OR-28: Baseline characteristics of participants in the lipid lowering component of ALLHAT

Introduction: ALLHAT is the largest antihypertensive trial ever done in the United States. Patients were initially randomized to one of 4 treatment groups: Chlorthalidone, amlodipine, lisinopril and Doxazosin. Of the 42,418 patients randomized to the antihypertensive trial, 10,356 were also randomized to the Lipid Lowering component (LLC). The objectives of this study, were 1) to evaluate the impact of pravastatin treatment on all-cause mortality in a hypertensive cohort with multiple risk factors and 2) to assess the applicability of benefits to populations that had been excluded or under-represented in previous trials (seniors, women, minority, racial and ethnic groups, diabetics, etc.). Eligible patients for the lipid component were those with no history of coronary heart disease (CHD) and fasting LDL cholesterol of 120-189 mg/dl on no lipid lowering therapy, or fasting LDL cholesterol of 100-129 and history of CHD. Of the LLC participants 5,185 were randomized to Usual Care and 5,171 to pravastatin 40mg daily. The study physician had the option of lowering the dose of pravastatin if poorly tolerated. Approximately 14% of LLC participants had a history of CHD and were equally distributed to Usual Care or Pravastatin therapy. Results: ALLHAT over-recruited groups of patients under-represented in previous lipid lowering trials. Thus the LLC included 49% women, 37% black patients, 32% over the age of 70, 60% current /past smokers and 34% diabetics. Baseline characteristics, such as body mass index, systolic and diastolic BP, serum creatinine, fasting blood glucose, and baseline lipids were similar between the UC and PRAV participants. Differences that emerged among the various subgroups are shown on table below.Lipid Profiles of Various Patient Sub-groups Men Women White African Am Diabetic Non-Diabetic Total-C 217 232* 224 226* 225 224 HDL-C 43 52* 44 52* 46 48* LDL-C 144 149* 145 148* 146 146 Triglycerides 150 152 169 124* 158 147* *P < .01 compared to respective subgroup. In Conclusion: Baseline characteristics were similar among ALLHAT Participants randomized to UC or PRAV. Subgroups of patients underrepresented in previous trials showed substantial differences in their baseline lipid profiles.