RESUMO
BACKGROUND: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) ended in 2002, but it is important to study its long-term outcomes during the posttrial period by incorporating posttrial antihypertensive medication uses in the analysis. PURPOSES: The primary aim is to explore the patterns of antihypertensive medication use during the posttrial period from Medicare Part-D data over the 11-year period from 2007 to 2017. The secondary aim is to examine the potential effects of these posttrial antihypertensive medications on the observed mortality and morbidity benefits. METHODS: This is a posttrial passive follow-up study of ALLHAT participants in 567 US centers in 1994-1998 with the last date of active in-trial follow-up on March 31, 2002, by linking with their Medicare and National Death Index data through 2017 among 8,007 subjects receiving antihypertensive drugs (3,637 for chlorthalidone, 2,189 for amlodipine, and 2,181 for lisinopril). Outcomes included posttrial antihypertensive drug use, all-cause mortality, and cardiovascular disease (CVD) mortality. RESULTS: Of 8007 subjects, 3,637 participants were initially randomized to diuretic (chlorthalidone). The majority (67.9%) of them still received diuretics in 2007, and 52.7%, 47.2%, and 44.0% received ß-blockers, angiotensin-converting enzyme (ACE) inhibitors, and calcium channel blockers (CCBs), respectively. Compared to participants who received diuretic-based antihypertensives, those who received CCB had a nonsignificantly higher risk of all-cause mortality (1.17, 0.99-1.37), whereas those who received ACE/ARB (angiotensin receptor blockers) had a significantly higher risk of all-cause mortality (1.26, 1.09-1.45). For the combined fatal or nonfatal hospitalized events, the risk of CVD was significantly higher in patients receiving CCB (1.30, 1.04-1.61) and ACE/ARB (1.49, 1.22-1.81) as compared to patients receiving diuretics. CONCLUSION: After the conclusion of the ALLHAT, almost all patients switched to combination antihypertensive therapies, independently by the original drug class, and the combination therapies (mostly based on diuretics) reduced the incidence of major cardiovascular outcomes and mortality.
RESUMO
OBJECTIVES: This post-trial data linkage analysis was to utilize the data of Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) participants linked with their Medicare data to examine the risk of hospitalized and non-hospitalized gastrointestinal (GI) bleeding associated with antihypertensives. SETTINGS: ALLHAT was a multicenter, randomized, double-blind, active-controlled trial conducted in a total of 42,418 participants aged ≥55 years with hypertension in 623 North American centers. Data for ALLHAT participants who were aged at ≥65 have been linked with their Medicare claims data. PARTICIPANTS: A total of 16,676 patients (4,480 for lisinopril, 4,537 for amlodipine, and 7,659 for chlorthalidone) with complete Medicare claims data were available for the final analysis. RESULTS: The cumulative incidences through March 31, 2002 of hospitalized GI bleeding were 5.4%, 5.8% and 5.4% for amlodipine, lisinopril, and chlorthalidone arms, respectively, but were not statistically significant among the 3 arms after adjusting for confounders in Cox regression models. The cumulative incidences of non-hospitalized GI bleeding were also similar across the 3 arms (12.0%, 12.2% and 12.0% for amlodipine, lisinopril, and chlorthalidone, respectively). The increased risk of GI bleeding by age was statistically significant after adjusting for confounders (HR = 1.04 per year, 95% CI: 1.03-1.05). Smokers also had a significantly higher risk of having hospitalized GI bleeding (1.45, 1.19-1.76). Hispanics, those who used aspirin or atenolol in-trial, had diabetes, more education, and a history of stroke had a significantly lower risk of having GI bleeding than their counterparts. Other factors such as gender, history of CHD, prior antihypertensive use, use of estrogen in women, and obesity did not have significant effects on the risk of GI bleeding. CONCLUSION: There were no statistically significant differences on the risk of hospitalized or non-hospitalized GI bleeding among the 3 ALLHAT trial arms (amlodipine, lisinopril, and chlorthalidone) during the entire in-trial follow-up.