Long‐Term Follow‐Up of Moderately Hypercholesterolemic Hypertensive Patients Following Randomization to Pravastatin vs Usual Care: The Antihypertensive and Lipid‐Lowering Treatment to Prevent Heart Attack Trial (ALLHAT‐LLT)

The authors conducted a randomized, controlled, multicenter trial, in which they assigned well‐controlled hypertensive participants aged 55 years and older with moderate hypercholesterolemia to receive pravastatin (n=5170) or usual care (n=5185) for 4 to 8 years, when trial therapy was discontinued. Passive surveillance using national databases to ascertain deaths and hospitalizations continued for a total follow‐up of 8 to 13 years to assess whether mortality and morbidity differences persisted or new differences developed. During the post‐trial period, fatal and nonfatal outcomes were available for 98% and 64% of participants, respectively. The primary outcome was all‐cause mortality and the secondary outcomes included cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, cardiovascular disease, and end‐stage renal disease. No significant differences appeared in mortality for pravastatin vs usual care (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.89–1.03) or other secondary outcomes. Similar to the previously reported in‐trial result, there was a significant treatment effect for CHD in black patients (HR, 0.79; 95% CI, 0.64–0.98). However, the in‐trial result showing a significant treatment by race effect did not remain significant during the entire follow‐up (P=.08). These findings are consistent with evidence from other large trials that show statins prevent CHD and add evidence that they are effective for CHD prevention in black patients.