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Prescription patterns for diabetes mellitus and therapeutic implications: A total of 3, patients were identified. Mean age of the patients was Sixty percent of the patients were treated with monotherapy.
Doses of oral antidiabetic drugs were lower in monotherapy than in polytherapy. Ten patients received doses of glibenclamide or metformin above the recommended maximum doses, and in elderly patients there was no reduction in drug doses. Monotherapy with oral antidiabetic drugs was the predominant procedure, and the doses were not individualized according to age. Unified Health System; diabetes mellitus ; drug use, pharmacoepidemiology; drug prescriptions; database. Sessenta por cento foram tratados com monoterapia.
Diabetes mellitus DMa chronic non-transmissible disease, is one of the most prevalent diseases in the world. According to the International Diabetes Federation, 6. It is estimated that byapproximately 7. Concerning DM treatment, it is important to emphasize that non-pharmacological treatment is essential in the care of the disease. However, if non-pharmacological treatment does not lead to acceptable glycemic control, patients should receive oral antidiabetic drugs OADor insulin, or both.
GLUCAGON: O QUE É, PRA QUE SERVE E COMO USAR
In Brazil, the two pharmacologic classes of OAD available in the National List of Essential Medicines for DM treatment are biguanide metforminand sulfonylurea glibenclamide and gliclazideas well as the hormone insulin 2. The increasing number of subjects diagnosed with the disease suggests that it is necessary to study and understand the profile of OAD and insulin use. In addition, in a previous study in Brazil, the greatest part of direct costs of DM treatment was attributed to medication In the current context, pharmacoepidemiological studies are necessary and may be carried out using the computerized drug monitoring systems.
Thus, it may possible to describe drug use patterns, analyze early signals of the irrational drug use, promote interventions vula improve drug use, analyze quality control cycles, and promote continuous quality improvement Moreover, these studies are highly relevant in Brazil. According to the Ministry of Health, The five districts are meant to ensure that both primary and emergency care are close to people’s homes.
This study was carried out in the western district, which comprises a population of approximatelyinhabitants and 8 healthcare units. They were selected from the district database, and all patients who received at least one of the OADs insulinq 5 mg; metformin mg; gliclazide 80 mg or insulin from March and February were included. There were 3, patients with DM types 1 or 2.
Patients with DM type 2 who received prescriptions for gliclazide 26 patients were not included in the statistical analysis due to the small size of group, and the total number of patients was reduced to 3, Information in this database includes patient identification, gender, age, generic drug prescribed, drug dispensing date, dose regimen, amount of drug dispensed, and the health unit where the drug was dispensed.
Database information was updated simultaneously with patient care.
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Drugs were dispensed monthly by the healthcare unit pharmacies upon presentation of a prescription, and were simultaneously recorded in the database. All the necessary information was collected from the database of a single pharmacist. It was used to stratify patients with DM into therapeutic groups according to the drug or drug combination prescribed: Analysis of drug dose for the treatment of diabetes mellitus.
Drug prescriptions insuilna evaluated for each month of the study. It was possible to analyze insulin and OAD doses according to age and therapeutic group. Dose regimen for oral antidiabetic drugs and insulin in the treatment of DM has been well established using a number of individual dosing studies and analyses of the worldwide clinical database.
In the treatment with metformin, the usual starting dose is mg orally twice a day, or mg orally once a day. To get to the maintenance dose, doses should be increased by mg weekly or mg every two weeks for insuina who do not show adequate therapeutic response. The therapeutic dose range is from 1 to 2. In the treatment with glibenclamide, the usual starting dose is 2. The dose is usually increased by 2. The therapeutic dose range is from 1. In the treatment with insulin, the dose is individualized according to the patient’s needs.
The average dose per patient with DM ranges from 0. Obese patients may require doses of 2. In the association of insulin with OAD, patients should continue taking OAD in the same dose possibly reducedadministering insulin in a single dose at bedtime starting with about The insulin dose is adjusted using 2. Analysis of variation in dose and number of drugs used for diabetes mellitus treatment. As described above, drug prescriptions were evaluated for each month of the study.
OAD and insulin doses were analyzed per patient to observe in which patients the doses were decreased, increased or maintained during the period. Furthermore, it was possible to analyze the number of drugs used for the DM treatment, classifying treatment as monotherapy or polytherapy and, at the end npg the study, it was possible to examine in which patients the number of drugs prescribed for the treatment of DM was modified, and if bulq were classified as simple addition combination with another drugaddition by substitution replacement with another drugor drug withdrawal.
There Was A Large mph Table 1 shows the Anatomical Therapeutic Chemical groups of this study in relation to the number of DM patients, their mean age, minimum and maximum ages. Box 1 shows therapeutic profiles of the patients with DM types 1 and 2 correlated with the age group and the respective mean dosages of metformin, glibenclamide, and insulin.
Glibenclamide and metformin were prescribed to four and six patients at doses above At the end of the study, it was possible to analyze in which patients the number of drugs prescribed was changed.
With respect to metformin, there were For insulin, there were Changes in OAD and insulin doses were analyzed during the period studied. In The Present Study, However, in Colombia, Alba And Cols. In the present study, Other reports insuoina the literature indicated values of These results illustrate differences in OAD prescriptions.
Indeed, biguanides and sulfonylurea are first-choice treatments, while metformin is mainly indicated for obese and insulin resistance patients, and glibenclamide is mainly used in patients with a normal body mass 13,20, Gliclazide, another OAD available on the National List of Essential Medicines, was little prescribed in either monotherapy or polytherapy.
The use of glicazide in the SUS is restricted to elderly patients. This OAD was only prescribed to 26 patients, and five of them used it in an inappropriate combination with glibenclamide. According to the Brazilian Society of Diabetes and the American Diabetes Association, when a combination of two or three OADs is required in the treatment of DM, agents from different classes should be used 13,20, Since glibenclamide, gliclazide, and metformin are the only OADs available in the SUS, therapeutic options are limited.
This probably explains the rather high number of individuals using monotherapy with glibenclamide or metformin. Another monotherapy identified in the study was insulin, but its use was discrete 3.
Generally, doses used in OAD monotherapy are reduced, to prevent or control adverse side effects, and these doses are changed or not according to the patient’s response to the treatment. A retrospective study demonstrated that patients with DM type 2 treated with metformin or sulfonylurea monotherapy did not need additional treatment for DM is a progressive disease that can cause deterioration of glycemic control glucose toxicitymaking it necessary to change pharmacotherapy with time 23, There were no statistical differences in the dose versus age group in patients treated with metformin or glibenclamide in monotherapy Box 1A and 1B.
Despite the fact that the authors did not have access to appropriate clinical information to verify the need to change the dose, reductions in the sulfonylurea dosages have been recommended in elderly patients, especially for OAD showing long elimination half-lives, such as glibenclamide, because of increased risks of adverse reactions such as hypoglycemia In addition, some authors warn against the use of metformin in elderly patients due to an increasing risk of lactic acidosis From the patients selected in this investigation, Other studies reported values of A United Kingdom Prospective Study demonstrated that the combination of these drugs improved the levels of HbA1c over a three-year period In another study, the combination of metformin plus glibenclamide reduced the levels of HbA1c to less than 6.
When glycemic control is not possible, another OAD should be added, provided that the first one was used in the maximum recommended dose, indicating dose optimization 13, However, this was not obvious in the database since the doses of metformin and glibenclamide were far from optimum when the second OAD was added. This may be partially explained if one considers that patients with DM type 2 show different pathological mechanisms, warranting an early introduction of polytherapy, or when drug optimization is carried out according to patient tolerance.
The third step in the treatment of patients with uncontrolled DM type 2 would be the introduction of a third OAD or insulin 13,20, The only option for SUS patients npph to receive insulin, because the system does not have a third standardized class of OAD.
In this instance, the practitioner may decide to add the hormone, or choose complete insulinization. The Collaborative Drug Therapy Management Service showed that the introduction of insulin or dose adjustment in patients with DM type 2 improves glycemic control in patients with HbA1c levels over 9.
However, in these cases, the introduction of insulin is less frequent than recommended, and usually started late in the course of the disease. This treatment is invasive and painful, and frequently negatively affects bla patient-physician relationship and, consequently, the physician is reluctant to start it. Other concerns are also involved, since physicians, patients and families worry about the side effects, such hypoglycemia and weight gain, specially in elderly patients 13, Insulin polytherapy was used to treat Note that the database used in the present study did not provide laboratory results.
According to the Brazilian Society of Diabetes, the combination of a biguanide or sulfonylurea agent with insulin contributes to reducing hormone doses, facilitating the transition to full insulin treatment, besides increasing treatment acceptance and compliance Other studies also reported reduction in insulin doses in patients treated with metformin 31, In the present study, 6.
However, recent data have shown favorable outcomes related to the recovery and maintenance of b-cell function and protracted glycemic remission in newly diagnosed patients with DM type 2, which made therapy with OAD plus insulin comparable with OAD alone 20, Concerning insulin doses, they were higher in the monotherapy group than the polytherapy group, with the exception of the combination metformin plus insulin.
In general, patients with DM types 1 or 2 in advanced stages require full insulinization with high doses 13,