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1.
West Afr J Med ; 38(8): 756-761, 2021 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-34503324

RESUMO

BACKGROUND: The use of fixed dose combination oral antidiabetic drugs (OADs) in the therapeutic management of type 2 diabetes mellitus (DM) patients is becoming popular among clinicians. Reduced pill burden with fixed combination OADs is generally perceived to improve adherence and efficacy. The aim of this study was to compare the efficacy, tolerability and side effects (SEs) profile of vildagliptin-metformin (VM) combination with metformin-glibenclamide (MG) combination in type 2 DM patients at the Aminu Kano Teaching Hospital (AKTH). METHODS: A descriptive prospective open-labeled comparative out-patient study of type 2 DM patients spanning over three months with 60 Patients assigned to two treatment groups - VM (Group 1) and MG (Group 2) of 30 patients each. Parameters measured at baseline, 6 weeks and 12 weeks of study included demographic and anthropometric data; fasting plasma glucose (FPG) level; 2-hour post-prandial (2-hrPPG) glucose; liver function tests (LFTs); Electrolyte, Urea and Creatinine (EUCr); and fasting plasma lipids. Glycated haemoglobin (HbA1c) was measured at baseline and at 12 weeks of the study. A p-value of <0.05 was considered to be significant. RESULTS: There was improvement in FPG, 2hr PPG, HbA1c in all subjects in both groups at the end of the study (6.44±0.79mmol/ l, 8.80±1.16mmol/l and 7.22±1.20% respectively in group 1(VM); and 6.40±0.83mmol/l, 9.29±1.39 and 7.25±0.96% respectively for group 2(MG). There was a significant improvement in body mass index (BMI) of subjects in group 1 (30.02±4.16 at baseline, 29.71±4.12 at study end) compared to those in group 2 (31.98±6.32 at baseline, 32.62±6.30 at study end), p=0.04. At the end of the study, the efficacy of VM (HbA1C-7.22±1.20%) was comparable to that of MG (HbA1c-7.25±0.96), P=0.92. The tolerability of MG (attrition rate 6.7%) was better than that of VM (attrition rate 13%), although this difference was not statistically significant P=0.16. The subjects on VM experienced more gastrointestinal (GIT) side effects compared to those on MG. The major SEs experienced by those on MG were hypoglycaemia and weight gain. VM was less tolerated and had more GIT side effects than MG. CONCLUSION: The use of single pill combination oral antidiabetic medications is associated with improved efficacy.


Assuntos
Adamantano , Diabetes Mellitus Tipo 2 , Metformina , Adamantano/efeitos adversos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Quimioterapia Combinada , Humanos , Metformina/efeitos adversos , Nigéria , Nitrilas/efeitos adversos , Estudos Prospectivos , Pirrolidinas/efeitos adversos , Vildagliptina/uso terapêutico
2.
Medicine (Baltimore) ; 100(31): e26622, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34397797

RESUMO

BACKGROUND: Several previous randomized controlled trials (RCTs) evaluated the efficacy of metformin combined with simvastatin in the treatment of polycystic ovary syndrome (PCOS), yet the results of the researches are not consistent. It is necessary to conduct a meta-analysis to explore the efficacy and safety of metformin combined with simvastatin in the treatment of PCOS, to provide evidence supports for the treatment of PCOS. METHODS: We searched PubMed, EMbase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, and Chinese biomedical literature databases online to identify the RCTs evaluating the efficacy of metformin combined with simvastatin in the treatment of PCOS. Standardized mean difference (SMD) and 95% confidence interval (95% CI) were calculated to evaluate the synthesized effects. RESULTS: Nine RCTs with a total of 746 PCOS patients were included. The synthesized results indicated that the combined use of metformin and simvastatin are more beneficial to reduce the total cholesterol (SMD -2.66, 95% CI -3.65 to -1.66), triglycerides (SMD -1.25, 95% CI -2.02 to -0.49), low density lipoprotein (SMD -2.91, 95% CI -3.98 to -1.84), testosterone (SMD -0.64, 95% CI -1.13 to -0.15), fasting insulin (SMD -1.17, 95% CI -2.09 to -0.26) than metformin alone treatment in PCOS patients (all P < .001), and there was no significant difference in the high density lipoprotein (SMD -0.05, 95% CI -0.56-0.46), luteinizing hormone (SMD -0.58, 95% CI -1.66 to -0.50), follicle stimulating hormone (SMD 0.41, 95% CI -0.78-1.59), prolactin (SMD -1.38, 95% CI -2.93-0.17), fasting blood sugar (SMD 0.23, 95% CI -0.52-0.97), and insulin sensitivity index (SMD -0.17, 95% CI -0.48-0.15) between experimental and control groups (all P > .05). CONCLUSIONS: Metformin combined with simvastatin is superior to metformin alone in the treatment of PCOS patients with more advantages in improving the levels of sex hormones, blood lipids, and blood sugar. However, the safety of this therapy still needs to be further explored in clinical studies with high-quality and large samples.


Assuntos
Metformina/uso terapêutico , Síndrome do Ovário Policístico/sangue , Síndrome do Ovário Policístico/tratamento farmacológico , Sinvastatina/uso terapêutico , Glicemia/metabolismo , Colesterol/sangue , Quimioterapia Combinada/efeitos adversos , Feminino , Hormônios Esteroides Gonadais/sangue , Humanos , Insulina/sangue , Lipoproteínas LDL/sangue , Metformina/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sinvastatina/efeitos adversos , Triglicerídeos/sangue
3.
Kidney Int ; 100(3): 513-515, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34420660

RESUMO

The biguanide metformin has been safely and widely used in the treatment of type 2 diabetes mellitus for decades. Preclinical studies have suggested that it may have a role in slowing disease progression in autosomal dominant polycystic kidney disease. In this issue, Perrone et al. report results from the Trial of Administration of Metformin in PKD (TAME PKD) study, a phase 2 randomized controlled trial investigating the safety and tolerability of metformin in patients in the early stages of autosomal dominant polycystic kidney disease. We discuss the implications of these findings and how they relate to a major phase 3 trial in autosomal dominant polycystic kidney disease that will start later in 2021.


Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Rim Policístico Autossômico Dominante , Diabetes Mellitus Tipo 2/tratamento farmacológico , Humanos , Hipoglicemiantes/efeitos adversos , Metformina/efeitos adversos , Rim Policístico Autossômico Dominante/tratamento farmacológico , Projetos de Pesquisa
4.
BMJ Case Rep ; 14(7)2021 Jul 08.
Artigo em Inglês | MEDLINE | ID: mdl-34244196

RESUMO

A 58-year-old female with known type 2 diabetes mellitus continued to take her usual medications, including metformin, an ACE inhibitor and a non-steroidal anti-inflammatory drug, while suffering from diarrhoea and vomiting. On presentation to the emergency department, she was found to have a profound lactic acidosis, cardiovascular instability and acute kidney injury. Despite a pH of 6.6, lactate of 14 mmol/L and a brief asystolic cardiac arrest, supportive treatment and the use of renal replacement therapy resulted in rapid improvement in her acid-base abnormalities and haemodynamic parameters. Metformin-associated lactic acidosis is a rare but life-threatening complication of diabetes management. Patient education and awareness amongst clinicians are paramount in the prevention and treatment of this condition.


Assuntos
Acidose Láctica , Injúria Renal Aguda , Diabetes Mellitus Tipo 2 , Metformina , Acidose Láctica/induzido quimicamente , Acidose Láctica/terapia , Injúria Renal Aguda/induzido quimicamente , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Metformina/efeitos adversos , Pessoa de Meia-Idade
6.
Kidney Int ; 100(3): 684-696, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34186056

RESUMO

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by growth of kidney cysts and glomerular filtration rate (GFR) decline. Metformin was found to impact cystogenesis in preclinical models of polycystic disease, is generally considered safe and may be a promising candidate for clinical investigation in ADPKD. In this phase 2 two-year trial, we randomly assigned 97 patients, 18-60 years of age, with ADPKD and estimated GFR over 50 ml/min/1.73 m2, in a 1:1 ratio to receive metformin or placebo twice daily. Primary outcomes were medication safety and tolerability. Secondary outcomes included estimated GFR decline, and total kidney volume growth. Thirty-eight metformin and 39 placebo participants still received study product at 24-months. Twenty-one participants in the metformin arm reduced drug dose due to inability to tolerate, compared with 14 in the placebo arm (not significant). Proportions of participants experiencing serious adverse events was similar between the groups. The Gastrointestinal Symptoms Rating Scale score was low at baseline and did not significantly change over time. The annual change for estimated GFR was -1.71 with metformin and -3.07 ml/min/1.73m2 per year with placebo (mean difference 1.37 {-0.70, 3.44} ml/min/1.73m2), while mean annual percent change in height-adjusted total kidney volume was 3.87% in metformin and 2.16% per year in placebo, (mean difference 1.68% {-2.11, 5.62}). Thus, metformin in adults with ADPKD was found to be safe and tolerable while slightly reducing estimated GFR decline but not to a significant degree. Hence, evaluation of efficacy requires a larger trial, with sufficient power to detect differences in endpoints.


Assuntos
Cistos , Metformina , Rim Policístico Autossômico Dominante , Adulto , Progressão da Doença , Taxa de Filtração Glomerular , Humanos , Rim , Metformina/efeitos adversos , Rim Policístico Autossômico Dominante/tratamento farmacológico
7.
Clin Drug Investig ; 41(7): 647-652, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34097256

RESUMO

BACKGROUND AND OBJECTIVE: Omecamtiv mecarbil (OM) is a novel cardiac myosin activator in development for the treatment of heart failure with reduced ejection fraction. The objective of this study was to evaluate the potential for OM to affect the pharmacokinetics of metformin. METHODS: This was an open-label, fixed-sequence study in 14 healthy subjects. On Day 1, subjects received an 850 mg oral dose of metformin. From Days 4 to 9, subjects received twice-daily 25 mg oral doses of OM tablets. On Day 10, subjects received an 850 mg oral dose of metformin and a single 25 mg tablet of OM. Blood and urine samples were collected up to 36 h post-dose following administration of metformin on Days 1 and 10 to characterize concentrations of metformin in plasma and urine. RESULTS: The ratios of the geometric least square means of metformin coadministered with OM compared to metformin alone were 98.7%, 99.3%, and 110.2% for AUCinf, AUClast, and Cmax, respectively. The mean renal clearance of metformin was similar following metformin administered alone (34.2 L/h) compared to metformin coadministered with OM (32.9 L/h). All adverse events were mild in severity and resolved prior to the end of the study. No serious adverse events or treatment-emergent adverse events led to discontinuation from the study. CONCLUSIONS: There was no clinically relevant effect of OM on the pharmacokinetics of metformin in healthy subjects.


Assuntos
Metformina/farmacocinética , Proteínas de Transporte de Cátions Orgânicos/metabolismo , Ureia/análogos & derivados , Administração Oral , Adulto , Área Sob a Curva , Diarreia/etiologia , Interações Medicamentosas/fisiologia , Feminino , Meia-Vida , Voluntários Saudáveis , Humanos , Análise dos Mínimos Quadrados , Masculino , Metformina/administração & dosagem , Metformina/efeitos adversos , Metformina/química , Pessoa de Meia-Idade , Curva ROC , Especificidade por Substrato , Comprimidos/química , Ureia/administração & dosagem , Ureia/efeitos adversos , Ureia/química
8.
Int J Clin Pharmacol Ther ; 59(9): 630-638, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34142951

RESUMO

OBJECTIVES: To assess the bioequivalence and safety of generic metformin hydrochloride (test preparation) and glucophage (reference preparation) in healthy Chinese subjects. MATERIALS AND METHODS: A bioequivalence and safety assessment of two formulations of metformin (850 mg) using a randomized, open, two-period, two cross-over, single-dose, fed trial in 36 healthy Chinese adult subjects was performed at our center from March 22, 2018, to April 9, 2018. Bioequivalence was determined as two-sided 90% confidence intervals (CI) of the test-to-reference ratio of area under the curve (AUC) and peak concentration (Cmax) for each constituent within 80.00 - 125.00%. SAS 9.4 software was employed for the statistical analysis. RESULTS: One subject was excluded from the trial. The 90% CIs (95.36 - 101.43% for AUC0→t, 95.65 - 101.66% for AUC0→∞; 94.43 - 101.74% for Cmax) of test/reference preparation for these pharmacokinetic parameters were within the range of 80.00 - 125.00%. No severe adverse events were observed during this trial. The two preparations were safe and well-tolerated. CONCLUSION: It was concluded that generic metformin was bioequivalent and as safe as glucophage under fed conditions in healthy Chinese subjects.


Assuntos
Metformina , Adulto , Área Sob a Curva , China , Estudos Cross-Over , Jejum , Humanos , Metformina/efeitos adversos , Comprimidos , Equivalência Terapêutica
9.
Am J Case Rep ; 22: e931311, 2021 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-34075013

RESUMO

BACKGROUND Metformin has a longstanding reputation as the first-line treatment for glycemic control in the setting of diabetes mellitus type 2. A contributing factor to this reputation is metformin having a low risk of inducing hypoglycemia compared to other oral hypoglycemics or insulin. There are no case reports of hypoglycemia while on conventional or therapeutic doses of metformin. This case report is of a patient who developed symptomatic hypoglycemia while being treated with a therapeutic dose of metformin. CASE REPORT A 58-year-old man with history including diabetes mellitus type 2, hypertension, and schizoaffective disorder was dismissed early from work due to symptoms of severe weakness, confusion, diaphoresis, dizziness, shortness of breath, palpitations, and a sensation of feeling hot. Continuous glucose monitoring revealed hypoglycemic episodes up to 4% of the time. The hypoglycemic events appeared to occur primarily between midnight and 7 A.M., with the second likely time frame being between 7A.M. and noon. Within 2 weeks of discontinuing metformin, there were no further "attacks", and the chronic daytime fatigue and somnolence significantly improved. CONCLUSIONS This case report suggests that there is a risk of symptomatic hypoglycemia with therapeutic doses of metformin. Although advised to be taken with meals to avoid gastrointestinal upset, patients should also be educated to take metformin with meals to reduce the risk of metformin-associated hypoglycemia.


Assuntos
Diabetes Mellitus Tipo 2 , Hipoglicemia , Metformina , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Quimioterapia Combinada , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/efeitos adversos , Pessoa de Meia-Idade
10.
Diabetes Obes Metab ; 23(9): 2035-2047, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34009711

RESUMO

AIM: To examine clinical and safety outcomes associated with metformin use in patients with impaired renal function. MATERIALS AND METHODS: We searched PubMed and Embase databases from inception to August 2020, supplementing our search with a review of investigator files and reference lists of included studies. Any study reporting original data on metformin and patient-centred outcomes in patients with impaired renal function, defined as an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m2 , was included. Post hoc meta-analysis was performed for the outcomes of mortality, cardiovascular events and acidosis. RESULTS: Nine small prospective studies enrolling patients with significantly impaired renal function identified only one case of clinically apparent lactic acidosis. Among 13 larger retrospective studies, seven examined the risk of mortality across patient subgroups; meta-analysis showed reductions in overall mortality at an eGFR of 45 mL/min/1.73m2 or higher but not at an eGFR of less than 45 mL/min/1.73m2 . Eight retrospective studies evaluated acidosis as an outcome; meta-analysis showed no increase in risk of acidosis except at an eGFR of less than 30 mL/min/1.73m2 , in which group the HR was 1.97 (95% CI 1.03-3.77). CONCLUSIONS: The literature shows metformin to be associated with reduced mortality and no increased risk of acidosis at an eGFR of 45 mL/min/1.73m2 or higher. Metformin appears to be associated with fewer benefits and possible increases in the risk of acidosis at an eGFR of less than 30 mL/min/1.73m2 . Consistent with US Food and Drug Administration guidelines, metformin should not be used at an eGFR less than 30 mL/min/1.73m2 , and further research on its risk-benefit profile at eGFR values approaching 30 mL/min/1.73m2 is warranted.


Assuntos
Metformina , Insuficiência Renal Crônica , Taxa de Filtração Glomerular , Humanos , Rim/fisiologia , Metformina/efeitos adversos , Estudos Prospectivos , Estudos Retrospectivos
13.
Gynecol Obstet Invest ; 86(3): 218-230, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33979807

RESUMO

AIM: This systematic and meta-analysis was conducted to evaluate the efficacy and safety of insulin, metformin, and glyburide on perinatal complications for gestational diabetes mellitus (GDM). METHODS: Medline (PubMed), EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials [CENTRAL], and Cochrane Methodology Register), Web of Science (Science and Social Science Citation Index), and ClinicalTrials (Clinicaltrials.gov) were searched, as well as manual searching. We included randomized controlled trials comparing efficacy and safety of metformin versus glyburide, metformin versus insulin, and glyburide versus insulin in patients with GDM. RESULTS: We included 32 articles including 5,964 patients published from inception to July 2020. Compared with insulin, metformin was more effective at lower incidence of macrosomia (RR: 0.66, 95% CI: 0.50-0.88, p = 0.005), lower incidence of neonatal intensive care unit admission (RR: 0.78, 95% CI: 0.67-0.91, p = 0.002), less neonatal hypoglycemia (RR: 0.67, 95% CI: 0.56-0.80, p < 0.0001), decreased birth weight (BW) (SMD: -0.37, 95% CI: -0.62 to -0.12, p = 0.004), lower incidence of large for gestational age (RR: 0.76, 95% CI: 0.50-0.90, p = 0.002), shorter gestation age at delivery (MD: -0.22, 95% CI: -0.34 to -0.10, p = 0.0002), lower maternal weight gain (MD: -1.41, 95% CI: -2.28 to -0.55, p = 0.001), less incidence of caesarean section delivery (RR: 0.86, 95% CI: 0.78-0.95, p = 0.0004), lower maternal postprandial blood glucose (SMD: -0.41, 95% CI: -0.72 to -0.11, p = 0.008), and lower incidence of pregnancy-induced hypertension (RR: 0.47, 95% CI: 0.27-0.83, p = 0.01). However, glyburide, compared with insulin, was associated with higher BW (MD: 54.95, 95% CI: 3.87-106.03, p = 0.03) and increased the incidence of neonatal hypoglycemia (RR: 1.52, 95% CI: 1.12-2.07, p = 0.007). Meanwhile, compared to glyburide, metformin was associated with higher maternal fasting blood glucose (SMD: 0.20, 95% CI: 0.05-0.36, p = 0.01) and lower incidence of induction of labor (RR: 0.76, 95% CI: 0.59-0.97, p = 0.03). CONCLUSIONS: This review suggests that metformin can decrease the incidence of perinatal complications, and it should be considered as a generally safe alternative to insulin.


Assuntos
Diabetes Gestacional , Metformina , Cesárea , Diabetes Gestacional/tratamento farmacológico , Diabetes Gestacional/epidemiologia , Feminino , Glibureto/efeitos adversos , Humanos , Hipoglicemiantes/efeitos adversos , Recém-Nascido , Insulina , Metformina/efeitos adversos , Gravidez
15.
Bratisl Lek Listy ; 122(5): 305-309, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33848178

RESUMO

BACKGROUND: Diabetes mellitus (DM) and malignancy are recognized among the most common complications increasing mortality in patients after heart transplantation (HTx). Clinical trials have shown a higher risk for different types of tumours in diabetic patients. This risk is potentiated by immunosuppressive therapy in transplant patients. Biguanide metformin has been shown to exhibit anti-tumour activity and we tried to find out whether this effect is valid for heart transplant patients. METHODS: We retrospectively analysed a group of 497 patients, who undergone HTx in our centre between 1998 and 2019. The primary outcome was any malignancy during the 15-year follow-up period and patient's survival. RESULTS: Out of the 497 patients enrolled in the study, 279 (56 %) had diabetes and 52 (19 %) were treated with metformin. Fifteen-year survival in treated patients without malignancy was 93 %, the remainder for the DM patients was 56 %, with survival in non-DM patients being 74 %. Untreated diabetic patients had 4.7 times higher chance of malignancy than those on metformin (p = 0.01). Fifteen-year survival in metformin treated patients was 53 %, in other DM patients 44 %, and in non-DM patients 51 %. CONCLUSION: Our study showed a significantly lower incidence of malignancies in metformin-treated patients and slightly better overall survival (Tab. 2, Fig. 3, Ref. 19) Keywords: biguanide, heart graft, malignancy, diabetes mellitus, survival.


Assuntos
Transplante de Coração , Metformina , Neoplasias , Transplante de Coração/efeitos adversos , Humanos , Hipoglicemiantes/efeitos adversos , Metformina/efeitos adversos , Neoplasias/epidemiologia , Estudos Retrospectivos
16.
Expert Opin Drug Metab Toxicol ; 17(6): 725-731, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33899649

RESUMO

BACKGROUND: Dipeptidyl peptidase-4 (DPP-4) inhibitors have significant clinical efficacy for type 2 diabetes mellitus (T2DM). The combination of fotagliptin (FOT) with metformin (MET) is a promising therapeutic approach in MET-resistant patients. The aim of the present study was to evaluate the pharmacokinetic (PK) interaction between FOT and MET in healthy subjects after multiple-dose administration. METHODS: Eighteen participants received a randomized open-label, three period treatment that included MET 1000 mg alone, co-administration of FOT 24 mg and MET, followed by FOT 24 mg alone. Serial blood samples were collected for PK analysis, which included geometric mean ratios (GMRs) with 90% confidence intervals (CIs), area under the concentration-time curve (AUC), and maximum plasma concentration (Cmax). RESULTS: Analysis results showed that for FOT alone or combination therapy, the 90% CIs of the GMR for AUC0-24,ss and Cmax,ss were 102.08% (98.9%, 105.36%) and 110.65% (102.19%, 119.82%), respectively. For MET, they were 113.41% (100.32%, 128.22%) and 97.11% (83.80%, 112.55%) for AUC0-12,ss and Cmax,ss, respectively. FOT or MET monotherapy and the combination therapy with both drugs were well tolerated. CONCLUSIONS: No PK drug-drug interactions were found in the combination therapy with FOT and MET. Therefore, FOT can be co-administered with MET without dose adjustment. TRIAL REGISTRATION: The trial is registered at http://www.chinadrugtrials.org.cn/(Registration No. CTR20190221).


Assuntos
Inibidores da Dipeptidil Peptidase IV/farmacocinética , Hipoglicemiantes/farmacocinética , Metformina/farmacocinética , Piperidinas/farmacocinética , Triazinas/farmacocinética , Adolescente , Adulto , Área Sob a Curva , Inibidores da Dipeptidil Peptidase IV/administração & dosagem , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Interações Medicamentosas , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Masculino , Metformina/administração & dosagem , Metformina/efeitos adversos , Pessoa de Meia-Idade , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Triazinas/administração & dosagem , Triazinas/efeitos adversos , Adulto Jovem
17.
Femina ; 49(4): 251-256, 20210430.
Artigo em Português | LILACS | ID: biblio-1224096

RESUMO

O diabetes mellitus gestacional (DMG) é uma complicação que atinge o metabolismo da gestante, resultando em intolerância à glicose e consequente hiperglicemia, originada pela insuficiência de insulina materna. Este estudo tem como objetivo identificar os tratamentos disponíveis e mais utilizados para o DMG. Trata-se de um uma revisão de literatura, feita a partir de 22 referências, acerca dos tratamentos para o DMG. As bases de dados escolhidas foram Google Acadêmico, UpToDate, SciELO e o acervo da Universidade do Planalto Catarinense. Estudos apontam a insulina humana ­ NPH e regular ­ como a principal escolha, quando comparada aos seus análogos, apesar de ainda existirem muitas controvérsias quanto ao início do tratamento, o esquema terapêutico e os ajustes das doses. Pesquisas têm demonstrado bons resultados sobre a eficácia e a segurança dos hipoglicemiantes orais ­ gliburida e metformina ­ no tratamento de gestantes diabéticas, mas é evidente a necessidade de mais estudos para confirmar a efetividade deles e garantir um bom desenvolvimento do concepto. Concluiu-se que o controle dietético e o exercício físico são a primeira opção de tratamento para o DMG. Todavia, caso a euglicemia não seja atingida, opta-se pelo tratamento medicamentoso por meio da insulinoterapia ou hipoglicemiantes orais, o que possibilita a redução da incidência dos efeitos adversos ao binômio materno-fetal.(AU)


Gestational diabetes mellitus (DMG) is a complication that affects the pregnant woman's metabolism, resulting in glucose intolerance and consequent hyperglycemia, caused by insufficient maternal insulin. This study aims to identify the available and most used treatments for DMG. This is a literature review, based on 22 references, about treatments for Gestational Diabetes; the databases chosen were Google Scholar, UpToDate, SciELO and the collection of the Universidade do Planalto Catarinense. Studies point to human insulin ­ NPH and regular ­ as the main choice when compared to its analogues, although there are still many controversies about the beginning of treatment, therapeutic scheme and dose adjustments. Researches have shown good results on the efficacy and safety of oral hypoglycemic agents ­ glyburide and metformin ­ in the treatment of diabetic pregnant women, but it is evident the need for further studies to confirm their effectiveness and to guarantee a good development of the fetus. It was concluded that dietary control and physical exercise are the first treatment option for DGM. However, if euglycemia is not achieved, drug treatment is chosen through insulin therapy or oral hypoglycemic agents, which makes it possible to reduce the incidence of adverse effects to the maternal-fetal binomial.(AU)


Assuntos
Humanos , Feminino , Gravidez , Diabetes Gestacional/dietoterapia , Diabetes Gestacional/tratamento farmacológico , Diabetes Gestacional/terapia , Diabetes Mellitus/tratamento farmacológico , Exercício Físico , Bases de Dados Bibliográficas , Glibureto/efeitos adversos , Glibureto/uso terapêutico , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Insulina/uso terapêutico , Metformina/efeitos adversos , Metformina/uso terapêutico
18.
J Drugs Dermatol ; 20(3): 302-306, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33683076

RESUMO

BACKGROUND: Hirsutism is estimated to affect 10% to 20% of females, provoking significant psychological damage and social embarrassment. Polycystic ovary syndrome is a major cause of hirsutism. AIM: Assessing the impact of adding combined oral contraceptives (COCs) or metformin to laser hair removal on the quality of life of polycystic ovarian syndrome (PCOS) patients with hirsutism. METHODOLOGY: One-hundred-fifty PCO patients diagnosed with hirsutism were included in this study. Patients were randomized into three groups: group 1 received laser hair removal alone, group 2 received metformin and laser hair removal, and group 3 received COCs and laser hair removal. A diode laser with a wavelength of 810 nm was used for hair removal in all patients according to a protocol of 6 monthly sessions followed by another two sessions after three and six months. Patients were assessed using a visual analog scale (VAS) and Dermatology Life Quality Index (DLQI) and a customized questionnaire (Hirsutism Life Quality Index; HLQI). RESULTS: All patients showed a significant improvement in both quality indices (DLQI and HLQI) after treatment relative to pretreatment. Group 3 showed significantly better improvements when compared with group 2 and group 1. At three and six months, group 3 showed non-significantly better DLQI and HLQI as compared with at zero months. On the other hand, group 2 patients displayed significant worsening of both DLQI and HLQI scores at three months, with subsequent improvements again at six. Finally, group 1 patients showed nonsignificant worsening at three months, and significant worsening at 6 months. CONCLUSION: Combining hormonal treatment with laser hair removal can achieve greater hair reduction, significant improvements in patients' QOL, and better maintenance as compared with when combining metformin with laser hair removal or conducting alone. J Drugs Dermatol. 2021;20(3):302-306. doi:10.36849/JDD.5652.


Assuntos
Anticoncepcionais Orais Combinados/administração & dosagem , Remoção de Cabelo/métodos , Hirsutismo/terapia , Lasers Semicondutores/uso terapêutico , Metformina/administração & dosagem , Síndrome do Ovário Policístico/complicações , Administração Oral , Adolescente , Adulto , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Anticoncepcionais Orais Combinados/efeitos adversos , Feminino , Seguimentos , Remoção de Cabelo/efeitos adversos , Hirsutismo/etiologia , Hirsutismo/psicologia , Humanos , Metformina/efeitos adversos , Síndrome do Ovário Policístico/terapia , Qualidade de Vida , Resultado do Tratamento , Adulto Jovem
20.
Cochrane Database Syst Rev ; 3: CD012650, 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33765343

RESUMO

BACKGROUND: Clinicians primarily recommend weight loss for obese women seeking pregnancy. The effectiveness of interventions aimed at weight loss in obese women with subfertility is unclear. OBJECTIVES: To assess the effectiveness and safety of pharmacological and non-pharmacological strategies compared with each other, placebo, or no treatment for achieving weight loss in obese women with subfertility. SEARCH METHODS: We searched the CGF Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED from inception to 18 August 2020. We also checked reference lists and contacted experts in the field for additional relevant papers. SELECTION CRITERIA: We included published and unpublished randomised controlled trials in which weight loss was the main goal of the intervention. Our primary effectiveness outcomes were live birth or ongoing pregnancy and primary safety outcomes were miscarriage and adverse events. Secondary outcomes included clinical pregnancy, weight change, quality of life, and mental health outcome. DATA COLLECTION AND ANALYSIS: Review authors followed standard Cochrane methodology. MAIN RESULTS: This review includes 10 trials. Evidence was of very low to low quality: the main limitations were due to lack of studies and poor reporting of study methods. The main reasons for downgrading evidence were lack of details by which to judge risk of bias (randomisation and allocation concealment), lack of blinding, and imprecision. Non-pharmacological intervention versus no intervention or placebo Evidence is insufficient to determine whether a diet or lifestyle intervention compared to no intervention affects live birth (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.65 to 1.11; 918 women, 3 studies; I² = 78%; low-quality evidence). This suggests that if the chance of live birth following no intervention is assumed to be 43%, the chance following diet or lifestyle changes would be 33% to 46%. We are uncertain if lifestyle change compared with no intervention affects miscarriage rate (OR 1.54, 95% CI 0.99 to 2.39; 917 women, 3 studies; I² = 0%; very low-quality evidence). Evidence is insufficient to determine whether lifestyle change compared with no intervention affects clinical pregnancy (OR 1.06, 95% CI 0.81 to 1.40; 917 women, 3 studies; I² = 73%; low-quality evidence). Lifestyle intervention resulted in a decrease in body mass index (BMI), but data were not pooled due to heterogeneity in effect (mean difference (MD) -3.70, 95% CI -4.10 to -3.30; 305 women, 1 study; low-quality evidence; and MD -1.80, 95% CI -2.67 to -0.93; 43 women, 1 study; very low-quality evidence). Non-pharmacological versus non-pharmacological intervention We are uncertain whether intensive weight loss interventions compared to standard care nutrition counselling affects live birth (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), clinical pregnancy (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), BMI (MD -3.00, 95% CI -5.37 to -0.63; 11 women, 1 study; very low-quality evidence), weight change (MD -9.00, 95% CI -15.50 to -2.50; 11 women, 1 study; very low-quality evidence), quality of life (MD 0.06, 95% CI -0.03 to 0.15; 11 women, 1 study; very low-quality evidence), or mental health (MD -7.00, 95% CI -13.92 to -0.08; 11 women, 1 study; very low-quality evidence). No study reported on adverse events . Pharmacological versus pharmacological intervention For metformin plus liraglutide compared to metformin we are uncertain of an effect on the adverse events nausea (OR 7.22, 95% CI 0.72 to 72.7; 28 women, 1 study; very low-quality evidence), diarrhoea (OR 0.31, 95% CI 0.01 to 8.3; 28 women, 1 study; very low-quality evidence), and headache (OR 5.80, 95% CI 0.25 to 133; 28 women, 1 study; very low-quality evidence). We are uncertain if a combination of metformin plus liraglutide vs metformin affects BMI (MD 2.1, 95% CI -0.42 to 2.62; 28 women, 1 study; very low-quality evidence) and total body fat (MD -0.50, 95% CI -4.65 to 3.65; 28 women, 1 study; very low-quality evidence). For metformin, clomiphene, and L-carnitine versus metformin, clomiphene, and placebo, we are uncertain of an effect on miscarriage (OR 3.58, 95% CI 0.73 to 17.55; 274 women, 1 study; very low-quality evidence), clinical pregnancy (OR 5.56, 95% CI 2.57 to 12.02; 274 women, 1 study; very low-quality evidence) or BMI (MD -0.3, 95% CI 1.17 to 0.57, 274 women, 1 study, very low-quality evidence). We are uncertain if dexfenfluramine versus placebo affects weight loss in kilograms (MD -0.10, 95% CI -2.77 to 2.57; 21 women, 1 study; very low-quality evidence). No study reported on live birth, quality of life, or mental health outcomes. Pharmacological intervention versus no intervention or placebo We are uncertain if metformin compared with placebo affects live birth (OR 1.57, 95% CI 0.44 to 5.57; 65 women, 1 study; very low-quality evidence). This suggests that if the chance of live birth following placebo is assumed to be 15%, the chance following metformin would be 7% to 50%. We are uncertain if metformin compared with placebo affects gastrointestinal adverse events (OR 0.91, 95% CI 0.32 to 2.57; 65 women, 1 study; very low-quality evidence) or miscarriage (OR 0.50, 95% CI 0.04 to 5.80; 65 women, 1 study; very low-quality evidence) or clinical pregnancy (OR 2.67, 95% CI 0.90 to 7.93; 96 women, 2 studies; I² = 48%; very low-quality evidence). We are also uncertain if diet combined with metformin versus diet and placebo affects BMI (MD -0.30, 95% CI -2.16 to 1.56; 143 women, 1 study; very low-quality evidence) or waist-to-hip ratio (WHR) (MD 2.00, 95% CI -2.21 to 6.21; 143 women, 1 study; very low-quality evidence). Pharmacological versus non-pharmacological intervention No study undertook this comparison. AUTHORS' CONCLUSIONS: Evidence is insufficient to support the use of pharmacological and non-pharmacological strategies for obese women with subfertility. No data are available for the comparison of pharmacological versus non-pharmacological strategies. We are uncertain whether pharmacological or non-pharmacological strategies effect live birth, ongoing pregnancy, adverse events, clinical pregnancy, quality of life, or mental heath outcomes. However, for obese women with subfertility, a lifestyle intervention may reduce BMI. Future studies should compare a combination of pharmacological and lifestyle interventions for obese women with subfertility.


Assuntos
Infertilidade Feminina/terapia , Nascido Vivo/epidemiologia , Obesidade/terapia , Perda de Peso , Aborto Espontâneo/epidemiologia , Depressores do Apetite/uso terapêutico , Viés , Carnitina/uso terapêutico , Clomifeno/uso terapêutico , Dexfenfluramina/uso terapêutico , Quimioterapia Combinada/métodos , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/uso terapêutico , Infertilidade Feminina/dietoterapia , Estilo de Vida , Liraglutida/efeitos adversos , Liraglutida/uso terapêutico , Saúde Mental , Metformina/efeitos adversos , Metformina/uso terapêutico , Obesidade/dietoterapia , Gravidez , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
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