Safety and tolerability of high‐intensity statin therapy in heart transplant patients receiving immunosuppression with tacrolimus

Abstract

BackgroundFollowing heart transplantation (HT), HMG CoA reductase inhibitors (statins) have been shown to reduce total and low‐density lipoprotein (LDL) cholesterol, development of cardiac allograft vasculopathy (CAV), and mortality. Studies in HT patients have demonstrated the safety of low/moderate intensity statins; however, little data exist using high‐intensity (HI) statins. The study aim was to evaluate the safety and efficacy of HI statins in HT recipients receiving tacrolimus.MethodsThis single‐center, retrospective analysis included adult HT recipients from January 1, 2005, to December 31, 2015, who received HI statin therapy during posttransplant follow‐up. The primary outcome, tolerability, was defined as the absence of myalgias, hepatotoxicity, rhabdomyolysis, or HI statin dose reduction/discontinuation. The secondary end point was the mean reduction in total and LDL cholesterol.ResultsAmong the 24 patients included, one experienced myalgias and therapy discontinuation (4%; P > 0.99). No other HI statin dose reduction/discontinuation occurred, and no instances of rhabdomyolysis or hepatotoxicity were observed. The average reduction in total and LDL cholesterol after conversion to HI statin was 35 mg/dL (P = 0.02) and 19 mg/dL (P = 0.10), respectively.ConclusionsHigh‐intensity statin therapy appears safe and efficacious in HT recipients receiving tacrolimus and is a reasonable option for the treatment of refractory hyperlipidemia.

A systematic review of the drug–drug interaction between statins and colchicine: Patient characteristics, etiologies, and clinical management strategies

“…The 16 case reports, 12 published as case report manuscripts and four published as editorial briefs, and two case series are charted in Table 1 8–25 . The three original research manuscripts, two retrospective observational cohort studies and one case‐control study, are charted in Table 2 26–28 . No randomized controlled studies were obtained from the literature search.…”

Clinical Controversy in Transplantation: Tacrolimus Versus Cyclosporine in Statin Drug Interactions

“…29 Recently, a retrospective analysis was completed of 24 heart transplant patients on tacrolimus who were transitioned to high-intensity statins (atorvastatin n = 23 and rosuvastatin n = 1) during posttransplant follow-up. 30 The primary aim of this study was to investigate the incidence of adverse effects such as myopathy, hepatotoxicity, and rhabdomyolysis. Patients demonstrated tolerance of low-moderate statins for 6 months prior to conversion to high-intensity statin.…”

“…Some transplant centers even include the use of statins preemptively as part of the standard posttransplant medication regimen regardless if hyperlipidemia was not present pretransplant, as recommended by international guidelines. 12,30 Another consideration is that transplant candidates may also have preexisting CVD, necessitating use of statins posttransplant. Statins have an important role in this population, and when used at the doses necessary to reduce LDL, they can provide significant benefit.…”

Chronic Rejection and Atherosclerosis in Post-Transplant Cardiovascular Mortality: Two Sides of the Same Coin

“…A recent Cochrane review identified four studies on the use of statin therapy in kidney transplant patients to minimise cardiovascular mortality [67], all reporting a non-statistically significant reduction in cardiovascular mortality. This was likely due to the low statin doses used (10 mg daily equivalent simvastatin), compared to the higher intensity statin therapy used to manage CAV (20 mg daily equivalent simvastatin) [68]. This point is further illustrated by a more recent study which revealed a dose-dependent benefit of statins in survival among kidney transplant patients [69].…”