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  • August 15, 2018 9:38 AM | Anonymous

    August 15,2018, Healio 

    Women in labor receiving IV remifentanil patient-controlled analgesia were half as likely to need a subsequent epidural than those receiving intramuscular pethidine injection, which is the current standard of care, according to data published in The Lancet.

    “Previous studies have shown that at least one in three women given pethidine to manage pain during labor require a subsequent epidural as the drug is not always effective. It also has unwanted side effects such as sedation and nausea for the mother, and it may pass into the baby’s bloodstream through the placenta,” Matthew J.A. Wilson, MD, from the School of Health and Related Research at the University of Sheffield, England, said in a press release.

    Remifentanil may be an alternative to pethidine but is not widely used or researched, according to Wilson and colleagues. Therefore, the researchers conducted a trial to investigate whether IV remifentanil patient-controlled analgesia during labor reduces the need for epidural analgesia and subsequent adverse maternal or neonatal events compared with intramuscular pethidine injection.

    A total of 400 women aged 16 years or older, beyond 37 weeks’ gestation were randomly assigned to receive either remifentanil (n = 201) or pethidine (n = 199) during labor if they requested opioid pain relief. Patients in the remifentanil group controlled their own IV drip and could receive a 40-g bolus of remifentanil on demand every 2 minutes. Patients in the pethidine group were injected with 100 mg of pethidine every 4 hours for up to 400 mg in a 24-hour period.

    All participants were able to request an epidural at any time. If patients received an epidural, the other form of pain relief was discontinued.

    The allocated drug was received by 93% of participants in the remifentanil group and 77% of participants in the pethidine group.

    The researchers found that 19% of patients in the remifentanil group and 41% of those in the pethidine group had an epidural (RR = 0.48; 95% CI, 0.34–0.66).

    Women in the remifentanil group reported that their pain was less severe than those in the pethidine group. The need for forceps and vacuum during labor was less common among women receiving remifentanil than those receiving pethidine (15% vs. 26%).

    The incidence of low oxygen levels was twice as likely among women in the remifentanil group than the pethidine group (14% vs. 5%). Additionally, supplementary oxygen was given to more patients in the remifentanil group.

    No serious adverse events or drug reactions were observed in either group.

    “Our findings challenge the routine use of pethidine for pain relief during labor,” Wilson said in the release. “Remifentanil reduced the need for an epidural by half and there were no lasting problems for the mothers and babies in our trial, although the effect of remifentanil on maternal oxygen levels needs to be clarified in further studies.” – by Alaina Tedesco

    Disclosure: The authors report no relevant financial disclosures.

  • August 08, 2018 10:13 AM | Anonymous

    August 8, 2018, JAAPA 

    Adverse reactions to hormonal contraceptives are a common patient concern. Alopecia, an adverse reaction to androgen activity caused by the progestin component of hormonal contraceptives, can cause considerable psychosocial distress for women. This article discusses how to identify the level of androgen activity in certain progestins, how increased androgen activity can lead to hair loss, and alternatives for patients experiencing androgenic alopecia due to high androgen index contraceptives.

    Read more.

  • August 06, 2018 4:50 PM | Anonymous

    August 6, 2018, MultiBrief 

    About 1.5 million Americans are diagnosed with diabetes every year. In 2015, 30.3 million Americans, or 9.4 percent of the population, had diabetes. Approximately 1.25 million American children and adults have type 1 diabetes.

    Diabetes kills more Americans every year (2010: 69,201 deaths) than acquired immunodeficiency syndrome (21,601 deaths, 2009) and breast cancer (40,676 deaths, 2009) combined. Nearly half of American adults have diabetes or prediabetes.

    Diabetes increases the risk of heart disease (the most common diabetes complication) by about four times in women but only about two times in men, and women have worse outcomes after a heart attack. Women are also at higher risk of other diabetes-related complications such as blindness, kidney disease and depression.

    Diabetes is different among women as well. African American, Hispanic/Latina, American Indian/Alaska Native and Asian/Pacific Islander women are more likely to have diabetes than white women.

    Epidemiologic evidence suggests that people with diabetes are at significantly higher risk for many forms of cancer. In fact, diabetes and cancer often coexist in the same individuals. In a previous study, 8 percent to 18 percent of individuals suffering from cancer also had diabetes, and prevalence rates varied according to tumor sites.

    A recent global review involving almost 20 million people has shown that having diabetes significantly raises the risk of developing cancer, and for women the risk is even higher. According to Dr. Toshiaki Ohkuma, research fellow with The George Institute for Global Health, the link between diabetes and the risk of developing cancer is now firmly established.

    Ohkuma and researchers have also demonstrated for the first time that women with diabetes are more likely to develop any form of cancer and have a significantly higher chance of developing kidney, oral and stomach cancers, and leukemia.

    This review indicated that women with diabetes were 27 percent more likely to develop cancer than women without diabetes, and for men the risk was 19 percent higher. Diabetes was a risk factor for the majority of cancers of specific parts of the body for both men and women. Overall, women with diabetes were 6 percent more likely to develop any form of cancer than men with diabetes.

    There were significantly higher risks for women with diabetes for developing cancer of the kidney (11 percent higher), oral cancer (13 percent higher), stomach cancer (14 percent higher) and leukemia (15 percent higher) compared to men. For liver cancer, the risk was 12 percent lower for women with diabetes compared to men with diabetes. One explanation is that heightened blood glucose may have cancer-causing effects by leading to DNA damage.

    Dr. Sanne Peters of The George Institute for Global Health at the University of Oxford believes that there are several possible reasons why women were subject to an excess risk of cancer. Women are in the pre-diabetic state of impaired glucose tolerance two years longer than men.

    According to the researchers, the more gender-specific research indicates that women are not only undertreated, they have different risk factors for other diseases, including stroke, heart disease, as well as diabetes.

  • July 31, 2018 10:11 AM | Anonymous

    July 21, 2018, Medical News Today  

    The Food and Drug Administration announce the approval of the commercial version of the drug elagolix for the treatment of endometriosis pain. This is the first time in over a decade that an oral treatment specifically designed for endometriosis pain has been approved.

    Endometriosis is a condition affecting around 1 in 10 women in the United States, and around 200 million people worldwide.

    The condition is characterized by an abnormal growth of endometrium, which is the tissue that normally lines the inside of the uterus.

    This tissue growth causes pain in the pelvis, lower back, and abdomen. Other symptoms include heavy periods or bleeding in-between periods, extremely painful menstrual cramps, pain during intercourse, and infertility.

    There is currently no cure for the condition, but surgery is often recommended to remove the tissue, which relieves the symptoms for a while. Birth controlpills are often prescribed to slow down the growth of abnormal tissue, and nonsteroidal anti-inflammatory drugs such as ibuprofen help ease the pain.

    Now, the Food and Drug Administration (FDA) have approved a new drug to ease the pain of women living with moderate to severe endometriosis.

    Elagolix is "the first and only oral gonadotropin-releasing hormone [...] antagonist" designed specifically for endometriosis.

    The drug — which will be marketed at the beginning of August this year under the brand name Orilissa — is the first of its kind to have been approved by the FDA in more than a decade. 

    Drug relieves pain in largest clinical trial yet 

    The drug was approved based on the results of two studies that formed the largest phase 3 clinical trial program to have ever been conducted on endometriosis.

    In total, the studies examined the effects of elagolix on almost 1,700 women who had moderate to severe endometriosis pain.

    In the two studies, the women were administered either 150 milligrams of elagolix once daily or 200 milligrams twice daily.

    Compared with the women who received placebo, those who received the treatment reported a significant reduction in three types of pain: nonmenstrual pelvic pain, menstrual pelvic pain, and pain during intercourse.

    These results were noted at 3 months and 6 months from the beginning of the treatment.

    The FDA approved the following recommended dosage and duration of use: the drug can be taken for up to 24 months in a dosage of 150 milligrams per day, or up to 6 months if the dose is 200 milligrams twice per day.

    However, the clinical trials also revealed a range of side effects. The most common ones were hot flashes, night sweats, headache, nausea, trouble sleeping, anxiety, joint pain, depression, and mood swings.

    The biopharmaceutical company AbbVie funded the clinical trials. Dr. Michael Severino, the vice president of the company, comments on the FDA approval, saying that it "represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease."

    First study author Dr. Hugh S. Taylor — the chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale School of Medicine in New Haven, CT — also weighs in, saying, "Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities."

  • July 27, 2018 9:23 AM | Anonymous

    July 27, 2018, Endocrine Today 

    The FDA has approved the first oral gonadotropin-releasing hormone antagonist indicated for women with moderate to severe endometriosis pain, AbbVie and Neurocrine Biosciences announced in a press release.

    The approval of elagolix (Orilissa) represents the first oral therapy for the management of moderate to severe pain associated with endometriosis in more than a decade, according to the release. Elagolix is available in two oral dosages of 150 mg and 200 mg twice daily, taken with or without food.

    “Orilissa represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the release. “The approval of Orilissa demonstrates AbbVie’s continued commitment to address serious diseases and unmet needs.”

    As has previously reported, endometriosis affects 6% to 10% of women of reproductive age, according to the American College of Obstetricians and Gynecologists. By some estimates, endometriosis has direct costs of $12,118 per patient, per year in the United States. Endometriosis-associated pain is often managed with medicines such as oral contraceptives, NSAIDs, opioids and hormonal therapies. In more extensive cases, surgical interventions (eg, laparotomy, laparoscopy or hysterectomy) are often pursued and may not be curative for all individuals.

    “Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis,” Kevin Gorman, PhD, CEO of Neurocrine Biosciences, said in the release. “Neurocrine discovered Orilissa nearly 20 years ago, and through our partnership with AbbVie, the approval of Orilissa reflects our joint commitment to develop therapies for difficult to manage conditions in underserved patient populations.”

    In two phase 3 extension studies reported by Healio Family Medicineelagolix demonstrated a long-term sustained reduction in average monthly menstrual pelvic pain, nonmenstrual pelvic pain and painful intercourse in women with endometriosis, without compromising safety or tolerability.

    Researchers conducted two extension studies (Elaris EM-III and Elaris EM-IV) to determine whether two doses of elagolix — 150 mg once daily and 200 mg twice daily — are safe and effective long-term options for the management of endometriosis with associated pain. The studies assessed an additional 6 months of treatment each for a total of 12 months in women aged 18 to 49 years who were surgically diagnosed with endometriosis and had moderate to severe pain related to endometriosis at baseline.

    The researchers evaluated efficacy by calculating the reduction of participants’ average monthly menstrual pain and nonmenstrual pelvic pain scores, which were measured using the Daily Assessment of Endometriosis Pain scale. They assessed safety by evaluating adverse events and changes in bone mineral density.

    Researchers found that across both extension studies and for both elagolix doses, menstrual pain and nonmenstrual pelvic pain were reduced after 6 months of treatment and maintained during an additional 6 months. Participants receiving the 200-mg dose of elagolix reported more painful intercourse after 12 months than those receiving the 150-mg dose.

    Overall, 4% to 8% of participants experienced new incidences of hot flush. At month 12, there was a dose-dependent average decline from baseline in BMD (0.6% and 1.1% with 150 mg in EM-III and EM-IV, respectively; and 3.6% and 3.9% with 200 mg in EM-III and EM-IV, respectively).

    The recommended duration of use for elagolix is up to 24 months for the 150-mg once-daily dose and up to 6 months for the 200-mg twice-daily dose, as it causes a dose-dependent decrease in BMD, according to the release. BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment. For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to 6 months.

    Elagolix is expected to be available in U.S. retail pharmacies in early August, according to the companies. – by Regina Schaffer

  • July 27, 2018 9:20 AM | Anonymous

    July 26, 2018, Healio

    The pelvic examination did not increase the sensitivity or specificity of chlamydia, gonorrhea or trichomonas diagnoses in young female patients with suspected cervicitis or pelvic inflammatory disease, according to findings recently published in Annals of Emergency Medicine.

    “Physicians are taught that the pelvic exam is a crucial part of the evaluation of lower abdominopelvic pain in adolescent girls. When I began working in the emergency room I followed this medical mantra, until realizing the exam findings never seemed very specific. I pursued this topic to see if this part of the physical exam is really still necessary,” Cena Tejani, MDof the Children’s Hospital of New Jersey, told Healio Family Medicine.

    Other groups, including the American College of Gynecology, AAP and CDC, have also noted pelvic exams lack utility in asymptomatic women, according to researchers.

    Tejani and colleagues obtained medical history and urine samples from 288 female patients aged 14 to 20 years who presented to an ED with lower abdominal pain or vaginal discharge. Tests for chlamydia, gonorrhea and trichomonas were conducted.

    Researchers found that 79 had positive urine test results for chlamydia, gonorrhea or trichomonas, with an STD rate of 27.4% (95% CI, 22.6-32.8). The sensitivity of history with pelvic examination in diagnosis of cervicitis or pelvic inflammatory disease was 48.1% (95% CI, 36.8-59.5), and specificity was 60.7% (95% CI, 53.8-67.3). The sensitivity of history alone in diagnosis of cervicitis or pelvic inflammatory disease was 54.4% (95% CI, 42.8-65.5), and specificity was 59.8% (95% CI, 52.8-66.4).

    In discussing the results, Tejani offered alternatives to the pelvic exam that primary care physicians can use.

    “The use of a pelvic examination to diagnose cervicitis and pelvic inflammatory needs to be reconsidered. I suggest use of rapid urine [nucleic acid amplification testing]. These tests take 1 hour to run, so patients can wait in the office or emergency room for results. Primary care physicians should consider purchasing and using this test to make an accurate quick diagnosis.” – by Janel Miller

    Disclosures:  The authors report no relevant financial disclosures.

  • July 19, 2018 10:06 AM | Anonymous


    Tuesday, August 28, 2018
    5PM PT/7PM CT/8PM ET 

    Registration - Link

    • APAOG Member - $0.00
    • Non-Member – $50.00

    APAOG Members, be sure you are logged in to see the member rate.

    Title: Women's Sexual Health

    Speaker: Alyse Kelly-Jones, MD


    •  Dr. Jones will discuss women's sexual health as it relates to PA's practice in OB/GYN.
    • Additional objectives coming soon!

  • July 19, 2018 9:45 AM | Anonymous

    July 19, 2018, Monthly Prescribing Reference  

    The Food and Drug Administration (FDA) has approved Kisqali (ribociclib; Novartis) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Previously, this CDK4/6 inhibitor was approved for use with an AI to treat HR-positive, HER2-negative breast cancer in postmenopausal women with advanced or metastatic breast cancer.

    In addition, Kisqali has also been approved in combination with fulvestrant to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

      The approval for Kisqali + an AI in pre/perimenopausal women was based on a double-blind, placebo-controlled study (MONALEESA-7) involving 495 patients who received Kisqali + a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen or placebo + NSAI or tamoxifen; all patients received ovarian suppression with goserelin. The primary endpoint of the study was progression-free survival (PFS). Compared with placebo, treatment with Kisqali was associated with longer PFS (median PFS: 27.5 months vs 13.8 months; hazard ratio [HR] 0.569; 95% CI, 0.436-0.743).

      The combination of Kisqali + fulvestrant was evaluated in a double-blind, placebo-controlled trial (MONALEESA-3) involving 726 postmenopausal women that also measured PFS as the primary endpoint. Compared with the placebo + fulvestrant arm, patients receiving Kisqali + fulvestrant had longer PFS (median PFS: 20.5 months vs 12.8 months; HR 0.593; 95% CI 0.480-0.732; <.0001).

      In a press statement, the FDA noted that the Kisqali approvals were the first to be granted as part of 2 new pilot programs (Real-Time Oncology ReviewAssessment Aid) created to improve the development and review of cancer drugs. “With today's approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor's analysis of the top-line data to tease out the most relevant information,” said FDA Commissioner Scott Gottlieb, MD, “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”

      Kisqali is supplied as a 200mg tablet in 14- and 21-count blister packs.

      For more information visit

    • July 10, 2018 10:55 AM | Anonymous

      July 10, 2018, Physician's Briefing/HealthDay News 

      Women enrolled in Medicare who undergo screening mammography seem to have increased awareness and use of other preventive screening measures, according to a study published online June 5 in Radiology.

      Stella K. Kang, M.D., from New York University in New York City, and colleagues used Medicare claims (2010 to 2014) to retrospectively assess whether there is an association between use of screening mammography and use of a variety of other preventive services in female Medicare enrollees.

      Of 555,705 patients, 33.4 percent underwent mammography. The researchers found that women who underwent index screening mammography were more likely than unscreened women to later undergo Papanicolaou test (odds ratio, 1.49), bone mass measurement (odds ratio, 1.70), and influenza vaccine (odds ratio, 1.45), when adjusting for patient demographics, comorbidities, geographic covariates, and baseline preventive care. Among women who had not used these preventive services in the two years before the index mammography, use of these preventive services was similar regardless of false-positive mammography findings or true-negative findings.

      "In beneficiaries of U.S. Medicare, use of screening mammography was associated with higher likelihood of adherence to other preventive guidelines, without a negative association between false-positive results and cervical cancer screening," the authors write.

      Abstract/Full Text (subscription or payment may be required)
    • July 09, 2018 10:08 AM | Anonymous

      Medical News Today

      The merits of vitamin D when it comes to cancer prevention have long been at the heart of medical debates.

      Where some studies have revealed that overall cancer risk is lower in people with higher levels of this vitaminothers have suggested that vitamin D has no impact on a person's vulnerability to the disease.

      Still, the case for ensuring that you get enough vitamin D is fairly strong, as low blood levels of this nutrient have been associated with a raised risk of bladder cancer and, in a study that was published earlier this year, an elevated risk of bowel cancer.

      Previous research has also suggested a link between high vitamin D levels and better survival rates in people going through breast cancer treatment.

      In a pooled analysis of a prospective cohort study and two randomized clinical trials, researchers at the University of California, San Diego School of Medicine in have now investigated whether and to what extent high levels of vitamin D in the blood were associated with a lower risk of developing breast cancer.

      Their analysis — which was conducted in collaboration with specialists from Creighton University in Omaha, NE, the Medical University of South Carolina in Columbia, and the nonprofit organization GrassrootsHealth in Encinitas, CA — suggests that certain levels of vitamin D correlate with a "markedly lower" risk of breast cancer.

      These results are now published in the journal PLOS ONE

      Read more. 

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