PMID- 28988251
OWN - NLM
STAT- MEDLINE
DCOM- 20180530
LR  - 20181113
IS  - 0975-4466 (Electronic)
IS  - 0256-4947 (Print)
IS  - 0256-4947 (Linking)
VI  - 37
IP  - 5
DP  - 2017 Sep-Oct
TI  - Efficacy and safety of a generic rosuvastatin in a real-world setting: 
      prospective, observational clinical study in Lebanese patients.
PG  - 366-374
LID - 10.5144/0256-4947.2017.366 [doi]
AB  - BACKGROUND: No published studies have assessed the efficacy and safety of 
      rosuvastatin generics. OBJECTIVES: Primary objective to assess the safety and 
      efficacy of a generic rosuvastatin in reducing plasma low-density-lipoprotein 
      cholesterol (LDL-C) in Lebanese dyslipidemic patients. Changes in high-density 
      lipoprotein cholesterol, triglycerides and adverse effects were secondary 
      objectives. DESIGN: Prospective, observational, non-comparative. SETTING: 
      Multiple outpatient clinics in Lebanon. PATIENTS AND METHODS: Dyslipidemic 
      patients requiring statin therapy were followed for 2 months after prescription 
      of a generic rosuvastatin at the physician's discretion. Efficacy and safety 
      measurements were collected from medical records. MAIN OUTCOME MEASURES: Efficacy 
      was assessed based on the evaluation of mean and percent change in LDL-C between 
      baseline and week 8 as well as the proportion of patients reaching target LDL-C 
      levels. Safety was assessed based on the evaluation of the incidence of adverse 
      events (AEs) during the study period. RESULTS: Two months after initiation of 
      generic rosuvastatin, LDL-C levels in the 313 eligible patients who completed the 
      study significantly decreased from 4.3 (0.8) mmol/L (168.2 [31.3] mg/dL) at 
      baseline to 2.7 (0.7) mmol/L (105.9 [25.5] mg/dL) (P < .001). The mean percent 
      change in LDL-C level was highest in subjects receiving generic rosuvastatin at a 
      dose of 40 mg/day (-47.4%), followed by 20 mg/day (-36.8%), and 10 mg/ day 
      (-31.4%); 82.5% of patients reached the target LDL-C level as set by their 
      physician at baseline. Thirteen patients (4%) reported six AEs during treatment: 
      abdominal pain, headache, stomach ache, insomnia, musculoskeletal pain/myalgia 
      and nausea. No clinically significant changes in serum creatinine, serum creatine 
      kinase, or liver function tests were reported. One patient withdrew because of an 
      adverse event. CONCLUSIONS: Generic rosuvastatin was efficacious and safe in 
      reducing LDL-C levels and helping the majority of patients achieve LDL-C targets 
      after a short treatment period. LIMITATIONS: The observational nature, and a 
      control group, and the relatively short duration of follow-up limit the 
      generalizability of results. The authors received fees for study activities at 
      patient visits from an independent clinical research organization subcontracted 
      by the sponsor.
FAU - Betto, Mohamad
AU  - Betto M
AD  - Correspondence: Dr. Mohamad Betto Department of Cardiology,, Makassed General 
      Hospital, Malaab Sector, Beirut 961, Lebanon mohamadbetto2017@gmail.com ORCID: 
      http://orcid.org/0000-0002-5892-8085.
FAU - Fares, Jocelyne
AU  - Fares J
FAU - Saliba, Nada
AU  - Saliba N
FAU - Ballout, Hajar
AU  - Ballout H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - Saudi Arabia
TA  - Ann Saudi Med
JT  - Annals of Saudi medicine
JID - 8507355
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Drugs, Generic)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Triglycerides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cholesterol, HDL/blood
MH  - Cholesterol, LDL/blood
MH  - Drugs, Generic/*administration & dosage/adverse effects
MH  - Dyslipidemias/*drug therapy
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage/adverse 
      effects
MH  - Lebanon
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Rosuvastatin Calcium/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Triglycerides/blood
PMC - PMC6074194
COIS- Statement of conflict of interest The generic formula, Superstat (Resova in Saudi 
      Arabia) was not supplied by the manufacturer and sponsor, Hikma Pharmaceuticals. 
      None of the authors or participating centers had any contractual agreement with 
      the pharmaceutical company. The authors received investigator fees from the 
      sponsor of this study but the company had no role in data collection, analysis, 
      and interpretation, nor in the preparation of the manuscript. The sponsor 
      contracted with an independent clinical research organization (CRO) (Clinserv 
      international, Beirut, Lebanon) to conduct the study, collect and analyze the 
      data, and prepare the manuscript on its behalf. The contractual agreement was 
      between the sponsor and the CRO. The authors were not part of this agreement. 
      Authors and investigators have signed the investigator protocol endorsement page 
      in the study protocol. The signed principle investigator agreements were between 
      the CRO and the authors directly.
EDAT- 2017/10/11 06:00
MHDA- 2018/05/31 06:00
PMCR- 2017/09/01
CRDT- 2017/10/09 06:00
PHST- 2017/10/09 06:00 [entrez]
PHST- 2017/10/11 06:00 [pubmed]
PHST- 2018/05/31 06:00 [medline]
PHST- 2017/09/01 00:00 [pmc-release]
AID - asm-5-366 [pii]
AID - 10.5144/0256-4947.2017.366 [doi]
PST - ppublish
SO  - Ann Saudi Med. 2017 Sep-Oct;37(5):366-374. doi: 10.5144/0256-4947.2017.366.