This year, 2025, is not an epidemic year, and if the country receives an award for control, it should be given to other countries on the continent that have better indicators. Rodríguez Monegro referred to the statements of the Minister of Public Health, Víctor Atallah, who stated that the Dominican Republic has recorded a 78% reduction in dengue cases, thanks to the work carried out by provincial and regional health departments. For the pediatrician and former director of the SNS, the reduction in dengue cases is not due to any implemented strategy; rather, 2025 is a non-epidemic year with a low incidence of the disease. “The decline in dengue cannot be attributed to official campaigns, since when there is a dengue prevention and control campaign, it is felt in the community,” he said.

What is happening in all countries of the Americas is that there is a significant reduction in the incidence of dengue, because this is a year of low incidence and possibly the next one as well, unlike 2022 and 2023, he explained.

Under the criteria used by the Dominican authorities, all of America should be declared champions in the fight against dengue.

Official position

The Ministry of Health called on citizens to join efforts to reduce dengue transmission. The Ministry of Health continues to strengthen vector control efforts to reduce dengue transmission in the country. It stated that mosquito breeding site elimination campaigns, community education on hygiene habits, and fumigation efforts have been intensified.

The Ministry also stated that it has implemented various actions as part of the National Dengue Plan, intending to reduce the incidence of this disease. It also said it has relaunched the “eliminate, clean, and cover” campaign. This week, data for week 33 were released.

Preventive measures against dengue include eliminating mosquito breeding sites (such as stagnant water in containers and tires), protecting against mosquito bites with repellent, and using mosquito nets over beds, doors, and windows.

Public Health urges people to visit the nearest health center if they experience symptoms such as a sudden high fever, severe headache (especially behind the eyes), muscle and joint pain (“breakbone fever”), nausea, vomiting, and a skin rash.

A confirmed case of dengue was reported this week, bringing the total number of cases to 174.

Durante una cena bajo palmeras en la terraza de Mar-a-Lago en diciembre, el presidente electo Donald Trump tranquilizó a los directores ejecutivos de las farmacéuticas Eli Lilly y Pfizer diciéndoles que el activista antivacunas Robert F. Kennedy Jr. no sería una elección radical para dirigir el Departamento de Salud y Servicios Humanos (HHS).

“Creo que va a ser mucho menos radical de lo que imaginan”, aseguró Trump ese mismo mes durante una conferencia de prensa en su complejo turístico en Palm Beach, Florida.

Ocho meses después, Kennedy ha intensificado sus ataques contra el sistema de vacunación.

Uno de sus principales objetivos es un programa federal de compensación que resuelve reclamos de daños por vacunas.

Según algunos expertos legales y líderes en salud pública, su estrategia podría llevar a la quiebra o al debilitamiento del fondo, obligando a las farmacéuticas a asumir riesgos legales y costos que las llevarían a dejar de fabricar vacunas por completo.

“Es una agenda radical”, dijo Angela Rasmussen, viróloga de la Organización de Vacunas y Enfermedades Infecciosas de la Universidad de Saskatchewan en Canadá. “Está usando varios mecanismos distintos y realmente no hay límites. La gente va a empezar a darse cuenta, pero no será suficiente para detener la ola de muertes, incluidas las de niños”.

Kennedy ha dicho que es necesario reformar el sistema de vacunación en el país porque, según él —sin ofrecer evidencia—, las vacunas están relacionadas con el autismo, la neurotoxicidad, las alergias y la muerte. Es una de las figuras líderes del movimiento “Make America Healthy Again” (“Hagamos a Estados Unidos Saludable Otra Vez”), una campaña informal que rechaza la medicina tradicional y promueve la llamada “libertad médica”.

Muchos de sus seguidores se oponen a las vacunas y creen que son peligrosas, a pesar de la evidencia científica que demuestra lo contrario.

Kennedy ha reconocido que quiere reformar el fondo de vacunas, conocido como el Programa de Compensación por Lesiones Causadas por Vacunas (VICP, por sus siglas en inglés). El 28 de julio escribió en la red social X que “el VICP está roto, y pienso arreglarlo”. El Departamento de Salud y Servicios Humanos (HHS) está trabajando con el Departamento de Justicia para reformar el programa, que protege a las farmacéuticas de la mayoría de las demandas por lesiones.

El HHS no respondió a la solicitud de entrevista con Kennedy, pero funcionarios de la agencia dijeron que él no está en contra de las vacunas. “El secretario Kennedy no es antivacunas: está a favor de la seguridad, la transparencia y la rendición de cuentas”, dijo por correo electrónico Vianca Rodríguez Feliciano, vocera del HHS.

Sin embargo, según personas familiarizadas con las discusiones internas —que pidieron no ser identificadas porque no están autorizadas para hablar sobre el tema—, Kennedy ha estado trabajando en silencio para restringir la disponibilidad de vacunas ampliamente utilizadas.

Una estrategia con varios frentes

La estrategia comenzó a tomar forma en la primavera. El primer paso fue sembrar dudas infundadas sobre la seguridad de las vacunas. En una reunión de gabinete en abril, Kennedy le dijo a Trump que el HHS estaba realizando un estudio masivo para identificar la causa del aumento de diagnósticos de autismo para septiembre.

Según informes de prensa, Kennedy asignó la tarea a David Geier, un investigador que ha repetido la afirmación —ya desacreditada— de que las vacunas causan autismo.

Luego, Kennedy redobló la apuesta cuestionando el uso de aluminio, que se agrega a muchas vacunas para reforzar la respuesta inmunitaria. En una reunión de gobernadores en julio, lo vinculó con las alergias, a pesar de que un estudio reciente en la revista Annals of Internal Medicine no encontró ninguna conexión. Se espera ampliamente que pida a un comité asesor federal que revise el uso del aluminio.

La investigación sobre el autismo y las dudas sobre el aluminio fueron los primeros pasos en su ofensiva contra el fondo de compensación, según dos fuentes.

Ese fondo ofrece compensaciones a personas con lesiones causadas por vacunas y ha pagado más de $5.000 millones desde su creación en 1988, según la Administración de Recursos y Servicios de Salud (HRSA, por sus siglas en inglés).

Antes de presentar una demanda en un tribunal, las personas afectadas presentan sus reclamos ante el “tribunal de vacunas”, que no tiene jurado y evalúa la evidencia. El dinero proviene de un pequeño impuesto especial sobre cada vacuna.

La compensación se determina en parte por una tabla que mantiene la HRSA y supervisa el secretario del HHS. Esta lista enumera las vacunas y sus posibles efectos secundarios, y abarca las inmunizaciones de rutina recomendadas por los Centros para el Control y Prevención de Enfermedades (CDC), que están sujetas al impuesto. Las lesiones incluyen anafilaxia y encefalitis. Quienes sufran esas condiciones dentro de cierto tiempo después de vacunarse pueden recibir una indemnización.

Kennedy quiere que se incluyan el autismo o las alergias en esa tabla, según dos personas familiarizadas con las discusiones internas y con preocupaciones expresadas públicamente por farmacéuticas y ex funcionarios. Podría lograrlo, por ejemplo, si una investigación dirigida por el HHS vinculara las vacunas con el autismo, o si un comité asesor recomendara eliminar el aluminio de las vacunas.

“Dado el índice de autismo, si se presentan muchos casos, eso podría llevar a la quiebra del programa”, dijo Dorit Reiss, profesora de la Universidad de California en San Francisco.

Si eso ocurriera, algunas farmacéuticas podrían dejar de fabricar vacunas —que no suelen ser productos muy rentables— para evitar demandas largas y costosas de personas que no puedan ser compensadas porque el fondo federal se haya agotado, dijeron expertos en estas leyes y fabricantes.

“El fondo de compensación, si desaparece, afectaría la decisión de seguir adelante o no con las vacunas”, dijo David Dodd, presidente y director ejecutivo de GeoVax Labs, una empresa biotecnológica que desarrolla vacunas e inmunoterapias.

Kennedy ha puesto a personas de su confianza para llevar adelante esta estrategia. Ha presionado para que escépticos de las vacunas ocupen puestos clave en los CDC, que recomiendan las vacunas, y en la Administración de Alimentos y Medicamentos (FDA), que las aprueba.

También seleccionó a líderes del movimiento antivacunas para que evaluaran candidatos para su equipo.

El resultado ha sido una serie de decisiones regulatorias y políticas que han limitado el acceso a las vacunas y el desarrollo de nuevas.

Este mes, el HHS anunció que suspendía $500 millones en subvenciones y contratos para el desarrollo de vacunas de ARNm, incluidas versiones más duraderas contra covid.

El gobierno federal dejó de recomendar las vacunas contra covid para mujeres embarazadas sanas y para niños, sin consultar al comité asesor de vacunas que tradicionalmente participaba en esas decisiones.

Además, Kennedy reorganizó ese comité con miembros elegidos por él, incluidos escépticos de las vacunas, y eliminó como enlaces a grupos como la Asociación Médica Estadounidense, la Asociación Nacional de Enfermeras y otras organizaciones. El comité modificado recomendó no aplicar vacunas contra la gripe que contienen un conservante que erróneamente se ha vinculado con el autismo.

Las llamadas de la Casa Blanca

La intención de Kennedy de mantener a escépticos de las vacunas en puestos de supervisión se evidenció en un acuerdo que hizo recientemente con Trump y su equipo, según dos fuentes. El acuerdo se concretó un domingo de julio por la noche, cuando Kennedy recibió una llamada de la Casa Blanca.

El tema era Vinay Prasad, un alto regulador de vacunas de la FDA. Recientemente había provocado una oleada de críticas en la industria por haber participado en la decisión de la agencia de pedir a la empresa Sarepta Therapeutics que suspendiera la distribución de una terapia génica, por razones de seguridad.

Las redes sociales y comentaristas conservadores encendieron la polémica. Laura Loomer, una provocadora de extrema derecha, dijo el 21 de julio en X que Prasad debía ser despedido y lo llamó “liberal progresista autoproclamado y fanático de Bernie Sanders”, en referencia al senador Bernie Sanders (independiente por Vermont). Varios legisladores comenzaron a presionar a la Casa Blanca con preguntas.

La controversia llegó a Trump, quien quería que Prasad se fuera, según las fuentes. Pero Kennedy no quería perderlo. Consideraba que necesitaba a alguien crítico de las vacunas al frente de la supervisión en la agencia.

Así que Kennedy negoció. A Prasad se le pediría que renunciara como director del Centro de Evaluación e Investigación de Productos Biológicos de la FDA, que regula vacunas y productos biológicos como las terapias génicas. Y el centro se dividiría en dos operaciones, lo que le permitiría a Kennedy elegir quién estaría a cargo del área de vacunas.

Algunos líderes en salud pública compartieron públicamente detalles del acuerdo y expresaron su preocupación. Scott Gottlieb, ex comisionado de la FDA, dijo el 1 de agosto en CNBC que pensaba que “sería muy destructivo para la agencia”.

Después de dejar la agencia en julio, Prasad ahora regresa, aunque no está claro si en el mismo cargo.

Recientemente, Kennedy fue demandado por Ray Flores, abogado externo principal de Children’s Health Defense, una organización antivacunas fundada por el propio Kennedy.

La demanda —financiada por esa organización— alega que Kennedy no lanzó un grupo de trabajo para estudiar la seguridad de las vacunas, como supuestamente se exige. Sin embargo, según una fuente, Kennedy y sus aliados consideran que se trata de una demanda “amigable” porque busca un resultado que él mismo desea.

El 14 de agosto, el HHS anunció que reactivaría un panel federal —disuelto en 1998— para supervisar las vacunas pediátricas.

Las acciones de Kennedy contra las vacunas también han generado demandas en su contra, incluida una presentada por la Academia Americana de Pediatría y otros grupos de salud pública. Su decisión de detener el financiamiento para el desarrollo de vacunas de ARNm provocó una oleada de críticas en redes sociales.

“Esto es irresponsable. Es peligroso. Va a costar vidas. Debemos contraatacar”, escribió el 5 de agosto el senador Edward Markey (demócrata por Massachusetts) en X.

“Intenté mantenerme objetivo y sin alarmismo frente a las acciones del HHS, pero sinceramente, esta medida va a costar vidas”, dijo ese mismo día Jerome Adams, ex cirujano general de Estados Unidos durante el anterior gobierno de Trump.

Kennedy y sus seguidores siguen decididos. En respuesta, sus aliados lanzaron una campaña de relaciones públicas sin precedentes para promover la figura del secretario de Salud, alimentando la especulación de que podría estar considerando una candidatura presidencial en 2028.

La organización sin fines de lucro MAHA Action organizó una llamada en julio para movilizar a los seguidores de Kennedy e inició una campaña publicitaria de seis cifras elogiando a Kennedy y a las iniciativas de salud del gobierno de Trump.

“Que no quepa duda: esta es una revolución que cambiará el rostro de las políticas de salud pública”, dijo Tony Lyons, presidente de MAHA Action, en un comunicado. “Los estadounidenses están exigiendo una transparencia radical y ciencia de primer nivel”.

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North Chicago: AbbVie and Gilgamesh Pharmaceuticals Inc. have announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).

Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrated rapid, robust and durable antidepressant effects. However, existing agents in this class are hampered by their long duration of psychoactive experience.

Bretisilocin, a 5-HT2A receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound designed to address development challenges observed within this class of compounds. Bretisilocin has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.

Positive topline results from a Phase 2a study of bretisilocin in MDD were recently announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. At Day 14, a single dose (10mg) of bretisilocin demonstrated robust antidepressant effect with a -21.6 point change from baseline in MADRS total score compared to a -12.1 point change from baseline for the low dose (1mg) active comparator (p = 0.003). Bretisilocin was well tolerated with no serious adverse events.

"The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective. We look forward to advancing bretisilocin to late-stage clinical development."

"AbbVie's leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions," said Jonathan Sporn, M.D., chief executive officer at Gilgamesh Pharmaceuticals.

Under the terms of the agreement, AbbVie will acquire Gilgamesh's bretisilocin program for up to $1.2 billion, inclusive of an upfront payment and development milestones. Additionally, as part of the transaction, Gilgamesh will spin off a new entity that will operate under the name Gilgamesh Pharma Inc. to hold its employees and other programs, including its oral NMDA receptor antagonist blixeprodil (GM-1020), cardio-safe ibogaine analog, M1/M4 agonist program and existing collaboration with AbbVie. The transaction is subject to customary closing conditions.

This transaction builds upon AbbVie and Gilgamesh's 2024 collaboration and option-to-license agreement to advance the development of next-generation therapies for the treatment of psychiatric disorders. This option-to-license remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out.

For AbbVie, Covington & Burling LLP is acting as legal counsel. For Gilgamesh, Centerview Partners LLC is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal counsel.

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A sharp increase in self-harm and attempted suicide among young girls marks a deepening mental health emergency, with a government expert sounding the alarm that the true scope of the problem remains hidden.

Dr Joy Sue, consultant psychiatrist at the Ministry of Health and based at the Psychiatric Hospital in Black Rock, warned on Wednesday that these issues may represent only the surface of a much wider crisis affecting the nation’s young people, as males remain largely absent from those seeking assistance.

She explained that one of the main reasons for this troubling mental health trend is the fallout from the COVID-19 pandemic, which is only now becoming apparent. 

“To tell you the truth, we have always seen a fair amount of cuttings, but it has increased. We had an increase in depressive anxiety [during COVID] for sure. And with that, we had an increase in persons who presented with cuttings and other forms of parasuicide or what we called self-harm, that is not necessarily meant to cause death.

“During COVID and post-COVID, those conditions increased. And the whole pandemic, and what came with the pandemic…meaning, the isolation, the online schooling, the lack of socialisation…we are only now seeing the fallout from that. Young people now have changed drastically from the way they behaved previously. I think a lot of it stems from that,” she said.

Addicted to devices

Dr Sue also addressed the addiction to mobile devices as a pressing mental health issue requiring intervention. 

She said: “There is a lot more of the digital world… It’s much more a part of their lives now. They are addicted to social media, and that can affect your self-esteem…. They are doing this social comparison thing…. For most people, it is something they put on, but social media is not real life. Or, they are getting bullied on social media. All of that is a part of it. They were isolated all of that time during COVID, they did not have the social support necessary, so they weren’t adapting.”

Extending her concern about social media’s pervasive influence, Dr Sue added: “Even lying down next to each other, people are on their devices.”

Silent struggle 

Dr Sue revealed that the majority of new clients she now sees are young people ranging from their early teens to age 35, further underlining how social and emotional challenges are affecting an entire generation.

She highlighted the importance of the home environment: “They didn’t just get depressed overnight. A lot of them have a lot of trauma dating back from childhood.”

Eating disorders and gender disparities

Eating disorders were flagged by Dr Sue as another disturbing trend, especially among young females seeking help. “You are going to have poor health outcomes later on. With all of these NCDs [non-communicable diseases] that we are talking about, it is going to put them at risk.”

The psychiatrist clarified that eating disorders are rarely the primary concern brought to her by clients, but emerge as a secondary diagnosis discovered during consultations: “They are not seeing me for eating on its own. So they usually are seeing me because of some kind of depressive anxiety. Eating habits is something that is a secondary diagnosis that is discovered when I speak to them, but not necessarily the reason why they are presenting.”

Asked about males turning up with eating disorders, Dr Sue noted: “You don’t get as many males presenting for depressive anxiety. That is from most females.

“There are a variety of reasons. The fact is that it is more common [for females] because of hormonal reasons. But that’s not the only reason. It could be cultural too. It is not that males aren’t experiencing that…but culturally, how ready females are to come forward and access services for something like that…which is not what the act says about males culturally. So, if males are going through something like that, culture says: ‘Suck it up, I am man, be strong;’ and perhaps because the males aren’t coming forward, we are not getting complaints from the males because they simply aren’t talking about it.”

This, she suggested, means the nation may be unaware of the true picture of mental health in Barbados, with women always more likely to seek help: “We are always trying to get to be the ones to come forward. A lot of emphasis is placed on males.”

Dr Sue emphasised the risks of men not seeking support: “The eating disorders in the men are associated with the other things that females also have. Don’t forget the males are the ones that are disproportionate by suicide as well. All those factors could contribute to increased risks, not only for NCDs, but for more severe mental health outcomes.”

Troubled home environments, missing girls

Touching on the possible link between mental health issues originating at home and the phenomenon of girls going missing, Dr Sue reflected on her work at the Government Industrial School (GIS) female section.

“The persons who were the perpetrators were [getting away] scot-free, while these girls were locked up. I always used to think this was foolishness. They are punishing them when they are victims and their rebellious behaviour is because of something that happened to them and those persons who did these things, they aren’t punished. 

“When they are finished with [the Government Industrial School], they got to go back into the same household because they don’t have anywhere else to go. They are back into the same problems that were never resolved. A vicious cycle.” 

emmanueljoseph@barbadostoday.bb

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Topline results from the ATTAIN-2 trial have demonstrated that adults taking 36 mg orforglipron lost an average of 10.5% body weight at 72 weeks, with over half of participants on any dose achieving an HbA1c of 6.5% or lower. The oral GLP-1 demonstrated significant benefits for adults with obesity and type 2 diabetes.

In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.1 With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.

"Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class," said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, and world-renowned obesity specialist. "Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results."

In the ATTAIN-2 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 22.9 lbs (10.5%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, orforglipron lowered A1C by 1.3% to 1.8% from a baseline of 8.1% across doses. In another key secondary endpoint, 75% of participants taking the highest dose of orforglipron achieved an A1C ≤6.5%, which is at or below the American Diabetes Association's definition of diabetes. Additionally, orforglipron showed clinically meaningful benefits across key cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure and triglycerides. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels, a marker of inflammation, by 50.6%.

iSuperiority test was adjusted for multiplicity with all three doses.

iiSuperiority test was adjusted for multiplicity with the 12 mg and 36 mg doses.

For the treatment-regimen estimand, each dose of orforglipron led to statistically significant improvements across the primary and all key secondary endpoints, including:

• Percent weight reduction: -5.1% (-5.3 kg; -11.7 lbs; 6 mg), -7.0% (-7.2 kg; -15.9 lbs; 12 mg), -9.6% (-9.6 kg; -21.2 lbs; 36 mg), -2.5% (-2.7 kg; -6.0 lbs; placebo)

• Percentage of participants achieving body weight reductions of ≥10%: 22.6% (6 mg), 31.2% (12 mg), 45.6% (36 mg), 9.0% (placebo)

• Percentage of participants achieving body weight reductions of ≥15%: 6.8% (6 mg), 14.4% (12 mg), 26.0% (36 mg), 3.0% (placebo)

• A1C reduction: -1.2% (6 mg), -1.5% (12 mg), -1.7% (36 mg), -0.5% (placebo)

• Percentage of participants achieving A1C <7%: 64.6% (6 mg), 75.9% (12 mg), 75.5% (36 mg), 30.5% (placebo)

• Percentage of participants achieving A1C ≤6.5%: 52.5% (6 mg), 57.6% (12 mg), 66.6% (36 mg), 15.4% (placebo)

"The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s," said Kenneth Custer, Ph.D., Lilly executive vice president and president of Lilly Cardiometabolic Health. "With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally-removing barriers and redefining how obesity is treated around the world."

The overall safety profile of orforglipron in ATTAIN-2 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (20.1%, 31.1% and 36.4%) vs. 8.4% with placebo, vomiting (12.8%, 20.2% and 23.1%) vs. 3.8% with placebo, diarrhea (21.3%, 24.8% and 27.4%) vs. 15.0% with placebo, constipation (17.7%, 21.1% and 22.4%) vs. 7.8% with placebo, and dyspepsia (9.1%, 15.4% and 10.9%) vs. 3.5% with placebo. Treatment discontinuation rates due to adverse events were 6.1% (6 mg), 10.6% (12 mg) and 10.6% (36 mg) for orforglipron vs. 4.6% with placebo. Overall treatment discontinuation rates were balanced across the treatment groups with 19.1% (6 mg), 22.3% (12 mg) and 20.5% (36 mg) for orforglipron vs. 20.0% with placebo. No hepatic safety signal was observed.

Detailed ATTAIN-2 results will be presented at a future medical meeting and published in a peer-reviewed journal.

About orforglipron

Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.5 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together. Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.

About ATTAIN-2 and ATTAIN clinical trial program

ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 6 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications. All participants receiving orforglipron started the study at a dose of 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 6 mg (via steps at 1 mg and 3 mg), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Dose reduction was only allowed for GI tolerability if other mitigations failed.

The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials.

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