Comparison of 26-week efficacy and tolerability of telmisartan and atenolol, in combination with hydrochlorothiazide as required, in the treatment of mild to moderate hypertension: a randomized, multicenter study

OBJECTIVE: This study was undertaken to compare the efficacy and tolerability of telmisartan, a novel antihypertensive agent, and atenolol, a well-established beta-blocker, in the treatment of mild to moderate hypertension. METHODS: This 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group, titration-to-response study compared doses of telmisartan (40 mg titrated to 80 mg titrated to 120 mg) with atenolol (50 mg titrated to 100 mg) required to achieve diastolic blood pressure (DBP) control (< or = 90 mm Hg or a decrease from baseline of > or = 10 mm Hg). Open-label hydrochlorothiazide (HCTZ) 12.5 or 25 mg was added if needed according to a prespecified titration rule. Men and women aged > 18 years with mild to moderate hypertension (morning mean supine DBP [SDBP] > or = 95 mm Hg and < or = 114 mm Hg) were eligible to participate. Patients with significant cardiovascular, metabolic, hepatic, or renal dysfunction or chronic obstructive pulmonary disease were excluded. The primary efficacy end point was trough SDBP response at 26 weeks; secondary efficacy end points included changes from baseline at trough in both standing and supine DBP and systolic blood pressure (SBP), and heart rate after 4, 8, 16, and 26 weeks; SBP control (reduction from baseline of > or = 10 mm Hg); normalization of supine SDBP to < or = 90 mm Hg; and the need for add-on HCTZ. Changes in quality of life were also examined. Adverse events were obtained from spontaneous reporting and recorded. Serious adverse events were reported to the sponsor according to predefined timelines. RESULTS: A total of 533 patients from 49 centers participated. Patients' mean age was 57.9 years (range, 22-79 years); 55.9% (298/533) of the population was male and 98.1% (523/533) was white. Of the 533 patients randomly assigned to treatment and included in the safety analysis, 520 (97.6%) were included in the efficacy analysis; 346 received telmisartan and 174 received atenolol. A total of 489 patients (91.7%) completed the study (325 [93.9%], telmisartan; 164 [94.2%], atenolol). Full SDBP response (trough SDBP < or = 90 mm Hg and/or a reduction from baseline of > or = 10 mm Hg) was observed in 84% and 78% of telmisartan- and atenolol-treated patients, respectively; this difference was not statistically significant. Final SBP/DBP reductions of 20.9/14.4 mm Hg were observed for the telmisartan regimen versus 16.7/13.3 mm Hg for the atenolol regimen; only the difference in SBP was significant (P = 0.005). Reduction from baseline in SBP of > or = 10 mm Hg was achieved by 80% of telmisartan-treated and 68% of atenolol-treated patients (P = 0.003). Adverse events were reported by 52.7% of patients given telmisartan and 61.2% of patients given atenolol; this difference was not statistically significant. Most events were mild or moderate. Although fatigue and male impotence were more common in atenolol-treated patients (3.4% and 4.0%, respectively), the incidence of these adverse events was too low to differentiate statistically. CONCLUSIONS: Telmisartan appears to be at least as effective as atenolol in the treatment of mild to moderate hypertension and may be better tolerated.     

Risk factors of recurrent choledocholithiasis following therapeutic endoscopic retrograde cholangiopancreatography

Background: The risk factors for the recurrent choledocholithiasis after endoscopic retrograde cholangiopancreatography(ERCP) have not been well studied. The aim of this study was to explore the risk factors of recurrent choledocholithiasis. Methods: We carried out a retrospective analysis of data collected between January 1, 2010 and January 1, 2020. Univariate analysis and multivariate analysis were used to explore the independent risk factors of recurrent choledocholithiasis following therape...     

Einmal geimpft,immer geimpft? Routinedatenanalyse zur wiederholten Influenzaimpfung von ≥ 60-Jährigen

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Die Ständige Impfkommission empfiehlt eine jährliche Influenzaimpfung als Standardimpfung für...     

How to improve infraorbital hollows with neuromodulators–A clinical prospective interventional study about the application of facial biomechanics

Background

A previous injection algorithm termed the “Toxin Lift” was recently introduced and described volume increases in the midface following neuromodulator treatments of the jawline. Increase in midfacial volume due to soft tissue repositioning could also affect the severity of infraorbital hollows.

Objective

The objective is therefore to evaluate whether the severity of infraorbital hollows can be improved by injecting neuromodulators in the supra-mandibular segment of the platysma.

Materials and Methods

A total of 35 volunteers (11 males/24 females) with a mean age of 39.8 (9.6) years and a mean BMI of 25.2 (5.2) kg/m² were investigated. Bilateral infraorbital regions were evaluated via clinical assessment and semi-quantitative 3D imaging. The applied injection technique targeted the platysma via four injection points administering 5 I.U. per injection point resulting in a total of 20 I.U. per facial side.

Results

Volume increase of the infraorbital region was 0.13 cc at 15 days (p = 0.001) and was 0.02 cc at 30 days (p = 0.452) whereas the skin displacement in cranial direction was 0.54 mm at 15 days (p < 0.001) and was 0.31 mm at 30 days (p < 0.001). Clinical evaluation revealed a highly statistically significant improvement of the tear trough, palpaebromalar groove, and of the lid-cheek junction when compared to baseline with all p < 0.001.

Conclusion

The results of this clinical prospective interventional analysis revealed that the “Toxin Lift” injection technique is capable to improve the clinical appearance of infraorbital hollows. The effects can be explained by the concepts of facial biomechanics.     

Safety considerations for treating the parotid and submandibular glands with neuromodulators for facial slimming

Background

Neuromodulators have predominantly been used for the treatment of upper facial lines, but their use has expanded to include lower face and neck treatments. However, the injection sites for these treatments are based on skin surface landmarks, which may pose risks to nearby structures and result in undesired outcomes.

Objective

To investigate the spatial relationship between the FDA-approved skin surface landmarks for neuromodulator injections in the parotid and submandibular glands and the topographical anatomy of critical facial structures such as the facial artery, facial vein, external carotid artery, and retromandibular vein.

Materials and methods

A cross-sectional retrospective analysis was conducted on contrast-enhanced cranial CT scans. The scans were analyzed for the morphology and location of the parotid and submandibular glands. Measurements were taken for gland volume, craniocaudal extent, anterior–posterior extent, and distances between the skin surface and gland capsule or nearby structures such as arteries.

Results

The study sample consisted of 53 subjects, including 7 males and 46 females, with a mean age of 36.91 years and a mean BMI of 23.28 kg/m². The mean volume of the parotid gland was 31.9 ± 3.0 cc in males and 28.5 ± 3.6 cc in females with p < 0.001, while the mean volume of the submandibular gland was 18.2 ± 2.0 cc in males and 14.5 ± 3.4 cc in females with p < 0.001. The mean distances between skin surface and the gland capsule were 5.98 ± 2.2 and 8.84 ± 4.0 mm for the parotid and submandibular gland, respectively. This distance increased with higher age and higher BMI values in a statistically significant manner with p < 0.001.

Conclusion

The distances between FDA-approved skin surface landmarks and the parotid and submandibular glands varied significantly depending on gender, age, and BMI. Optimal injection depth and location for neuromodulator treatments cannot be generalized based on these landmarks alone, emphasizing the need for real-time ultrasound imaging guidance.