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Sospendere le statine se la prognosi è infausta?

Sospendere la statina nei pazienti con malattie a prognosi infausta? Non è una domanda retorica. Una volta prescritte, le statine spesso vengono continuate, anche in presenza di malattie gravi che condizionano la vita, per il timore che la loro sospensione pregiudichi la sopravvivenza. Alcuni studi hanno in effetti sollevato il dubbio che la sospensione della statina possa avere un effetto negativo per la comparsa in tempi brevi di incidenti cardiovascolari. D'altra parte, continuare la terapia può essere inutile, se non dannoso. Pur essendo ben tollerate, le statine non sono del tutto esenti da effetti collaterali, soprattutto nei soggetti che per patologie diverse sono costretti a varie e spesso multiple terapie farmacologiche. Kutner e collaboratori hanno affrontato il problema del rapporto rischio-beneficio della sospensione delle statine in un gruppo di 381 pazienti affetti da malattie gravi, per la metà tumori, con un'aspettativa di vita di circa un anno. Tutti assumevano statine da più di 3 mesi per prevenzione primaria o secondaria di malattie cardiovascolari. I pazienti sono stati divisi in due gruppi uguali ed in uno dei gruppi la terapia con statine è stata sospesa. La sospensione della statina non ha avuto effetto sulla mortalità, sui sintomi fisici e sullo stato generale.

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP

JAMA Intern Med 2015;175:691-700

IMPORTANCE: For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy.
OBJECTIVE: To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting.
DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach.
INTERVENTIONS: Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins.
MAIN OUTCOMES AND MEASURES: Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings.
RESULTS: A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were $3.37 per day and $716 per patient.
CONCLUSIONS AND RELEVANCE: This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted.

JAMA Intern Med 2015;175:691-700