ABSTRACT
To evaluate the efficacy and tolerability, any changes in lipid parameters including free fatty acids and effect on weight and blood pressure, of adding Rosiglitazone to patients with type 2 DM who are not adequately controlled on maintenance dose of Metformin. Prospective study of 14 patients with type 2 DM who were maintained on Metformin alofte [1.5-2.5 g/day]. Twelve patients met the inclusion criteria, and received 4 mg of Rosiglitazone daily in addition to Metformin. Patients were followed for 24 weeks and seen for 6-7 visits. The dose of Rosiglitazone was increased after 8 weeks if FBG was still >/= 160 mg/dl. Full biochemical evaluation was done and safety parameters were observed at base line, at intervals during the study and at the end of the study. All patients completed the study. T test was used for comparison. Eight males and four females were studied. They had the following characteristics: Mean age was [52 +/- 6.9] years, weight was [78.2 +/- 10.1] kg BMI was [28 +/- 4] kg/m[2], waist circumference was [97.5 +/- 6.5] cm, and duration of DM was [7.3 +/- 6] years. Four patients required an increase of Rosiglitazone dose to 8 mg after 8 weeks. All patients showed improvement of HbAlc levels by the end of the study. When mean base line parameters were compared to those at the end of study: HbAlc level dropped from [8.9% +/- 1.5] to [7.1% +/- 1.1] [P: 0.00003] and FBG from [205 + 50.6] to [150 +/- 28] mg/dl [P: 0.002]. Free Fatty Acids [FFA] dropped from [703 +/- 213] to [510 +/- 303.6] by 8 weeks and to [574 +/- 184.6] microeq/L by the end of the study, [P: 0.01 and 0.06, respectively]. Improvement in HbAlc did not however correlate with the level of FFA drop. There was also significant increase in HDL level [1.15 +/- 0.14]-[1.27 +/- 0.2] mmol/L, [P: 0.02], and weight [78.2 +/- 10.1]-[80.1 +/- 10.9] kg [P: 0.01]. The changes in LDL [3.02 +/- 0.57] - [3.23 +/- 0.5] mmol/L, TG [2.16 +/- l.l]-[2.2 +/- 1.33] mmol/L, waist circumference [97.5 +/- 6.5]-[99 +/- 8.1] cm, and BP [132.5 +/- 17]-[130.2 +/- 18.8] mm Hg [systolic], were not significant. When [Good Responders], [HbAlc drop of >1.5%], [nine subjects] were compared to those with less than 1.5% drop [three subjects], there were no specific characteristics to define responders. Rosiglitazone, added to Metformin in type 2 DM patients, was effective and well tolerated. There was a significant decrease in FFA levels with treatment. The response to treatment, however could not be predicted from biochemical or clinical parameters. A larger study may be needed to define respon-der characteristics