Risk Of Genital Tract Infection Research Articles

Comparative Safety Analysis of Empagliflozin in Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease versus Normal Kidney Function: A Nationwide Cohort Study in Korea.

Empagliflozin has been shown to reduce cardiovascular morbidity and mortality in patients with type 2 diabetes. Various research on its efficacy in patients with chronic kidney disease (CKD) have been actively conducted. So far, few studies have investigated the safety of these adverse effects specifically in Asians with CKD. We aim to address these safety concerns on a patient population of Asian CKD patients using real-world data. We conducted a retrospective cohort study using health insurance data from the Korean Health Insurance Review & Assessment Service and compared safety outcomes between empagliflozin and sitagliptin in 26,347 CKD patients diagnosed with diabetes. Adverse outcomes, including major adverse cardiac events (MACEs), all-cause mortality, myocardial infarction (MI), stroke, and hospitalization for heart failure (HHF), among others, were assessed. Among a 1:1 matched cohort (6170 on empagliflozin, 6170 on sitagliptin), empagliflozin was associated with a significant reduction in MACEs, all-cause mortality, MI, hospitalization for unstable angina, coronary revascularization, HHF, hypoglycemic events, and urinary tract infections, but increased the risk of genital tract infections. No significant changes were observed for transient ischemic attack, acute kidney injury, volume depletion, diabetic ketoacidosis, thromboembolic events, and fractures. The usage of empagliflozin in diabetic CKD patients shows a significant reduction in many adverse outcomes compared to sitagliptin, but with an increased risk of genital tract infections. These findings provide evidence for future clinical decision-making around the use of empagliflozin in Asian CKD patients.

Safety of sodium-glucose cotransporter 2 inhibitors in elderly patients with type 2 diabetes: A meta-analysis of randomized controlled trials.

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) are particularly effective in preventing adverse outcomes of heart failure and chronic kidney disease, which are highly prevalent in the elderly. Here, we aimed to access the safety of SGLT2i in elderly patients with type 2 diabetes. We performed a meta-analysis of randomized controlled trials (RCTs) reporting safety outcomes of the elderly (≥65 years) patients with type 2 diabetes, randomized to an SGLT2i or placebo. We recorded the incidence of acute kidney injury, volume depletion, genital tract infections, urinary tract infections, bone fractures, amputations, diabetic ketoacidosis, hypoglycaemia and drug discontinuation, by group of treatment. Of the 130 RCTs screened, only six reported data on elderly patients. In total, 19 986 patients were included. The SGLT2i discontinuation rate was approximately 20%. The risk of acute kidney injury was significantly lower among SGLT2i users compared with placebo [risk ratio (RR) 0.73; 95% CI 0.62-0.87]. SGLT2i were associated with a six-fold increased risk of genital tract infections (RR 6.55; 95% CI 2.09-20.5). The rate of amputations was increased only among canagliflozin users (RR 1.94, 95% CI 1.25-3). The risk of fractures, urinary tract infection, volume depletion, hypoglycaemia and diabetic ketoacidosis was similar between SGLT2i and placebo. SGLT2is were well tolerated in the elderly. However, older patients are underrepresented in most RCTs and a call for action is need to favour clinical trials reporting safety outcomes stratified by age.

P-439 Intimate hygiene practices and the correlation with abnormal vaginal microbiota in in vitro fertilization (IVF) patients – a cohort study in 1421 patients

Abstract Study question What are the intimate hygiene practices of women in IVF treatment and do they correlate with the vaginal microbiota? Summary answer Hygiene practices, in specific douching and use of intimate soap significantly increased the risk of abnormal vaginal microbiota (AVM). What is known already The normal vaginal microbiota acts as a defense system against infection. AVM is a molecularly defined vaginal dysbiosis, resembling bacterial vaginosis (BV) and is dominated by anaerobic bacteria such as Gardnerella vaginalis. Importantly, AVM is associated with an increased risk of genital tract infections, poor IVF outcomes, early miscarriage and preterm labor. The cause of AVM is multifactorial and hygiene practices may interrupt the normal microbiota. Previous small studies suggested vaginal douching to be associated with an increased risk of AVM. Few studies have investigated the possible correlation between intimate hygiene practices, menstrual practices and the vaginal microbiota. Study design, size, duration Observational cohort study, including a total of 1421 IVF patients from four Danish fertility centers. The inclusion period was from 2017 to January 2022. Participants/materials, setting, methods Patients aged 18-42 years and undergoing their first, second or third IVF stimulation cycle were eligible for inclusion. The intimate hygiene practices in terms of type of soap, menstrual protection, douching and probiotics, were reported in a structured questionnaire including a total of 40 questions. Vaginal swabs were obtained prior to ovarian stimulation and subsequently subjected to quantitative PCR testing, targeting DNA of dysbiotic bacteria. Main results and the role of chance AVM was present in a total of 34 % (479/1421) of women, and 20% (272/1384) reported vaginal douching, which significantly correlated with AVM (p < 0.01, OR = 1.62 [1.23-2.12]). Intimate soap was used by 39 % (535/1384) of patients, which also significantly increased the risk of AVM ( P = 0.04, OR = 1.35 [1.08-1.69]). Water only was used by 36% (492/1384), and regular soap was used by 27% (374/1384). No correlation between use of water only and regular soap and AVM was detected. For menstrual protection 40% (433/1078) used pads, followed by tampons alone 25% (265/1078) or a combination 21% (230/1078), and 14 % (148/1078) used a menstrual cup. A trend for an increased risk of AVM when using tampons, OR 1.21 [0.91-1.62] was seen whereas use of a menstrual cup seemed to lower the risk of AVM, OR 0.71 [0.48-1.04] Active smoking, higher BMI, drinking >7 units per week and previous chlamydia infection significantly correlated with AVM (p = 0.01, p = 0.01, p = 0.04 and p = 0.01). Finally, 84% (1190/1421) reported gynecological symptoms such as vaginal discharge, dyspareunia and fungal infection, but only fishy odor significantly correlated with AVM (p < 0.01). Limitations, reasons for caution To the best of our knowledge, this is the largest study investigating the intimate hygiene practice and its correlation with AVM in an IVF population. As these results describe the practices of a Scandinavian IVF population, results may differ from other settings and ethnicities. Wider implications of the findings Exploration of the cause-and-effect relations between intimate hygiene practices and AVM is needed, requiring intervention-based prospective studies. This would lead to evidence-based advice on intimate hygiene practices and AVM prevention, possibly increasing live birth rates. The unexpected high prevalence of douching in a Danish IVF population needs further exploration. Trial registration number NCT03420859

Five comparative cohorts to assess the risk of genital tract infections associated with sodium-glucose cotransporter-2 inhibitors initiation in type 2 diabetes mellitus.

AimTo assess the association between SGLT‐2 inhibitors initiation and genital tract infections (GTIs) among patients with type 2 diabetes.MethodsA population‐based cohort study using administrative healthcare data from Alberta, Canada, and primary care data from the UK’s Clinical Practice Research Datalink (CPRD). Among new metformin users, we identified new users of SGLT‐2 inhibitors and five active comparator cohorts (new users of dipeptidyl peptidase‐4 (DPP‐4) inhibitors, sulfonylureas (SU), glucagon‐like peptide‐1 receptor agonists (GLP‐1 RA), thiazolidinediones (TZD) and insulin). The outcome of interest was a composite GTI outcome. In each cohort, we used high‐dimensional propensity score matching to adjust for confounding and conditional Cox proportional hazards regression to estimate the hazard ratios (HR). We used random‐effects meta‐analysis to combine aggregate data across databases.ResultsThe risk of GTI was higher for SGLT‐2 inhibitors users compared with DPP4inhibitor users (pooled HR 2.68, 95% CI 2.19 3.28), SU users (3.29, 2.62–4.13), GLP1‐RA users (2.51, 1.90–3.31), TZD users (4.17, 2.46–7.08) and insulin users (1.86, 1.27–2.73).ConclusionIn five comparative cohorts, SGLT‐2 inhibitors initiation is associated with a higher risk of GTIs. These findings from real‐world data are consistent with placebo‐controlled randomized controlled trials.

Prevalence of Genitourinary Infections with Sodium Glucose Co-transporter-2 (sglt2) inhibitors in patients with type 2 diabetes

Objectives: The present study was conducted to observe the prevalence of urine and genital infections by the SGLT-2 inhibitors patients with type 2 diabetes Methods: This multi centre cross sectional study was conducted on type 2 diabetic patients using two different SGLT-2 inhibitors dapagliflozin and empagliflozin either as monotherapy or combination therapy over a period of 03 months from 02-02-2020 to 02-05-2020. The risk of urinary and genital tract infection was assessed on the basis of structured questionnaire performa and medical records. Results: Out of 615, 296(48%) patients were using dapagliflozin and 319(52%) were using empagliflozin. Male to female ratio in both group were i.e dapagliflozin: 65 %( 192) and 35 %( 104) empagliflozin 72 %( 230) and 28 %( 89%) respectively. The risk of urinary infection in dapagliflozin group was 4.3% while it was 6.5% in and empagliflozin. On the other hand the risk of genital tract infection was 3% in dapagliflozin and 4.3% empagliflozin respectively. The prevalence of genital infection was more in female 6(67%) by dapagliflozin and 10(71%) by empagliflozin versus male 3(33%) by dapagliflozin and 4(29%) by empagliflozin respectively. Similarly the prevalence of urinary infection was more in female 8(62%) by dapagliflozin and 14(67%) by empagliflozin versus male 5(38%) by dapagliflozin and 7(33%) by empagliflozin respectively. A significant co relation was found between prevalence of genitourinary infection with female sex and uncontrolled diabetes with p.value 0.001 and 0.003 respectively. Conclusion: SGLT-2 inhibitors are not associated with increased of risk of genitourinary infection in diabetic patients. Keywords: SGLT-2 Inhibitors, Dapagliflozin, Empagliflozin, Genitourinary infection

Sodium\u2013glucose cotransporter 2 inhibitors as an add-on therapy to insulin for type 1 diabetes mellitus: Meta-analysis of randomized controlled trials

AimsThe aim was to systematically review the efficacy and safety of sodium–glucose cotransporter inhibitor (SGLT2i) as an adjunct to insulin at different follow-up durations in randomized, double-blind clinical trials in patients with type 1 diabetes.MethodsWe conducted a search on Medline, Embase, and the Cochrane Library for relevant studies published before May 2020. According to the duration of follow-up, the subgroup analysis included four periods: 1–4, 12–18, 24–26, and 52 weeks. In the five trials included both 24–26 and 52 weeks of follow-up, we compared the efficacy by the placebo-subtracted difference and changes in SGLT2i groups.ResultsFifteen trials including 7109 participants were analyzed. The combination of SGLT2i and insulin improved hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), daily insulin dose, body weight, and blood pressure, which varied greatly by different follow-ups. Compared with %HbA1c at 24–26 weeks, placebo-subtracted differences and changes in the SGLT2i groups slightly increased. SGLT2i plus insulin treatment showed no difference in the occurrence of urinary tract infections (UTIs), hypoglycemia, or severe hypoglycemia but increased the risk of genital tract infections (GTIs) in a duration-dependent manner. SGLT2i treatment was associated with a significantly higher rate of ketone-related SAEs and diabetic ketoacidosis (DKA) at 52 weeks.ConclusionSGLT2i as an add-on therapy to insulin improved glycemic control and body weight and decreased the required dose of insulin without increasing the risk of hypoglycemia. However, after 6 months the benefits of SGLT2is on glycemic control may weaken and the risks of GTIs and DKA increased.

Adverse events associated with sodium glucose co-transporter 2 inhibitors: an overview of quantitative systematic reviews.

Background:Multiple published quantitative systematic reviews have reported on adverse events associated with the use of sodium glucose co-transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes mellitus.Aims:To summarize and appraise the quality of evidence from quantitative systematic reviews assessing adverse events of SGLT-2 inhibitors.Methods:We searched PubMed, EMBASE and the Cochrane Library for quantitative systematic reviews assessing SGLT-2 inhibitor safety. Two reviewers extracted data and assessed methodological quality using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) tool. Main outcomes included pooled and single study point estimaates (in the absence of pooled estimates) with corresponding 95% confidence intervals (CIs) of SGLT-2 inhibitors versus placebo or active comparators for genitourinary infections, volume depletion, acute kidney injury, bone fractures, diabetic ketoacidosis, lower limb amputations, cancers, and other notable adverse events.Results:Out of 1289 citations screened, 47 reviews assessed SGLT-2 inhibitor safety, of which 35 were of low quality. Canagliflozin, dapagliflozin and empagliflozin were consistently associated with an increased risk of genital tract infections versus placebo (point estimates ranged from 2.5 to 9.8) and other antihyperglycemic agents (point estimates ranged from 2.7 to 12.0). Canagliflozin and dapagliflozin were associated with an increased risk of diabetic ketoacidosis. Canagliflozin was the only agent associated with an increased amputation risk; however, this was driven by results from a single trial program. Dapagliflozin was the only agent that exhibited a statistically significant increased risk of urinary tract infections. Empagliflozin was associated with a statistically significant increased risk of bladder cancer; however, this finding was susceptible to detection bias. None of the agents were associated with a statistically significant increased risk of acute kidney injury, or bone fractures compared to placebo or mixed (active or placebo) comparators. Upper 95% CI limits do not rule out clinically meaningful outcomes.Conclusion:The majority of quantitative systematic reviews reporting on adverse events of SGLT-2 inhibitors were of low methodological quality. Despite almost 50 quantitative systematic reviews published on the safety of SGLT-2 inhibitors, clinicians are still left uncertain of the risks of important adverse effects.Plain Language Summary SGLT-2 iInhibitor side effects: overview of reviews Many published systematic reviews have reported on side effects associated with the use of sodium glucose co-transporter 2 (SGLT-2) inhibitors in patients with type 2 diabetes. We aimed to summarize and appraise the quality of evidence from quantitative systematic reviews assessing side effects of SGLT-2 inhibitors. Using the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) tool, two authors extracted data and assessed the methods of included reviews. Main outcomes included reported pooled and single study point estimates for several SGLT-2 inhibitor side effects such as genital infections, bone fractures, lower limb amputations, increased blood acidity, among others. Of the reviews included in our study, 35 of the 47 reviews assessed were of low quality. Canagliflozin and dapagliflozin were associated with an increased risk of blood acidity in a 2020 review. Canagliflozin was the only agent associated with an increased amputation risk; however, this was driven by results from a single trial program. Dapagliflozin was the only agent that exhibited a significantly increased risk of urinary tract infections. Empagliflozin was associated with an increased risk of bladder cancer; however, this finding was susceptible to bias. None of the agents were associated with an increased risk of kidney injury or bone fractures.

Prospect of Sodium-Glucose Co-transporter 2 Inhibitors Combined With Insulin for the Treatment of Type 2 Diabetes.

Sodium–glucose co-transporter 2 (SGLT2) inhibitors are a new family of antidiabetic drugs that reduce blood glucose independent of insulin. In this review, we present the advantages and adverse effects of SGLT2 inhibitors plus insulin therapy as a treatment regimen for patients with type 2 diabetes (T2D). Compared with placebo, SGLT2 inhibitors plus insulin therapy could significantly decrease fasting blood glucose and HbA1c, thereby reducing the daily required dose of insulin. A reduction in body weight and improvements in insulin resistance and β-cell function have also been widely reported with this therapy, and other potential advantages, including the reduction in blood pressure, adverse cardiovascular outcomes, and visceral adipose tissue volume, have been revealed. SGLT2 inhibitors cause a greater reduction than dipeptidyl peptidase-4 (DPP-4) inhibitors in body weight and the risk of cardiovascular disease. Furthermore, compared with glucagon-like peptide-1 (GLP-1) agonists, SGLT2 inhibitors reduce blood pressure, and heart failure. As this therapy is an oral preparation, an improvement in patient compliance is also achieved. Despite these advantages, however, combination therapy with SGLT2 inhibitors and insulin has several risks. Although no difference has been found in the incidence of hypoglycemic events and urinary tract infection between the administration of this combination and that of placebo, the risk of genital tract infections was reported to increase with the combination therapy. Additionally, bone adverse effects, euglycemic diabetic ketoacidosis, and volume depletion—and osmotic diuresis—related adverse effects have been observed. Altogether, we could conclude that SGLT2 inhibitors plus insulin therapy is an efficient treatment option for patients with T2D, especially those requiring high daily insulin doses and those with insulin resistance, obesity, and a high risk of cardiovascular events. However, careful monitoring of the adverse effects of this combination is also warranted.

Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in East Asians with Type 2 Diabetes: A Systematic Review and Meta-Analysis.

IntroductionThe aim of this study was to assess the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors in East Asians with type 2 diabetes mellitus (T2DM).MethodsA literature search that focused primarily on the PubMed, Embase, and Cochrane library databases was performed. All randomized controlled trials (RCTs) which satisfied the inclusion and exculsion criteria were eligible to be included in the meta-analysis. Risk ratios (RRs) and weighted mean differences (WMDs) were used as statistical indicators for the analysis of dichotomous data and continuous outcomes, respectively. Pooled estimates were obtained using random-effects models in RevMan version 5.3.5.ResultsThirty-three RCTs (8496 randomized patients) fulfilled the eligibility criteria for inclusion in the meta-analysis. The meta-analysis showed that, compared with the control group, the use of SGLT2 inhibitors improved both glycated hemoglobin (HbA1c) in patients (WMD − 0.73%; 95% confidence interval [CI] − 0.84, − 0.61) and the percentage of patients with HbA1c < 7% (RR 2.33; 95% CI 1.74, 3.12); lowered both fasting plasma glucose (WMD − 28.47 mg/dl; 95% CI − 32.86, − 24.08) and postprandial glucose (WMD − 52.32 mg/dl; 95% CI − 67.67, − 39.96); reduced body weight (WMD − 1.73 kg; 95% CI − 2.28, − 1.17); and did not increase the risk of hypoglycemia (RR 1.27; 95% CI 0.89, 1.82) and urinary tract infections (RR 0.93; 95% CI 0.68, 1.27). However, SGLT2 inhibitors did increase the risk of genital tract infections (GTIs) (RR 1.73; 95% CI 1.02, 2.96). The stratified analysis showed that patients with higher HbA1c levels at baseline may achieve a greater improvement in HbA1c after taking SGLT2 inhibitors, while those with higher body weight or a longer history of diabetes may have an increased risk of developing GTIs.ConclusionCurrent research suggests that SGLT2 inhibitors have favorable efficacy and safety in East Asian patients with T2DM.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-019-0674-7) contains supplementary material, which is available to authorized users.

Practices of Menstrual Sanitary Care among Post Primary School Girls in Nigeria

&lt;p&gt;&lt;strong&gt;&lt;em&gt;Background:&lt;/em&gt;&lt;/strong&gt;&lt;em&gt; Adolescents at this tender age often may lack knowledge regarding standard menstrual care required to be free from the risk of genital tract infections. The study aimed to assess the menstrual sanitary care practices among adolescent girls in Nigeria to determine the unmet need. &lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Methods:&lt;/em&gt;&lt;/strong&gt;&lt;em&gt; The study was a cross?sectional survey conducted among adolescent girls in four secondary schools at Port Harcourt, from 1st March to 31&lt;sup&gt;st&lt;/sup&gt; August, 2018. Ethical approval was obtained from Rivers State Management School Board and State Ministry of Health.&lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;em&gt;Consent was obtained from all the participants. Data obtained were recorded on questionnaires and analyzed using SPSS version 18 Statistical Software and descriptive statistics was used for the analysis. &lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Results: &lt;/em&gt;&lt;/strong&gt;&lt;em&gt;During the study period (from March to August, 2018), 648 adolescent secondary school girls participated in the survey. The mean age ± SD at menarche was 12.8 ± 1.31., and the mean age of the respondents was 16.1 ± 1.34 years. Sanitary pads were the most used menstrual absorbent among the adolescents 455 (70%). Other menstrual absorbent used by the adolescents were Tissue paper, cotton wool and pieces of clothes (30%). Majority washed genital area twice daily with soap and water 474 (73%) and changed used sanitary absorbents twice daily. In disposing used sanitary material, 390 (60%) wrapped it and put in the dust bins.&lt;/em&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;&lt;em&gt;Conclusion: &lt;/em&gt;&lt;/strong&gt;&lt;em&gt;There was good menstrual sanitary care among the adolescent school girls. Sanitary pads were the most used menstrual absorbent.&lt;/em&gt;&lt;/p&gt;

Evidence-Based Consensus on Positioning of SGLT2i in Type 2 Diabetes Mellitus in Indians.

The current diabetes management strategies not only aim at controlling glycaemic parameters but also necessitate continuous medical care along with multifactorial risk reduction through a comprehensive management concept. The sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a group of evolving antidiabetic agents that have the potential to play a pivotal role in the comprehensive management of patients with diabetes due to their diverse beneficial effects. SGLT2i provide moderate glycaemic control, considerable body weight and blood pressure reduction, and thus have the ability to lower the risk of macrovascular and microvascular complications. Some of the unique characteristics associated with SGLT2i, such as reduction in body weight (more visceral fat mass loss than subcutaneous fat loss), reduction in insulin resistance and improvement in β-cell function, as measured by homeostatic model assessment-β (HOMA-β) could be potentially beneficial and help in overcoming some of the challenges faced by Indian patients with diabetes. In addition, a patient-centric approach with individualised treatment during SGLT2i therapy is inevitable in order to reduce diabetic complications and improve quality of life. Despite their broad benefits profile, the risk of genital tract infections, volume depletion, amputations and diabetic ketoacidosis associated with SGLT2i should be carefully monitored. In this compendium, we systematically reviewed the literature from Medline, Cochrane Library, and other relevant databases and attempted to provide evidence-based recommendations for the positioning of SGLT2i in the management of diabetes in the Indian population.Funding: AstraZeneca Pharma India Limited.

SGLT-2 inhibitors and the risk of infections: a systematic review and meta-analysis of randomized controlled trials.

There is concern about the infection-related safety profile of sodium-glucose co-transporter 2 (SGLT-2) inhibitors. We aimed to determine the effect of SGLT-2 inhibitors on genitourinary and other infections via systematic review and meta-analysis of randomized controlled trials (RCTs). We conducted a systematic search of Medline, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov to identify double-blinded RCTs enrolling ≥50 patients with type 2 diabetes which compared an SGLT-2 inhibitor to placebo or active comparator. Two independent reviewers extracted data and appraised study quality. Data were pooled using random-effects models. Eighty-six RCTs enrolling 50,880 patients were included. SGLT-2 inhibitors increased the risk of genital infections compared to placebo (relative risk [RR] 3.37, 95% CI 2.89-3.93, I2 0%) and active comparator (RR 3.89, 95% CI 3.14-4.82, I2 0.3%). The risk of urinary tract infection (UTI) was not increased with SGLT-2 inhibitors compared to placebo (RR 1.03, 95% CI 0.96-1.11, I2 0%) or active comparator (RR 1.08, 95% CI 0.93-1.25, I2 22%). In drug-specific analyses, only dapagliflozin 10mg daily was associated with a significantly increased risk of UTI compared to placebo (RR 1.33, 95% CI 1.10-1.61, I2 0%). SGLT-2 inhibitors were associated with a reduced risk of gastroenteritis (RR 0.38, 95% CI 0.20-0.72, I2 0%) but did not affect the risk of respiratory tract infections. SGLT-2 inhibitors are associated with an increased risk of genital tract infections. Although there is no association overall between SGLT-2 inhibitors and UTI, higher doses of dapagliflozin are associated with an increased risk.

Does interval laparoscopic sterilisation influence the risk of lower genital tract infections and menstrual abnormalities?

Background. Tubal sterilisation is a safe, accessible and effective contraceptive method. There is a paucity of data regarding the risk of genital tract infections and menstrual abnormalities post sterilisation in Durban, South Africa. Objectives . To evaluate the risk of lower genital tract infections (LGTIs) and menstrual abnormalities following interval laparoscopic sterilisation. Methods . A prospective cohort study of 225 women undergoing sterilisation between August 2012 and April 2013, with follow-up 1 year post procedure, was conducted at King Dinuzulu Hospital, Durban. Results. Following sterilisation, LGTIs were increased only in women with a history of infection pre sterilisation (odds ratio 6.7; 95% CI 2.2 - 20.9; p =0.002). There was no significant risk of HIV acquisition post sterilisation. In women who had not used contraception or used barrier methods pre sterilisation, we found no significant change in menstrual patterns post sterilisation. There was an increase in menstrual bleeding and dysmenorrhoea post sterilisation among previous combined oral contraceptive users. Among women with amenorrhoea on injectable contraception pre sterilisation, 73.8% reported return to regular menses and 26.2% reported abnormal uterine bleeding post sterilisation. Among injectable contraceptive users with regular menses pre sterilisation, 71.4% reported no change in menses post sterilisation and 28.6% reported abnormal uterine bleeding post sterilisation. Conclusion . In women undergoing interval tubal sterilisation, the risk of LGTIs was only increased in those women with a history. Menstrual abnormalities post sterilisation were more likely in women who used steroid contraception prior to sterilisation.

Safety and efficiency of SGLT2 inhibitor combining with insulin in subjects with diabetes: Systematic review and meta-analysis of randomized controlled trials.

Background:We aimed to assess the safety and efficiency of the novel sodium glucose co-transporter 2 (SGLT2) inhibitor in combinations with insulin for type 1 and type 2 diabetes mellitus (T1DM and T2DM).Methods:We searched Medline, Pubmed, Embase, and the Cochrane Collaboration Library from January 2010 to December 2016 without restriction of language. FDA data and Clinical Trials (http://www.clinicaltrials.gov) were also searched. Study selection, data extraction, and evaluation of risk of bias were performed by 2 persons independently. The risk of bias was assessed by Cochrance System Evaluate Method and Q test was used to evaluate the heterogeneity between studies. We used random effect model to analyze the results by Revman 5.3. This meta-analysis has been registered at online public registry PROSPERO (registration number is: CRD42017054718).Results:Nine trials including 3069 patients were analyzed. Compared with control group, SGLT2 inhibitor produced absolute reduction in glycosylated hemoglobin A1c (HbA1c) (MD −1.35%, 95% confidence interval [CI] [−2.36 to −0.34], P = .009), fasting plasma glucose (FPG) (MD −1.01 mmol/L, 95%CI [−1.98 to 0.04], P = .04), insulin dosage (MD −4.85 U/24 hours, 95%CI [−7.42 to −2.29], P = .002), and body weight (MD −2.30 kg, 95%CI [−3.09 to −1.50], P < .00001). But the risk of hypoglycemia (OR 1.18, 95%CI [0.86, 1.61], P = . 30) and urinary tract infection (UTI) (OR 1.34, 95%CI [0.79, 2.27], P = .28) were proved as no difference and genital tract infection (GTI) with SGLT2 inhibitors was higher than control group (OR 2.96, 95%CI [1.05, 8.37], P = .04), in which cases were mild and responded to the therapy. According to the subgroup analysis, SGLT2 inhibitors had a similar effect in effective factors of both T1DM and T2DM, but the risk of GTI mainly increased in T2DM versus T1DM (T1DM OR 0.27 [0.01, 7.19], P = .43 vs T2DM OR 4.28 [2.00, 9.16], P = .0002).Conclusion:SGLT2 inhibitors have improved the HbA1c, FPG, and body weight when combined with insulin and decreased the dose of insulin without increasing the risk of hypoglycemia. However, SGLT2 inhibitor was proved to be related to the events of GTI, despite SGLT2 inhibitors appeared to be well tolerated. We suggest that more monitoring should be done to prevent the events of GTI, and more randomized controlled trials should be planned next step.

Fungi and diabetes

Fungi and diabetes

O18.2 Injectable progestin contraception and acquisition of hsv-2 infection among south african women participating in the voice trial

Introduction Observational data suggest HIV-1 acquisition differs between users of two common injectable progestin-only contraceptives (IPC), depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN). Data are limited on the potential impact of both IPC types on herpes simplex virus type 2 (HSV-2) acquisition. Methods We conducted a secondary analysis among IPC users enrolled at South African sites in VOICE, a multi-centre randomised trial of topical and oral HIV-1 chemoprophylaxis. Contraceptive use assessment was conducted monthly. HSV-2 was diagnosed by Focus HerpeSelect EIA at enrollment and repeat EIA at study exit in all participants (seroconversion cutoff value ≥3.5); quarterly EIA was available for a subset to assess seroconversion timing. Using Cox proportional hazards regression, we assessed the association between IPC type and HSV-2 acquisition with adjustment for potential confounders (age, marriage/cohabitation, education, condom use, number of partners, VOICE study arm). Results Among 1776 IPC users who were HSV-2-seronegative at enrollment, 922 (51.9%) used DMPA, 716 (40.3%) used NET-EN, and 138 (7.8%) used both IPC types at different times during follow-up. Among the 1638 IPC users who did not switch IPC type during follow-up, 1506 (91.9%) had baseline and exit HSV-2 serology available. Over 1534.1 person-years (py) of follow-up, 178 incident HSV-2 cases occurred: 107 in DMPA users (crude incidence rate [IR] 11.3/100 py) and 71 in NET-EN users (crude IR 12.1/100 py). Among 640 participants with quarterly HSV-2 serology, 45 cases occurred among DMPA users over 350.4 py and 31 among NET-EN users over 231.1 py (HR = 0.97; 95% CI 0.61–1.53; aHR = 1.02; 95% CI 0.64–1.62). Conclusion HSV-2 risk did not differ by DMPA versus NET-EN use. These results are consistent with our findings that DMPA users in VOICE did not have higher risk of genital tract infection (gonorrhoea, chlamydia or trichomoniasis) compared to NET-EN users, despite having higher risk for HIV-1 infection. Disclosure of interest statement The authors report no conflicts of interest.

Efficacy and safety of antihyperglycaemic drug regimens added to metformin and sulphonylurea therapy in Type 2 diabetes: a network meta-analysis.

To assess the efficacy and safety of third-line adjuvant antihyperglycaemic agents in people with Type 2 diabetes mellitus failing metformin and sulphonylurea combination therapy. We searched MEDLINE, CENTRAL, clinicaltrials.gov and regulatory websites, and conducted a manual search of references in the identified studies. Randomized trials evaluating antihyperglycaemic agents in adults with Type 2 diabetes experiencing poor glycaemic control despite optimized metformin and sulphonylurea therapy (≥ 1500 mg metformin or maximum tolerated dose; ≥ 50% of maximum sulphonylurea dose for ≥ 3 weeks) were included. Data extraction included: study characteristics; change in HbA1c concentration; weight; systolic blood pressure; and relative risk of hypoglycaemia, urinary tract infections; and genital tract infections. A network meta-analysis was performed. A total of 20 trials evaluating 13 antihyperglycaemic agents were included. Compared with placebo/control, all antihyperglycaemic agents reduced HbA1c levels, albeit by differing magnitudes [range 7 mmol/mol (0.6%) for acarbose to 13 mmol/mol (1.20%) for liraglutide]. Sodium glucose cotransporter-2 inhibitors reduced weight (1.43-2.07 kg) whereas thiazolidinediones, glargine and sitagliptin caused weight gain (1.48-3.62 kg) compared with placebo/control. Sodium glucose cotransporter-2 inhibitors, rosiglitazone and liraglutide decreased systolic blood pressure compared with placebo/control, pioglitazone, glargine and sitagliptin (2.41-8.88 mm Hg). Glargine, thiazolidinediones, liraglutide, sitagliptin and canagliflozin increased hypoglycaemia risk compared with placebo/control (relative risk 1.92-7.47), while glargine and rosiglitazone increased hypoglycaemia compared with most antihyperglycaemic agents (relative risk 2.81-7.47). No antihyperglycaemic agent increased the risk of urinary tract infection, but canagliflozin increased the risk of genital tract infection by 3.9-fold compared with placebo/control. When added to metformin and a sulphonylurea, antihyperglycaemic agents had varying effects on efficacy and safety endpoints. These conclusions should be considered when clinicians choose between possible adjunctive agents.

Antibiotics Not Beneficial for IUD Insertion.

There is a small risk of introducing bacteria at the time of insertion of an intrauterine device (IUD); the risk of upper genital tract infection lasts