La lettura di LEORCT (prova forte)
La domandaNegli anziani (≥75 anni) con diabete tipo 2 trattati con insulina e/o sulfaniluree e HbA1c ≤8%, affiancare l'attivazione del paziente prima della visita alla formazione del medico aumenta la deprescrizione dei farmaci a rischio ipoglicemia?
Cosa hanno trovatoRCT in un grande sistema sanitario integrato (California del Nord), 211 medici di base e 450 pazienti (età media 79,9 anni; 49,6% femmine; in media 6,2 patologie croniche; HbA1c media 7,5%). Confronto tra 'academic detailing del medico + foglio di attivazione pre-visita al paziente' vs 'solo academic detailing'. Deprescrizione a 6 mesi: 15,8% (36/232) vs 9,0% (19/218); differenza di rischio aggiustata +7,5% (IC 95% 1,5%-13,6%; P=0,01); persistente a 12 mesi 22,8% vs 16,3%, RD aggiustata +7,9% (IC 95% 0,4%-15,5%; P=0,04). Ipoglicemia grave auto-riferita a 6 mesi: 4,7% (10/232) vs 6,5% (13/218); RD aggiustata -2,3% (IC 95% da -7,1% a +2,5%), differenza non significativa.
Cosa significa per teRiguarda l'anziano con tipo 2. Un intervento semplice ed economico (un foglio informativo consegnato al paziente prima della visita) aumenta la probabilità di ridurre i farmaci che possono causare ipoglicemia. Lo studio non ha però dimostrato una riduzione degli episodi ipoglicemici gravi (non era dimensionato per quell'esito). Ogni riduzione o sospensione di terapia va concordata con il curante.
Abstract (lingua originale)
IMPORTANCE: Medication-related hypoglycemia is the leading cause of iatrogenic complications among older adults with type 2 diabetes. OBJECTIVE: To compare physician academic detailing (AD) with or without patient previsit activation for insulin and/or sulfonylurea deprescribing in older patients with diabetes. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from September 2020 to March 2024 with 6 and 12 months of follow-up in a large integrated health care system in Northern California. Primary care physicians (PCPs) and their patients with type 2 diabetes who were 75 years and older, had hemoglobin A1c of 8.0% or lower, and were treated with insulin and/or sulfonylureas were included. INTERVENTIONS: Participating PCPs attended at least 1 AD session that provided evidence to support diabetes medication reassessment and potential deprescribing strategies in older patients with type 2 diabetes. Prior to their visit with a participating PCP, trial patients were randomly assigned to receive either a previsit activation deprescribing handout (AD plus previsit arm) or an attention control healthy lifestyle handout (AD-only arm). MAIN OUTCOMES AND MEASURES: Primary outcomes (assessed at 6 months) were diabetes medication deprescribing (an aggregate measure) and any patient-reported severe hypoglycemia episodes. RESULTS: A total of 211 PCPs were able to attend at least 1 AD session and treated 450 eligible patients (mean [SD] age, 79.9 [4.0] years; 223 [49.6%] female; mean [SD] concurrent chronic conditions, 6.2 [3.6]; and mean [SD] hemoglobin A1c, 7.5% [1.1%]). At 6 months, there was a statistically significant higher diabetes medication deprescribing rate in the AD plus previsit activation arm compared with the AD-only arm (36 of 232 patients [15.8%] vs 19 of 218 patients [9.0%]; adjusted risk difference [RD], 7.5%; 95% CI, 1.5%-13.6%; P = .01); this difference persisted at 12 months (50 of 232 patients [22.8%] vs 33 of 218 patients [16.3%]; adjusted RD, 7.9%; 95% CI, 0.4%-15.5%; P = .04). There was not a statistically significant difference in severe self-reported hypoglycemia at 6 months between the AD plus previsit and AD-only arms (10 of 232 patients [4.7%] vs 13 of 218 patients [6.5%]; adjusted RD, -2.3%; 95% CI, -7.1% to 2.5%; P = .04). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, AD with previsit activation was a simple and effective strategy for increasing diabetes medication deprescribing in older patients with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04585191.
Come leggerlo: un singolo studio non è una prescrizione. Discuti cambiamenti di dieta o terapia con il tuo diabetologo.