Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin.
Objective: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. Methods: In this double-blind, multicenter, randomized, phase III study (VERTIS SU; NCT01999218), adults with T2DM and glycated hemoglobin (HbA1c) 7.0-9.0% on metformin ≥1500 mg/day received ertugliflozin 5 mg or 15 mg, or glimepiride. The primary efficacy time point was Week 52; double-blinded treatment continued until Week 104. ⋯ Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively. The incidence of urinary tract infection and hypovolemia AEs was similar across groups. Conclusions: Ertugliflozin was well tolerated and provided clinically meaningful glycemic control and durable reductions in body weight and SBP over 104 weeks.
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Objective: Baloxavir marboxil (baloxavir) is the first cap-dependent endonuclease inhibitor being studied for the treatment of influenza in single oral dosing regimen. This network meta-analysis (NMA) evaluated the efficacy and safety of baloxavir compared to other antivirals for influenza in otherwise healthy patients. Methods: A systematic literature review was performed on 14 November 2016 in Medline, Embase, CENTRAL, and ICHUSHI to identify randomized controlled trials assessing antivirals for influenza. ⋯ No significant differences were found between baloxavir and the other antivirals for safety, except total drug-related adverse events where baloxavir demonstrated a decrease compared to oseltamivir and laninamivir. Conclusions: The NMA suggests that baloxavir demonstrated better or similar efficacy results compared to other antivirals with a comparable safety profile. Baloxavir led to a significant decrease in viral titer versus zanamivir, oseltamivir and peramivir and decreased viral shedding versus zanamivir and oseltamivir.
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Multicenter Study Observational Study
China STudy of valsartan/amlodipine fixed-dose combination-bAsed long-Term blood pressUre management in HypertenSive patients: a one-year registry (China STATUS III).
Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC) in a real-world setting in China (Chinese Clinical Trial Registry number ChiCTR1900021324). Methods: This was a prospective, observational, multicenter, real-world registry study wherein patients with hypertension who had already received Val/Aml SPC (80/5 mg) for at least 4 weeks before study enrollment were observed for 1 year. Investigators recorded patient data every 3 months and essentially five times during the 1 year follow-up period. ⋯ AEs were reported in 23.3% of patients. The majority of AEs were mild to moderate, and 0.6% of patients discontinued Val/Aml SPC because of SAEs. Conclusion: This study provides evidence that Val/Aml SPC effectively reduced BP over the long term among Chinese hypertensive patients, with a good adherence and tolerability profile, and that most hypertensive patients may benefit from this combination.
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Objective: To investigate the coexistence effect of hypertension and angiotensin II on the risk of coronary heart disease based on a prospective study in an Inner Mongolian population of China. Methods: The participants were categorized into four subgroups according to hypertension status and median of angiotensin II level. Incident coronary heart disease (CHD) was defined as study outcome. ⋯ Furthermore, compared to normotensives with angiotensin II ≤49 pg/mL, the multivariate-adjusted HRs (95% CIs) of CHD for normotensives with angiotensin II >49 pg/mL, hypertensives with angiotensin II ≤49 pg/mL and hypertensives with angiotensin II >49 pg/mL were 1.33 (0.60-2.91), 2.35 (1.16-4.76) and 3.00 (1.52-5.92), respectively (p for trend <.05). The hypertensives with angiotensin II >49 pg/mL were at the highest risk of CHD. Conclusions: Hypertension not angiotensin II was an independent risk factor for incident CHD, but the coexistence of both hypertension and high angiotensin II level further increased risk of incident CHD among the Inner Mongolians.
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Background: The varicella zoster virus (VZV) can reactivate later in life as herpes zoster infection (HZI), a severe disease resulting in painful complications such as post-herpetic neuralgia (PHN). The herpes zoster (HZ) vaccine has been indicated for use among adults 50 years and older for prevention of HZI. Currently, no clinical practice guideline or funding exists specifically for HZ immunization in long-term care facilities (LTCF) for adults age >60 years. ⋯ All reviewed studies highlighted the efficacy of the HZ vaccine for the LTCF population. Conclusions: The studies reviewed showed the efficacy of the HZ vaccine in relevant elderly populations residing either in LTCF or in the community including those of advanced age with multiple comorbidities. Consideration can be given to the use of the HZ vaccine for individuals over 60 in LTCF, as well as in the community.