Gemfibrozil only offers modest control of triglycerides in HIV patients

This article is more than 22 years old.

Gemfibrozil, one of the standard therapies used to control triglyceride levels, has only modest effects in patients with HAART-associated triglyceride elevations, according to a small randomised study reported this month in the journal AIDS.

The study, conducted by St Vincent’s Hospital in Sydney, randomised 37 men with a median fasting triglyceride level of 5.6mmol/L to receive either gemfibrozil 600mg twice daily or placebo after a four week diet phase.

Triglyceride levels fell by 1.22mmol/L in the gemfibrozil group (-18%) and rose by 0.35mmol/L in the placebo group over 12 weeks, a non-significant difference (p=0.08). The study was powered to detect a difference of at least 2mmol/L between the groups. Only one individual experienced a reduction in triglyceride levels to the normal range.

Glossary

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

placebo

A pill or liquid which looks and tastes exactly like a real drug, but contains no active substance.

powered

A study has adequate statistical power if it can reliably detect a clinically important difference (i.e. between two treatments) if a difference actually exists. If a study is under-powered, there are not enough people taking part and the study may not tell us whether one treatment is better than the other.

statin

Drug used to lower cholesterol (blood fats).

p-value

The result of a statistical test which tells us whether the results of a study are likely to be due to chance and would not be confirmed if the study was repeated. All p-values are between 0 and 1; the most reliable studies have p-values very close to 0. A p-value of 0.001 means that there is a 1 in 1000 probability that the results are due to chance and do not reflect a real difference. A p-value of 0.05 means there is a 1 in 20 probability that the results are due to chance. When a p-value is 0.05 or below, the result is considered to be ‘statistically significant’. Confidence intervals give similar information to p-values but are easier to interpret. 

The authors note that whilst gemfibrozil treatment has resulted in triglyceride reductions of up to 55% in HIV-negative patients, the reduction seen in this study was much smaller (18%), and the authors suggest that further studies should look at higher doses (gemfibrozil was well tolerated in this study) and combination therapy with a statin. However, they also admit that gemfibrozil may not be addressing the root cause of hypertriglyceridemia – ongoing insulin resistance or another metabolic disturbance generated by HAART.

References

Miller J et al. A randomised, double blind study of gemfibrozil for the treatment of protease inhibitor-associated hypertriglyceridemia. AIDS 16: 2195-2200, 2002.