7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 13–16 November 2005, Dublin, Ireland

CARDIOVASCULAR RISK FACTORS IN PATIENTS WITH HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS)

C Grunfeld¹, S Brown², G Richmond³, N Muurahainen⁴ and DP Kotler⁵ on behalf of Study 24380 Investigators
¹ UCSF–VA Med Center, San Francisco, CA, USA; ² AIDS Research Alliance, W. Hollywood, CA, USA; ³ Broward General Med Center, Ft Lauderdale, FL, USA; ⁴ Serono Inc, Rockland, MA, USA; ⁵ Columbia University St. Luke’s-Roosevelt Hospital Center, New York, NY, USA

Antiviral Therapy 2005; Supplement 3:L23 (abstract no. 32)

OBJECTIVES: To describe characteristics, including cardiovascular risk factors, of HIV-infected (HIV+) adults selected for increased truncal fat and likely to have excess visceral adipose tissue (VAT) or HIV-associated adipose redistribution syndrome (HARS).

METHODS: Subjects were HIV+ adults entering a multicentre, double-blind, placebo-controlled Phase III trial to investigate recombinant human growth hormone for treatment of HARS. To enter, they had to be on stable antiretroviral therapy and have a likelihood of having increased VAT based on anthropometric criteria [waist-to-hip ratio (WHR) >0.95 and waist circumference (WC) >88.2 cm if male, or WHR >0.90 and WC >75.3 cm if female]. Those on antihypertensive and lipid-lowering agents had to be stable prior to study entry. Exclusion criteria included: uncontrolled hypertension (SBP >140 or DBP >90 mmHg at screening, on or off medication), fasting triglycerides >1000mg/dl, cancer, diabetes, fasting glucose >110 mg/dl, or 2-h glucose >140mg/dl on oral glucose tolerance testing.

RESULTS: Of 322 patients with post-baseline assessments, 85% were male. Mean (SD) age was 45 (7) years, BMI 27 (4) kg/m², CD4 counts 499 (282) cells/µl and 82% had HIV-RNA 400 copies/ml. The fasting lipid profile included: a mean (SD) total cholesterol (mg/dl) of 194 (44), LDL-C 115 (34), Non-HDL-C 155 (40), HDL 39 (11) and triglycerides 221 (164) mg/dl. Of all the patients, 95% were receiving NRTIs, 62% PIs, 47% NNRTIs, 22% statins, 10% fibrates, 11% ACE inhibitors, 9% beta-blockers, 5% thiazides, 4% calcium-channel blockers, 4% angiotensin II inhibitors and 3% niacin. On medical history, 24% reported that they were currently smoking, 44% had a history of smoking within the past 10 years and 10% were closely related to persons who had developed coronary artery disease (CAD) before the age of 45.

CONCLUSIONS: Despite exclusion criteria of diabetes, severe hypertriglyceridaemia, uncontrolled hypertension and impaired glucose tolerance, many patients with HARS who entered this trial had, in addition to increased WC and WHR, significant other additional cardiovascular risk factors: male gender, age over 40, dyslipidaemia, hypertension, high BMI, current or recent smoking history and family history of premature CAD. Increased attention should be paid to modifiable cardiovascular risk factors in this population.

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2005-11-13
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