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The objective of this study was to investigate the effects and tolerability of an omega-3 ethyl ester concentrate (Omacor(trade mark)) on serum lipid concentrations in patients with hyperlipidaemia. A multicentre, double-blind, randomised, placebo-controlled trial was performed in the hospital and general practice setting. 84 patients with hyperlipidaemia were given a therapeutic lipid-lowering diet for 10 weeks. Of these, 55 patients were randomised to a 12-week treatment period. 47 patients completed the study and two patients withdrew because of adverse events. Randomised patients received omega-3 ethyl ester concentrate or corn oil (placebo), both administered at a dose of 2g twice daily in soft gelatin capsules. Main outcome measures included changes in eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) content of serum phospholipids, total serum triglycerides, total serum cholesterol, and high density lipoprotein (HDL) cholesterol between baseline (week 10) and the end of treatment (week 22). After 12 weeks of treatment, patients receiving the omega-3 ethyl ester concentrate showed a significant increase in the EPA/DHA content of serum phospholipids (p < 0.0001). No significant changes in serum phospholipids were observed in the patients given placebo. A mean [standard deviation (SD)] reduction in serum triglyceride of 28.3 (19.1)% (p = 0.0001) occurred in patients given the omega-3 ethyl ester concentrate. Patients receiving corn oil showed a nonsignificant mean (SD) increase in serum triglyceride of 9.1 (24.8)%. Therefore, a difference between the groups of 37.4% in favour of active treatment was found (p < 0.0001). Total serum cholesterol did not change significantly in either treatment group. Mean (SD) HDL cholesterol concentrations showed an increase of 0.9 (21.6)% in patients receiving omega-3 ethyl ester concentrate and 3.6 (24.3)% in the corn-oil group; however, neither increase was significant. In conclusion, omega-3 ethyl ester concentrate, 4 g/day, produced a significant reduction in mean serum triglyceride concentration in patients with hyperlipidaemia and was well tolerated.

SUMMARY N-Acetyl-~-D-glucosaminidase(NAG) levels in serum and urine from diabetics have been measured over a three-year period to assess their potential as indicators of the onset of retinopathy and nephropathy. The presence of retinopathy and nephropathy was confirmed by fluorescein angiography performed at the end of the study and by proteinuria, respectively. Three groups of diabetics were investigated, those on insulin, on oral hypoglycaemics, or on diet only. There was no apparent correlation between total NAG activity in serum with the development of retinopathy, nor were serum isoenzyme variations useful in this context. However, urine total NAG activity demonstrated a striking difference between diabetics of all groups and normals. In particular the B isoenzyme doubled in diabetics. The potential use of this finding in relation to prediction of the onset of microangiopathy is discussed.Retinopathy and proteinuria are two serious consequences of diabetes mellitus, the former being the single most common cause of blindness in the UK between the ages of 30 and 64. Good control may delay the onset or reduce the severity of the complications although the evidence is by no means conclusive.l" A biochemical marker reflecting early renal damage or retinopathic change would be a useful adjunct to recognising the diabetic patient at risk.The lysosomal hydrolase N-acetyl-~-D-gluco saminidase (NAG) has been shown to be elevated in the serum from diabetics at diagnosis'v" and has been suggested as a good indicator of diabetic retinopathy," although Poon et al. 6and Van Haeringen, Vrooland, and Glasius? were unable to verify this observation. Urine levels of NAG are a sensitive measure of renal cell damage and are elevated in diabetics with proteinuria, retinopathy, or a combination of both" and in many types of proteinuria."We have conducted a longitudinal study to assess the potential of urine and serum NAG levels and the isoenzyme variations as an indication of the onset of retinopathy and nephropathy, respectively. Materials and methods PATIENTSDiabetic patients who were adequately treated insulin, oral hypoglycaemic agents, or diet were seen at the Diabetic Clinic, Woolmanhill, Aberdeen. For the purpose of this study patients were selected with differing ages and duration of known diabetes, and were seen at approximately three-monthly intervals over a period of three years. Venous blood samples and specimens of urine were obtained approximately 2 hours after breakfast at each clinic visit. The venous blood sample was split into two aliquots: one was placed in a vial containing no preservative to obtain serum for routine biochemistry and NAG levels,and the other aliquot was placed in a vial containing fluoride-oxalate as preservative, for haemoglobin Al and blood glucose determinations. Serum and urine samples were stored at -15°C without preservative for up to 48 hours before enzyme assay. This did not affect the activity of the enzyme. An aliquot of the urine sample was analysed for glucose and protein before st...

An insulin injection device, NovoPen, incorporating cartridged U100 Human Actrapid insulin was used in a group of 31 insulin-dependent diabetic patients aged 31.4 +/- 11.2 years (mean +/- S.D.; range 16.5-57.0) to assess its acceptance and suitability in a regimen involving an injection before each of their three main meals plus an evening injection of Human Monotard insulin from a conventional syringe. Twenty-seven patients completed 48 weeks of NovoPen therapy and preferred to continue with the multiple injection regimen in the long term. The device was well accepted and may make multiple injection regimens more feasible.