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HGH for AIDS Related Wasting
Reported by Jules Levin
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Wasting occurred more often before successful HAART treatment and was defined essentially as an involuntary 10% or greater weight loss. It was often accompanied by diarrhea & fever. Patients lost lean body mass & fat mass and this could accelerate HIV disease progression. Since the advent of HHART wasting should not & I think does not occur as much. But some patients present themselves to the clinic or for care or HIV testing with advanced HIV.
This is a phase 4 study following the FDA accelerated approval of HGH for wasting, to confirm HGH's benefits. This was a double-blind, placebo controlled, multi-center study. Patients with 10% weight loss, a body mass index <20, or weight <90% of the ideal body weight were randomized to 12 weeks of treatment with HGH, 6 mg daily (DD), 6 mg on alternate days (AD), or placebo.
The primary endpoint of the study was to confirm the clinical efficacy of HGH compared with placebo, based on exercise function change as assessed by cycle ergometer work output from baseline to week 12. The secondary endpoint was the change in lean body mass (was LBM increased) as measured by bioimpedance spectroscopy (BIS). LBM and total body and trunk fat mass were assessed bt DEXA (dual energy X-ray absorptionetry). Quality of life questionaires were used to assess patient's response to treatment. Below is a review of the adverse events profile for the patients in the study.
RESULTS
A total of 757 patients (247 placebo, 253 DD, 257 AD) started the study and 646 completed 12 weeks. In the evaluable population (n=555) patients were mostly white (77%) and male (91%). Average age was 41. All patients were on ART with 88% on HAART. 8% Black. 10% Hispanic.
EXERCISE OUTPUT INCREASED
Over 12 weeks cycle ergometry performance significantly increased by 2.60 kj from baseline in the DD group (9.9%) (p<0.0001), compared to the placebo group. This compared with a 1% decrease in performance by the placebo group. The AD group had an increase in performance work output of 2.35 kj but this improvement was not statistically significant.
LEAN BODY MASS INCREASED
The secondary study endpoint was lean body mass (LBM) as assessed by BIS. LBM increased by 5.21 kg from baseline in the DD group, and by 3.33 kg in the AD group (both were significant, p<0.001), compared to the placebo group (average gain in LBM of 0.6 kg). The difference in gain in LBM between the DD & AD groups was significant (p=0.017). 1 kg equals 2.2 lbs.
BODY FAT DECREASED
Total body fat mass and trunk fat mass decreased (by DEXA) in both the DD & AD groups. Total body fat mass decreased 1.41 kg in the DD group and 1.04 kg in the AD group. Trunk fat mass decreased by 1.23 kg in the DD group and 0.80 kg in the AD group (all these improvements were statistically significant, p<0.001 vs placebo).
BODY WEIGHT INCREASED
Body weight increased by 2.91 kg from baseline in the DD group and by 2.22 kg in the AD group (both significant p<0.001 vs placebo).
PATIENT SURVEY
The score for patient satisfaction was 51 in the placebo group, 72 in the DD group, and 65 in the AD group. The differences were all significant.
Viral load did not change over the 12 weeks.
ADVERSE EVENTS & SAFETY
Most of the patients in all study groups developed adverse events. The most common adverse events seen were known to be related to HGH therapy. 2 of the 11 serious adverse events in the AD group and 2 of the 17 in the DD group were deemed to be related to HGH, and included squamous cell carcinoma in situ, Buergers's disease, gynaecomastia (increased breast size), and upper gastrintestinal haemorrhage.
Most Frequently Occurring Adverse Events
Arthralgia: 24% in 6 mg AD, 36% in 6 mg DD, 11% in placebo
Mylagia: 17% in AD, 30% in DD, 11% in placebo
Arthrosis: 8% in AD, 10% in DD, 3.6% in placebo
Oedema: 12% in AD, 32% in DD, 4% in placebo
Dysaesthesia: 9% AD, 13% DD, 7% placebo
Headache: 10% AD, 12% DD, 9% placebo
Nausea: 5% AD, 9% DD, 5% placebo
Gynaecomastia 3.5% AD, 5.5% DD, 0.4% placebo
DISCONTINUATIONS
Of the 111 patients who discontinued (14.7%), 37% were reported to be due to adverse events (23 in the DD group), and the majority were due to symptoms & signs related to fluid retention, and 1 patient withdrew following diabetes onset. The printed program reported 2.1% withdrew due to limb pain, 5.4% due to patient decision, and 6.3% for other causes.
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