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Astrup A.,Copenhagen University | Carraro R.,University Hospital la Princesa | Finer N.,University College London | Harper A.,Novo Nordisk AS | And 8 more authors.
International Journal of Obesity | Year: 2012

Objective: Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.Design:A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/ investigators at 1 year) in 19 European clinical research centers.Subjects:A total of 564 adults (n90-98 per group; body mass index 30-40 kg m2) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg, n90-95), placebo (n98) or open-label orlistat (120 mg × 3, n95). After 1 year, liraglutide/placebo recipients switched to liraglutide 2.4 mg, then 3.0 mg (based on 20-week and 1-year results, respectively). The trial ran from January 2007-April 2009 and is registered with Clinicaltrials.gov, number NCT00480909. Results: From randomization to year 1, liraglutide 3.0 mg recipients lost 5.8 kg (95% confidence interval 3.7-8.0) more weight than those on placebo and 3.8 kg (1.6-6.0) more than those on orlistat (P=0.0001; intention-to-treat, last-observation-carried-forward). At year 2, participants on liraglutide 2.4/3.0 mg for the full 2 years (pooled group, n184) lost 3.0 kg (1.3-4.7) more weight than those on orlistat (n95; P=0.001). Completers on liraglutide 2.4/3.0 mg (n92) maintained a 2-year weight loss of 7.8 kg from screening. With liraglutide 3.0 mg, 20-week body fat decreased by 15.4% and lean tissue by 2.0%. The most frequent drug-related side effects were mild to moderate, transient nausea and vomiting. With liraglutide 2.4/3.0 mg, the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59%, with improvements in blood pressure and lipids.Conclusion:Liraglutide is well tolerated, sustains weight loss over 2 years and improves cardiovascular risk factors. © 2012 Macmillan Publishers Limited All rights reserved.

Kiljander T.,Terveystalo Hospital | Helin T.,University of Helsinki | Venho K.,Central Hospital of Central Finland | Jaakkola A.,Boehringer Ingelheim | Lehtimaki L.,University of Tampere
npj Primary Care Respiratory Medicine | Year: 2015

Background: The overlap between asthma and chronic obstructive pulmonary disease (COPD) is an important clinical phenomenon. However, the prevalence of asthma-COPD overlap syndrome (ACOS) is not known. Aims: To investigate the prevalence of ACOS among asthmatic patients with a smoking history, and evaluate the factors predicting ACOS in this patient group. Methods: We investigated 190 primary care asthma patients with no previous diagnosis of COPD, but who were either current or ex-smokers, with a smoking history of at least 10 pack-years. Spirometry was performed on all the patients while they were taking their normal asthma medication. Patients were considered to have ACOS if their postbronchodilator forced expiratory volume in 1 s/forced vital capacity was <0.70.Results:Fifty-two (27.4%) of the patients were found to have ACOS. Age ≥ 3/460 years and smoking for ≥ 3/420 pack-years were the best predictors of ACOS. If both of these criteria were met, the odds ratio (95% confidence interval) for ACOS was 6.08 (2.11-17.49), compared with the situation where neither of these criteria were fulfilled. Conclusions: There is a high prevalence of ACOS among primary health care asthmatics with a positive smoking history but no previous diagnosis of COPD. In this population, age over 60 years and a smoking history of more than 20 pack-years were the best predictors of ACOS. © 2015 Primary Care Respiratory Society UK/Macmillan Publishers Limited.

Axelin A.,University of Turku | Kirjavainen J.,Central Hospital of Central Finland | Salantera S.,University of Turku | Lehtonen L.,University of Turku
European Journal of Pain | Year: 2010

Background: This study was conducted to gain better understanding of the prolonged effects of pain and pain management on preterm infants' sleep. Aim: The hypothesis was that the sleep structure in very preterm infants is different after painful procedures with pain management (facilitated tucking by parents (FTP), oral glucose, and oxycodone) than without pain management (oral water as placebo). Methods: A prospective randomized placebo-controlled cross-over trial design was used. Thirteen-hour polysomnographic recordings were conducted when the study infants (n = 18) were at a post-conceptional age of 28-32 weeks. During the recordings, the standardized nursing care periods were carried out with different forms of pain management administered at 3-h intervals. Sleep structure was analyzed before and after the interventions. The main hypothesis was analyzed using mixed models. Results: During the first post-intervention hour, the amount of rapid eye movement (REM) sleep decreased after all interventions regardless of pain management (p < 0.001). However, the oxycodone treatment further reduced the amount of REM sleep to 48.0% (SD 14.9) compared to other interventions: oral glucose to 64.4% (SD 12.8), (p < 0.001); placebo to 62.9% (SD 16.1), (p < 0.001); and FTP to 61.6% (SD 1.9), (p = 0.004). In addition, sleep onset comprised non-rapid eye movement (NREM) sleep more frequently after oxycodone (50%) compared to placebo (6%, p = 0.006), oral glucose (11%, p = 0.019) or FTP (17%, p = 0.056). Conclusion: Pain management with oxycodone markedly altered the structure of the subsequent sleep period. This reduced amount of REM sleep may have consequences for brain development in preterm infants. © 2009 European Federation of International Association for the Study of Pain Chapters. Published by Elsevier Ltd. All rights reserved.

Nieminen K.,University of Tampere | Hiltunen R.,Central Hospital of South Ostrobothnia | Takala T.,Central Hospital of Pijt Hme | Heiskanen E.,Central Hospital of Central Finland | And 3 more authors.
American Journal of Obstetrics and Gynecology | Year: 2010

Objective: The objective of the study was to compare anterior colporrhaphy with and without a mesh. Study Design: Two hundred two women with anterior prolapse were assigned to undergo colporrhaphy alone or reinforced with a tailored polypropylene mesh. Before and 2, 12, 24, and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of anterior vaginal prolapse. Secondary outcomes were symptom resolution, reoperation, and mesh exposure. Results: Recurrences of anterior vaginal prolapse were noted in 40 of the 97 (41%) in the colporrhaphy group and 14 of 105 (13%) in the mesh group (P < .0001). The number needed to treat was thus 4. The proportion of symptomatic patients, including those with dyspareunia, did not differ between the groups. The mesh erosion rate was 19%. Conclusion: At 3 year follow-up, anterior colporrhaphy with mesh reinforcement significantly reduced anatomic recurrences of anterior vaginal prolapse, but no difference in symptomatic recurrence were noted and the mesh erosion rate was high. The use of mesh was not associated with an increase in dyspareunia. © 2010 Mosby, Inc. All rights reserved.

Ylinen J.,Central Hospital of Central Finland | Nikander R.,UKK Institute for Health Promotion Research | Nykanen M.,Kruunupuisto Punkaharju Rehabilitation Center | Kautiainen H.,Unit of Family Practice | Hakkinen A.,University of Jyvaskyla
Journal of Rehabilitation Medicine | Year: 2010

Objective: To compare the efficacy of three 12-month training programmes on headache and upper extremity pain in patients with chronic neck pain. Methods: A total of 180 female office workers, with chronic, non-specific neck pain were randomly assigned to 3 groups. The strength group performed isometric, dynamic and stretching exercises. The endurance group performed dynamic muscle and stretching exercises. The control group performed stretching exercises. Pain was assessed with a visual analogue scale. Each group was divided into 3 subgroups according to headache intensity. Results: At the 12-month follow-up headache had decreased by 69% in the strength group, 58% in the endurance group and 37% in the control group compared with baseline. Neck pain diminished most in the strength group with the most severe headache (p<0.001). In the dose analysis, one metabolic equivalent per hour of training per week accounted for a 0.6mm decrease in headache on the visual analogue scale. Upper extremity pain decreased by 58% in the strength group, 70% in the endurance group and 21% in the control group. Conclusion: All of the training methods decreased headache. However, stretching, which is often recommended for patients, was less effective alone than when combined with muscle endurance and strength training. Care must be taken in recommending the type of training to be undertaken by patients with severe cervicogenic headache. © 2010 Foundation of Rehabilitation Information.

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