Effects of metformin on fibrinogen levels in obese patients with type 2 diabetes.

OBJECTIVE: To determine fibrinogen levels in obese patients with type 2 diabetes and assess its changes with the use of metformin. METHODS: 60 obese patients (BMI > 27) with type 2 diabetes were studied in an open, two phase, prospective, randomized and comparative study. The pre-treatment phase was a period of four weeks of a controlled diet. In the treatment phase they were divided in two subgroups of 30. One received metformin as a daily single tablet of 850 mg and increasing the dosage to two or three tablets depending on their metabolic control. The second subgroup received 24 units of DNA-recombinant insulin subcutaneously (two thirds of dose before breakfast, and the remaining third before dinner). The insulin dosage was adjusted according to the metabolic response. A control group was formed by 60 non diabetic obese patients with only the controlled diet. RESULTS: The mean values of plasma glucose, fibrinogen levels and body mass index did not change in the pretreatment phase in controls and diabetics. These parameters decreased significantly in the metformin subgroup in the treatment phase (p < 0.001). Only glucose decreased in the insulin subgroup. There were no changes in the controls. CONCLUSIONS: In addition to improving metabolic control, metformin showed to be a good therapeutic alternative in modifying fibrinogen levels in type 2 diabetic patients.

Comparative accuracy of glucose monitors.

BACKGROUND: Self-monitoring of blood glucose levels has become an important instrument for the management of patients with diabetes mellitus. Both patients and physicians expect that the monitors will provide reliable results. Numerous environmental, physiologic, and operational factors can affect system performance, yielding results that are inaccurate or unpredictable. METHODS: This study examined the effect of one factor--high altitude--on the performance of seven blood glucose monitoring systems. The following monitors were compared: two One Touch II; two One Touch Basic; two Reflolux II (Accu-Chec in the USA); two Glucometer 3; one Glucometer 2, and one Accutrend Alpha. Double blood glucose level values were compared with a controlled reference laboratory test value, which was unknown to the investigator until the end of the study because the study was double blind. Blood glucose values were obtained using each of the monitors in 200 patients; 150 with diabetes mellitus, and 50 healthy subjects. RESULTS: The One Touch monitors were the only monitors that reported adjusted straight lines (Y = a+bX) that were very similar for all three techniques. In addition, these adjusted straight lines are those closest to the ideal line, Y = X. These same monitors were the only ones that did not reject the null hypothesis Ho: a = 0. The relative deviation index at the 20% level was less than 3.5% for the One Touch II and One Touch Basic monitors; for the rest of the monitors, the index was over 14%. The clinically accepted EGA region was similar for all study monitors. CONCLUSIONS: In conclusion, the One Touch II and One Touch Basic Monitors showed greater accuracy in comparison to the other devices. The evaluation of the clinically acceptable region shows practical reliability for all of the monitors used.

Digit preferences observed in the measurement of blood pressure: repercussions on the success criteria in current treatment of hypertension.

In a multicenter, open, noncomparative trial to assess the efficacy of an angiotensin-converting enzyme inhibitor, quinapril (Accupril; Parke-Davis), after 12 weeks of treatment in 667 adult patients 19-83 years of age with stage 1-3 hypertension, conducted by 85 physicians in primary health care, with systolic blood pressure (SBP) < 140 mm Hg and diastolic blood pressure (DBP) < 90 mm Hg as criteria for normalization, the efficacy of the drug was 75.1%. When an analysis was made of the frequency tables of BP recorded by the physicians in the case-report forms, a clear numerical preference was found in which the DBP was expressed in multiples of 5 in 81.3% of the cases and the SBP was expressed in multiples of 10 in 19% of the records, so that when a cutoff point <140/90 mm Hg is chosen in daily practice, 130/85 mm Hg is actually being selected. It suffices to change the criteria to accept as normal values less than or equal to instead of less than 140/90 mm Hg to increase the efficacy of the drug from 75.1% to 90.7% in our trial. Therefore, it is proposed to use multiples of 5 for DBP and multiples of 10 for SBP as cutoff points and the diffusion of clear recommendations on BP measurement.

Metformin's effects on glucose and lipid metabolism in patients with secondary failure to sulfonylureas.

OBJECTIVE: To compare results obtained with metformin versus those obtained with DNA-recombinant insulin in obese patients with NIDDM suffering from secondary failure to sulfonylureas. RESEARCH DESIGN AND METHODS: We conducted an open, prospective, randomized, and comparative study comprising a total of 60 patients selected and placed in two parallel groups. We had previously confirmed that the subjects had secondary failure to high doses of sulfonylureas. The initial metformin dosage was a single 850 mg tablet, and the dosage was increased to two or three tablets depending on the patient's metabolic changes. The initial dosage of DNA-recombinant insulin was 24 U, subcutaneously administered and divided into two portions: two-thirds at around 8:00 A.M., before breakfast, and the remaining third at 8:00 P.M., before dinner. The dosage was adjusted based on the patient's clinical and metabolic response. RESULTS: The initial average glucose value for the metformin group was 269.1 +/- 32.2 mg/dl, decreasing by the end of the study to 159.7 +/- 30.5 mg/dl. For the insulin group, these figures went from 270.7 +/- 24.0 mg/dl at the beginning of the study to 134.8 +/- 26.7 mg/dl. This decrease correlates with the reduction in glycosylated hemoglobin from 12.8 to 8.9% for the first group and from 12.3 to 8.2% for the second, as well as with the reduction in triglyceride values from 230.3 to 183.1 mg/dl and from 218.4 to 186.3 mg/dl, respectively. The BMI (27.5-26.4), blood pressure (systolic from 145.7-132.1 mmHg, diastolic from 90.3-84.8 mmHg), and total cholesterol levels (235-202 mg/dl) decreased in only the metformin group. CONCLUSIONS: Metformin is an effective, safe, and well-tolerated treatment that improves metabolic control and favorably modifies secondary clinical alterations due to insulin resistance, such as arterial hypertension, overweight, and hyperlipidemia, in obese patients with NIDDM suffering from secondary failure to sulfonylureas.

Meta-analysis of three trials with quinapril in the treatment of mild-to-moderate hypertension in the Mexican population.

A meta-analysis was performed to examine the therapeutic effect of quinapril in the treatment of patients with mild-to-moderate hypertension. Data from three clinical trials conducted in Mexico and including a total of 426 patients were examined using a retrospective approach and statistical methods. The meta-analysis proved that quinapril induces positive diastolic and systolic responses at all the doses studied, particularly at the 10-mg dose. At this dose, 94.1% of patients reduced their diastolic blood pressure (DBP) by 10 mm Hg or attained a DBP of < or = 90 mm Hg. Overall, quinapril reduced DBP by between 14.8 and 24.8 mm Hg proportionally to the baseline DBP. Systolic blood pressure decreased 16 to 35.7 mm Hg from baseline levels. We conclude that the meta-analysis allowed a clearer and more dependable handling of the results regarding effectiveness and optimum dose of quinapril.

Quinapril in the treatment of hypertension in primary care centers.

A multicenter, open, prospective study was carried out to establish the efficacy and safety of quinapril 10.0, 20.0, or 40.0 mg, or 20 mg plus 12.5 mg hydrochlorothiazide (HCTZ) given once daily in 256 patients with mild-to-moderate essential hypertension treated in primary care units in Mexico. The study consisted of a 4-week placebo washout period, followed by 12 weeks of active treatment. Quinapril doses were titrated upward at 4-week intervals to three dosage levels. Patients who did not respond to 20-mg doses were randomly assigned to receive 40 mg quinapril daily or 20 mg quinapril plus 12.5 mg HCTZ daily until the end of the study. Quinapril was useful as monotherapy in 78% of the 256 patients (92.9% of patients who completed the study were evaluable): 73.3% of patients required only 10 mg, and their average blood pressure was similar to that of patients who required doses of greater than 10 mg. Only 12.2% of responsive patients required either 40 mg of quinapril or 20 mg of quinapril plus HCTZ 12.5 mg. Quinapril was equally effective and safe in elderly patients (> 60 years old) and in obese and nonobese patients. A low incidence of adverse effects in our patients confirms quinapril's safety, and no adverse changes were observed in laboratory tests.