Subjects. A total of 263 patients with type 2 diabetes treated with oral agents or insulin, age (mean ± SD) 60 ± 10 years, body mass index (BMI) 31.4 ± 6.1 kg m )2 , 46% males. Intervention. After a 6-week dietary lead-in period, patients were randomized to RSV (n ¼ 131) or ATV (n ¼ 132) treatment in a dose escalation scheme (RSV: 10, 20 and 40 mg or ATV: 20, 40 and 80 mg for 6 weeks each sequentially). Main outcome measures. Primary outcome was the change in apolipoprotein B (apoB) and apoB/ apolipoprotein A1 (apoA1) ratio, which has been suggested a better predictor for cardiovascular events than total (TC) or low-density lipoprotein cholesterol (LDL-C). Secondary outcomes were the changes in other lipid parameters. Results. Baseline LDL-C in the RSV and ATV groups was 4.23 ± 0.98 mmol L )1 and 4.43 ± 0.99 mmol L )1 , whilst apoB/apoA1 was 0.86 ± 0.22 and 0.92 ± 0.35, respectively. A greater reduction in apoB/apoA1 was seen with RSV ()34.9%, )39.2% and )40.5%) than with ATV ()32.4%, )34.7% and )35.8%, P < 0.05 at weeks 12 and 18). Significantly greater reductions in LDL-C were also seen with RSV ()45.9%, )50.6% and )53.6%) than with ATV ()41.3%, )45.6% and )47.8%, all P < 0.05). The American Diabetes Association (ADA) LDL-C goal of <2.6 mmol L )1 was reached by 82%, 84% and 92% of patients with RSV and 74%, 79% and 81% with ATV. Triglyceride reductions ranged from 16 to 24% and were not different between treatments. Both treatments were well-tolerated: nine patients in the RSV and 11 in the ATV group withdrew from treatment because of adverse events after randomization. Conclusion. In subjects with type 2 diabetes, greater improvements of apoB/apoA1 and across the lipid profile were observed with RSV compared with ATV.
The trough:peak (T:P) ratio serves as an index of efficacy of antihypertensive drugs with respect to their dose and dose interval. There is no consensus regarding the method for the calculation of the T:P ratio. We assessed the influences of curve smoothing, the average fall in 24-h mean arterial pressure (MAP) and the length of the peak effect period on the result of T:P ratio calculation. Forty-two patients with essential hypertension (aged 27-81 years; 20 males) had a 24-h ambulatory blood pressure (BP) measurement on two occasions. The first was performed at baseline, the second after 12 weeks of treatment with a -blocker, angiotensin-converting enzyme inhibitor, calcium slowchannel blocker, diuretic or a centrally acting drug, all taken once daily. BP data were analysed both by Fourier analysis (FA) with four harmonics and by time block analysis (TBA). The peak effect was defined as the maximum drop in MAP over a period of 0 to 3 h following drug intake at any time in the 24 h, and the trough effect as the fall in MAP over the last 2 h of the dose interval. FA gave higher T:P ratio values than TBA (0.51 vs 0.43;
In 34 out-patients with essential hypertension, the antihypertensive effect and the trough-to-peak ratios of once-daily enalapril or lisinopril were compared by ambulatory blood pressure monitoring (
In this multicenter study, the efficacy of and tolerability for meropenem were compared with those for the combination of cefuroxime-gentamicin (±metronidazole) for the treatment of serious bacterial infections in patients ≥65 years of age. A total of 79 patients were randomized; thirty-nine received meropenem (1 g/8 h), and 40 received cefuroxime (1.5 g/8 h) plus gentamicin (4 mg/kg of body weight daily) for 5 to 10 days. Metronidazole (500 mg/6 h) could be added to the cefuroxime-gentamicin regimen for the treatment of intra-abdominal infections (n = 10). Seventy patients were evaluable for clinical efficacy; the primary diagnoses were as follows: pneumonia in 41 patients (20 treated with meropenem, 21 treated with cefuroxime-gentamicin), intra-abdominal infection in 10 patients (7 meropenem, 3 cefuroxime-gentamicin-metronidazole), urinary tract infection (UTI) in 11 patients (6 meropenem, 5 cefuroxime-gentamicin), sepsis syndrome in 7 patients (4 meropenem, 3 cefuroxime-gentamicin), and “other” in 1 patient (cefuroxime-gentamicin). The pathogens isolated from 18 patients with bacteremia were as follows:Staphylococcus spp. (n = 2),Streptococcus spp. (n = 2), members of the family Enterobacteriaceae (n = 11), and Bacteroides spp. (n = 3). A satisfactory clinical response at the end of therapy was achieved in 26 of 37 (70%) and 24 of 33 (73%) evaluable patients treated with meropenem and combination therapy, respectively. Clinical success was achieved in 23 of 31 (74%) and 21 of 28 (75%) evaluable patients with infections other than UTIs, respectively. A satisfactory microbiological response occurred in 15 of 22 (68%) patients in the meropenem group compared with 12 of 19 (63%) treated with combination therapy. Renal failure occurred during therapy in 2 of 39 (5%) meropenem recipients compared with 5 of 40 (13%) of those treated with combination therapy. The findings in this small study indicate that meropenem is as efficacious for and as well tolerated by elderly patients as the combination of cefuroxime-gentamicin (±metronidazole).
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