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Chemnitz, Germany

Schweizer J.,Chemnitz Hospital | Ulmer H.-J.,Practice for Internal Medicine | Benduhn H.,Practice for Internal Medicine | Klebs S.,Novartis
Current Medical Research and Opinion | Year: 2011

Aims: The majority of patients with essential hypertension of moderate severity (WHO grade 2) require combination therapy. We aimed to investigate whether the single-pill combination of aliskiren 300mg and hydrochlorothiazide (HCT) 25mg (ALIS 300/HCT 25) improves the BP reduction in hypertensive patients not adequately controlled by the free combination of candesartan 32mg and HCT 25mg (CAN 32HCT 25). Methods: In an open-label, single-arm study, patients with mean sitting diastolic blood pressure (DBP) between 100109mmHg at baseline received 4-week treatment with CAN 32HCT 25 (Phase 1), followed in patients whose BP was not controlled by 4-week treatment with ALIS 300/HCT 25 (Phase 2). The DBP change between weeks 4 and 8 was the primary endpoint. The ClinicalTrials.gov Identifier is NCT00867490. Results: In the 186 patients treated, CAN 32HCT 25 reduced systolic BP (SBP)/DBP by 18.9/12.2mmHg. Those 123 patients with uncontrolled hypertension switched to ALIS 300/HCT 25 experienced a further SBP/DBP reduction of 2.8/3.1mmHg between week 4 and week 8 (p0.0064 and p<0.0001), and 33.3 achieved DBP normalisation. In 61 patients not controlled after week 8 (SBP140mmHg or DBP90mmHg), who participated in an optional study extension, amlodipine 5mg was added. Triple therapy over 4 weeks decreased SBP/DBP by further 9.2/5.9mmHg (p<0.0001 each). Adverse events with suspected drug relationship were noted in 4.3 (Phase 1), 3.3 (Phase 2), and 1.6 (extension) of the patients. Limitations of the study include the open-label, non-randomised approach and short treatment duration across the individual phases. Conclusions: In this open-label, single-arm switch study reflecting clinical practice, patients with moderate hypertension not controlled by the free combination of CAN 32HCT 25 achieved a clinically and statistically significant reduction of blood pressure from the single pill combination of ALIS 300/HCT 25, and the optional addition of amlodipine. © 2011 Informa UK Ltd.

Thiele O.C.,Maxillofacial and Facial Plastic Surgery | Kreppel M.,University of Cologne | Bittermann G.,Albert Ludwigs University of Freiburg | Bonitz L.,Witten/Herdecke University | And 56 more authors.
Journal of Cranio-Maxillofacial Surgery | Year: 2016

Orthognathic surgery has always been a classical focus of maxillofacial surgery. Since more than 100 years, various surgical techniques for mandibular repositioning have been developed and clinically tested. Since the establishment of plate and screw osteosynthesis, orthognathic surgery became more stable and safe. Nowadays, different surgical methods for mobilising the mandible are existing. This international multicenter analysis (n = 51 hospitals) is providing first evidence based data for the current use of different surgical methods. The dominating techniques were Obwegeser/dal Pont (61%) followed by Hunsuck/Epker (37%) and Perthes/Schlössmann (29%). The main osteosynthesis materials were plates (82%), bicortical screws (23.5%), or a combination of both (5.9%). 47% of all centers reported to use several surgical methods at the same time, depending on the anatomical problem and the surgeon's preference. This shows that different surgical methods seem to work as comparable, safe, and reliable procedures in everydays clinical practise. On this basis, further prospective studies could evaluate possible advantages for our patients. © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

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