessed by multivariate Cox proportional hazards regression models. The secondary outcome was nonfatal MACEs, assessed by multivariate competing risk models. Results: The study included 3035 matched pairs of patients (total, 6070; mean [SD] age, 51.0 [9.5] years; 3938 women [64.9%]), who were followed up for a median of 6.8 years (IQR, 4.1-9.4 years). Among those with a diabetes duration of 10 years or less (2371 pairs), mortality was lower for those who underwent BMS than for those treated with GLP-1RAs (hazard ratio [HR], 0.38; 95% CI, 0.25-0.58). This association became nonsignificant when weight loss during the follow-up period was also included in the model (HR, 0.79; 95% CI, 0.43-1.48). Among patients with a duration of diabetes longer than 10 years (664 pairs), no survival advantage was demonstrated for BMS over GLP-1RA (HR, 0.65; 95% CI, 0.39-1.08). The risk for nonfatal MACEs did not differ between the treatment groups (HR, 0.74; 95% CI, 0.49-1.10 among patients with a diabetes duration of ≤10 years; HR, 1.21; 95% CI, 0.80-1.85 among patients with a diabetes duration of >10 years). Conclusions and Relevance: In this cohort study, BMS was associated with greater reduced mortality compared with first-generation GLP-1RAs among individuals with a diabetes duration of 10 years or less, mediated via greater weight loss. No differences in the risk for mortality were observed between the treatment modalities among individuals with a longer duration of diabetes, nor in the occurrence of nonfatal MACEs among all patients.


Asunto(s)
Cirugía Bariátrica , Receptor del Péptido 1 Similar al Glucagón , Humanos , Femenino , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Receptor del Péptido 1 Similar al Glucagón/agonistas , Cirugía Bariátrica/mortalidad , Cirugía Bariátrica/métodos , Adulto , Israel/epidemiología , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/mortalidad , Obesidad , Hipoglucemiantes/uso terapéutico , Enfermedades Cardiovasculares/mortalidad , Modelos de Riesgos Proporcionales , Agonistas Receptor de Péptidos Similares al Glucagón
17.
Vaccine ; 42(18): 3830-3837, 2024 Jul 11.
Artículo en Inglés | MEDLINE | ID: mdl-38729910

RESUMEN

BACKGROUND: A large vaccination campaign was initiated worldwide in December 2020 in order to prevent infection with SARS-CoV-2 and severe Covid-19 disease. However, long-term adverse effects of vaccination remain unclear. Therefore, our objective was to examine the association between vaccination and the incidence of autoimmune diagnoses in the first year after vaccine uptake. METHODS: This retrospective cohort study based on Clalit Health Services (CHS) comprehensive database compared the rates of immune-mediated diagnoses among BNT162b2 vaccinated versus unvaccinated individuals. As a reference, a secondary cohort compared individuals infected with Sars-CoV-2 versus uninfected individuals. The minimum follow-up period was 4 months. The cohorts were divided into 4 age groups (12-17, 18-44, 45-64, 65 years or older). Multivariate Cox proportional hazard regression models were applied, followed by a correction for multiple comparisons using the False Discovery Rate (FDR) method, hence accounting for the investigation of multiple clinical outcomes. RESULTS: Increased risk for immune-mediated diagnoses following vaccination with BNT162b2 was observed for psoriasis in all age groups (HR 1.41-1.69), colitis among patients younger than 65 years (HR 1.38-1.93), vitiligo in patients aged 45-64 (HR 2.82, 95 %CI: 1.57-5.08) and for polymyalgia-rheumatica in patients aged 65 years or older (HR 2.12, 95 % CI: 1.3-3.47). In the reference cohort, patients who were infected by Covid-19 were at increased risk for fibromyalgia (HR 1.72, 95 % CI: 1.36-2.19 in individuals aged 18-44; HR 1.71, 95 % CI: 1.31-2.22 in individuals aged 45-64), and hypothyroidism (HR 1.54, 95 % CI: 1.15-2.07 in individuals aged 65 years or older). CONCLUSIONS: The BNT162b2 vaccine was associated with increased risk (though rare) for psoriasis, colitis and polymyalgia rheumatica. These findings should be considered as a part of the risk-benefit assessment when planning future vaccination programs for various population groups.


Asunto(s)
Vacuna BNT162 , COVID-19 , Humanos , Vacuna BNT162/inmunología , Vacuna BNT162/efectos adversos , Persona de Mediana Edad , Estudios Retrospectivos , Masculino , Adulto , Femenino , COVID-19/prevención & control , COVID-19/epidemiología , COVID-19/inmunología , Anciano , Adolescente , Adulto Joven , Incidencia , Niño , Vacunación/efectos adversos , Vacunación/estadística & datos numéricos , SARS-CoV-2/inmunología , Comorbilidad , Enfermedades Autoinmunes/epidemiología , Enfermedades Autoinmunes/etiología , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , Psoriasis/epidemiología , Psoriasis/inmunología
18.
Artículo en Inglés | MEDLINE | ID: mdl-38942382

RESUMEN

OBJECTIVES: Previous research reported inconsistent results on the efficacy of molnupiravir in treating COVID-19. Moreover, efficacy was not assessed in the intended-use population (IUP), as defined by the FDA. Therefore, we aimed to evaluate the effectiveness and safety of molnupiravir for the treatment of COVID-19 in the IUP. METHODS: We conducted a retrospective cohort study on all IUP in Israel's Clalit Health Services (CHS) from Jan. 16, 2022, to Feb. 16, 2023. The effectiveness outcome was the incidence of hospitalization or death due to COVID-19, and the safety outcome was the incidence of all-cause mortality within 35 days of SARS-CoV-2 infection. Cox-proportional hazard models were used to analyze the data after 1:5 propensity score matching. RESULTS: 49,515 patients met the eligibility criteria. Of them, 3,957 molnupiravir-treated patients were matched to 19,785 untreated patients. In molnupiravir-treated patients, 70 out of 3,957 (5.1 per 10,000 person-days) experienced COVID-19-related hospitalization or death, compared to 699 out of 19,785 untreated patients (10.4 per 10,000 person-days); RR: 0.50, (95% CI: 0.39-0.64). All-cause mortality was also lower in the treated group, with 41 out of 3,957 (3.0 per 10,000 person-days) experiencing mortality compared to 414 out of 19,785 untreated patients (6.1 per 10,000 person-days); RR: 0.50 (0.36-0.68). CONCLUSIONS: In a real-world cohort of IUP, molnupiravir therapy was associated with a significant reduction in hospitalizations or deaths due to COVID-19 and all-cause mortality.

19.
Obesity (Silver Spring) ; 31(6): 1510-1513, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37203328

RESUMEN

OBJECTIVE: Higher doses of the glucagon-like peptide-1 agonists liraglutide and, more recently, semaglutide have demonstrated a significant reduction in body weight. However, their comparative value for money for this indication is unclear. METHODS: The cost needed to treat to achieve a 1% reduction in body weight using semaglutide or liraglutide was calculated. The body weight reductions were extracted from the published STEP 1 trial and the SCALE trial results, respectively. A scenario analysis was performed to mitigate the primary differences between the two studies' populations. Drug costs were based on US GoodRx prices as of October 2022. RESULTS: Liraglutide in STEP 1 resulted in a weight loss of 5.4% (95% CI: 5%-5.8%). Semaglutide in SCALE resulted in a weight loss of 12.4% (95% CI: 11.5%-13.4%). The total cost of therapy with liraglutide during the trial was estimated at $17,585 compared with $22,878 with semaglutide. Accordingly, the cost needed to treat per 1% of body weight reduction with liraglutide is estimated at $3256 (95% CI: $3032-$3517) compared with $1845 (95% CI: $1707-$1989) with semaglutide. CONCLUSIONS: Semaglutide provides significantly better value for money than liraglutide for weight reduction.


Asunto(s)
Diabetes Mellitus Tipo 2 , Liraglutida , Humanos , Liraglutida/farmacología , Liraglutida/uso terapéutico , Hipoglucemiantes/farmacología , Hipoglucemiantes/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hemoglobina Glucada , Pérdida de Peso , Peso Corporal
20.
Front Pharmacol ; 14: 1227199, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37601066

RESUMEN

Background and Aim: Dapagliflozin and empagliflozin have demonstrated favorable clinical outcomes among patients with chronic kidney disease (CKD). However, their comparative monetary value for improving outcomes in CKD patients is unestablished. We examined the cost-per-outcome implications of utilizing dapagliflozin as compared to empagliflozin for prevention of renal and cardiovascular events in CKD patients. Methods: For calculation of preventable events we divided the allocated budget by the cost needed to treat (CNT) for preventing a single renal or cardiovascular event. CNT was derived by multiplying the annualized number needed to treat (aNNT) by the annual therapy cost. The aNNTs were determined based on data from the DAPA-CKD and EMPEROR-KIDNEY trials. The budget limit was defined based on the threshold recommended by the United States' Institute for Clinical and Economic Review. Results: The aNNT was 42 both dapagliflozin (95% confidence interval [CI]: 34-59) and empagliflozin (CI: 33-66). The CNT estimates for the prevention of one primary event for dapagliflozin and empagliflozin were comparable at $201,911 (CI: $163,452-$283,636) and $209,664 (CI: $164,736-$329,472), respectively. However, diabetic patients had a higher CNT with dapagliflozin ($201,911 [CI: $153,837-$346,133]) than empagliflozin ($134,784 [CI: $109,824-$214,656]), whereas non-diabetic patients had lower CNT for dapagliflozin ($197,103 [CI: $149,029-$346,133]) than empagliflozin ($394,368 [CI: $219,648-$7,093,632]). The CNT for preventing CKD progression was higher for dapagliflozin ($427,858 [CI: $307,673-$855,717]) than empagliflozin ($224,640 [CI: $169,728-$344,448]). For preventing cardiovascular death (CVD), the CNT was lower for dapagliflozin ($1,634,515 [CI: $740,339-∞]) than empagliflozin ($2,990,208 [CI: $1,193,088-∞]). Conclusion: Among patients with CKD, empagliflozin provides a better monetary value for preventing the composite renal and cardiovascular events in diabetic patients while dapagliflozin has a better value for non-diabetic patients. Dapagliflozin provides a better monetary value for the prevention of CVD, whereas empagliflozin has a better value for the prevention of CKD progression.

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