An observational study of pregnancy and post-partum outcomes in women with prolactinoma treated with dopamine agonists.

BACKGROUND: In women with prolactinoma medical treatment with dopamine agonists (DA) can restore fertility. A number of studies have established the safety of DA during pregnancy and the impact of pregnancy and lactation on remission of prolactinoma. However, the total number of reported cases remains modest and further evidence is needed. AIMS: To evaluate the safety of DA during pregnancy and remission of prolactinoma after pregnancy and lactation. MATERIALS AND METHODS: Retrospective cohort study (2002-2014) of 57 pregnancies in 47 women with prolactinoma who received DA. Neonatal and pregnancy complications were recorded. Prolactin levels and treatment data were collected at the time of diagnosis, pre-conception, during pregnancy and lactation, and post-partum (up to 114 months). RESULTS: DA treatment was stopped a median of 4.5 weeks after conception in 49 pregnancies (86%). There were 49 live births (86% of pregnancies) and six miscarriages. Six pregnancies had an adverse neonatal outcome including two with congenital malformations. Following 26% of pregnancies women achieved remission after birth or lactation, and 25% of women were in remission at last follow-up. Remission was associated with older maternal age (P = 0.036), a lower prolactin level at diagnosis (P = 0.037), and a smaller adenoma at diagnosis (P = 0.045). CONCLUSIONS: Successful pregnancy and lactation is common after DA treatment for prolactinoma. Fetal exposure in the first four weeks of pregnancy appears to be generally safe. Encouragingly, post-partum and after lactation a quarter of women had a normal prolactin level without medical treatment.

The use of dextrose/insulin infusions during labour and delivery in women with gestational diabetes mellitus: Is there any point?

We compared, in 733 women with gestational diabetes mellitus treated with metformin and/or insulin, rates of neonatal hypoglycaemia in those who had received a dextrose/insulin infusion during labour and prior to delivery (n = 132) with those who did not (n = 601). Women who had infusions were more likely to have been treated with insulin (87.1% vs 70.4%, P < 0.01) and have higher mean capillary glucose values (measured four times daily) in the two weeks prior to delivery (P < 0.01). They had lower mean (SD) glucose values in the 12 h prior to delivery (5.1 (1.1) mmol/L vs 5.4 (0.9) mmol/L, P < 0.01). There was no difference between the groups in rates of neonatal hypoglycaemia (glucose <2.6 mmol/L on two or more occasions), 15.9% versus 17.8%, P = 0.78, or of severe neonatal hypoglycaemia (one or more glucose <1.6 mmol/L), 8.3% versus 5.2%, P = 0.15. In the absence of randomised data comparing use of infusions with no infusions, these data are reassuring for clinicians who do not routinely use infusions.

Association of HIV, cardiovascular risk factors, and carotid intimal media thickness: A cross-sectional study in Western Kenya.

The carotid intimal media thickness (CIMT) is a validated measure of subclinical atherosclerosis. Human immunodeficiency virus (HIV) is a risk factor for cardiovascular disease (CVD) and has been associated with CIMT in North America and Europe; however, there are limited data from Sub-Saharan Africa (SSA). In this cross-sectional study, we measured CIMT in a cohort of 262 people living with HIV (PLHIV) on antiretroviral therapy (ART) for ≥6 months and HIV-negative adults in western Kenya. Using linear regression, we examined the associations between CVD risk factors and CIMT, both overall and stratified according to the HIV status. Among the PLHIV, we examined the association between CIMT and HIV-related factors. Of 262 participants, approximately half were women. The HIV-negative group had a higher prevalence of age ≥55 years (P = .002), previously diagnosed hypertension (P = .02), treatment for hypertension (P = .03), and elevated blood pressure (BP) (P = .01). Overall prevalence of carotid plaques was low (15/262 [6.0%]). HIV-positive status was not significantly associated with a greater mean CIMT (P = .19). In multivariable regression models, PLHIV with elevated blood pressure or treatment for hypertension had a greater mean CIMT (P = .002). However, the CD4 count, viral load, and ART regimen were not associated with differences in CIMT. In the HIV-negative group, older age (P = .006), high total cholesterol levels (P = .01), and diabetes (P = .02) were associated with a greater mean CIMT. In this cross-sectional study of Kenyan adults, traditional CVD risk factors were found to be more prevalent among HIV-negative participants. After multivariable regression analysis, we found no association between HIV status and CIMT, and PLHIV had fewer CVD risk factors associated with CIMT than HIV-negative participants did. HIV-specific factors were not associated with the CIMT.

Acceptability of the oral hormonal male contraceptive prototype, 11ß-methyl-19-nortestosterone dodecylcarbonate (11ß-MNTDC), in a 28-day placebo-controlled trial.

OBJECTIVE: To determine men's satisfaction with and the potential acceptability of 11ß-methyl-19-nortestosterone dodecylcarbonate (11ß-MNTDC) when used for 28 days as an experimental, once-daily, oral hormonal male contraceptive (HMC). STUDY DESIGN: We surveyed participants from a double-blind, randomized, placebo-controlled, phase 1 clinical trial, examining their experience with and willingness to use daily oral 11ß-MNTDC for male contraception. RESULTS: Of 42 trial participants, 40 (30 11ß-MNTDC, 10 placebo) completed baseline and end-of-treatment surveys. Based on a 28-day experience, few cited any baseline concerns about safety and drug adherence. Following treatment, nearly three-quarters (72.5%) of participants reported satisfaction with the study drug and nearly all (92.5%) would recommend the method to others. More than half of participants would be willing to pay for the study drug (62.5%) and indicated that the method exceeded initial expectations (53.9%). Nearly 90% reported that taking the pill was easy to remember and did not interfere with their daily routines. Approximately one-third of participants reported bothersome side effects (37% 11ß-MNTDC vs. 20% placebo, p = 0.45). Given the option, 42% of participants would prefer a daily HMC pill over injectable regimens or a daily topical gel. CONCLUSION: A majority of participants in this short-term trial of daily oral 11ß-MNTDC reported satisfaction with the regimen, would recommend it to others, and would pay to use the drug as HMC despite some bothersome side effects. IMPLICATIONS: Oral 11ß-MNTDC would be an acceptable and preferable method among men desiring reversible hormonal male contraception (HMC). These data support further trials of novel oral HMCs such as 11ß-MNTDC.

Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype.

OBJECTIVE: To determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days. STUDY DESIGN: After a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception. RESULTS: Fifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal. CONCLUSION: Most participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability. IMPLICATIONS: Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.

Ambulatory vs office blood pressure monitoring in renal transplant recipients.

Hypertension is common following renal transplantation and has adverse effects on cardiovascular and graft health. Ambulatory blood pressure monitoring (ABPM) is better at overall blood pressure (BP) assessment and is necessary to diagnose nocturnal hypertension, which is also implicated in poor outcomes. The authors performed a retrospective analysis of 98 renal transplant recipients (RTRs) and compared office BP and ambulatory BP recordings. ABPM revealed discordance between office BP and ambulatory BP in 61% of patients, with 3% caused by white-coat and 58% caused by masked hypertension (of which 33% were caused by isolated nocturnal hypertension). Overall, mean systolic BP was 3.6 mm Hg (0.5-6.5) and diastolic BP was 7.5 mm Hg (5.7-9.3) higher via ambulatory BP than office BP. This was independent of estimated glomerular filtration rate, proteinuria, transplant time/type, and comorbidities. A total of 42% of patients had their management changed after results from ABPM. ABPM should be routinely offered as part of hypertension management in RTRs.