s) plus venetoclax (Venclexta; AbbVie, Genentech) remained consistent with already known adverse events of either agent alone, according to the researchers.“The combination of these

Related Links

• Police Blame Some Deaths on ‘Excited Delirium.’ ER Docs Consider Pulling the Plug on the Term.

  Oct 2, 2023

• California Bans Controversial ‘Excited Delirium’ Diagnosis

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• Doctors Abandon a Diagnosis Used to Justify Police Custody Deaths. It Might Live On, Anyway.

  Oct 16, 2023

Quinto, 30, had been pinned on the ground for at least 90 seconds by police in California and stopped breathing. He died three days later.

Now his relatives are asking a federal judge to exclude any testimony about “excited delirium” in their wrongful death case against the city of Antioch. Their case may be stronger than ever.

Their push comes at the end of a pivotal year for the long-standing, nationwide effort to discard the use of excited delirium in official proceedings. Over the past 40 years, the discredited, racially biased theory has been used to explain away police culpability for many in-custody deaths. But in October, the American College of Emergency Physicians disavowed a key paper that seemingly gave it scientific legitimacy, and the College of American Pathologists said it should no longer be cited as a cause of death.

That same month, California’s Democratic Gov. Gavin Newsom signed the nation’s first law to ban the term “excited delirium” as a diagnosis and cause of death on death certificates, autopsy reports, and police reports. Legislators in other states are expected to consider similar bills next year, and some law enforcement agencies and training organizations have dropped references to excited delirium from their policy manuals and pulled back from training police on the debunked theory.

Despite all that momentum, families, attorneys, policing experts, and doctors say much remains to be done to correct the mistakes of the past, to ensure justice in ongoing trials, and to prevent avoidable deaths in the future. But after years of fighting, they’re heartened to see any movement at all.

“This entire thing, it’s a nightmare,” said Bella Collins, Angelo’s sister. “But there are silver linings everywhere, and I feel so fortunate to be able to see change happening.”

Ultimately, the campaign against excited delirium seeks to transform the way police deal with people undergoing mental health crises.

“This is really about saving lives,” said Joanna Naples-Mitchell, an attorney who worked on an influential Physicians for Human Rights review of excited delirium.

Changing Law Enforcement Training

The use of the term “excited delirium syndrome” became pervasive after the American College of Emergency Physicians published a white paper on it in 2009. It proposed that individuals in a mental health crisis, often under the influence of drugs or alcohol, can exhibit superhuman strength as police try to control them, and then die suddenly from the condition, not the police response.

The ACEP white paper was significant in catalyzing police training and policy, said Marc Krupanski, director of criminal justice and policing at Arnold Ventures, one of the largest nonprofit funders of criminal justice policy. The theory contributed to deaths, he said, because it encouraged officers to apply greater force rather than call medical professionals when they saw people in aggressive states.

After George Floyd’s 2020 death, which officers blamed on excited delirium, the American Medical Association and the American Psychiatric Association formally rejected it as a medical condition. Then came disavowals from the National Association of Medical Examiners and the emergency physicians’ and pathologists’ groups this year.

The moves by medical societies to renounce the term have already had tangible, albeit limited, effects. In November, Lexipol, a training organization used by thousands of public safety agencies in the U.S., reiterated its earlier move away from excited delirium, citing the California law and ACEP’s retraction of the 2009 white paper.

Lexipol now guides officers to rely on what they can observe, and not to guess at a person’s mental status or medical condition, said Mike Ranalli, a lawyer and police trainer with the Texas-based group. “If somebody appears to be in distress, just get the EMS,” he said, referring to emergency medical services.

Patrick Caceres, a senior investigator at the Bay Area Rapid Transit’s Office of the Independent Police Auditor, successfully pushed to remove excited delirium from the BART Police Department’s policy manual after learning about Quinto’s death in 2020 and seeing the American Medical Association’s rejection of it the following year.

Caceres fears that rooting out the concept — not just the term — more broadly will take time in a country where law enforcement is spread across roughly 18,000 agencies governed by independent police chiefs or sheriffs.

“The kinds of training and the kinds of conversations that need to happen, we’re still a long way away from that,” said Caceres.

In Tacoma, Washington, where three police officers have been charged with the 2020 death of Manuel Ellis, The Seattle Times reported that local first responders testified as recently as October that they still “embrace” the concept.

But in Colorado, the state’s Peace Officer Standards and Training board ruled on Dec. 1 to drop excited delirium training for new law enforcement officers, KUSA-TV reported.

And two Colorado lawmakers, Democratic state Reps. Judy Amabile and Leslie Herod, have drafted a bill for the 2024 legislative session banning excited delirium from other police and EMS training and prohibiting coroners from citing it as a cause of death.

“This idea that it gives you superhuman strength causes the police to think they should respond in a way that is often completely inappropriate for what’s actually happening,” Amabile said. “It just seems obvious that we should stop doing that.”

She would like police to focus more on de-escalation tactics, and make sure 911 calls for people in mental health crisis are routed to behavioral health professionals who are part of crisis intervention teams.

Taking ‘Excited Delirium’ Out of the Equation

As the Quinto family seeks justice in the death of the 30-year-old Navy veteran, they are hopeful the new refutations of excited delirium will bolster their wrongful death lawsuit against the city of Antioch. On the other side, defense lawyers have argued that jurors should hear testimony about the theory.

On Oct. 26, the family cited both the new California law and the ACEP rebuke of the diagnosis when it asked a U.S. District Court judge in California to exclude witness testimony and evidence related to excited delirium, saying it “cannot be accepted as a scientifically valid diagnosis having anything to do with Quinto’s death.”

“A defense based on BS can succeed,” family attorney Ben Nisenbaum said. “It can succeed by giving jurors an excuse to give the cops a way out of this.”

Meanwhile, advocates are calling for a reexamination of autopsies of those who died in law enforcement custody, and families are fighting to change death certificates that blame excited delirium.

The Maryland attorney general’s office is conducting an audit of autopsies under the tenure of former chief medical examiner David Fowler, who has attributed various deaths to excited delirium. But that’s just one state reviewing a subset of its in-custody deaths.

The family of Alexander Rios, 28, reached a $4 million settlement with Richland County, Ohio, in 2021 after jail officers piled on Rios and shocked him until he turned blue and limp in September 2019. During a criminal trial against one of the officers that ended in a mistrial this November, the pathologist who helped conduct Rios’ autopsy testified that her supervisor pressured her to list “excited delirium” as the cause of death even though she didn’t agree. Still, excited delirium remains his official cause of death.

The county refused to update the record, so his relatives are suing to force a change to his official cause of death. A trial is set for May.

Changing the death certificate will be a form of justice, but it won’t undo the damage his death has caused, said Don Mould, Rios’ stepfather, who is now helping to raise one of Rios’ three children.

“Here is a kid that’s life is upside down,” he said. “No one should go to jail and walk in and not be able to walk out.”

In some cases, death certificates may be hard to refile. Quinto’s family has asked a state judge to throw out the coroner’s findings about his 2020 death. But the California law, which takes effect in January and bans excited delirium on death certificates, cannot be applied retroactively, said Contra Costa County Counsel Thomas Geiger in a court filing.

And, despite the 2023 disavowals by the main medical examiners’ and pathologists’ groups, excited delirium — or a similar explanation — could still show up on future autopsy reports outside California. No single group has authority over the thousands of individual medical examiners and coroners, some of whom work closely with law enforcement officials. The system for determining a cause of death is deeply disjointed and chronically underfunded.

“One of the unfortunate things, at least within forensic pathology, is that many things are very piecemeal,” said Anna Tart, a member of the Forensic Pathology Committee of the College of American Pathologists. She said that CAP plans to educate members through conferences and webinars but won’t discipline members who continue to use the term.

Justin Feldman, principal research scientist with the Center for Policing Equity, said that medical examiners need even more pressure and oversight to ensure that they don’t find other ways to attribute deaths caused by police restraint to something else.

Only a minority of deaths in police custody now cite excited delirium, he said. Instead, many deaths are being blamed on stimulants, even though fatal cocaine or methamphetamine overdoses are rare in the absence of opioids.

Yet advocates are hopeful that this year marks enough of a turning point that alternative terms will have less traction.

The California law and ACEP decision take “a huge piece of junk science out of the equation,” said Julia Sherwin, a California civil rights attorney who co-authored the Physicians for Human Rights report.

Sherwin is representing the family of Mario Gonzalez, who died in police custody in 2021, in a lawsuit against the city of Alameda, California. Excited delirium doesn’t appear on Gonzalez’s death certificate, but medical experts testifying for the officers who restrained him cited the theory in depositions. 

She said she plans to file a motion excluding the testimony about excited delirium in that upcoming case and similar motions in all the restraint-asphyxia cases she handles.

“And, in every case, lawyers around the country should be doing that,” Sherwin said.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Type 2 diabetes mellitus (T2DM) prevalence has been increasing globally, particularly in India (1) T2DM in general increases the risk of CVD outcomes by a twofold and is independent of other risk factors. (1) The risk of coronary artery disease (CAD) in Indian T2DM patients is two to four times higher, and CAD occurs one to two decades earlier than in the West. (3) Impaired glucose metabolism, inflammation, and abnormal cell signaling all contribute to premature atherosclerosis, myocardial remodeling, and left ventricular fibrosis, which contribute to cardiovascular damage. (2)

Managing Cardiovascular Disease in Diabetes: Going Beyond HbA1c

The focus of CVD management in diabetes should extend beyond glycemic control and on antidiabetic drugs that alleviate the risk factors and improve CV outcomes. It is critical to identify pharmacological strategies that target cardiovascular inflammation, fibrosis; induce weight and blood pressure reduction; and provide renal and cardiovascular protection in managing CVD in T2DM.

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a unique class of antidiabetic drugs. The primary advantage of SGLT2i is that they act independently of insulin, inhibiting proximal tubular glucose reabsorption and lowering plasma glucose levels and glucosuria. They also provide organ protection, including cardio-renal protection, lowering the risk of heart failure and cardiovascular mortality due to their direct and indirect pleiotropic effects. (2)

Dipeptidyl peptidase 4 (DPP4) inhibitors also reduce myocardial inflammation by inhibiting cytokine release, monocyte activation, and chemotaxis. Also, gliptins improve systolic and diastolic left ventricular dysfunction in CV diseases and support overall cardiovascular protection. (4)

Optimising Guideline Directed Medical Therapy in T2DM & High-Risk CVD

• The RSSDI (Research Society for the Study of Diabetes in India) Clinical Practice Recommendations for the Management of Type 2 Diabetes: The RSSDI 2022 guidelines suggested the use of dual therapy to achieve glucose targets or to extend the time to treatment failure and also recommended using antidiabetic agents, including SGLT2 and DPP-4 inhibitors. The guideline further recommended SGLT2i for patients with established or high risk for ASCVD, heart failure, and in need of weight reduction. In elderly patients with an increased risk of hypoglycemia, the guideline suggested the use of DPP-4 inhibitors. (5)
• American Association of Clinical Endocrinology (AACE) Consensus Statement for Management of Type 2 Diabetes Mellitus: The 2023 update for T2DM Management recommends using SGLT2 inhibitors to improve cardiorenal outcomes. AACE guidelines recommend SGLT2 inhibitors as first-line treatment for cardiorenal risk reduction regardless of background metformin use or HbA1c level within the complications-centric algorithm. (6)
• ESC Guidelines for the Management of Cardiovascular Disease in Patients with Diabetes: The 2023 ESC Guideline for “Management of Cardiovascular Disease in Diabetes” recommend SGLT2i (Class I) to reduce CV risk independent of glucose control in T2DM with ASCVD. (7).
• International Guidelines Expanding the Applicability of SGLT2-inhibitors: The ESC Guideline for ”Management of Cardiovascular Disease in Diabetes 2023 (7), the American Diabetes Association (ADA) “Standards of Care in Diabetes” 2023 (8), and the Kidney Disease Improving Global Outcomes (KDIGO) 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (9) recommended the use of SGLT2i for patients with T2DM and CKD who have eGFR ≥20 mL/min/1.73 m2.

Scientific Rationale for Considering Linagliptin & Dapagliflozin among T2DM Patients with High CV Risk

Linagliptin: The Gliptin Applicable in Wide Group of Type 2 Diabetes Patients Improving Macrovascular & Microvascular Complications: Linagliptin is a DPP-4 inhibitor with potent and durable DPP-4 inhibition. It is known to increase GLP-1(glucagon-like peptide-1) and GIP (gastric inhibitory polypeptide) levels, which may provide beneficial cardioprotection (10)

• Linagliptin treatment benefits CV dysfunction associated with T2DM. It decreases cardiac hypertrophy and fibrosis and improves cardiac function (11)
• Linagliptin treatment also provides renal protection by lowering albuminuria, and tubulo-interstitial fibrosis and preventing the progression of renal tissue injury.
• It also decreases inflammation and pericytes and provides retinal capillary vaso-regression, thereby providing protection in retinopathy. (11)
• Linagliptin also benefits neuropathy by suppressing arterial stiffening and vascular inflammation and improving vascular relaxation. (11)

Dapagliflozin: Durable Evidence with Robust Glycemic & CV-CKD Benefits

Dapagliflozin is a widely utilized SGLT2i in clinical settings. The mechanism of dapagliflozin in cardiovascular protection may involve improving ventricular loading conditions, improvement of cardiac metabolism and bioenergetics, Na+/H+ exchange, sugar and lipid metabolism & circulatory load. (12)

• It improves cardiorenal outcomes through various pathways, including by reducing blood pressure, arterial stiffness, and endothelial dysfunction. (12)
• Dapagliflozin treatment lowers the risk of hospitalization for heart failure, CV death, and all-cause mortality. (13)
• It improves glomerular hemodynamics, resulting in long-term kidney function preservation. It provides renoprotective benefits regardless of diabetes status, age, cause of CKD, baseline albuminuria, and eGFR. (13)

Beneficial Impact of Linagliptin and Dapagliflozin on CV Outcomes- Clinical Evidence

Linagliptin Leads to CV Risk Reduction in Asian Type 2 Diabetes Patients: A real-world observational study evaluated the effect of linagliptin on CV risk reduction in Asian T2DM patients. The study enrolled 73 patients on Linagliptin and noted that the 12-month treatment with Linagliptin significantly reduced CV risk by 6.36% (P=0.17). It also reduces the atherosclerotic cardiovascular disease risk in patients with high ASCVD risk and the elderly population. These findings showed a promising effect of Linagliptin in cardiovascular risk reduction in Asian T2DM patients with higher baseline cardiovascular risk and older age. (14)

Linagliptin Improves Microalbuminuria in Diabetic Nephropathy: A double-blind, randomized, placebo-controlled trial analyzed the effect of linagliptin on microalbuminuria in patients with diabetic nephropathy (DN). The trial enrolled 92 patients with DN, divided into the intervention and control groups, who received linagliptin 5 mg and placebo for 24 weeks, respectively. Linagliptin significantly improved microalbuminuria (urine albumin creatinine ratio of < 30 mg/g) by 68.3% (p<0.001). This suggests that linagliptin therapy improves microalbuminuria in diabetic nephropathy patients. (15)

CARMELINA and CAROLINA: Linagliptin Reassures for CV Safety in Asian T2DM Patients:

The CARMELINA trial's subgroup analysis explored Linagliptin's CV safety in Asian T2DM (N=6979, 8.0% Asian). Linagliptin treatment reduced the risk of hospitalization for heart failure (HR 0.47; 95% CI 0.24–0.95; P=0.0368), the composite of hospitalization for heart failure or all-cause mortality (HR 0.55; 95% CI 0.32–0.95; P=0.2191), and all-cause hospitalization (HR 0.74; 95% CI 0.57–0.96; P=0.2182). This suggests the CV safety of linagliptin in Asian T2DM patients. (16)

Another subgroup analysis of the CAROLINA trial assessed the CV outcomes of linagliptin among Asian T2DM patients. Linagliptin reduced 3P-MACE (first occurrence of CV death, non-fatal MI, or non-fatal stroke events, HR 0.85), 4P-MACE (CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina HR 0.86; 95% CI 0.59–1.26), all-cause mortality (HR 0.74; 95% CI 0.46–1.20) over a follow-up of 6.2 years. These findings suggest the CV safety of Linagliptin in Asian T2DM patients. (17)

Dapagliflozin for CV risk reduction-Insights from DECLARE TIMI 58 Trial: The DECLARE TIMI 58 trial assessed the effect of Dapagliflozin; enrolling 17160 patients with T2DM; 6974 had known ASCVD, of whom 3584 had a history of MI, with a median duration of 5.4 years from their last event. The trial randomized the participants to receive dapagliflozin (10mg once daily) or a placebo. Dapagliflozin significantly reduced MACE by 16% (hazard ratio [HR], 0.84; 95% CI, 0.72–0.99; P=0.039) in those with a history of prior MI. The efficacy result based on ejection fraction showed that in T2DM with Heart Failure with reduced Ejection Fraction (HFrEF), dapagliflozin treatment reduced CV death by 45%, hospitalization for HF by 36%, and all-cause mortality by 41%. Among HF without reduced EF, the treatment reduced CV death by 12% and hospitalization for HF by 24%. These findings suggest the CV benefit & safety of dapagliflozin in T2DM patients. (18)

Dapagliflozin Improves Cardio-Renal Outcomes in DAPA CKD Trial: The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial, designed in a randomized, double-blind, placebo-controlled, multicenter design, assessed the long-term efficacy and safety of the SGLT2 inhibitor dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes. The trial enrolled 4304 subjects with an eGFR of 25-75 ml/minute/1.73 m2. Treatment with dapagliflozin has a lower hazard ratio for the composite of a sustained decline in the eGFR of at least 50%, end-stage kidney disease, or death from renal causes was by 35% (95% CI, 0.45 to 0.68; P<0.001), reduced the chance of composite of death from cardiovascular causes or hospitalization for heart failure by 41% (95% CI, 0.55 to 0.92; P=0.009). The study's findings highlight Dapagliflozin's renal safety and benefit in T2DM patients with CKD. (19)

Robust Clinical Benefits of Linagliptin & Dapagliflozin in High CV Risk Patients

• Linagliptin therapy provides beneficial cardiorenal protection, and its use is guideline-directed owing to its CV safety profile. (7,11)
• Linagliptin treatment improves microalbuminuria (urine albumin creatinine ratio of < 30 mg/g) by 68.3% among patients with diabetic nephropathy(DN). (15)
• Dapagliflozin is a glucose-lowering agent with CV benefits and provides cardio-protection and renal protection in T2DM patients. (12,13)
• Dapagliflozin treatment reduces seated SBP by 10.4 mmHg (21), 24-hour ambulatory BP by 9.6 mmHg (21), weight by 4.27 kgs (22), BMI by 1.53 kg/m2 (22), and left ventricular mass by 2.82g (22).
• Dapagliflozin reduces CV death by 45%, hospitalization for HF by 36%, and all-cause mortality by 41%. (18)
• Dapagliflozin reduces albuminuria by 33% and reduces death from renal causes in T2DM patients. (19)

Clinical Takeaways:

• Managing CVD in patients with T2DM is a rapidly evolving scientific field, and using antidiabetic agents with proven CV safety is important in this patient population.
• Linagliptin provides cardioprotection benefits, and dapagliflozin improves ventricular loading conditions, cardiac metabolism, and bioenergetics.
• Linagliptin treatment improves the progression of CKD and reduces microalbuminuria in diabetic nephropathy.
• Dapagliflozin improves cardiorenal outcomes through various pathways, including reducing blood pressure, arterial stiffness, and endothelial dysfunction.
• Dapagliflozin treatment led to a reduction in heart failure hospitalization, CV death, and all-cause mortality in patients with diabetes and high CV risk. Treatment with dapagliflozin prevents CKD progression, ESKD, and death from renal causes.

Linagliptin and dapagliflozin seem effective in achieving glycemic control, alleviating CV risk factors and improving CV-CKD outcomes; potentially allowing these agents to be an ‘evergreen duo’ in the management of the Type 2 Diabetes continuum.

References:

1. Unnikrishnan AG, Sahay RK, Phadke U, Sharma SK, Shah P, Shukla R, Viswanathan V, Wangnoo SK, Singhal S, John M, Kumar A, Dharmalingam M, Jain S, Shaikh S, Verberk WJ. Cardiovascular risk in newly diagnosed type 2 diabetes patients in India. PLoS One. 2022 Mar 31;17(3):e0263619. doi: 10.1371/journal.pone.0263619.

2. Hodrea J, Saeed A, Molnar A, Fintha A, Barczi A, Wagner LJ, Szabo AJ, Fekete A, Balogh DB. SGLT2 inhibitor dapagliflozin prevents atherosclerotic and cardiac complications in experimental type 1 diabetes. PLoS One. 2022 Feb 17;17(2):e0263285. doi: 10.1371/journal.pone.0263285.

3. Mohan V, Venkatraman JV, Pradeepa R. Epidemiology of cardiovascular disease in type 2 diabetes: the Indian scenario. J Diabetes Sci Technol. 2010;4(1):158-170. Published 2010 Jan 1. doi:10.1177/193229681000400121

4. Zakaria EM, Tawfeek WM, Hassanin MH, Hassaballah MY. Cardiovascular protection by DPP-4 inhibitors in preclinical studies: an updated review of molecular mechanisms. Naunyn Schmiedebergs Arch Pharmacol. 2022;395(11):1357-1372. doi:10.1007/s00210-022-02279-3

5. Kumar V, Agarwal S, Saboo B, Makkar B. RSSDI Guidelines for the management of hypertension in patients with diabetes mellitus [published online ahead of print, 2022 Dec 15]. Int J Diabetes Dev Ctries. 2022;42(Suppl 1):1-30. doi:10.1007/s13410-022-01143-7

6. Samson SL, Vellanki P, Blonde L, Christofides EA, Galindo RJ, Hirsch IB, Isaacs SD, Izuora KE, Low Wang CC, Twining CL, Umpierrez GE, Valencia WM. American Association of Clinical Endocrinology Consensus Statement: Comprehensive Type 2 Diabetes Management Algorithm - 2023 Update. Endocr Pract. 2023 May;29(5):305-340. doi: 10.1016/j.eprac.2023.02.001. Erratum in: Endocr Pract. 2023 Sep;29(9):746.

7. Marx N, Federici M, Schütt K, Müller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mullens W, Rocca B, Sattar N; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023 Oct 14;44(39):4043-4140. doi: 10.1093/eurheartj/ehad192.

8. ElSayed NA, Aleppo G, Aroda VR, et al. 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes-2023. Diabetes Care. 2023;46(Suppl 1):S191-S202. doi:10.2337/dc23-S011

9. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. Kidney Int. 2022 Nov;102(5S):S1-S127. doi: 10.1016/j.kint.2022.06.008.

10. Johansen, O.E., Neubacher, D., von Eynatten, M. et al. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol 11, 3 (2012). https://doi.org/10.1186/1475-2840-11-3

11. Aroor AR, Manrique-Acevedo C, DeMarco VG. The role of dipeptidylpeptidase-4 inhibitors in management of cardiovascular disease in diabetes; focus on linagliptin. Cardiovasc Diabetol. 2018 Apr 18;17(1):59. doi: 10.1186/s12933-018-0704-1.

12. Zhai M, Du X, Liu C, Xu H. The Effects of Dapagliflozin in Patients With Heart Failure Complicated With Type 2 Diabetes: A Meta-Analysis of Placebo-Controlled Randomized Trials. Front Clin Diabetes Healthc. 2021 Jun 30;2:703937. doi: 10.3389/fcdhc.2021.703937.

13. Bell, DSH, McGill, JB, Jerkins, T. Management of the ‘wicked’ combination of heart failure and chronic kidney disease in the patient with diabetes. Diabetes Obes Metab. 2023; 25(10): 2795-2804. doi:10.1111/dom.15181

14. Poonchuay N, Wattana K, Uitrakul S. Efficacy of linagliptin on cardiovascular risk and cardiometabolic parameters in Thai patients with type 2 diabetes mellitus: A real-world observational study. Diabetes Metab Syndr. 2022 May;16(5):102498. doi: 10.1016/j.dsx.2022.102498. Epub 2022 May 13.

15. Karimifar, M., Afsar, J., Amini, M. et al. The effect of linagliptin on microalbuminuria in patients with diabetic nephropathy: a randomized, double-blinded clinical trial. Sci Rep 13, 3479 (2023). https://doi.org/10.1038/s41598-023-30643-7

16. Inagaki N, Yang W, Watada H, et al. Linagliptin and cardiorenal outcomes in Asians with type 2 diabetes mellitus and established cardiovascular and/or kidney disease: subgroup analysis of the randomized CARMELINA® trial. Diabetol Int. 2019;11(2):129-141. Published 2019 Oct 22. doi:10.1007/s13340-019-00412-x

17. Kadowaki T, Wang G, Rosenstock J, et al. Effect of linagliptin, a dipeptidyl peptidase-4 inhibitor, compared with the sulfonylurea glimepiride on cardiovascular outcomes in Asians with type 2 diabetes: subgroup analysis of the randomized CAROLINA® trial. Diabetol Int. 2020;12(1):87-100. Published 2020 Jun 27. doi:10.1007/s13340-020-00447-5

18. Verma S, McMurray JJV. The Serendipitous Story of SGLT2 Inhibitors in Heart Failure. Circulation. 2019 May 28;139(22):2537-2541. doi: 10.1161/CIRCULATIONAHA.119.040514. Epub 2019 Mar 18.

19. Heerspink HJL, Stefánsson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjöström CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

20. McGill JB. Linagliptin for type 2 diabetes mellitus: a review of the pivotal clinical trials. Ther Adv Endocrinol Metab. 2012;3(4):113-124. doi:10.1177/2042018812449406

21. Weber MA, Mansfield TA, Alessi F, Iqbal N, Parikh S, Ptaszynska A. Effects of dapagliflozin on blood pressure in hypertensive diabetic patients on renin-angiotensin system blockade. Blood Press. 2016;25(2):93-103. doi: 10.3109/08037051.2015.1116258. Epub 2015 Dec 1. Erratum in: Blood Press. 2016 Aug;25(4):x.

22. Brown AJM, Gandy S, McCrimmon R, Houston JG, Struthers AD, Lang CC. A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Eur Heart J. 2020 Sep 21;41(36):3421-3432. doi: 10.1093/eurheartj/ehaa419.

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DID YOU know the key to successfully manage diabetes is you? But you do not have to figure it out alone. If you have diabetes, you know that managing it day to day can take time and practice. Even when you have a daily routine down, life happens...

PAHO Director highlights efforts of the Americas to recover public health gains lost during the pandemic

Oscar Reyes

12 Dec 2023

Impulsado por los planes Medi-Cal del condado —que proporcionan seguro médico a los residentes con bajos ingresos— en colaboración con su Oficina de Educación y el Departamento de Salud Mental, el programa se basa en servicios de teleterapia proporcionados por Hazel Health, una de las empresas que han surgido para hacer frente a la escasez nacional de servicios de salud mental, algo que se agravó durante la pandemia de covid-19.

La teleterapia es uno de los cuatro proyectos del condado de Los Angeles que recibirán en conjunto hasta $83 millones del Programa de Incentivos de Salud Mental para Estudiantes del estado, uno de los componentes del “plan maestro” del gobernador demócrata para subsanar las deficiencias en el acceso de los jóvenes a los servicios de salud mental.

El contrato de Hazel Health en Los Angeles tiene como meta ayudar a las escuelas sobrecargadas a hacer frente al aumento de la demanda de estos servicios. Promete ser una iniciativa piloto para demostrar tanto la eficacia de la terapia virtual para los alumnos, como la capacidad de educadores y administradores para gestionar eficazmente un programa extenso y delicado en colaboración con una empresa con fines de lucro.

Para algunos educadores y familias los resultados iniciales son prometedores.

Anjelah Salazar, de 10 años, dijo que el especialista de Hazel la ha ayudado a sentirse mucho mejor. La estudiante de quinto grado empezó a sufrir ataques de pánico diarios al cambiar de escuela este año a la primaria Stanton de Glendora.

Su madre, Rosanna Chavira, contó que no sabía qué hacer —aunque es coordinadora clínica de una empresa que trata enfermedades mentales— y le preocupaba no poder pagar un terapeuta que aceptara su seguro. Cuando Chavira supo de Hazel, no lo dudó.

“El hecho de que sea gratis y de que un profesional le enseñe estrategias para sobrellevar distintas situaciones significa mucho”, dijo Chavira. “Ya se notan los resultados”.

Salazar dijo que hasta ahora tuvo cinco citas virtuales con su terapeuta. Una técnica de afrontamiento que aprecia especialmente es un ejercicio de tapping: todas las noches, antes de acostarse, se presiona con el dedo un poquito los ojos, las mejillas, el pecho y las rodillas. Con cada toque, dice: “Soy valiente”.

Christine Crone, madre de Brady, alumno de séptimo grado, afirmó que aún no ha comprobado si las sesiones son eficaces para su hijo, que estudia en Arroyo Seco Junior High en Santa Clarita, pero sí sabe que las disfruta.

“Normalmente le cuesta llegar a tiempo y estar preparado, pero con estas sesiones siempre deja lo que está haciendo y es puntual”, dijo Crone. “Dice que su terapeuta es agradable, divertido y que es fácil hablar con él”.

Jennifer Moya, consejera de salud mental en la escuela primaria Martha Baldwin de Alhambra, una ciudad al este de Los Angeles, dijo que a sus alumnos les gusta la flexibilidad de la teleterapia, que les permite reunirse con los terapeutas en cualquier momento entre las 7 de la mañana y las 7 de la tarde.

“Esta generación de niños ha crecido en la era digital”, señaló Moya, que se encarga de remitir a los alumnos a Hazel en su centro. “Les encanta que esto sea fácil”.

Pablo Isais, consejero de salud mental en la escuela primaria Granada’s Alhambra, dijo que los servicios también pueden ser una solución provisional mientras un estudiante espera una cita en persona, que puede tomar de seis a ocho semanas.

“Ser capaz de comunicarles que hay servicios disponibles a los que pueden acceder en la próxima semana es increíble”, dijo Moya.

Hasta ahora, sólo 607 estudiantes del condado de Los Angeles han participado en las sesiones desde que se ofrecieron por primera vez, en Compton, en diciembre de 2022, explicó Alicia Garoupa, jefa de servicios de bienestar y apoyo de la Oficina de Educación. Ella reconoció algunos problemas iniciales, pero aseguró que Hazel es “otra herramienta en nuestra caja de herramientas”.

El estado confía en las empresas con fines de lucro

La teleterapia desempeña un papel cada vez más importante en las escuelas del país, a medida que educadores y trabajadores sociales se enfrentan a la presión de abordar los crecientes problemas de salud mental. Según un informe de abril de Chalkbeat, 13 de los 20 distritos escolares más grandes del país, incluido Los Angeles Unified, la han incorporado desde que comenzó la pandemia.

El acuerdo del condado de Los Angeles con Hazel prevé el pago a la empresa de hasta $20 millones hasta finales de 2024. Además, Hazel puede facturar a los seguros de los estudiantes.

La empresa con sede en San Francisco, fundada en 2015, ha recaudado $112,5 millones de inversores y tiene contratos en 15 estados. Entre las empresas que buscan los dólares destinados para la salud mental de los jóvenes están otra startup de San Francisco, Daybreak Health, graduada de la prestigiosa incubadora tecnológica Y Combinator, junto con BeMe, Brightline y Kooth.

California eligió a Brightline y Kooth para una iniciativa estatal de $532 millones, en 2024, sobre servicios virtuales de comportamiento juvenil, otro componente importante del plan maestro de Newsom. Algunos programas estatales y locales se superponen, reconoció Naomi Allen, cofundadora y CEO de Brightline, pero dijo que la oferta de Brightline es más amplia que lo que Hazel hace en las escuelas, con servicios que incluyen desde sesiones de coaching para cuidadores hasta recursos de meditación.

“El estado financia el acceso gratuito a los servicios para todos los niños del estado, lo cual es un programa extraordinariamente ambicioso”, afirmó Allen.

Aún así, quedan muchos interrogantes sobre la eficacia de la teleterapia para estudiantes. Tampoco ha resultado ser una fuente de ingresos segura para las empresas: Brightline despidió al 20% de su plantilla la primavera pasada, la segunda ronda de despidos en seis meses.

Complemento, no solución

Chelsy Duffer-Dunbar, que en aquel momento trabajaba para Los Angeles Unified como trabajadora social psiquiátrica, declaró a KFF Health News en octubre que aún no había trabajado con Hazel, pero señaló que el condado exige que un miembro del personal permanezca a la vista del estudiante durante sus citas y le ayude si surgen problemas técnicos.

“Le sigue quitando tiempo al personal”, aseguró Duffer-Dunbar. “Mi día ya es muy estresante. No puedo imaginar tener una evaluación por amenaza y otra por suicidio en el trabajo y luego tener que buscar a alguien para que se siente en esta sesión de terapia con el niño o la niña y su iPad”.

Duffer-Dunbar añadió que quiere que el distrito dé prioridad a los terapeutas en persona que trabajan con la comunidad local, especialmente para los niños más pequeños que tienen problemas con la teleterapia.

Duffer-Dunbar ha dejado el distrito por recortes presupuestarios que la obligaban a desempeñar un trabajo más agobiante.

Hazel insistió en que la teleterapia no es una solución para todas las situaciones.

“Es una oportunidad para ampliar el acceso”, apuntó Andrew Post, jefe de innovación de la empresa.

Colaboración entre educación y salud

Fue necesaria una complicada colaboración entre los distritos escolares, las agencias del condado y los dos planes de Medi-Cal, L.A. Care Health Plan y Health Net, para poner en marcha el programa de terapia escolar. Las normas de financiación estatales se diseñaron para ayudar a las entidades a trabajar juntas.

“Este programa nos ha ayudado a acercarnos a los distritos escolares”, comentó Michael Brodsky, director de salud comunitaria de L.A. Care Health Plan. “Si podemos tratar a los niños cuando van a la escuela y derivarlos para que reciban tratamiento mientras están en la escuela, eso es bueno”.

Hazel ofrece principalmente sesiones de terapia individual de corta duración con trabajadores sociales clínicos u otros consejeros, el 40% de los cuales son bilingües. Son los más indicados para prestar apoyo temporal a quienes tienen necesidades leves o moderadas, como los estudiantes que luchan contra el estrés académico o empiezan en una escuela nueva, pero también pueden derivar a pacientes para que reciban atención a largo plazo.

El mayor distrito inscrito en el programa, Los Angeles Unified, cuenta con el 41% de los alumnos del condado, pero no todos los distritos están preparados para dar el salto. Cuatro de cada 10 distritos han optado por no ofrecer los servicios de Hazel, lo que Garoupa atribuye en parte a la preocupación por el intercambio de información sobre los estudiantes.

El contrato con Hazel termina en diciembre de 2024, pero Garoupa dijo que la Oficina de Educación y sus socios tienen la intención de mantener los servicios hasta junio de 2025. Cualquier prórroga posterior dependerá de los resultados.

Sonya Smith, colega de Garoupa, indicó que la Oficina de Educación evaluará la eficacia de Hazel a través de una encuesta anual, informes mensuales de impacto y reuniones semanales.

“El número de estudiantes que utilizan Hazel va a ser, obviamente, una medida clave”, añadió Smith. “La tasa de utilización de Hazel es del 3% al 8%. Evaluaremos si esas cifras se mantienen, si los estudiantes acceden a la atención en el momento oportuno y si alivia la carga del personal escolar y los proveedores comunitarios”.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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