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Purpose: This randomized, open, controlled, multicenter study (110886/NCT00578227) evaluated human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (HPV-16/18 vaccine) coadministered with inactivated hepatitis A and B (HAB) vaccine. Coprimary objectives were to demonstrate noninferiority of hepatitis A, hepatitis B, and HPV-16/18 immune responses at month 7 when vaccines were coadministered, compared with the same vaccines administered alone. Methods: Healthy girls (9-15 years) were age-stratified (9, 10-12, and 13-15 years) and randomized to receive HPV (n = 270), HAB (n = 271), or HPV + HAB (n = 272). Vaccines were administered at months 0, 1, and 6. Immunogenicity was evaluated at months 0 and 7. Results: The hepatitis A immune response was noninferior for HPV + HAB, versus HAB, for seroconversion rates (100% in each group) and geometric mean antibody titers (GMTs) (95% CI) (4,504.2 [3,993.0-5,080.8] and 5,288.4 [4,713.3-5,933.7] mIU/mL, respectively). The hepatitis B immune response was noninferior for HPV + HAB, versus HAB, for anti-HBs seroprotection rates (98.3% and 100%); GMTs were 3,136.5 [2,436.0-4,038.4] and 5,646.5 [4,481.3-7,114.6] mIU/mL, respectively. The HPV-16/18 immune response was noninferior for HPV + HAB, versus HPV, for seroconversion rates (99.6% and 100% for both antigens) and GMTs (22,993.5 [20,093.4-26,312.0] and 26,981.9 [23,909.5-30,449.1] EL.U/mL for HPV-16; 8,671.2 [7,651.7-9,826.6] and 11,182.7 [9,924.8-12,600.1] EL.U/mL for HPV-18, respectively). No subject withdrew because of adverse events. No vaccine-related serious adverse events were reported. Immune responses and reactogenicity were similar in girls aged 9 years compared with the entire study population. Conclusions: Results support coadministration of HPV-16/18 vaccine with HAB vaccine in girls aged 9-15 years. The HPV-16/18 vaccine was immunogenic and generally well tolerated in 9-year-old girls.

Sibutramine is the first of a new generation of weight management drugs, and offers long-term control of weight when used as an adjunct to diet and exercise. This paper considers the criteria set down by the European Union's regulatory agency for its use and how this relates to the information now available on its efficacy, side-effect profile and benefits in different patient groups. The data presented relate to 18-65y olds; its use in other age groups has not been established. The EU licence permits continuous treatment for periods of up to 1y; the STORM study has now led the US Food and Drug Administration to extend clearance to 2y. The addition of sibutramine to a regimen of diet, exercise and lifestyle modification results in 3-5 times more patients responding to a weight-reduction programme, ie achieving more than 5% weight maintenance. Sibutramine is indicated for use in obese patients (BMI > 30 kg/m2) and also overweight patients with a BMI > 27 kg/m2 who have additional obesity-related risk factors such as type 2 diabetes or dyslipidaemia.

Sibutramine is the first of a new generation of weight management drugs, and offers long-term control of weight when used as an adjunct to diet and exercise. This paper considers the criteria set down by the European Union's regulatory agency for its use and how this relates to the information now available on its efficacy, side-effect profile and benefits in different patient groups. The data presented relate to 18-65y olds; its use in other age groups has not been established. The EU licence permits continuous treatment for periods of up to 1y; the STORM study has now led the US Food and Drug Administration to extend clearance to 2y. The addition of sibutramine to a regimen of diet, exercise and lifestyle modification results in 3-5 times more patients responding to a weight-reduction programme, ie achieving more than 5% weight maintenance. Sibutramine is indicated for use in obese patients (BMI > 30 kg/m2) and also overweight patients with a BMI > 27 kg/m2 who have additional obesity-related risk factors such as type 2 diabetes or dyslipidaemia.